記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Immediate breast reconstruction (IBR) is a common oncoplastic procedure used in breast cancer surgery. This study aims to investigate compliance with prosthetic breast reconstruction guidelines and its impact on perioperative treatment. METHODS: We reviewed data from the National Clinical Database-Breast Cancer Registry between January 2019 and December 2020. We compared perioperative treatment implementation between the IBR and non-IBR groups by subtype matching for age, menopausal status, T stage, N stage, and histology. RESULTS: A total of 8,860 patients with breast cancer who underwent IBR (6,075 breast prostheses, 2,492 autologous tissues, and 293 others) were identified. The compliance rate with the guidelines for prosthetic breast reconstruction was 97.7%. After matching, chemotherapy for luminal A-like diseases was significantly less frequent in the IBR group than in the non-IBR group (16.3% vs 20.5%, p < 0.001), and radiotherapy was less frequent in luminal A-like and HER2-positive patients (7.2% vs 9.0%, p = 0.010 and 7.1% vs 11.4%, p = 0.005, respectively). Among the 1-3 node-positive cases, fewer patients with prosthetic IBR received radiotherapy than those without IBR (15.7% vs 26.4%, p < 0.001). CONCLUSION: Prosthetic breast reconstruction was performed with strict adherence to the Japanese guidelines. The implementation rates of chemotherapy and radiotherapy were lower in the specific IBR group than those in the non-IBR group. Therefore, large-scale, long-term follow-up data are required.

DOI： 10.1007/s12282-024-01604-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The increasing prevalence of frailty has gained considerable attention due to its profound influence on clinical outcomes. However, our understanding of the progression of frailty and long-term clinical outcomes in older individuals with atrial fibrillation remains scarce. METHODS: Using data from 2012 to 2018 from a comprehensive claims database incorporating primary and hospital care records in Shizuoka, Japan, we selected patients aged ≥65 years with atrial fibrillation who initiated oral anticoagulant therapy. The trajectory of frailty was plotted using Sankey plots, illustrating the annual changes in their frailty according to the electronic frailty index during a 3-year follow-up after oral anticoagulant initiation, along with the incidence of clinical adverse outcomes. For deceased patients, we assessed their frailty status in the year preceding their death. RESULTS: Of 6247 eligible patients (45.1% women; mean age, 79.3±8.0 years) at oral anticoagulant initiation, 7.7% were categorized as fit (electronic frailty index, 0-0.12), 30.1% as mildly frail (>0.12-0.24), 35.4% as moderately frail (>0.24-0.36), and 25.9% as severely frail (>0.36). Over the 3-year follow-up, 10.4% of initially fit patients transitioned to moderately frail or severely frail. Conversely, 12.5% of severely frail patients improved to fit or mildly frail. Death, stroke, and major bleeding occurred in 23.4%, 4.1%, and 2.2% of patients, respectively. Among the mortality cases, 74.8% (N=1183) and 3.5% (N=55) had experienced moderately or severely frail and either a stroke or major bleeding in the year preceding their death, respectively. CONCLUSIONS: In a contemporary era of atrial fibrillation management, a minor fraction of older patients on oral anticoagulants died following a stroke or major bleeding. However, their frailty demonstrated a dynamic trajectory, and a substantial proportion of death was observed after transitioning to a moderately or severely frail state.

DOI： 10.1161/CIRCOUTCOMES.123.010642

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: Although minimally invasive cardiac surgery (MICS) procedures are widely performed throughout Japan, nationwide data regarding treated cases are limited. Up-to-date results for cardiovascular surgery are vital for quality control in clinical practice. Presented here is the 2021 annual report based on data from the Japan Cardiovascular Surgery Database (JCVSD). METHODS: Records noted in the JCVSD of patients who underwent mitral valve surgery, aortic valve replacement (AVR), coronary artery bypass grafting (CABG), atrial septum defect (ASD) closure, or cardiac tumor resection via right or left minithoracotomy, as well as thoracoscopic- or port-assisted, or robotic-assisted approaches, in 2021 were examined. Perioperative parameters including mortality and morbidity was evaluated. RESULTS: The 30-day and in-hospital mortalities for isolated mitral valve repair (n = 1211) were 0.1% and 0.2%, respectively, while those for all mitral valve repair (n = 2017) were 0.05% and 0.2%, respectively. More than 100 facilities were found to perform fewer than five MICS mitral valve surgery cases per year. As for MICS-AVR, 30-day and in-hospital mortalities for isolated AVR (n = 818) were 0.5% and 0.5%, respectively, while those for all AVR (n = 987) were 0.6% and 1.1%, respectively. Additionally, those for MICS-CABG (n = 400) were 0.8% and 0.5%, respectively. Those for ASD (n = 183) and cardiac tumor (n = 96), were 0.5% and 0.5%, respectively, and 0% and 1.0%, respectively. CONCLUSION: This is the first report of MICS results of procedures performed in Japan based on the 2021 JCVSD data. Additional results obtained with a similar data collection method are expected and details on MICS are being collected starting 2024.

DOI： 10.1007/s11748-024-02066-2

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記述言語：英語  

DOI： 10.1161/CIRCULATIONAHA.124.069363

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: The hospital-based cancer registry is used extensively for research to support cancer control activities by providing an overview of how cancer treatments are provided nationwide. This study aimed to shed light on the quality and characteristics of treatment data in the hospital-based cancer registry using the linked dataset on gastric cancer. METHODS: Using the nationally linked data of the hospital-based cancer registry and the health services utilization data, the treatment data in the hospital-based cancer registry for patients who were newly diagnosed with gastric cancer in 2016 and 2017 and received the first course of treatment at their own institutions were examined. The agreement rates between registry data and utilization data were analyzed by stage, treatment, age, period from the date of diagnosis to the date of treatment and hospital type. RESULTS: The sensitivity of open surgery, laparoscopic surgery and endoscopic treatment tended to decrease in advanced stages, whereas the sensitivity of chemotherapy and radiation therapy increased. Specificity was high for all treatments and stages, at ˃90%. Sensitivity by age was slightly different for chemotherapy and radiation therapy, but specificities did not differ.For all treatments, the longer the time from diagnosis to treatment implementation, the higher the coverage rate. CONCLUSIONS: The hospital-based cancer registry recorded the treatment performed appropriately. It is necessary to interpret the data from the hospital-based cancer registry whilst keeping in mind that, chemotherapy and radiation therapy are registered less frequently than surgical treatments administered.

DOI： 10.1093/jjco/hyae014

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: We compared the clinical outcomes of mitral valve repair for mitral regurgitation via the robot-assisted approach and small right thoracotomy approach 3 years after the reimbursement of the robot-assisted approach in Japan. METHODS: Patients who underwent isolated mitral valve repair by minimally invasive approach between 2018 and 2020 from the Japan Cardiovascular Surgery Database were included. Patients in the robot-assisted approach group were matched to the small right thoracotomy approach group based on propensity scores estimated from patient and surgical characteristics. Perioperative outcomes were compared among all cases as well as in subgroups categorized on the basis of the yearly number of robot-assisted approach cases and small right thoracotomy approach cases (≥10 or <10) at the hospital. RESULTS: We identified 2443 patients who had undergone isolated mitral valve repair at 250 institutions in the database, and analysis of propensity-matched 577 patient-pairs demonstrated that operation time, cardiopulmonary bypass time, and aortic crossclamp time were significantly shorter with the robot-assisted approach. Although the intensive care unit stay was longer in the robot-assisted approach, the time to discharge was significantly shorter in the robot-assisted approach. There was no meaningful difference in the in-hospital mortality. The incidences of postoperative stroke, renal failure, and prolonged ventilation, and the number of patients who converted to mitral valve replacement were similarly low. Procedural time, blood transfusions, explorative procedures for bleeding, postoperative stroke, and prolonged ventilation occurred at a lower rate in the high-volume institutions. CONCLUSIONS: The study found that the robot-assisted approach is just as effective as the small right thoracotomy approach. The introduction of robot-assisted mitral valve repair in Japan has been successful.

DOI： 10.1016/j.jtcvs.2024.05.014

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Recent guidelines discourage the use of pulmonary arterial hypertension (PAH)-targeted therapies in patients with pulmonary hypertension (PH) associated with respiratory diseases. Therefore, stratifications of the effectiveness of PAH-targeted therapies are important for this group. OBJECTIVES: The authors aimed to identify phenotypes that might benefit from initial PAH-targeted therapies in patients with PH associated with interstitial pneumonia and combined pulmonary fibrosis and emphysema. METHODS: We categorized 270 patients with precapillary PH (192 interstitial pneumonia, 78 combined pulmonary fibrosis and emphysema) into severe and mild PH using a pulmonary vascular resistance of 5 WU. We investigated the prognostic factors and compared the prognoses of initial (within 2 months after diagnosis) and noninitial treatment groups, as well as responders (improvements in World Health Organization functional class, pulmonary vascular resistance, and 6-minute walk distance) and nonresponders. RESULTS: Among 239 treatment-naive patients, 46.0% had severe PH, 51.8% had mild ventilatory impairment (VI), and 40.6% received initial treatment. In the severe PH with mild VI subgroup, the initial treatment group had a favorable prognosis compared with the noninitial treatment group. The response rate in this group was significantly higher than the others (48.2% vs 21.8%, ratio 2.21 [95% CI: 1.17-4.16]). In multivariate analysis, initial treatment was a better prognostic factor for severe PH but not for mild PH. Within the severe PH subgroup, responders had a favorable prognosis. CONCLUSIONS: This study demonstrated an increased number of responders to initial PAH-targeted therapy, with a favorable prognosis in severe PH cases with mild VI. A survival benefit was not observed in mild PH cases. (Multi-institutional Prospective Registry in Pulmonary Hypertension associated with Respiratory Disease; UMIN000011541).

DOI： 10.1016/j.jacasi.2024.01.009

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Pulmonary arterial hypertension (PAH) remains a significant challenge in cardiology, necessitating advancements in treatment strategies. This study explores the safety and efficacy of transitioning patients from beraprost to selexipag, a novel selective prostacyclin receptor agonist, within a Japanese cohort. Employing a multicenter, open-label, prospective design, 25 PAH patients inadequately managed on beraprost were switched to selexipag. Key inclusion criteria included ongoing beraprost therapy for ≥3 months, a diagnosis of PAH confirmed by mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, and current treatment with endothelin receptor antagonists and/or phosphodiesterase type 5 inhibitors. Outcomes assessed were changes in hemodynamic parameters (mPAP, cardiac index, pulmonary vascular resistance) and the 6 min walk distance (6-MWD) over 3-6 months. The study found no statistically significant changes in these parameters post-switch. However, a subset of patients, defined as responders, demonstrated improvements in all measured hemodynamic parameters, suggesting a potential benefit in carefully selected patients. The transition was generally well-tolerated with no serious adverse events reported. This investigation underscores the importance of personalized treatment strategies in PAH, highlighting that certain patients may benefit from switching to selexipag, particularly those previously on higher doses of beraprost. Further research is needed to elucidate the predictors of positive response to selexipag and optimize treatment regimens for this complex condition.

DOI： 10.3390/ph17050555

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Quality indicators (QIs) have been developed to improve and standardize care quality in percutaneous coronary intervention (PCI). In Japan, consecutive PCI procedures are registered in a nationwide database (the Japanese Percutaneous Coronary Intervention registry), which introduces a benchmarking system for comparing individual institutional performance against the national average. OBJECTIVES: The aim of this study was to assess the impact of the benchmarking system implementation on QI improvement at the hospital level. METHODS: A total of 734,264 PCIs were conducted at 1,194 institutions between January 2019 and December 2021. In January 2018, a web-based benchmarking system encompassing 7 QIs for PCI at the institutional level, including door-to-balloon time and rate of transradial intervention, was introduced. The process by which institutions tracked their QIs was centrally monitored. RESULTS: During the 3-year study period, the benchmarking system was reviewed at least once at 742 institutions (62.1%) (median 4 times; Q1-Q3: 2-7 times). The institutions that reviewed their records had higher PCI volumes. Among these institutions, although door-to-balloon time was not directly associated, the proportion of transradial intervention increased by 2.3% in the system review group during the initial year compared with 0.7% in their counterparts. However, in the subsequent year, the association between system reviews and QI improvement was attenuated. CONCLUSIONS: The implementation of a benchmarking system, reviewed by participating institutions in Japan, was partially associated with improved QIs during the first year; however, this improvement was attenuated in the subsequent year, highlighting the need for further efforts to develop effective and sustainable interventions to enhance care quality in PCI.

DOI： 10.1016/j.jacasi.2023.12.003

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s11748-023-01997-6

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

This is a prognostic report by the Japanese Breast Cancer Society on breast cancer extracted from the National Clinical Database-Breast Cancer Registry of Japan. Here, we present a summary of 457,878 breast cancer cases registered between 2004 and 2016. The median follow-up duration was 5.6 years. The median age at the start of treatment was 59 years (5-95%: 38-82 years) and increased from 57 years between 2004 and 2008 to 60 years between 2013 and 2016. The proportion of patients with Stage 0-II disease increased from 74.5% to 78.3%. The number of cases with estrogen and progesterone receptor positivity increased from 74.8% to 77.9% and 60.5% to 68.1%, respectively. Regarding (neo-)adjuvant chemotherapy, the taxane (T) or taxane-cyclophosphamide (C) regimen increased by 2.4% to 8.2%, but the (fluorouracil (F)) adriamycin (A)-C-T/(F) epirubicin (E)C-T and (F)AC/(F)EC regimens decreased by 18.6% to 15.2% and 13.5% to 5.0%, respectively. Regarding (neo-)adjuvant anti-human epidermal growth factor-2 (HER2)-targeted therapy, the use of trastuzumab increased from 4.6% to 10.5%. The rate of sentinel lymph node biopsy increased from 37.1% to 60.7%, while that of axillary dissection decreased from 54.5% to 22.6%. Improvements in disease-free and overall survival were observed in patients with HER2-positive breast cancer, but there was no apparent trend in patients with hormone receptor-positive, HER2-negative, or triple-negative breast cancers.

DOI： 10.1007/s12282-024-01545-x

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Although open surgical repair (OSR) is the gold standard for treating arch aneurysms, thoracic endovascular aortic repair (TEVAR) may be a less invasive alternative. However, it remains unclear which of the 2 methods yields better outcomes. In this study, we compared the perioperative outcomes of both procedures for arch aneurysms using a nationwide surgical database. METHODS: Data of patients who underwent elective aortic repair for true arch aneurysms were extracted from the National Clinical Database of Japan. Patients who underwent OSR and Zone 0/1 TEVAR were matched in a 1:1 ratio using propensity scores and their mortality and morbidity rates were compared. RESULTS: A total of 2,815 and 1,125 patients underwent OSR and Zone 0/1 TEVAR, respectively. After propensity score matching, 1,058 patients were included in both groups. Compared with OSR, Zone 0/1 TEVAR was associated with a significantly higher incidence of stroke (5.8 vs. 10.0%, P < 0.001) and paraplegia/paraparesis (1.6 vs. 4.4%, P < 0.001). However, there were no significant differences in the 30-day and operative mortality rates between the 2 groups (2.2 vs. 2.7% and 4.5 vs. 5.4%, respectively). In the Zone 0/1 TEVAR group, postoperative computed tomography was performed in 92.4% of patients, and types I and III endoleaks were identified in 6.4% and 1.1% of patients, respectively. CONCLUSIONS: Zone 0/1 TEVAR has higher incidences of stroke and paraplegia/paraparesis than OSR, with a risk of postoperative endoleaks. Resolving these problems is the key for expanding the application of Zone 0/1 TEVAR and in the meantime OSR remains the gold standard for surgically fit patients.

DOI： 10.1016/j.avsg.2023.10.012

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: Infective native aneurysms (INAs) of the abdominal aorta and iliac arteries are uncommon, but potentially fatal. Endovascular aneurysm repair (EVAR) has recently been introduced as a durable treatment option, with outcomes comparable to those yielded by conventional open repair (OR). However, due to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-OR and post-EVAR outcomes and to clarify factors affecting short-term and late prognosis following each treatment. METHODS: Using a nationwide clinical registry, we investigated 600 patients treated with OR and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative/operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent/recurrent aneurysm-related infection, were examined. RESULTS: Prosthetic grafts were used in > 90% of patients treated with OR, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Anemia and imaging findings suggestive of aneurysm-enteric fistula were independently associated with poor outcomes in terms of both 3-year mortality (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.01-2.62; P=0.046, and HR, 2.24; 95% CI, 1.12-4.46; P=0.022, respectively) and persistent/recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P=0.039, and OR, 4.96; 95% CI, 1.81-13.55; P=0.002, respectively) after OR, whereas omental wrapping/packing and antibiotic impregnation of the prosthetic graft for in situ reconstruction contributed to improved 3-year survival (HR, 0.60; 95% CI, 0.39-0.92; P=0.019, and HR, 0.53; 95% CI, 0.32-0.88; P=0.014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent/recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P=0.034) whereas an elevated white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P=0.048). CONCLUSIONS: Profiles of prognostic factors differed between OR and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. OR may be more suitable than EVAR for patients with abscess formation.

DOI： 10.1016/j.jvs.2024.01.199

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Springer Science and Business Media LLC  

The Japanese Breast Cancer Society initiated the breast cancer registry in 1975, which transitioned to the National Clinical Database-Breast Cancer Registry in 2012. This annual report presents data from 2020 and analyzes the ten-year mortality rates for those aged 65 and older. We analyzed data from 93,784 breast cancer (BC) cases registered in 2020 and assessed 10-year mortality rates for 36,279 elderly patients diagnosed between 2008 and 2012. In 2020, 99.4% of BC cases were females with a median age of 61. Most (65%) were diagnosed at early stages (Stage 0 or I). Breast-conserving surgery rates varied with stages: 58.5% at cStage I, 30.8% at cStage II, and 13.1% at cStage III. Sentinel lymph node biopsy was done in 73.6% of cases, followed by radiotherapy in 70% of those post-conserving surgery and chemotherapy in 21.1% post-surgery. Pathology showed that 63.4% had tumors under 2.0 cm, 11.7% had pTis tumors, and 77.3% had no axillary lymph node metastasis. ER positivity was seen in 75.1%, HER2 in 14.3%, and 30% had a Ki67 positivity rate above 30%. Across all stages and subtypes, there was a trend where the 10-year mortality rates increased for individuals older than 65 years. In Stage I, many deaths were not directly linked to BC and, for those with HER2-type and triple-negative BC, breast cancer-related deaths increased with age. Within Stage II, patients older than 70 years with luminal-type BC often experienced deaths not directly linked to BC, whereas patients below 80 years with HER2-type and triple-negative BC, likely had breast cancer-related deaths. In Stage III, breast cancer-related deaths were more common, particularly in HER2 and triple-negative BC. Our prognostic analysis underscores distinct mortality patterns by stage, subtype, and age in elderly BC patients. It highlights the importance of personalized treatment strategies, considering subtype-specific aggressiveness, age-related factors, and comorbidities.

DOI： 10.1007/s12282-023-01532-8

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その他リンク： https://link.springer.com/article/10.1007/s12282-023-01532-8/fulltext.html

記述言語：英語   掲載種別：研究論文（学術雑誌）  

IMPORTANCE: Short interpregnancy intervals (SIPIs) are associated with increased risk of adverse maternal and neonatal outcomes. Disparities exist across socioeconomic status, but there is little information on SIPIs among women experiencing homelessness. OBJECTIVE: To investigate (1) differences in rates and characteristics of SIPIs between women experiencing homelessness and domiciled women, (2) whether the association of homelessness with SIPIs differs across races and ethnicities, and (3) whether the association between SIPIs of less than 6 months (very short interpregnancy interval [VSIPIs]) and maternal and neonatal outcomes differs between participant groups. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a Colorado statewide database linking the Colorado All Payer Claims Database, Homeless Management Information System, death records, and infant birth records. Participants included all women who gave birth between January 1, 2016, and December 31, 2021. Data were analyzed from September 1, 2022, to May 10, 2023. EXPOSURES: Homelessness and race and ethnicity. MAIN OUTCOMES AND MEASURES: The primary outcome consisted of SIPI, a binary variable indicating whether the interval between delivery and conception of the subsequent pregnancy was shorter than 18 months. The association of VSIPI with maternal and neonatal outcomes was also tested. RESULTS: A total of 77 494 women (mean [SD] age, 30.7 [5.3] years) were included in the analyses, of whom 636 (0.8%) were women experiencing homelessness. The mean (SD) age was 29.5 (5.4) years for women experiencing homelessness and 30.7 (5.3) years for domiciled women. In terms of race and ethnicity, 39.3% were Hispanic, 7.3% were non-Hispanic Black, and 48.4% were non-Hispanic White. Associations between homelessness and higher odds of SIPI (adjusted odds ratio [AOR], 1.23 [95% CI, 1.04-1.46]) were found. Smaller associations between homelessness and SIPI were found among non-Hispanic Black (AOR, 0.59 [95% CI, 0.37-0.96]) and non-Hispanic White (AOR, 0.57 [95% CI, 0.39-0.84]) women compared with Hispanic women. A greater association of VSIPI with emergency department visits and low birth weight was found among women experiencing homelessness compared with domiciled women, although no significant differences were detected. CONCLUSIONS AND RELEVANCE: In this cohort study of women who gave birth from 2016 to 2021, an association between homelessness and higher odds of SIPIs was found. These findings highlight the importance of conception management among women experiencing homelessness. Racial and ethnic disparities should be considered when designing interventions.

DOI： 10.1001/jamanetworkopen.2023.50242

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s11748-023-01979-8

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: The Database Task Force of the Japan Society for Pharmacoepidemiology began its annual surveys of databases available for clinico and pharmacoepidemiological studies in 2010. In this report, we summarize the characteristics of the databases available in Japan based on the results of our 2021 survey to illustrate the recent developments in the infrastructure for database research in Japan. METHODS: We included 20 major databases from the academia, government, or industry that were accessible to third parties. We used a web-based questionnaire to ask the database providers about their characteristics, such as their organization, data source(s), numbers of individuals enrolled, age distribution, code(s) used, and average follow-up periods. RESULTS: We received responses from all 20 databases approached: eight hospital-based databases, six insurer-based databases, four pharmacy-based databases, and two in the "other" category. Among them, 17 contained information from medical claims, pharmacy claims, and/or Diagnosis Procedure Combination data. Most insurer databases contained health check-up data that could be attached to the claims component. Some hospital-based databases had data from electronic medical records. Most insurer-based databases collected data from the insurers of working-age employees and therefore had limited coverage of older people. Most databases coded their medication data using the Japanese reimbursement codes, and many provided Anatomical Therapeutic Chemical Classification codes. CONCLUSIONS: The number of databases available for clinico and pharmacoepidemiological research and the proportion of the population they cover are increasing in Japan. The differences in their characteristics mean that the appropriate database must be selected for a particular study purpose.

DOI： 10.1002/pds.5680

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Western guidelines often recommend biguanides as the first-line treatment for diabetes. However, dipeptidyl peptidase-4 (DPP-4) inhibitors, alongside biguanides, are increasingly used as the first-line therapy for type 2 diabetes (T2DM) in Japan. However, there have been few studies comparing the effectiveness of biguanides and DPP-4 inhibitors with respect to diabetes-related complications and cardio-cerebrovascular events over the long term, as well as the costs associated. OBJECTIVE: We aimed to compare the outcomes of patients with T2DM who initiate treatment with a biguanide versus a DPP-4 inhibitor and the long-term costs associated. METHODS: We performed a cohort study between 2012 and 2021 using a new-user design and the Shizuoka Kokuho database. Patients were included if they were diagnosed with T2DM. The primary outcome was the incidence of cardio-cerebrovascular events or mortality from the initial month of treatment; and the secondary outcomes were the incidences of related complications (nephropathy, renal failure, retinopathy, and peripheral neuropathy) and the daily cost of the drugs used. Individuals who had experienced prior events during the preceding year were excluded, and events within 6 months of the start of the study period were censored. Propensity score matching was performed to compare between two groups. RESULTS: The matched 1:5 cohort comprised 529 and 2,116 patients who were initially treated with a biguanide or a DPP-4 inhibitor, respectively. Although there were no significant differences in the incidence of cardio-cerebrovascular events or mortality and T2DM-related complications between the two groups (p = 0.139 and p = 0.595), daily biguanide administration was significantly cheaper (mean daily cost for biguanides, 61.1 JPY; for DPP-4 inhibitors, 122.7 JPY; p<0.001). CONCLUSION: In patients with T2DM who initiate pharmacotherapy, there were no differences in the long-term incidences of cardio-cerebrovascular events or complications associated with biguanide or DPP-4 use, but the former was less costly.

DOI： 10.1371/journal.pone.0308734

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p = 0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p = 0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p = 0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

DOI： 10.1016/j.amjcard.2023.09.094

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To clarify the current status of surgical treatment of acute aortic dissection (AAD) in Japan through the Japan Cardiovascular Database analysis. METHODS: In total, 7194 patients who underwent surgical treatment for AAD in 2021, including type A (TAAAD) (n = 6416) and type B (TBAAD) (n = 778), were investigated. RESULTS: The median age was 70 years, with patients older than age 80 years constituting 21.7% and 23.4% of TAAAD and TBAAD cases. Emergency admission was 88.5% and 78.5%. Shock was found in 11.8% and 6.0%. Rupture/impending rupture occurred in 10.7%/6.0% and 24.0%/11.1%, respectively. Branch malperfusion was complicated in 10.4% and 25.2%. Open repairs were performed in 97.7% and 20.3%, whereas endovascular repairs were performed in 2.3% and 79.7%, respectively. In the increased prevalence of endografting procedures, neurological complications and renal failure occurred frequently after open repair with frozen elephant trunk for 29.9% and 50.3%. The operative mortality rate was 9.8% and 11.5% for open repair and 8.1% and 10.0% for endovascular repair. In patients with TAAAD, age older than 80 years, preoperative critical comorbidities, classical dissection, and coexisting chronic vital organ diseases were independent risk factors for mortality. In frozen elephant trunk procedures, neurologic complications and renal failure were frequent. The operative mortality was higher during the superacute phase within 1 or 2 hours from onset to arrival and between arrival and surgery. CONCLUSIONS: The current status of surgical treatments for AAD including the increased prevalence of endografting of thoracic endovascular aortic repair and frozen elephant trunk were demonstrated with favorable outcomes in the Japan Cardiovascular Database analyses.

DOI： 10.1016/j.jtcvs.2023.11.044

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Springer Science and Business Media LLC  

This is an annual report by the Japanese Breast Cancer Society regarding the clinical data on breast cancer extracted from the National Clinical Database-Breast Cancer Registry (NCD-BCR) of Japan. Here, we present an updated summary of 98,300 breast cancer cases registered in 2019. The median age at cancer diagnosis was 61 years (interquartile range 49-72 years), and 30.6% of the breast cancer patients were premenopausal. Of the 93,840 patients without distant metastases, 14,118 (15.0%) and 42,047 (44.8%) were diagnosed with stage 0 and I disease, respectively. Breast-conserving surgery was performed in 42,080 (44.8%) patients. Regarding axillary procedures, 62,677 (66.8%) and 7371 (7.9%) patients underwent sentinel node biopsy and axillary node dissection after biopsy, respectively. Whole breast irradiation was administered to 29,795 (70.8%) of the 42,080 patients undergoing breast-conserving surgery. Chest wall irradiation was administered to 5524 (11.1%) of the 49,637 patients who underwent mastectomy. Of the 6912 clinically lymph node-negative patients who received preoperative therapy, 5250 (76.0%) and 427 (6.2%) underwent sentinel node biopsy and axillary node dissection after biopsy, respectively; however, 602 (8.7%) patients initially underwent axillary node dissection without biopsy.

DOI： 10.1007/s12282-023-01526-6

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その他リンク： https://link.springer.com/article/10.1007/s12282-023-01526-6/fulltext.html

記述言語：英語   掲載種別：研究論文（学術雑誌）  

INTRODUCTION: There remains a lack of evidence regarding the optimal abdominal approach, including laparoscopy, hand-assisted, and open laparotomy for minimally invasive thoracoscopic esophagectomy. We aimed to compare the incidence of postoperative complications, particularly pulmonary complications, between laparoscopy and open laparotomy for minimally invasive thoracoscopic esophagectomy using nationwide Japanese databases. METHODS: Data from patients in the National Clinical Database (NCD) who underwent thoracoscopic esophagectomy for esophageal cancer were analyzed. The incidence of pulmonary complications was compared between abdominal laparoscopy and laparotomy after matching the propensity scores (PS) from preoperative factors to account for confounding bias. Laparoscopic-assisted surgery (LAS) was also compared to hand-assisted laparoscopic surgery (HALS). RESULTS: Of the 24,790 patients who underwent esophagectomy between 2018 and 2021, data from 12,633 underwent thoracoscopic procedure. The proportion of patients who experienced pulmonary complications did not significantly differ between the laparoscopy group and the laparotomy group after matching (664/3195 patients, 20.8% versus 702/3195 patients, 22.0%; P = 0.25). No difference in the incidence of pulmonary complications was observed among patients treated using the laparoscopic approach (508/2439 patients, 20.8% in the LAS group versus 498/2439 patients, 20.4% in the HALS group; P = 0.72). CONCLUSIONS: We observed no significant difference in the incidence of postoperative pulmonary complications between laparoscopy and laparotomy for thoracoscopic esophagectomy. Short-term outcomes were similar between the laparoscopic-assisted approach and the hand-assisted approach. This study provides valuable insights into the optimal abdominal approach for thoracoscopic esophagectomy using data from a nationwide database that reflect real-world clinical practice.

DOI： 10.1007/s10388-023-01032-w

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: To illustrate the utility of the self-controlled study design for studies without an active comparator, we compared the results of a cohort design study with a non-user comparator with those of a self-controlled design study in evaluating the risk of varenicline on cardiovascular outcomes, using a Japanese medical claims database. METHODS: The participating smokers were identified from health-screening results collected between May 2008 and April 2017. Using a non-user-comparator cohort study design, we estimated the hazard ratios (HRs) and 95% confidence intervals (CIs) of varenicline on initial hospitalization with cardiovascular outcomes using Cox's model adjusted for patients' sex, age, medical history, medication history, and health-screening results. Using a self-controlled study design, the within-subject HR was estimated using a stratified Cox's model adjusted for medical history, medication history, and health-screening results. The estimate from a recent meta-analysis was considered the gold standard (risk ratio: 1.03). RESULTS: We identified 460 464 smokers (398 694 males [86.6%]; mean (standard deviation) age: 42.9 [10.8] years) in the database. Of these, 11 561 had been dispensed varenicline at least once, and 4511 had experienced cardiovascular outcomes. The estimate of the non-user-comparator cohort study design exceeded the gold standard (HR [95% CI]: 2.04 [1.22-3.42]), whereas that of the self-controlled study design was close to the gold standard (within-subject HR [95% CI]: 1.12 [0.27-4.70]). CONCLUSIONS: The self-controlled study design is useful alternative to a non-user-comparator cohort design when evaluating the risk of medications relative to their non-use, based on a medical information database.

DOI： 10.1002/pds.5634

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: Many studies have shown that the prognosis of invasive lobular carcinoma (ILC) is better than that of invasive ductal carcinoma (IDC). However, both disorders exhibit different prognoses according to molecular subtype, and the prognosis of ILC subtypes might depend on their hormone receptor positivity rate. This study clarified the prognosis of ILC and IDC in each subtype and examined the effectiveness of adjuvant chemotherapy (CT) in luminal ILC. METHODS: We planned the analysis using data from the Breast Cancer Registry in Japan. Because it was presumed that there are differences in characteristics between ILC and IDC, we created matched cohorts using exact matching to compare their prognoses. We compared the prognosis of ILC and IDC for each subtype. We also compared the prognosis of luminal ILC between the CT and non-CT groups. RESULTS: For all subtypes, the disease-free survival (DFS) and overall survival (OS) of ILC were poorer than those of IDC. In the analysis by each subtype, no statistically significant difference was found in DFS and OS in luminal human epidermal growth factor 2 (HER2), HER2, and triple-negative cohorts; however, luminal ILC had significantly poorer DFS and OS than luminal IDC. The CT effects on the prognosis of luminal ILC were greater in more advanced cases. CONCLUSION: Luminal ILC had a poorer prognosis than luminal IDC, contributing to the worse prognosis of ILC than that of IDC in the overall cohort. Different therapeutic approaches from luminal IDC are essential for a better prognosis of luminal ILC.

DOI： 10.1007/s10549-023-07022-x

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The association between successful reconstructive surgery with a free flap and hospital volume has not been well established. This study was designed to retrospectively analyze the outcome of free-flap surgery registered in a nationwide surgical registration system in Japan to clarify the relationship between free-flap survival and facilities' average annual number of free-flap surgeries. METHODS: We analyzed data from 19,482 free flaps performed during 2017-2020 at 407 facilities throughout Japan. After adjusting for sex, age, and disease classification that differ between the groups, we examined the differences in the flap survival rates among the different facilities in terms of the average number of free-flap surgeries performed annually. RESULTS: The total overall necrosis rate was 2.8%. Of all procedures, 14.9%, 12.9%, 33.4%, and 38.8% were performed at facilities with an average number of free-flap procedures <10, 10-19, 20-49, and ≥ 50 per year, respectively, and the respective rates of total necrosis were 6.0%, 3.8%, 2.1%, and 1.7%, respectively. The odds ratios and 95% confidence intervals of flap necrosis for facilities with ≥ 50 cases per year relative to those <10 were 2.70 (1.98-3.68) for nonbreast reconstruction cases and 5.72 (2.77-11.8) for breast reconstruction cases. CONCLUSION: This analysis of a nationwide plastic surgery database showed that free-flap surgeries in institutions with a low average annual number of free-flap surgeries had a higher risk of total necrosis. Measures should be taken to either aggregate cases into high-volume centers or improve management at low-volume centers.

DOI： 10.1016/j.bjps.2023.07.047

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Operative indication of the additional mitral repair for moderate ischemic mitral regurgitation (MR) in the setting of coronary artery bypass grafting (CABG) is still unclear. METHODS: This study was designed as the nation-wide multi-center retrospective analysis with additional survival data. CABGs without past heart surgery registered in 2014 and 2015 were included. Concomitant surgery other than tricuspid or arrhythmia surgery, mitral replacement, and off-pump cases, was excluded. Grade 1 or 4 MR, and ejection fraction < 20 or > 50 were excluded. Additional questionnaire was sent to each hospital, regarding the pathology of MR and clinical outcomes. Additional data were registered between May 28, 2021 and Dec 31, 2021, and the primary outcomes were all-death and cardiac death. The secondary outcomes were heart failure and cerebrovascular event requiring admission, mitral re-intervention. Patients underwent on-pump CABG (CABG only group 221 cases) and CABG with mitral repair (CABG + Mitral repair group 276 cases) were enrolled. RESULTS: After Propensity score matching, 362 cases (CABG only 181cases vs CABG + mitral repair 181 cases) were matched. Cox regression model showed no statistical difference in the long-term survival between CABG alone group and combined procedure group (p = 0.52). Cardiac death (p = 1.00), heart failure (p = 0.68), and cerebrovascular event (p - 0.80) requiring admission were not different between groups as well. The incidence of mitral re-intervention was very few (2 cases in CABG only group, 4 cases in CABG + mitral repair group). CONCLUSIONS: In patients with moderate ischemic MR, additional mitral repair to CABG did not improve long-term survival, freedom from heart failure, or cerebrovascular event.

DOI： 10.1007/s11748-023-01925-8

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Use of combinations of long-acting β2 agonists/long-acting muscarinic antagonists (LABA/LAMA) in patients with chronic obstructive pulmonary disease (COPD) is increasing. Nevertheless, existing evidence on cardiovascular risk associated with LABA/LAMA versus another dual combination, LABA/inhaled corticosteroids (ICS), was limited and discrepant. AIM: The present cohort study aimed to examine comparative cardiovascular safety of LABA/LAMA and LABA/ICS with a target trial emulation framework, focusing on dual fixed-dose combination (FDC) therapies. METHODS: We identified patients with COPD who initiated LABA/LAMA FDC or LABA/ICS FDC from a nationwide Taiwanese database during 2017-2020. The outcome of interest was a hospitalized composite cardiovascular events of acute myocardial infarction, unstable angina, heart failure, cardiac dysrhythmia, and ischemic stroke. Cox regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for composite and individual cardiovascular events after matching up to five LABA/LAMA FDC initiators to one LABA/ICS FDC initiator using propensity scores (PS). RESULTS: Among 75,926 PS-matched patients, use of LABA/LAMA FDC did not show a higher cardiovascular risk compared to use of LABA/ICS FDC, with a HR of 0.89 (95% CI, 0.78-1.01) for the composite events, 0.80 (95% CI, 0.61-1.05) for acute myocardial infarction, 1.48 (95% CI, 0.68-3.25) for unstable angina, 1.00 (95% CI, 0.80-1.24) for congestive heart failure, 0.62 (95% CI, 0.37-1.05) for cardiac dysrhythmia, and 0.82 (95% CI, 0.66-1.02) for ischemic stroke. The results did not vary substantially in several pre-specified sensitivity and subgroup analyses. CONCLUSION: Our findings provide important reassurance about comparative cardiovascular safety of LABA/LAMA FDC treatment among patients with COPD.

DOI： 10.1186/s12931-023-02545-9

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: Prosthetic graft infection (PGI) after open abdominal aortic and iliac artery reconstruction is life threatening. However, because it is rare and frequently difficult to diagnose, robust evidence on its treatment and optimal management strategies are lacking. This study aimed to clarify the clinical characteristics and surgical treatment outcomes of this condition and to identify pre-operative and operative factors affecting its prognosis. METHODS: This was a nationwide cohort study. Using a nationwide clinical registry system, patients who were treated surgically for PGI after open abdominal aortic and iliac artery reconstruction between 2011 and 2017 were investigated, and their profiles and clinical courses were analysed. The relationships between the pre-operative and operative factors and the post-operative outcomes, including death and persistent or recurrent graft related infection, were evaluated. RESULTS: The study included 213 patients. The median duration between the index arterial reconstruction and surgical treatment for PGI was 644 days. Fistula development to the gastrointestinal tract was confirmed during surgery in 53.1% of patients. The cumulative overall survival rates at 30 and 90 days, one, three, and five years were 87.3%, 74.8%, 62.2%, 54.5%, and 48.1%, respectively. Pre-operative shock was the only factor independently associated with 90 day and three year death. Short term and late mortality rates, as well as the rate of persistent or recurrent graft related infection, did not differ significantly between patients treated with total removal of the infected graft and those treated with partial removal of the graft. CONCLUSION: Surgery for PGI after open reconstruction of the abdominal aorta and iliac arteries is complex, and the post-operative mortality rate remains high. Partial removal of the infected graft may be an alternative in selected patients with limited extent of infection.

DOI： 10.1016/j.ejvs.2023.06.034

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: Continuous annual reporting on coronary artery bypass grafting (CABG) surgical practice is key for quality control and improvement of clinical results. In this report, Japanese nationwide features and trends in the extent of coronary artery disease and the characteristics of those undergoing CABG procedures in 2019 are presented. Clinical results of related ischemic heart disease are also presented. METHODS AND RESULTS: The Japanese Cardiovascular Surgery Database (JCVSD) is a nationwide surgical case registry system. Data regarding CABG cases in the year 2019 (1 January-31 December) were captured with questionnaires regularly administered by the Japanese Association for Coronary Artery Surgery (JACAS). We analyzed trends in the number and types of grafts selected according to the number of diseased vessels in patients undergoing CABG. We also analyzed descriptive clinical results of those undergoing surgery for acute myocardial infarction or ischemic mitral regurgitation. CONCLUSIONS: This is the second publication summarizing the results following the JACAS annual report based on JCVSD Registry data from the year 2019. Clinical outcomes and surgical strategy trends were relatively stable. Further accumulation of information with a similar data collection system is expected.

DOI： 10.5761/atcs.sr.23-00026

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：International Heart Journal (Japanese Heart Journal)  

Upfront combination therapy including intravenous prostaglandin I2 (PGI2-IV) is recognized as the most appropriate treatment for patients with severe pulmonary arterial hypertension (PAH). This retrospective study aimed to determine reasons why this therapy is not used for some patients with severe PAH and describe the hemodynamic and clinical prognoses of patients receiving initial combination treatment with (PGI2-IV+) or without (PGI2-IV-) PGI2-IV.Data for patients with severe PAH (World Health Organization Functional Class III/IV and mean pulmonary arterial pressure [mPAP] ≥ 40 mmHg) were extracted from the Japan Pulmonary Hypertension Registry. Overall, 73 patients were included (PGI2-IV + n = 17; PGI2-IV- n = 56). The PGI2-IV+ cohort was younger than the PGI2-IV- cohort (33.8 ± 10.6 versus 52.6 ± 18.2 years) and had higher mPAP (58.1 ± 12.9 versus 51.8 ± 9.0 mmHg), greater prevalence of idiopathic PAH (88% versus 32%), and less prevalence of connective tissue disease-associated PAH (0% versus 29%). Hemodynamic measures, including mPAP, showed improvement in both cohorts (post-treatment median [interquartile range] 38.5 [17.0-40.0] for the PGI2-IV + cohort and 33.0 [25.0-43.0] mmHg for the PGI2-IV - cohort). Deaths (8/56) and lung transplantation (1/56) occurred only in the PGI2-IV - cohort.These Japanese registry data indicate that older age, lower mPAP, and non-idiopathic PAH may influence clinicians against using upfront combination therapy including PGI2-IV for patients with severe PAH. Early combination therapy including PGI2-IV was associated with improved hemodynamics from baseline, but interpretation is limited by the small sample size.

DOI： 10.1536/ihj.23-047

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s11748-023-01945-4

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: We investigated the influence of concomitant mitral regurgitation (MR) in patients undergoing transcatheter aortic valve implantation on the 1-year outcome using Japan Transcatheter Valve Therapy (J-TVT) registry data. METHODS: The patients who underwent the transcatheter aortic valve implantation for aortic stenosis performed from August 2013 to December 2019 in Japan were included. History of previous valve surgery and dialysis patients were excluded. A total of 24,979 patients were included, and 1-year follow-up data were obtained from the registry (follow-up rate 98.5 %). Propensity-score matching, using multivariable logistic regression and 1:1 matching without replacement, was performed between the patients with grade 3-4 MR (MR 3-4 group) and those with grade 0-2 MR (MR 0-2 group). All-cause death and the composite outcome of death and/or heart failure events were compared. RESULTS: After propensity score matching, 3920 cases (1960 cases each in MR 0-2 group and MR 3-4 group) were extracted. The procedure success rate was 96.4 % in MR 0-2 and 96.0 % in MR 3-4 group (p = 0.56) and the surgical conversion rate was 0.7 % in MR 0-2 group and 0.8 % in MR 3-4 group (p = 0.58). Cox regression model showed no statistical difference in 1-year survival rate between MR 0-2 group (89.4 %) and MR 3-4 group (89.6 %) (p = 0.80). However, freedom from 1-year death and/or heart failure event was lower in MR 3-4 (86.3 %) than in MR 0-2 group (88.9 %) (p = 0.01). This trend was also found in the subgroup of New York Heart Association (NYHA) class 1-2 but not in the subgroup of NYHA class 3-4. CONCLUSIONS: One-year survival rate was not different between groups but freedom from death and/or heart failure events was lower in patients with preoperative MR grade 3-4 than in patients with preoperative MR grade 0-2 after transcatheter aortic valve replacement.

DOI： 10.1016/j.jjcc.2023.01.002

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

The outcome of transcatheter aortic valve replacement (TAVR) for patients with bicuspid aortic valve (BAV) remains unclear, particularly among Asian patients that are known to have different valvular morphology and lower body habitus. This study investigated patient characteristics, procedural and 1-year outcome of TAVR for BAV within national TAVR registry in Japan. The patient-level data were extracted from the J-TVT (Japanese Transcatheter Valvular Therapy) registry between August 2013 and December 2018; overall, there were 423 patients (2.5%) with BAV and 16,802 patients with tricuspid aortic valve (TAV). At baseline, patients with BAV were younger and had less arteriosclerotic comorbidities. There was no statistically significant difference between BAV and TAV groups in conversion to surgery (0.5% vs. 1.1%, p = 0.34) and 30-day mortality (0.5% vs. 1.3%, p = 0.18). Cumulative all-cause survival and survival from major adverse events were analyzed. Cox proportional hazard regression model was used to estimate the hazard ratio. All-cause mortality and major adverse event rate at 1 year were comparable between the two groups. Relative hazard for all-cause mortality for BAV compared to TAV was 1.01 (0.70-1.45; p = 0.96), and for major adverse event was 0.94 (0.69-1.27; p = 0.67). From the Japanese nationwide TAVR registry, procedural and 1-year outcome of TAVR in BAV was as favorable as TAVR in TAV.

DOI： 10.1007/s12928-023-00933-y

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Myocardial flow reserve (MFR) and the extent of myocardial ischemia identify patients at high risk of major adverse cardiovascular events (MACEs). Associations between positron emission tomography (PET)-assessed extent of ischemia, MFR, and MACEs is unclear. METHOD: Overall, 640 consecutive patients with suspected or known coronary artery disease undergoing 13N-ammonia myocardial perfusion PET were followed-up for MACEs. Patients were categorized into three groups based on myocardial ischemia severity: Group I (n = 335), minimal (myocardial ischemia < 5%); Group II (n = 150), mild (5-10%); and Group III (n = 155), moderate-to-severe (> 10%). RESULTS: Cardiovascular death and MACEs occurred in 17 (3%) and 93 (15%) patients, respectively. Following statistical adjustment for confounding factors, impaired MFR (global MFR < 2.0) was revealed as an independent predictor of MACEs in Groups I (hazard ratio [HR], 2.89; 95% confidence interval [CI], 1.48-5.64; P = 0.002) and II (HR, 3.40; 95% CI 1.37-8.41; P = 0.008) but was not significant in Group III (HR, 1.15; 95% CI 0.59-2.26; P = 0.67), with a significant interaction (P < 0.0001) between the extent of myocardial ischemia and MFR. CONCLUSION: Impaired MFR was significantly associated with increased risk of MACEs in patients with ≤ 10% myocardial ischemia but not with those having > 10% ischemia, allowing a clinically effective risk stratification.

DOI： 10.1007/s12350-023-03255-x

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記述言語：英語  

DOI： 10.1016/j.ejvs.2022.12.025

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: In older patients with atrial fibrillation (AF), frailty is frequently prevalent. However, the prognostic value of frailty for adverse events after initiation of oral anticoagulants (OACs) is unclear. OBJECTIVES: We assessed whether frailty at the time of OAC initiation is associated with subsequent bleeding or embolic events. METHODS: We extracted patients aged ≥65 years with nonvalvular AF in whom OACs were initiated from a universal administrative claims database incorporating primary and hospital care records in Shizuoka, Japan, between 2012 and 2018. Frailty was assessed using the electronic frailty index (eFI). The association of frailty with bleeding events and ischemic stroke/transient ischemic attack were evaluated using the Fine-Gray model and restricted cubic spline model. RESULTS: Among 12,585 patients with AF, 7.8% were categorized as fit, 31.5% as mildly frail, 34.8% as moderately frail, and 25.9% as severely frail. The risk of bleeding was associated with a higher eFI (adjusted subdistribution hazard ratio [95% CI] for fit or mild frailty: 1.15 [1.02-1.30]; moderate frailty: 1.42 [1.24-1.61]; and severe frailty: 1.86 [1.61-2.15]), whereas the association was weaker for ischemic stroke/transient ischemic attack. The spline models demonstrated that the relative hazard for bleeding increased steeply with increasing eFI. CONCLUSION: Patients with frailty in whom OAC therapy is initiated have higher risk of bleeding, highlighting the importance of discussing this increased risk with patients with AF who have frailty and assessing frailty at the time of OAC initiation.

DOI： 10.1016/j.rpth.2023.100129

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Information regarding patients who were treated for breast cancer in 2018 was extracted from the National Clinical Database (NCD), which is run by Japanese physicians. This database continues from 1975, created by the Japanese Breast Cancer Society (JBCS). A total of 95,620 breast cancer cases were registered. The demographics, clinical characteristics, pathology, surgical treatment, adjuvant chemotherapy, adjuvant endocrine therapy, and radiation therapy of Japanese breast cancer patients were summarized. We made comparisons with other reports to reveal the characteristics of our database. We also described some features in Japanese breast cancer that changed over time. The unique characteristics of breast cancer patients in Japan may provide guidance for future research and improvement in healthcare services.

DOI： 10.1007/s12282-022-01423-4

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Contemporary guidelines emphasize the importance of risk stratification in improving the quality of care for patients undergoing percutaneous coronary intervention (PCI). We aimed to investigate whether adding information from a procedure-based academic registry to administrative claims data would improve the performance of risk prediction model. METHODS: We combined two nationally representative administrative and clinical databases. The study cohort comprised 43,095 patients; 18,719 and 23, 525 with acute [ACS] and chronic [CCS] coronary syndrome, respectively. Each population was randomly divided into the logistic regression model (derivation cohort, 80%) and model validation (validation cohort, 20%) groups. The performances of the following models were compared using C-statistics: (1) variables restricted to baseline claims data (model #1), (2) clinical registry data (model #2), and (3) expanded to both claims and clinical registry data (model #3). The primary outcomes were in-hospital mortality and bleeding. RESULTS: The primary outcomes occurred in 3.7% (in-hospital mortality)/5.0% (bleeding) of patients with ACS and 0.21%/0.95% of CCS patients. For each event, the model performance was 0.65 (95% confidence interval [CI], 0.60-0.69) /0.67 (0.63-0.71) in ACS and 0.52 (0.35-0.76) /0.62 (0.54-0.70) for CCS patients in model #1, 0.83 (0.80-0.87) /0.77 (0.74-0.81) in ACS and 0.76 (0.60-0.92) /0.67 (0.59-0.75) in CCS for model #2, and 0.83 (0.79-0.86) /0.78 (0.75-0.81) in ACS and 0.76 (0.61-0.92) /0.67 (0.58-0.74) in CCS for model #3. CONCLUSIONS: Combining clinical information from the academic registry with claims databases improved its performance in predicting adverse events.

DOI： 10.1016/j.ijcard.2022.10.144

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: Postprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR. METHODS: This study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method. RESULTS: The 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, p<0.001 and 2.8% vs 2.0% vs 0.8%, p<0.001) and bleeding events (3.3% vs 2.5% vs 0.8%, p<0.001 and 3.7% vs 3.0% vs 2.4%, p<0.001) when compared with intermediate and low-risk patients. The receiver operating characteristic area under the curves for these models were 0.53, 0.58, 0.56 and 0.55, respectively. After the models were recalibrated to incorporate variables more applicable to TAVR, the performance of ischaemic and bleeding models modestly improved (0.58 and 0.61, respectively). CONCLUSIONS: The PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up. TRIAL REGISTRATION NUMBER: 3395.

DOI： 10.1136/openhrt-2022-002172

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

We evaluated the association between implementation of state-mandated pulse oximetry screening (POS) and rates of emergency hospitalizations among infants with Critical Congenital Heart Disease (CCHD) and assessed differences in that association across race/ethnicity. We hypothesized that emergency hospitalizations among infants with CCHD decreased after implementation of mandated POS and that the reduction was larger among racial and ethnic minorities compared to non-Hispanic Whites. We utilized statewide inpatient databases from Arizona, California, Kentucky, New Jersey, New York, and Washington State (2010-2014). A difference-in-differences model with negative binomial regression was used. We identified patients with CCHD whose hospitalizations between three days and three months of life were coded as "emergency" or "urgent" or occurred through the emergency department. Numbers of emergency hospitalizations aggregated by month and state were used as outcomes. The intervention variable was an implementation of state-mandated POS. Difference in association across race/ethnicity was evaluated with interaction terms between the binary variable indicating the mandatory policy period and each race/ethnicity group. The model was adjusted for state-specific variables, such as percent of female infants and percent of private insurance. We identified 9,147 CCHD emergency hospitalizations. Among non-Hispanic Whites, there was a 22% (Confidence Interval [CI] 6%-36%) decline in CCHD emergency hospitalizations after implementation of mandated POS, on average. This decline was 65% less among non-Hispanic Blacks compared to non-Hispanic Whites. Our study detected an attenuated association with decreased number of emergency hospitalizations among Black compared to White infants. Further research is needed to clarify this disparity.

DOI： 10.1007/s00246-022-03027-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Limited data are available for clinical outcomes in patients who underwent urgent or emergency transcatheter aortic valve implantation (TAVI). This study investigated in-hospital and 1-year outcomes and explored prognostic covariates in urgent/emergency TAVI using nationwide registry data.Methods and Results: Among 26,775 patients who underwent TAVI between August 2013 and December 2019, 25,495 with 1-year follow-up information were analyzed in this study. Baseline and procedural characteristics, as well as clinical adverse events, were compared between the urgent/emergency and elective TAVI groups. The primary outcome was all-cause mortality within 1 year after TAVI. Multivariable Cox regression models were constructed to identify independent predictors after urgent or emergency TAVI. Urgent or emergency TAVI was performed in 578 (2.3%) patients. The Society of Thoracic Surgeons score was significantly higher in the urgent/emergency than elective TAVI group (13.3% vs. 6.0%; P<0.001). Device success rate was comparable between the 2 groups. All-cause death-free survival within 1 year was lower in the urgent/emergency than elective TAVI group (77.2% vs. 92.2%; log rank P<0.001). Malignancy, albumin and creatinine concentrations, ejection fraction, and mean pressure gradient were associated with 1-year mortality in the urgent/emergency TAVI group. CONCLUSIONS: Despite higher surgical risk and more comorbidities, the procedure was successfully performed in patients undergoing urgent/emergency TAVI, although it should be noted that prognosis was worse than for elective TAVI.

DOI： 10.1253/circj.CJ-22-0536

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: Anemia is a common complication of chronic kidney disease (CKD). The aim of this study was to evaluate hemoglobin levels at the initiation of erythropoiesis stimulating agent (ESA) therapy in patients with non-dialysis-dependent CKD (NDD-CKD) and anemia using a large-scale administrative database in Japan. METHODS: The longitudinal data of adult patients who initiated ESA therapy between April 2008 and December 2018 were extracted from a hospital-based administrative database. The primary outcome was hemoglobin level at the initiation of ESA therapy, whereas the exploratory outcome was hemoglobin level recorded 6 months after the onset of the ESA therapy. RESULTS: A total of 4939 patients were included in the primary analysis. The mean hemoglobin level at the initiation of ESA therapy was 9.1 g/dL, which was lower than the level (11 g/dL) recommended for the initiation of treatment by the current Japanese treatment guidelines. Moreover, 42.1% and 15.0% of the patients had hemoglobin levels <9.0 and <8.0 g/dL, respectively, at the initiation of ESA therapy. In 2964 patients for whom hemoglobin levels at 6 months after the initiation of ESA therapy were available, the mean hemoglobin level increased to 10.3 g/dL, and 61.9% and 31.1% of these patients had hemoglobin levels ≥10.0 and ≥11.0 g/dL, respectively. CONCLUSION: This real-world database study revealed that hemoglobin levels at the initiation of ESA therapy in new users of ESA were lower than those recommended by treatment guidelines in Japan.

DOI： 10.1080/03007995.2022.2125256

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Nonagenarians are a growing age group in patients undergoing transcatheter aortic valve replacement (TAVR); however, the appropriate use of TAVR in this population remains discussed because of their limited life expectancy and worse outcome reported. OBJECTIVES: The authors aimed to evaluate clinical characteristics and the prognostic impact of nonagenarians. METHODS: We analyzed consecutive patients undergoing transfemoral TAVR and were registered in the nationwide registry for TAVR in Japan (Japanese Transcatheter Valvular Therapies registry) between 2013 and 2018. The rate of 30-day and 1-year mortality and composite adverse event, comprising all-cause death, all stroke, and life-threatening/major bleeding, were assessed. RESULTS: Of the 15,028 registered patients during the study period, 2,215 (14.7%) were nonagenarians. Although the nonagenarians were less likely to have comorbid conditions (eg, diabetes mellitus and malignancy) than patients aged <90 y, they had a higher Society of Thoracic Surgeons risk score (8.8% vs 5.6%), mainly owing to their advanced age. The procedural characteristics were identical between 2 groups. The rate of 30-day mortality and composite endpoint was similar, whereas 1-year mortality and composite adverse events were increased among nonagenarians (10.3% vs 6.8% and 13.5% vs 9.2%, respectively), and nonagenarians were independently associated with these endpoints (HR: 1.21; 95% CI: 1.03-1.42; P = 0.023; HR: 1.24; 95% CI: 1.07-1.42; P = 0.004). CONCLUSIONS: Of the 15,028 TAVR procedures performed in Japan between 2013 and 2018, 14.7% were performed in nonagenarians. These patients were carefully selected by a multidisciplinary heart team and showed 21% and 24% increase of 1-year mortality and composite adverse outcome.

DOI： 10.1016/j.jacasi.2022.08.007

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: We aimed to determine the prognosis and potential benefit of postoperative chemotherapy according to subtype of medullary breast carcinoma (MedBC), a very rare invasive breast cancer. METHODS: A cohort of 1518 female patients with unilateral MedBC and 284,544 invasive ductal carcinoma (IDC) cases were enrolled from the Japanese Breast Cancer Registry. Prognosis of MedBC was compared to IDC among patients with estrogen receptor (ER)-negative and HER2-negative subtype (553 exact-matched patients) and ER-positive and HER2-negative subtype (163 MedBC and 489 IDC patients via Cox regression). Disease free-survival (DFS) and overall survival (OS) were compared between propensity score-matched adjuvant chemotherapy users and non-users with ER-negative and HER2-negative MedBC. RESULTS: Among ER-negative and HER2-negative subtype patients, DFS (hazard ratio (HR) 0.45; 95% confidence interval (95% CI), 0.30-0.68; log-rank P < 0.001) and OS (HR 0.51; 95% CI 0.32-0.83; log-rank P = 0.004) were significantly better in MedBC than IDC. Patients treated with postoperative chemotherapy showed better DFS (HR 0.27; 95% CI 0.09-0.80; log-rank P = 0.02) and OS (HR 0.27; 95% CI 0.09-0.80; log-rank P = 0.02) compared to those without. For the ER-positive and HER2-negative subtype, the point estimate for HR for DFS was 0.60 (95% CI 0.24-1.22) while that for OS was 0.98 (95% CI 0.46-1.84) for MedBC. CONCLUSION: In ER-negative and HER2-negative MedBC, the risk of recurrence and death was significantly lower than that of IDC, about half. Postoperative chemotherapy reduced recurrence and mortality. ER-positive and HER2-negative MedBC may have a lower risk of recurrence compared to IDC.

DOI： 10.1007/s10549-022-06749-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: Portopulmonary hypertension (PoPH) is one of the major underlying causes of pulmonary arterial hypertension (PAH). However, PoPH, especially treatment strategies, has been poorly studied. Therefore, this study evaluated current treatments for PoPH, their efficacy, and clinical outcomes of patients with PoPH. Methods and Results: Clinical data were collected for patients with PoPH who were enrolled in the Japan Pulmonary Hypertension Registry between 2008 and 2021. Hemodynamic changes, functional class, and clinical outcomes were compared between patients with PoPH treated with monotherapy and those treated with combination therapies. Clinical data were analyzed for 62 patients with PoPH, including 25 treatment-naïve patients, from 21 centers in Japan. In more than half the patients, PAH-specific therapy improved the New York Heart Association functional class by at least one class. The 3- and 5-year survival rates of these patients were 88.5% (95% confidence interval [CI] 76.0-94.7) and 80.2% (95% CI 64.8-89.3), respectively. Forty-one (66.1%) patients received combination therapy. Compared with patients who had received monotherapy, the mean pulmonary arterial pressure, pulmonary vascular resistance, and cardiac index were significantly improved in patients who had undergone combination therapies. Conclusions: Combination therapy was commonly used in patients with PoPH with a favorable prognosis. Combination therapies resulted in significant hemodynamic improvement without an increased risk of side effects.

DOI： 10.1253/circrep.CR-22-0098

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: Percutaneous coronary intervention (PCI) is increasingly performed via transradial access (TRA). This study aimed to investigate the clinical and economic benefits of TRA compared with transfemoral access (TFA) under universal healthcare coverage system in Japan. Methods: A total of 36,153 patients (acute coronary syndrome [ACS], 15,266; stable ischemic heart disease [SIHD], 20,052) across 714 institutions in the Japanese nationwide PCI registry (J-PCI) in 2015 were analyzed (mean age 69.9 ± 11.1 years and 23.6% female). Cost was defined as the total amount of healthcare resources used to care for the patient during hospitalization. Propensity score matching analysis was conducted to balance the baseline characteristics of patients undergoing TRA and TFA. Findings: The median total cost of PCI was JPY 1,341,176 (interquartile range, 959,052), with higher expenses for ACS (JPY 1,772,116 [1,117,107]) compared with SIHD (JPY 1,119,153 [540,440]) patients. Most patients underwent PCI via TRA (73.8%), and after propensity score matching, TRA was associated with a reduced risk of in-hospital death and bleeding (0.88% vs. 1.91% [P < 0.0001] and 2.18% vs. 4.53% [P < 0.0001] in ACS, and 0.10% vs. 0.28% [P = 0.070] and 0.53% vs. 1.72% [P < 0.0001] in SIHD, respectively), which led to lower costs in both ACS (JPY 1,699,279 [1,164,554] for TRA vs. JPY 1,931,255 [1,070,222] for TFA; P < 0.0001), and SIHD (JPY 1,102,352 [505,904] for TRA vs. JPY 1,311,525 [706,450] for TFA; P < 0.0001) patients. Interpretation: In this direct cost analysis of a nationwide registry, the use of TRA was associated with cost saving for both ACS and SIHD patients. Funding: This study was funded by the Japan Society for the Promotion of Science (grant nos. 20H03915, 16H05215, 16KK0186, 20K22883, and 21K08064), Japan Agency for Medical Research and Development [AMED] (grant number 16lk1010004h0002), and the National Clinical Database. The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics.

DOI： 10.1016/j.lanwpc.2022.100555

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Autosomal dominant polycystic kidney disease (ADPKD) is a rare hereditary disease leading to end-stage renal failure in approximately half of patients by seventy years of age. It is important to continuously take tolvaptan to control disease progression. However, adherence to tolvaptan in a real-world setting, rather than randomized controlled trials (RCTs), has not been sufficiently reported. We aimed to investigate tolvaptan persistence among patients with ADPKD using a large claims database. Using the Shizuoka Kokuho Database, we identified patients diagnosed with ADPKD who were prescribed tolvaptan from March 2014-September 2018 in Japan. The persistence rate of tolvaptan medication was estimated by Kaplan-Meier analysis, and patient background factors associated with treatment discontinuation were exploratively evaluated with log-rank tests. We identified 1714 eligible patients with ADPKD, and among them, 25 patients used tolvaptan medication. We followed up these patients, whose median treatment duration was 21 months. The persistence rates at 12, 24, and 36 months were estimated to be 70.8% (95% confidence interval: 48.2-93.4), 46.5% (23.2-66.9), and 38.7% (16.4-60.8), respectively. In the exploratory analysis, there were no factors that were obviously associated with tolvaptan discontinuation. The persistence rate of tolvaptan in patients with ADPKD in a real-world setting may be lower than that in previous RCTs. Our innovative method, particularly in Japan, to analyze adherence using large claims data should change the way clinical epidemiological research and health policies of rare diseases are designed in the future.

DOI： 10.1097/MD.0000000000030923

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Although transcatheter aortic valve replacement (TAVR) has demonstrated favorable outcomes in randomized studies, there remains a sizable group of patients in whom TAVR may be futile. Characterizing the survival rate in a wide array of patients undergoing TAVR can help develop effective strategies for improving the allocation of medial resources. OBJECTIVES: The aim of this study was to develop a risk model to estimate 1-year mortality after TAVR from a representative nationwide registry in Japan. METHODS: The J-TVT (Japan Transcatheter Valve Therapies) registry contains complete data, including 1-year outcomes, on patients undergoing TAVR in Japan. A total of 17,655 patients underwent TAVR between 2013 and 2018. They were randomly divided into 2 groups in a 7:3 ratio to form a derivation cohort of 12,316 patients and a validation cohort of 5,339 patients. A risk model was constructed for 1-year mortality in the derivation cohort, and its discrimination and calibration were assessed in the validation cohort. RESULTS: The mean age of all registered patients was 84.4 years, and 68.8% were women. The mean body size area was 1.43 m2, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.3%. The estimated 1-year survival was 91.8%; 202 and 1,316 deaths were observed at 30 days and 1 year, respectively; The estimated C index for the developed model was 0.733 (95% CI: 0.709-0.757) in the validation cohort, with good calibration. CONCLUSIONS: A prediction model for 1-year survival following TAVR derived from a national clinical database performed well and should aid physicians managing TAVR patients.

DOI： 10.1016/j.jacasi.2022.06.002

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記述言語：英語  

DOI： 10.1186/s12873-022-00701-w

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Despite advances in technology and technique, a certain proportion of patients experience non-cardiovascular (CV) readmissions after transcatheter aortic valve replacement (TAVR). However, the actual burden and details of non-CV readmission remain uncertain. METHODS: The Japan-Transcatheter Valve Therapies (J-TVT) registry is a representative nationwide registry, and mandates complete data entry, including 1-year outcomes, for patients undergoing TAVR in Japan. We analyzed the non-CV adverse events (AEs) requiring readmission after the index TAVR procedure between 2013 and 2018. RESULTS: A total of 14,472 patients were analyzed (68.8% of women with median age of 85 years). Overall, 367 patients (2.5%) and 1050 patients (7.2%) had non-CV readmission at 30 days and 1 year, respectively. The most frequent non-CV AEs were related to respiratory (24.0%) and gastrointestinal disease (19.3%). Specifically, 79.0% of all respiratory AEs were pneumonia (infectious, interstitial, or aspiration). Of the gastrointestinal AEs, 22.1% were malignancies, and 18.5% were non-procedural-related bleeding. Age ≥90 years, male sex, body mass index <20 kg/m2, New York Heart Association functional class III/IV, atrial fibrillation/flutter, malignancy, chronic obstructive pulmonary disease, dialysis, hemoglobin level, albumin level, creatinine level, and non-transfemoral approach were independent predictors of non-CV readmission. CONCLUSIONS: In this analysis of the nationwide registry of patients undergoing TAVR, rate of non-CV readmission at 30 days and 1 year, particularly those related to respiratory and gastrointestinal conditions, were lower than those previously reported. However, caution is still needed when performing TAVR on patients susceptible to these conditions.

DOI： 10.1016/j.jjcc.2022.03.010

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: A research subgroup was established by the Japanese Society of Gastroenterological Surgery to improve the health care quality in the Chushikoku area of Western Japan. METHODS: The records of four surgical procedures were extracted from the Japanese National Clinical Database and analyzed retrospectively to establish the association between hospital characteristics, defined using a combination of hospital case-volume and patients' hospital travel distance, and the incidences of perioperative complications of ≥ Grade 3 of the Clavien-Dindo classification after gastroenterological surgery. RESULTS: This study analyzed 11,515 cases of distal gastrectomy for gastric cancer, 4,705 cases of total gastrectomy for gastric cancer, 4,996 cases of right hemicolectomy for colon cancer, and 5,243 cases of lower anterior resection for rectal cancer, with composite outcome incidences of 5.6%, 10.2%, 5.5%, and 10.7%, respectively. After adjusting for patient characteristics and surgical procedures, no association was identified between the hospital category and surgical outcomes. CONCLUSION: The findings of our study of the Chushikoku region did not provide positive support for the consolidation and centralization of hospitals, based solely on hospital case volume. Our grouping was unique in that we included patient travel distance in the analysis, but further investigations from other perspectives are needed.

DOI： 10.1007/s00595-022-02569-6

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The risk of choking increases with aging, and the number of cases of choking-induced cardiac arrest is increasing. However, few studies have examined the prognosis of choking-induced cardiac arrest. The aim of this study was to reveal the rates of survival and dependence on devices in the long term after choking-induced cardiac arrest. METHODS: We analyzed data from the Shizuoka Kokuho Database, which consists of claims data of approximately 2.2 million people, from April 2012 to September 2018. We selected patients with choking-induced cardiac arrest who received cardiopulmonary resuscitation in the hospital. Patients were excluded if they were less than 20 years old, had an upper airway tumor, received ventilation assistance, or received enteral nutrition in the month prior to cardiac arrest. The primary outcome was death, and the secondary outcomes were the rates of survival at 3-months and independence on devices. Descriptive statistics are presented and compared among age groups (20-64 years, 65-74 years, 75-84 years, 85 years and older), and survival time analysis (Kaplan-Meier method) was performed. RESULTS: In total, 268 patients were analyzed, including 26 patients in the 20-64 age group, 33 patients in the 65-74 age group, 70 patients in the 75-84 age group, and 139 patients in the ≥85 age group. The overall 3-month survival rate was 5.6% (15/268). The 3-month survival rates were 3.8% (1/26) in the 20-64 age group, 15.2% (5/33) in the 65-74 age group, 8.6% (6/70) in the 75-84 age group, and 2.2% (3/139) in the ≥85 age group. The overall 12-month survival rate was 2.6% (7/268). Of the 7 patients who survived for 12 months, 3 received ventilation management and 5 received tube or intravenous feedings at 3 months. These survivors were still receiving ventilation assistance and tube feedings in the hospital and had not been discharged at 12 months. CONCLUSIONS: The prognosis of choking-induced cardiac arrest was extremely poor when patients were not resuscitated before hospital arrival. Those who survived were mostly dependent on assistive devices. Additionally, none of the survivors dependent on assistive devices had discontinued the use of the devices at the long-term follow-up.

DOI： 10.1186/s12873-022-00676-8

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

INTRODUCTION: The purpose of this study was to examine the association between prior emergency department (ED) visit or hospitalization and subsequent suicide attempt among homeless youth aged 10-17 years old. METHODS: With New York statewide databases, a case-control design was conducted. Cases and controls were homeless patients with an ED visit or hospitalization due to suicide attempt (cases) or appendicitis (controls) between April and December. We examined ED and inpatient records for 90 days prior to the visit for suicide attempt or appendicitis. The primary exposure variable was prior healthcare utilization for any reason other than the following four reasons: mental health disorder, substance use, self-harm, and other injuries. Multivariable logistic regression models, with year fixed effect and hospital random effect, were used. RESULTS: A total of 335 cases and 742 controls were identified. Cases had lower odds of prior healthcare utilization for any reason other than the four reasons listed above. (adjusted Odds Ratio [aOR]: 0.53, p-value = 0.03). CONCLUSIONS: The association between prior healthcare utilization and decreased risk of suicide attempt among homeless youth may be due to comprehensive care provided during healthcare utilization. It may also reflect the presence of a social network that provided a protective effect.

DOI： 10.1111/sltb.12897

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Male breast cancer (MBC) is rare; however, its incidence is increasing. There have been no large-scale reports on the clinicopathological characteristics of MBC in Japan. METHODS: We investigated patients diagnosed with breast cancer in the Japanese National Clinical Database (NCD) between January 2012 and December 2018. RESULTS: A total of 594,316 cases of breast cancer, including 3780 MBC (0.6%) and 590,536 female breast cancer (FBC) (99.4%), were evaluated. The median age at MBC and FBC diagnosis was 71 (45-86, 5-95%) and 60 years (39-83) (p < 0.001), respectively. MBC cases had a higher clinical stage than FBC cases: 7.4 vs. 13.3% stage 0, 37.2 vs. 44.3% stage I, 25.6 vs. 23.9% stage IIA, 8.8 vs. 8.4% stage IIB, 1.9 vs. 2.4% stage IIIA, 10.1 vs. 3.3% stage IIIB, and 1.1 vs. 1.3% stage IIIC (p < 0.001). Breast-conserving surgery was more frequent in FBC (14.6 vs. 46.7%, p = 0.02). Axillary lymph node dissection was more frequent in MBC cases (32.9 vs. 25.2%, p < 0.001). Estrogen receptor(ER)-positive disease was observed in 95.6% of MBC and 85.3% of FBC cases (p < 0.001). The HER2-positive disease rates were 9.5% and 15.7%, respectively (p < 0.001). Comorbidities were more frequent in MBC (57.3 vs. 32.8%) (p < 0.001). Chemotherapy was less common in MBC, while endocrine therapy use was similar in ER-positive MBC and FBC. Perioperative radiation therapy was performed in 14.3% and 44.3% of cases. CONCLUSION: Japanese MBC had an older age of onset, were more likely to be hormone receptor-positive disease, and received less perioperative chemotherapy than FBC.

DOI： 10.1007/s12282-022-01378-6

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

AIM: Postmastectomy radiotherapy (PMRT) is the standard treatment for locally advanced breast cancer. However, the effectiveness of PMRT in patients with pT1-2 and N1 tumours remains controversial. Therefore, this study aimed to determine the prognostic impact of PMRT in patients with breast cancer and with pT1-2 and 1-3 lymph node metastases. METHODS: Using data from the Japanese National Clinical Database from 2004 to 2012, we evaluated the association of PMRT with locoregional recurrence (LRR), any recurrence, and mortality. We enrolled patients who had undergone mastectomy and axillary node dissection and were diagnosed with pT1-2 and N1. We compared clinicopathological factors and prognosis between patients who received (PMRT group) and those who did not receive (No-PMRT group) PMRT. RESULTS: Among 8914 patients enrolled, 492 patients belonged to the PMRT group and 8422 to the No-PMRT group. The median observation time was 6.3 years. There was no significant difference in the incidences of LRR (4.0% versus 5.0%, P = 0.61), recurrence (13.8% versus 11.8%, P = 0.23) and breast cancer death (6.0% versus 4.3%, P = 0.08) at 5 years between the groups. Multivariable analysis revealed that LRR was significantly associated with tumour size, number of node metastases and triple-negative subtype but not with PMRT. CONCLUSIONS: The LRR rate in the No-PMRT group was 5.0% at 5 years among patients with T1-2 and N1. PMRT did not significantly influence LRR in patients with T1-2 and N1. However, PMRT administration should be tailored considering the individual risks of tumour size, 3 node metastases and triple-negative subtype.

DOI： 10.1016/j.ejca.2022.05.017

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: The objective of this study was to create prediction models for two-year overall survival (OS) and amputation free survival (AFS) after revascularization in patients with chronic limb threatening ischemia (CLTI). DESIGN: This was a retrospective analysis of prospectively collected multicenter registry data (JAPAN Critical Limb Ischemia Database; JCLIMB). MATERIALS: Data from 3 505 unique patients with CLTI who had undergone revascularization from 2013 to 2017 were extracted from the JCLIMB for the analysis. METHODS: The cohort was randomly divided into development (2 861 patients) and validation cohorts (644 patients). In the development cohort, multivariable risk models were constructed to predict two-year OS and AFS using Cox proportional hazard regression analysis. These models were applied to the validation cohort and their performances were evaluated using Harrell's C-index and calibration plots. RESULTS: Kaplan-Meier estimates of two-year OS and AFS post-revascularization in the whole cohort were 69% and 62%, respectively. Strong predictors for OS consisted of age, activity, malignant neoplasm, chronic kidney disease (CKD), congestive heart failure (CHF), geriatric nutritional risk index (GNRI), and sex. Strong predictors for AFS consisted of age, activity, malignant neoplasm, CKD, CHF, GNRI, body temperature, white blood cells, urgent revascularization procedure, and sex. Prediction models for two-year OS and AFS showed good discrimination with Harrell's C-indexes of 0.73 [95% confidence interval (CI); 0.69-0.77] and 0.72 (95% CI; 0.68-0.76), respectively CONCLUSIONS: Prediction models for two-year OS and AFS post-revascularization in patients with CLTI were created. They can assist in determining treatment strategies and serve as risk-adjustment modalities for quality benchmarking for revascularization in patients with CLTI at each facility.

DOI： 10.1016/j.ejvs.2022.05.038

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Elsevier BV  

BACKGROUND: Pulmonary arterial hypertension (PAH) is a rare, progressive disease. The treatment landscape for PAH in Japan has evolved considerably in recent years, but there is limited knowledge of the changes in treatment practices or patient characteristics. OBJECTIVES: The aim of this study was to evaluate the changes in characteristics and initial treatments for PAH in Japan over time. METHODS: This study used data from the Japan Pulmonary Hypertension Registry (JAPHR) to compare patient characteristics and treatment practices between 2008-2015 (n = 316) and 2016-2020 (n = 315). RESULTS: The mean ± standard deviation age at diagnosis increased from 47.9 ± 16.7 years in 2008-2015 to 52.7 ± 16.9 years in 2016-2020. The mean pulmonary arterial pressure decreased from 45.4 ± 15.0 to 38.6 ± 13.1 mm Hg. Idiopathic/hereditary PAH was the most common etiology in both periods (50.0% and 51.1%, respectively). The proportion of patients prescribed oral/inhaled combination therapies increased from 47.8% to 57.5%. Oral/inhaled combination therapies were frequently prescribed to patients with congenital heart disease-related PAH (81.8%). There was no significant trend in prescribing practices based on French low-risk criteria: among patients with 0, 1, 2, 3, or 4 criteria, 53.8%, 68.8%, 52.8%, 66.7%, and 39.4% were prescribed oral/inhaled combination therapies, and 0%, 16.7%, 27.0%, 17.3%, and 15.2% were prescribed oral/inhaled monotherapies. Macitentan, tadalafil, selexipag, and epoprostenol were the most frequently prescribed drugs. CONCLUSIONS: The severity of PAH decreased over time in Japan. Oral/inhaled combination therapies were generally preferred. Physicians generally prescribed therapies after considering the patients' hemodynamics and clinical severity. (Japan Pulmonary Hypertension Registry [JAPHR]; UMIN000026680).

DOI： 10.1016/j.jacasi.2022.02.011

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: Centralization of high-risk surgeries has become a widespread strategy. However, whether or not the hospital volume affects the outcomes of common surgeries remains unclear. This study explored the association between hospital volume and short-term outcomes of common surgeries, as represented by appendectomy, cholecystectomy, and pneumothorax surgery, by analyzing data from a Japanese nationwide database. METHODS: All hospitals were categorized into four groups (very low-, low-, high-, and very high-volume) according to the annual hospital volume of all gastrointestinal surgeries or all respiratory surgeries in 2017. Patient demographic data and surgical outcomes were evaluated across hospital volume categories. RESULTS: We analyzed 2392 facilities which performed 771,182 gastrointestinal surgeries, and 992 facilities which performed 98,656 respiratory surgeries. Short-term outcomes of patients who underwent appendectomy (n = 50,568), cholecystectomy (n = 104,262), and pneumothorax surgery (n = 11,723) were evaluated. The incidences of postoperative complications, reoperation, and readmission were similar among the groups. Multivariable logistic regression analyses revealed hospital volume to have no association with these short-term outcomes. CONCLUSION: Analyses of a Japanese nationwide database revealed that the hospital volume was not associated with short-term outcomes of appendectomy, cholecystectomy, and pneumothorax surgery. These common surgical procedures may not require centralization into high-volume hospitals.

DOI： 10.1007/s00595-022-02467-x

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: To assess the increase in hospital costs associated with postoperative complications after lower anterior resection (LAR) for rectal cancer. METHODS: The subjects of this retrospective analysis were patients who underwent elective LAR surgery between April, 2015 and March, 2017, collected from a Japanese nationwide gastroenterological surgery registry linked to hospital-based claims data. We evaluated total and category-specific hospitalization costs based on the level of postoperative complications categorized using the Clavien-Dindo (CD) classification. We assessed the relative increase in hospital costs, adjusting for preoperative factors and hospital case volume. RESULTS: We identified 15,187 patients (mean age 66.8) treated at 884 hospitals. Overall, 71.8% had no recorded complications, whereas 7.6%, 10.8%, 9.0%, 0.6%, and 0.2% had postoperative complications of CD grades I-V, respectively. The median (25th-75th percentiles) hospital costs were $17.3 K (16.1-19.3) for the no-complications group, and $19.1 K (17.3-22.2), $21.0 K (18.5-25.0), $27.4 K (22.4-33.9), $41.8 K (291-618), and $22.7 K (183-421) for the CD grades I-V complication groups, respectively. The multivariable model identified that complications of CD grades I-V were associated with 11%, 21%, 61%, 142%, and 70% increases in in-hospital costs compared with no complications. CONCLUSIONS: Postoperative complications and their severity are strongly associated with increased hospital costs and health-care resource utilization. Implementing strategies to prevent postoperative complications will improve patients' clinical outcomes and reduce hospital care costs substantially.

DOI： 10.1007/s00595-022-02523-6

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: This study compared operative mortality and morbidity based on the number of previous cardiac operations to identify whether this was a risk factor for outcomes after valve reoperation. METHODS: Among valve surgery patients in the Japan Cardiovascular Surgery Database (2013‒2015), 4436 patients who underwent valve reoperation with a previous cardiac surgery were included. Patients were divided into three groups based on the number of previous cardiac operations (NPO1, NPO2, and NPO3+). Multivariable logistic regression analyses were conducted, adjusting for patient- and surgery-related factors to estimate the association of the NPO with the clinical outcomes of valve reoperation. RESULTS: Postoperative mortality was 8.6% in the NPO1, 11.2% in the NPO2, and 14.4% in the NPO3 + group, and the corresponding postoperative morbidity rates were 40.0, 46.2, and 59.2%, respectively. On multivariable logistic regression analysis, the odds of operative death were 1.36 (95% confidence interval [CI] 0.98‒1.87, p = 0.06) times higher for the NPO2 and 1.61 (95% CI 0.89‒2.90, p = 0.11) times higher for the NPO3+ group than for the NPO1 group. The odds ratios for postoperative complications were 1.31 (95% CI 1.08‒1.59, p < 0.01) for the NPO2 and 2.49 (95% CI 1.66‒3.74, p < 0.01) for the NPO3+ relative to the NPO1 group. CONCLUSION: The number of previous cardiac operations is associated with postoperative outcomes in patients undergoing valve reoperations. Considering the risk of repeat cardiac surgery, we recommend careful selection of operative procedures to avoid reoperation in patients requiring primary valve surgery.

DOI： 10.1007/s11748-022-01828-0

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: Elective laparoscopic surgery is now widely accepted in the treatment of abdominal diseases because of its minimal invasiveness and rapid postoperative recovery. It is also used in the emergency setting for the diagnosis and treatment of acute diffuse peritonitis regardless of the causative disease. However, the value of laparoscopy in acute diffuse peritonitis remains unclear. In this study we aimed to show trends in the use of laparoscopy over time and compare the real-world performance of laparoscopic surgery with that of open surgery for acute diffuse peritonitis due to gastrointestinal perforation. Methods: We extracted data from the National Clinical Database, a nationwide surgery registration system in Japan, for patients with a diagnosis of acute diffuse peritonitis due to gastroduodenal or colorectal perforation between 2016 and 2019. Trends in the use of laparoscopy over time were identified. Patient characteristics, laboratory findings, surgical findings, and postoperative complications were compared between laparoscopic surgery and open surgery. Results: Patients in poor condition and those with abnormal laboratory findings tended to undergo open surgery. Anesthesia time and operating time were longer for laparoscopic surgery in patients with gastroduodenal perforation but shorter in those with colorectal perforation. Fewer complications occurred in patients who underwent laparoscopic surgery. The number of institutions where laparoscopic surgery was performed and the proportion of the use of laparoscopy at each institution increased over time. Conclusion: The use of laparoscopy is becoming common in surgery for acute diffuse peritonitis due to gastrointestinal perforation. This approach may be a useful option for acute diffuse peritonitis.

DOI： 10.1002/ags3.12533

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To assess differences in rates of postpartum hospitalisations among homeless women compared with non-homeless women. DESIGN: Cross-sectional secondary analysis of readmissions and emergency department (ED) utilisation among postpartum women using hierarchical regression models adjusted for age, race/ethnicity, insurance type during delivery, delivery length of stay, maternal comorbidity index score, other pregnancy complications, neonatal complications, caesarean delivery, year fixed effect and a birth hospital random effect. SETTING: New York statewide inpatient and emergency department databases (2009-2014). PARTICIPANTS: 82 820 and 1 026 965 postpartum homeless and non-homeless women, respectively. MAIN OUTCOME MEASURES: Postpartum readmissions (primary outcome) and postpartum ED visits (secondary outcome) within 6 weeks after discharge date from delivery hospitalisation. RESULTS: Homeless women had lower rates of both postpartum readmissions (risk-adjusted rates: 1.4% vs 1.6%; adjusted OR (aOR) 0.87, 95% CI 0.75 to 1.00, p=0.048) and ED visits than non-homeless women (risk-adjusted rates: 8.1% vs 9.5%; aOR 0.83, 95% CI 0.77 to 0.90, p<0.001). A sensitivity analysis stratifying the non-homeless population by income quartile revealed significantly lower hospitalisation rates of homeless women compared with housed women in the lowest income quartile. These results were surprising due to the trend of postpartum hospitalisation rates increasing as income levels decreased. CONCLUSIONS: Two factors likely led to lower rates of hospital readmissions among homeless women. First, barriers including lack of transportation, payment or childcare could have impeded access to postpartum inpatient and emergency care. Second, given New York State's extensive safety net, discharge planning such as respite and sober living housing may have provided access to outpatient care and quality of life, preventing adverse health events. Additional research using outpatient data and patient perspectives is needed to recognise how the factors affect postpartum health among homeless women. These findings could aid in lowering readmissions of the housed postpartum population.

DOI： 10.1136/bmjqs-2020-012898

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Occult breast cancer (OBC) is classified as carcinoma of an unknown primary site, and the adequate therapy for OBC remains controversial. This retrospective study aimed to reveal the transition in breast cancer therapy and the frequency of primary breast tumors after resection in clinical OBC (cT0N+) patients using the Japanese Breast Cancer Registry database. METHODS: We enrolled OBC patients with cT0N+ from the registry between 2010 and 2018. On the basis of the period of diagnosis, OBC patients were divided into the following two groups: 2010-2014 and 2015-2018. We described the transition in treatments and tumor characteristics. After breast resection, the frequency of pathological identification of primary tumors and tumor sizes was assessed. RESULTS: Of the 687,468 patients registered, we identified 148 cT0N+ patients with a median age of 61 years. Of these patients, 64.2% (n = 95) received breast surgery (2010-2014: 79.1%, 2015-2018: 50.0%). Axillary lymph node dissection was performed in 92.6% (n = 137, 2010-2014: 91.6%, 2015-2018: 93.4%). The breast tumor size in the resected breast was 0-7.0 cm (median: 0 cm, 2010-2014: 0-7.0 cm [median: 0 cm], 2015-2018: 0-6.2 cm [median: 0 cm]). The pathological identification rate of the primary tumor was 41.1% (n = 39, 2010-2014: 40.4%, 2015-2018: 42.1%). CONCLUSIONS: Breast surgery for cT0N+ decreased between 2010 and 2018. Despite the high identification rate of primary tumors, most tumors were small, and there was no significant change in the identification rate or invasive diameter of the identified tumors after 2010.

DOI： 10.1007/s12282-022-01348-y

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P<0.001), were more frequently women (45.9% versus 68.1%; P<0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P<0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P<0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P<0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P<0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

DOI： 10.1161/JAHA.121.023848

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: To assess the applicability of Electronic Frailty Index (eFI) and Hospital Frailty Risk Score (HFRS) algorithms to Japanese administrative claims data and to evaluate their association with long-term outcomes. STUDY DESIGN AND SETTING: A cohort study using a regional government administrative healthcare and long-term care (LTC) claims database in Japan 2014-18. PARTICIPANTS: Plan enrollees aged ≥50 years. METHODS: We applied the two algorithms to the cohort and assessed the scores' distributions alongside enrollees' 4-year mortality and initiation of government-supported LTC. Using Cox regression and Fine-Gray models, we evaluated the association between frailty scores and outcomes as well as the models' discriminatory ability. RESULTS: Among 827,744 enrollees, 42.8% were categorised by eFI as fit, 31.2% mild, 17.5% moderate and 8.5% severe. For HFRS, 73.0% were low, 24.3% intermediate and 2.7% high risk; 35 of 36 predictors for eFI, and 92 of 109 codes originally used for HFRS were available in the Japanese system. Relative to the lowest frailty group, the highest frailty group had hazard ratios [95% confidence interval (CI)] of 2.09 (1.98-2.21) for mortality and 2.45 (2.28-2.63) for LTC for eFI; those for HFRS were 3.79 (3.56-4.03) and 3.31 (2.87-3.82), respectively. The area under the receiver operating characteristics curves for the unadjusted model at 48 months was 0.68 for death and 0.68 for LTC for eFI, and 0.73 and 0.70, respectively, for HFRS. CONCLUSIONS: The frailty algorithms were applicable to the Japanese system and could contribute to the identifications of enrollees at risk of long-term mortality or LTC use.

DOI： 10.1093/ageing/afac009

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1093/bjs/znab400

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Confounding by indication is a serious threat to comparative studies using real world data. We assessed the utility of automated data-adaptive analytic approach for confounding adjustment when both claims and clinical registry data are available. METHODS: We used a comparative study example of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in 2005-2008 when CAS was only indicated for patients with high surgical risk. We included Medicare beneficiaries linked to the Society for Vascular Surgery's Vascular Registry >65 years old undergoing CAS/CEA. We compared hazard ratios (HRs) for death while adjusting for confounding by combining various 1) Propensity score (PS) modeling strategies (investigator-specified [IS-PS] vs. automated data-adaptive [ada-PS]); 2) data sources (claims-only, registry-only and claims-plus-registry); and 3) PS adjustment approaches (matching vs. quintiles-adjustment with/without trimming). An HR of 1.0 was used as a benchmark effect estimate based on CREST trial. RESULTS: The cohort included 1,999 CAS and 3,255 CEA patients (mean age 76). CAS patients were more likely symptomatic and at high surgical risk, and experienced higher mortality (crude HR = 1.82 for CAS vs. CEA). HRs from PS-quintile adjustment without trimming were 1.48 and 1.52 for claims-only IS-PS and ada-PS, 1.51 and 1.42 for registry-only IS-PS and ada-PS, and 1.34 and 1.23 for claims-plus-registry IS-PS and ada-PS, respectively. Estimates from other PS adjustment approaches showed similar patterns. CONCLUSIONS: In a comparative effectiveness study of CAS vs. CEA with strong confounding by indication, ada-PS performed better than IS-PS in general, but both claims and registry data were needed to adequately control for bias.

DOI： 10.1371/journal.pone.0272975

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Springer Science and Business Media LLC  

<title>Abstract</title><sec>
<title>Background</title>
Hemoglobin A1c (HbA1c) levels are routinely measured during health check-ups and are used as an indicator of glycemic control in Japan. However, only a few studies have followed up individuals to assess the risk of diabetes development and worsening based on HbA1c screening results. This study evaluated the relationship between HbA1c screening results and the risk of diabetes development and worsening.


</sec><sec>
<title>Methods</title>
Data were collected from the Shizuoka Kokuho Database, a Japanese administrative claims database of insured individuals aged &gt; 40 years. We included individuals available for follow-up from April 2012 to March 2018 who had not received any diabetes treatment before March 2014. HbA1c screening results were categorized into 4 groups based on the HbA1c levels at the 2012 and 2013 health check-ups: group A, those whose HbA1c levels were &lt; 6.5% in 2012 and 2013; group B, those whose HbA1c levels &gt; 6.5% in 2012 but &lt; 6.5% in 2013; group C, those whose HbA1c levels were &gt; 6.5% in 2012 and 2013; and group D, those whose HbA1c levels were &lt; 6.5% in 2012 and &gt; 6.5% in 2013. Logistic regression models were used to analyze diabetes development and worsening, defined as the initiation of diabetes treatment by March 2018 and the use of injection drugs by participants who initiated diabetes treatment by March 2018.


</sec><sec>
<title>Results</title>
Overall, 137,852 individuals were analyzed. After adjusting for covariates, compared with group A, group B was more likely to initiate treatment within 4 years (odds ratio: 22.64; 95% confidence interval: 14.66–34.99). In patients who initiated diabetes treatment by March 2018, injection drugs were less likely used by group D than by group A (odds ratio: 0.28; 95% confidence interval: 0.12–0.61).


</sec><sec>
<title>Conclusions</title>
Our study suggests that although HbA1c levels measured during health check-ups were correlated with the risk of diabetes development and worsening, HbA1c levels in a single year may not necessarily provide sufficient information to consider these future risks.


</sec>

DOI： 10.1186/s12889-021-11933-z

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その他リンク： https://link.springer.com/article/10.1186/s12889-021-11933-z/fulltext.html

記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: This study aimed to clarify the clinical features, postoperative outcomes, and prognostic factors in patients with endograft infection in the abdominal aorta and iliac artery. SUMMARY BACKGROUND DATA: Endograft infection in the abdominal aorta and iliac artery is a potentially fatal condition. However, due to its rarity, clinical characteristics and optimal treatment strategy remain to be established. METHODS: In this nationwide retrospective cohort study, we investigated 112 patients who underwent surgical treatment for endograft infection in the abdominal aorta and/or iliac artery between 2011 and 2017 using a Japanese clinical registry. We examined the relationships between the preoperative and operative factors and the outcomes after surgery including persistent or recurrent infection related to the endograft and 90-day and 3-year mortality. RESULTS: The median period between the index endograft placement and surgery for infection was 369.5 days. Persistent or recurrent endograft-related infection occurred in 34 patients (30.4%). The cumulative overall survival rates at 30 days, 90 days, 1 year, 3 years, and 5 years were 90.2%, 76.5%, 66.7%, 50.9%, and 31.5%, respectively. Partial removal or total preservation of the infected endograft was independently associated with short-term and late mortality. Preoperative anemia and imaging findings suggestive of fistula development to the gastrointestinal tract also showed an independent association with late mortality. CONCLUSIONS: Surgical intervention for endograft infection in the abdominal aorta and iliac artery was associated with a high risk of postoperative morbidity and mortality. Total removal of the infected endograft should be attempted because partial removal or total preservation can lead to a poor prognosis.

DOI： 10.1097/SLA.0000000000005293

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記述言語：英語  

DOI： 10.1016/j.athoracsur.2021.09.059

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：SPRINGER JAPAN KK  

Purpose Radiotherapy (RT) and endocrine therapy (ET) are standard treatment options after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). We investigated the national patterns of adjuvant therapy use after BCS for DCIS in Japan. Methods We obtained relevant data of patients diagnosed with DCIS undergoing surgery and treated with BCS between 2014 and 2016 from the Japanese Breast Cancer Registry database. The relationship between the clinicopathologic, institutional, and regional factors, and adjuvant treatment was examined using multivariable analyses. Results We identified 9516 patients who underwent BCS for DCIS. Overall, 23% received no adjuvant treatment, 71% received RT, 32% received ET, and 26% received combination therapy. The percentages of patients who received ET and combination therapy in 2016 were significantly lower [odds ratio (OR): 0.71, 0.77, respectively] than in 2014. The proportion of RT was low among young or elderly patients (OR: 0.75, 0.44, respectively) and in non-certified facilities (OR: 0.56). The proportion of ET was high in non-certified facilities (OR: 1.58) and among patients with positive margins (OR: 1.62). Combination therapy was higher among patients with positive margins (OR: 1.53). Conclusions Our study found a distinct adjuvant treatment pattern after BCS for DCIS depending on clinicopathologic factors, year, age, which indicate that physicians provide individualized treatment according to the background of the patients and the biology of DCIS. The facilities and regions remain significant factors of influencing adjuvant treatment pattern.

DOI： 10.1007/s12282-021-01307-z

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.3400/avd.ar.20-00160

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: The principal of this analysis was to understand global feature of the number and type of grafts and number of diseased vessels of those undergoing coronary artery bypass grafting (CABG) and their short-term clinical results. METHODS AND RESULTS: This report presents annual report on the collective data of CABG in the year 2018 (1 January-31 December). Data were collected based on the series of questionnaire which has been performed by The Japanese Association for Coronary Artery Surgery (JACAS), capturing the corresponding data from the Japan Adult Cardiovascular Surgery Database (JCVSD). We also analyzed descriptive clinical results of those undergoing surgeries for acute myocardial infarction and ischemic mitral regurgitation. CONCLUSION: This is the first article summarizing the results from annually performed questionnaires by JACAS based on JCVSD, on the trend of CABG procedures and clinical results in Japan as a scientific manuscript.

DOI： 10.5761/atcs.sr.21-00159

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Vasodilator capacity of coronary circulation is an important diagnostic and prognostic tool in patients with coronary artery disease (CAD). We aimed to clarify the incidence of coronary microvascular dysfunction (CMD), defined as impaired modified coronary flow capacity (mCFC) proposed by Johnson and Gould and measured by 13N-ammonia myocardial perfusion positron emission tomography (PET), in patients without obstructive CAD and to evaluate the risk of future cardiovascular events. METHODS: This retrospective study recruited 407 consecutive CAD-suspected patients who underwent both pharmacological stress/rest 13N-ammonia PET and coronary angiography. Of the 407 patients, 137 patients (median age, 70 years; 63 women) were eligible and followed up (median, 19.8 months). Endpoints were defined as cardiovascular death or major adverse cardiovascular events (MACEs), such as cardiovascular death, nonfatal myocardial infarction, unplanned hospitalization for any cardiac reasons, and unplanned coronary revascularization. The impaired mCFC group included patients with mildly to severely reduced regional CFC in, at least, one vascular territory (n=34), while the remaining patients (n=103) were categorized as having preserved mCFC. RESULTS: Overall, cardiovascular death and MACEs occurred in five (4%) patients. The Kaplan-Meier curve showed a significant reduction in event-free survival for cardiovascular death (p=0.004) and MACEs (p<0.0001) in the impaired mCFC group, compared to the preserved mCFC group. Impaired mCFC was independently associated with the incidence of both cardiovascular death and MACEs after propensity-score adjustments [hazard ratio (HR), 10.7; 95% confidence interval (CI), 1.0-106.0; p=0.04 and HR, 9.5; 95% CI, 2.5-36.2; p<0.001, respectively]. CONCLUSIONS: In CAD-suspected patients without obstructive coronary arteries, impaired mCFC was observed in approximately 25% and was associated with a higher risk of cardiovascular death and MACEs. The mCFC concept can help identify patients who would benefit from specific therapies or lifestyle modifications to prevent future MACEs and can clarify potential mechanisms of CMD.

DOI： 10.1016/j.jjcc.2021.09.001

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

AIM: This study aimed at investigating the real-world prognostic impact of systemic treatment in older patients with stage II/III breast cancer (BC). METHODS: This retrospective cohort study included patients with stage II/III primary BC, aged ≥55 years, and registered in the Japanese Breast Cancer Registry from 2004 to 2011. The clinicopathological characteristics, treatments, and prognosis of patients aged ≥75 years (older) were compared to those of younger patients. RESULTS: In total, 56,093 patients (12,727, ≥75 years; 17,860, 65-74 years; 25,506, 55-64 years) were enrolled. In the older group, 9.2% with a luminal (hormone receptor [HR]+/human epidermal growth factor receptor 2 [HER2]-), 32.9% with a triple-negative (TN, HR-/HER2-), and 27.4% with a HER2-positive (any-HR/HER2+) receptor were administered chemotherapy. In those with luminal cancer, the 5-year breast cancer-specific survival (BCSS) was approximately 95% in all age groups. Meanwhile, among those with TN and HER2-positive BC, the older group had a poorer BCSS. The 5-year overall survival (OS) was also poorer in the older group across all subtypes. Among older patients matched using clinicopathological factors, chemotherapy use was associated with improved OS in the luminal and HER2-positive subtypes. CONCLUSIONS: Chemotherapy use was lower among older patients with stage II/III breast cancer. Those with TN and HER2-positive BC had a lower BCSS than their younger counterparts. Chemotherapy may be beneficial in improving the OS in older patients with luminal and HER2-positive BCs. Treatment for older patients should be individualized, based on tumor-related factors, quality of life, and the patient's health status.

DOI： 10.1016/j.ejca.2021.06.006

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: The association between advanced age and postoperative morbidity and mortality after major gastroenterological surgeries remains unclear. This study aimed to assess the association between old age and the short-term postoperative outcomes of gastroenterological surgeries. METHODS: We evaluated 327,642 patients who underwent any of the seven major gastroenterological surgeries-esophagectomy, total gastrectomy, distal gastrectomy, right hemicolectomy, low anterior resection, hepatectomy, and pancreatoduodenectomy-and were registered with the Japanese national surgical registry between January 2011 and December 2013. Perioperative characteristics, frequency/nature of postoperative morbidities, and postoperative mortality were compared according to age at the time of surgery. RESULTS: Overall, 18% (59,182/327,642) of the entire cohort were aged ≥ 80 years. The overall mortality rates in the entire cohort and in those aged ≥ 80 years were 1.7% and 3.3%, respectively. The postoperative mortality increased with increasing age for all procedures, with the trend persisting even after adjusting for various confounding factors. The incidence of postoperative pneumonia increased with increasing age, and with all procedures, except esophagectomy, subjects aged ≥ 80 years had a markedly higher risk of developing postoperative pneumonia than those aged < 60 years. CONCLUSION: Advanced age is associated with significantly worse short-term outcomes in older patients undergoing gastroenterological surgeries. However, we could not identify any distinct cutoff age beyond which major gastroenterological surgery could be considered as being contraindicated. The mortality risk should be carefully considered before recommending major gastroenterological surgeries for older patients.

DOI： 10.1007/s00423-021-02296-5

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Suicide remains the leading cause of death among homeless youth. We assessed differences in health-care utilization between homeless and nonhomeless youth presenting to the emergency department or hospital after a suicide attempt. New York Statewide Inpatient and Emergency Department Databases (2009-2014) were used to identify homeless and nonhomeless youth aged 10-17 who utilized health-care services following a suicide attempt. To evaluate associations with homelessness, we used logistic regression models for use of violent means, intensive care unit utilization, log-transformed linear regression models for hospitalization cost, and negative binomial regression models for length of stay. All models adjusted for individual characteristics with a hospital random effect and year fixed effect. We identified 18,026 suicide attempts with health-care utilization rates of 347.2 (95% confidence interval (CI): 317.5, 377.0) and 67.3 (95% CI: 66.3, 68.3) per 100,000 person-years for homeless and nonhomeless youth, respectively. Length of stay for homeless youth was statistically longer than that for nonhomeless youth (incidence rate ratio = 1.53, 95% CI: 1.32, 1.77). All homeless youth who visited the emergency department after a suicide attempt were subsequently hospitalized. This could suggest a higher acuity upon presentation among homeless youth compared with nonhomeless youth. Interventions tailored to homeless youth should be developed.

DOI： 10.1093/aje/kwab037

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The details and consequences of a small aortic annulus among transcatheter aortic valve replacement (TAVR) patients remain uncertain. This study investigated the short-term outcomes in patients with small annular size and compared the 30-day outcome between intra- and supra-annular devices, with similar outer casing diameter in this subgroup.Methods and Results:Cases registered in the Japanese national TAVR registry between August 2013 and December 2017 were analyzed. Among a total of 5,870 registered patients, 647 (11.0%) had small annulus (area ≤314 mm2) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm2/m2[0.92-1.35] vs. 1.16 cm2/m2[0.96-1.39], P<0.001) and higher mean pressure gradient (mPG, 10.0 mmHg [6.9-14.2] vs. 8.5 mmHg [6.0-11.5], P<0.001) compared with a normal-sized annulus. Among patients with a small annulus, those receiving a 20 mm intra-annular device had a smaller iEOA (0.94 cm2/m2[0.78-1.06] vs. 1.07 cm2/m2[0.8-1.24], P=0.001) and higher mPG (14.0 mmHg [10.0-18.5] vs. 11.0 [7.0-14.0], P<0.001) compared with those receiving a 23-mm supra-annular device, although the incidence of paravalvular leakage (≥moderate) was similar (14.4% vs. 16.5%, P=0.69). CONCLUSIONS: Patients with a small annulus were associated with less hemodynamic improvement. A supra-annular device is associated with better echocardiographic improvement in patients with a small annulus, without increasing paravalvular leakage.

DOI： 10.1253/circj.CJ-20-1084

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: The incidence of type 1 diabetes mellitus (T1DM) and hypothyroidism as immune-related adverse events (irAEs) after programmed cell death-1 inhibitor (PD-1i) administration has not yet been sufficiently evaluated in a real clinical setting. To assess the incidence of T1DM and hypothyroidism among PD-1is and to identify the risk factors associated with hypothyroidism using a large claims database. METHODS: This cohort study used the Shizuoka Kokuho database in Japan from 2012 to 2018, including approximately 2.2 million people. We enrolled 695 PD-1i-treated patients. T1DM and hypothyroidism as irAEs were identified using International Classification of Diseases 10th Revision and Anatomical Therapeutic Chemical classification codes. Risk factors for hypothyroidism were explored using the multivariable Fine and Gray regression model after adjusting for age group and sex, treating death as a competing risk. RESULTS: The cumulative incidences of T1DM and hypothyroidism were 0.3% and 8.3%, respectively. We described the detailed onset timing of irAEs in patients with T1DM and hypothyroidism; hypothyroidism was observed evenly within 1 year of the PD-1i prescription. Sex and certain cancer types, such as lung and urothelial cancers, were significantly associated with subdistribution hazard ratio (sHR) (female: sHR, 2.04 [95% CI, 1.20-3.47]; lung cancer: sHR, 0.55 [95% CI, 0.32-0.95]; and urothelial carcinoma: sHR, 2.40 [95% CI, 1.05-5.49]). CONCLUSION: The incidence of T1DM and hypothyroidism as irAEs and associated risk factors identified in this analysis were comparable to those found in previous studies. The use of a large claims database to detect irAEs, such as T1DM and hypothyroidism, may lead to safer use of PD-1is.

DOI： 10.1016/j.eprac.2020.12.009

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

AIM: To assess the risk of urinary tract infection (UTI) occurrence associated with sodium-glucose cotransporter-2 (SGLT2) inhibitor use relative to biguanide use in diabetes in a population-based cohort study using a target trial emulation framework. METHODS: Using a Japanese nationwide administrative claims database, we constructed a cohort of patients aged ≥40 years who were dispensed SGLT2 inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors or biguanides between April 2014 and March 2015. For computational ease, we randomly sampled 100% of SGLT2 inhibitor users, 3% of DPP-4 inhibitor users, and 20% of biguanide users; new antidiabetic drug initiators were analysed. We estimated the intention-to-treat (ITT) hazard ratios (HRs) of UTI with inverse probability of treatment (IPT)-weighted Cox's proportional hazards models that ignored subsequent treatment changes. Treatment weights were computed using patient sex, age, medications, medical history and hospitalization history. We also estimated per-protocol (PP) HRs using IPT- and inverse probability of censoring-weighted Cox's models that adjusted for nonrandom treatment changes. RESULTS: We analysed 11 364 SGLT2 inhibitor initiators, 9035 DPP-4 inhibitor initiators, and 10 359 biguanide initiators. When compared with biguanide initiators, SGLT2 inhibitor initiators had a crude HR of 1.14 (95% confidence interval [CI] 1.05-1.24), an ITT HR of 0.94 (95% CI 0.86-1.03), and a PP HR of 0.90 (95% CI 0.78-1.03); and DPP-4 inhibitor initiators had a crude HR of 1.13 (95% CI 1.04-1.23), an ITT HR of 0.85 (95% CI 0.77-0.94), and a PP HR of 0.83 (95% CI 0.71-0.95). CONCLUSION: Use of SGLT2 inhibitors or DPP-4 inhibitors did not increase the risk of UTI compared with biguanide use. Accounting for treatment changes did not substantially influence the estimated effects.

DOI： 10.1111/dom.14353

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Aim: We evaluated the association of profiles of institutional departments with operative outcomes of eight major gastroenterological procedures. Methods: We administered a 15-item online survey to 2634 institutional departments in 2016 to investigate the association of questionnaire responses with operative mortality for the procedures. The proportions of conditions met were listed according to institutional volume and classified according to annual operative cases in 1464 departments. Group A included departments with annual performance of <40 cases of the eight procedures, B 40-79 cases, C 80-199 cases, D 200-499 cases, and E ≥ 500 cases. We evaluated the number of conditions met for 10 of 15 items that could be improved by efforts of institutional departments, to assess whether the profiles of institutional departments had impacts on operative mortality. We built a multivariable logistic regression model for operative mortality with facilities categorized based on the number of conditions met and procedure-specific predicted mortality as explanatory variables using generalized estimating equation to account for facility-level clustering. We also examined how operative outcomes differed between facilities meeting nine or more conditions and those that did not. Results: We recognized meeting nine out of the 10 conditions as being a good indicator for having appropriate structural and process measures for gastroenterological surgery. The facilities meeting nine or more of the conditions had better operative mortality for all eight procedures. Conclusions: Our findings reveal that the profiles of institutional departments can reflect the outcomes of gastroenterological surgery in Japan.

DOI： 10.1002/ags3.12431

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担当区分：筆頭著者   記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: We aimed to present data regarding the current status and trends of valvular heart surgeries in Japan from the Japan Cardiovascular Surgery Database for the 2017-2018. METHODS: We extracted data on cardiac valve surgeries performed in 2017 and 2018 from the Japan Cardiovascular Surgery Database. We determined the trend in the number of aortic valve replacement procedures from 2013 to 2018. The operative mortality rates were calculated for representative valve procedures stratified by age group. Data regarding minimally invasive procedures and transcatheter aortic valve replacement in the Japan Cardiovascular Surgery Database are also presented. RESULTS: In conjunction with the dramatic increase in the number of transcatheter aortic valve replacements in 2017 and 2018, surgical aortic valve replacement also increased from 26,054 to 28,202. The operative mortality rate in first-time valve procedures was 1.8% in isolated aortic valve replacement, 0.9% in isolated mitral valve repair, and 8.2% and 4.6% in mitral valve replacement with biological prostheses and with mechanical prostheses, respectively. Regarding minimally invasive procedures, 30.8% of first-time isolated mitral valve plasty procedures were performed by a right thoracotomy. Although patients who underwent surgery by a right thoracotomy had better clinical outcomes, it was also apparent that patients who underwent surgery by a right thoracotomy had lower operative risk profiles. The overall mortality rates after transcatheter aortic valve replacement and surgical aortic valve replacement were 1.5% and 1.8%, respectively. CONCLUSION: We have reported benchmark data on heart valve surgery in 2017 and 2018 from the Japan Cardiovascular Surgery Database.

DOI： 10.1177/0218492320981459

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Clinical outcomes (as national clinical data) of isolated coronary artery bypass grafting have been successively reported, based on data registered in the Japan Cardiovascular Surgery Database, since 2013. In this study, we analysed the clinical results of isolated coronary artery bypass from 2017 to 2018 as a biannual report. METHODS: Data from the Japan Cardiovascular Surgery Database on isolated coronary artery bypass performed in 2017 and 2018 were reviewed for preoperative characteristics, postoperative outcomes, and choice of graft material for the left anterior descending artery. RESULTS: Isolated off-pump coronary artery bypass was performed in 54.6% (n = 14,684) of all coronary artery bypass cases (n = 26,913), and graft material for the left anterior descending artery was the left internal thoracic artery in 76.4% of cases and the right internal thoracic artery in 19.0% of cases. Operative mortality was 1.5% in elective cases (on-pump coronary artery bypass 1.9% and off-pump 1.2%, p < 0.001), 7.4% in emergency cases (on-pump 10.2% and off-pump 4.3%, p < 0.001), and 2.5% overall. Postoperative morbidity was generally lower in off-pump coronary artery bypass. The severity of surgery with expected mortality, evaluated using JapanSCORE II, is increasing every year. CONCLUSIONS: Our findings suggest that short-term operative results for isolated coronary artery bypass are stable, and operative candidates are shifting to higher-risk patients.

DOI： 10.1177/0218492320981499

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Primary infected aneurysms of the abdominal aorta and iliac arteries are potentially life-threatening. However, because of the rarity of the disease, its pathogenesis and optimal treatment strategy remain poorly defined. METHODS: A nationwide retrospective cohort study investigated patients who underwent surgical treatment for a primary infected abdominal aortic and/or common iliac artery (CIA) aneurysm between 2011 and 2017 using a Japanese clinical registry. The study evaluated the relationships between preoperative factors and postoperative outcomes including 90-day and 3-year mortality, and persistent or recurrent aneurysm-related infection. Propensity score matching was used to compare survival between patients who underwent in situ prosthetic grafting and those who had endovascular aneurysm repair (EVAR). RESULTS: Some 862 patients were included in the analysis. Preceding infection was identified in 30.2 per cent of the patients. The median duration of postoperative follow-up was 639 days. Cumulative overall survival rates at 30 days, 90 days, 1 year, 3 years and 5 years were 94.0, 89.7, 82.6, 74.9 and 68.5 per cent respectively. Age, preoperative shock and hypoalbuminaemia were independently associated with short-term and late mortality. Compared with open repair, EVAR was more closely associated with persistent or recurrent aneurysm-related infection (odds ratio 2.76, 95 per cent c.i. 1.67 to 4.58; P < 0.001). Propensity score-matched analyses demonstrated no significant differences between EVAR and in situ graft replacement in terms of 3-year all-cause and aorta-related mortality rates (P = 0.093 and P =0.472 respectively). CONCLUSION: In patients undergoing surgical intervention for primary infected abdominal aortic and CIA aneursyms, postoperative survival rates were encouraging. Eradication of infection following EVAR appeared less likely than with open repair, but survival rates were similar in matched patients between EVAR and in situ graft replacement.

DOI： 10.1093/bjs/znaa090

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.3400/avd.ar.20-00162

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: There is limited evidence for pulmonary arterial hypertension (PAH)-targeted therapy in patients with pulmonary hypertension associated with respiratory disease (R-PH). Therefore, we conducted a multicenter prospective study of patients with R-PH to examine real-world characteristics of responders by evaluating demographics, treatment backgrounds, and prognosis.Methods and Results:Among the 281 patients with R-PH included in this study, there was a treatment-naïve cohort of 183 patients with normal pulmonary arterial wedge pressure and 1 of 4 major diseases (chronic obstructive pulmonary diseases, interstitial pneumonia [IP], IP with connective tissue disease, or combined pulmonary fibrosis with emphysema); 43% of patients had mild ventilatory impairment (MVI), whereas 52% had a severe form of PH. 68% received PAH-targeted therapies (mainly phosphodiesterase-5 inhibitors). Among patients with MVI, those treated initially (i.e., within 2 months of the first right heart catheterization) had better survival than patients not treated initially (3-year survival 70.6% vs. 34.2%; P=0.01); there was no significant difference in survival in the group with severe ventilatory impairment (49.6% vs. 32.1%; P=0.38). Responders to PAH-targeted therapy were more prevalent in the group with MVI. CONCLUSIONS: This first Japanese registry of R-PH showed that a high proportion of patients with MVI (PAH phenotype) had better survival if they received initial treatment with PAH-targeted therapies. Responders were predominant in the group with MVI.

DOI： 10.1253/circj.CJ-20-0939

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Wiley  

AIM: Preoperative inflammation-based Glasgow prognostic score (GPS) is a useful tool for predicting long-term prognosis in cancer patients. However, its association with postoperative short-term outcomes remains unknown. The aim of this study is to investigate the association between GPS and postoperative morbidity and mortality among patients undergoing surgery for various gastrointestinal malignancies. METHODS: Using the Japanese National Clinical Database, we analyzed the records of 312 357 patients with gastrointestinal malignancy who underwent six typical elective surgeries, including esophagectomy, distal gastrectomy, total gastrectomy, right hemicolectomy, low anterior resection, and pancreaticoduodenectomy, between January 2015 and December 2018. We assigned GPS of 0, 1, or 2 to patients with no, one, or both decreased albumin and elevated C-reactive protein levels, respectively. We investigated the relationship of GPS with operative morbidity and mortality for each procedure with adjustments for patients' demographics, preoperative status, comorbidities, and cancer stages. RESULTS: Crude operative morbidity was significantly higher for GPS 1 and 2 than GPS 0 patients in all procedures except pancreaticoduodenectomy. The postoperative length of hospital stay was significantly longer for GPS 1 and 2 patients in all procedures (P < .001). Operative mortality was also higher for GPS 1 and 2 patients in all procedures. The associations remained significant after adjustments for potential confounders of age, sex, physical status, tumor classification, use of preoperative therapy, and comorbidities. CONCLUSION: This nationwide study provides solid evidence on the strong association between GPS and postoperative outcomes.

DOI： 10.1002/ags3.12456

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その他リンク： https://onlinelibrary.wiley.com/doi/full-xml/10.1002/ags3.12456

掲載種別：研究論文（学術雑誌）   出版者・発行元：Oxford University Press (OUP)  

<title>Abstract</title>
<sec>
<title>Background</title>
Quantifying the risks and benefits of revascularization for chronic limb-threatening ischaemia (CLTI) is important. The aim of this study was to create a risk prediction model for treatment outcomes 30 days after revascularization in patients with CLTI.


</sec>
<sec>
<title>Methods</title>
Consecutive patients with CLTI who had undergone revascularization between 2013 and 2016 were collected from the JAPAN Critical Limb Ischemia Database (JCLIMB). The cohort was divided into a development and a validation cohort. In the development cohort, multivariable risk models were constructed to predict major amputation and/or death and major adverse limb events using least absolute shrinkage and selection operator logistic regression. This developed model was applied to the validation cohort and its performance was evaluated using c-statistic and calibration plots.


</sec>
<sec>
<title>Results</title>
Some 2906 patients were included in the analysis. The major amputation and/or mortality rate within 30 days of arterial reconstruction was 5.0 per cent (144 of 2906), and strong predictors were abnormal white blood cell count, emergency procedure, congestive heart failure, body temperature of 38°C or above, and hemodialysis. Conversely, moderate, low or no risk in the Geriatric Nutritional Risk Index (GNRI) and ambulatory status were associated with improved results. The c-statistic value was 0.82 with high prediction accuracy. The rate of major adverse limb events was 6.4 per cent (185 of 2906), and strong predictors were abnormal white blood cell count and body temperature of 38°C or above. Moderate, low or no risk in the GNRI, and age greater than 84 years were associated with improved results. The c-statistic value was 0.79, with high prediction accuracy.


</sec>
<sec>
<title>Conclusion</title>
This risk prediction model can help in deciding on the treatment strategy in patients with CLTI and serve as an index for evaluating the quality of each medical facility.


</sec>

DOI： 10.1093/bjs/znab036

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掲載種別：研究論文（学術雑誌）  

DOI： 10.21203/rs.3.rs-242898/v1

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Since there was no previous report, we analyzed the relationship between French Risk Stratification parameters in pulmonary arterial hypertension (PAH) and mean pulmonary arterial pressures (mPAP) using Japan PH Registry (JAPHR) national-wide cohort. METHODS: We enrolled 108 patients with PAH from JAPHR from previous reported cohort and analyzed the relations between French Risk Stratification scores and hemodynamic improvements. RESULTS: The ratio meeting 0 to 4 French Risk Stratification score was 21.3%, 31.5%, 32.4%, 13.0%, and 1.9% at baseline, and 6.5%, 23.2%, 33.3%, 23.2%, 13.9% at follow-up, respectively. The improvements in the number of criteria met were associated both with mPAP at follow-up (p = 0.03) and with the improvements in mPAP (p < 0.001). CONCLUSION: The improvements in French Risk Stratification may become a marker of improved hemodynamics including mPAP.

DOI： 10.1186/s12890-021-01398-6

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUNDS: Increased incidence of hospitalization for heart failure (HHF) among patients with diabetes are increasingly being reported. We investigated the incidence of adverse cardiovascular events including HHF among patients with type 2 diabetes mellitus (T2DM), and the potential clinical improvement from sodium-glucose cotransporter 2 inhibitors (SGLT2i) using a contemporary administrative claims database from a large governmental district of Japan. METHODS AND RESULTS: We included initiators of any oral glucose-lowering drugs between 2013 and 2018. We estimated 5-year cumulative incidence of hospitalization for HF, myocardial infarction (MI), and stroke, treating death as a competing risk. We evaluated the possible impact of introducing SGLT2i to the potential recipients of the drug, using the inclusion criteria from EMPA-REG OUTCOME and DECLARE-TIMI 58 trials assuming the same risk reduction as theirs. Among 23,340 drug initiators (54.0% men, and 6.4% aged >85 years), the 5-year cumulative incidence was 5.4% (95%CI: 4.9%-5.9%) for HHF, 1.9% (95%CI: 1.7%-2.2%) for MI admission, and 6.1% (95%CI: 5.7%-6.6%) for stroke admission. Among 6192 patients with laboratory test data, 651 (10.5%) and 2680 (43.3%) patients met the EMPA-REG-like and DECLARE-like criteria, respectively. The 5-year cumulative incidence among the 2849 patients meeting either of the criteria was estimated to decrease from 97.1 to 75.6 events via 75% adoption of SGLT2i. CONCLUSIONS: The incidence of HHF was similar to that of stroke. Significant portion of our cohort met the inclusion criteria for major randomized clinical trials for SGLT2i, and estimated reduction in the HHF events was substantial.

DOI： 10.1111/jdi.13485

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: The aim of this study was to compare the incidence of operative death and postoperative complications between primary and reoperation valve surgeries and to identify independent risk factors for these events among valve-reoperation patients. METHODS: Between 2013 and 2015, 54 269 patients who underwent valve surgery were retrospectively analyzed using the Japan Cardiovascular Surgery Database. They were divided into the primary (group P; n = 49 833) and reoperation (group R; n = 4436) surgery groups. Among the reoperation patients, we conducted multivariable logistic regression analyses to identify risk factors for the incidences of operative mortality and postoperative complications. Then, we also conducted propensity score matched analyses to compare the incidences of these 2 outcomes for primary versus reoperation procedures separately for patients with and without infective endocarditis (IE). RESULTS: Incidences of postoperative mortality (4.6% vs 9.1%; P < 0.001) and any complications (36.6% vs 41.4%; P < 0.001) were higher in the reoperation group. For patients undergoing reoperation, strong risk factors for operative mortality included urgency status, ejection fraction <30%, IE, dialysis, chronic kidney disease, New York Heart Association class 3/4, concomitant coronary artery bypass grafting and aorta procedure, tricuspid valve surgery only, multivalve surgery and age. In the propensity score matched cohort, the relative odds of operative mortality were 1.53 (95% confidence interval: 1.26-1.86, P < 0.001) among patients with IE and were 1.58 (95% confidence interval: 1.18-2.13, P < 0.002) among those without. CONCLUSIONS: Outcomes for reoperation were significantly worse than those for primary surgery. At the primary operation, the risk of reoperation should be considered and when considering the indications for reoperation, the preoperative state, surgical timing and intervention method should be considered.

DOI： 10.1093/ejcts/ezaa384

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Minimal data are available to support the clinical management of older breast cancer patients. Consequently, the standard of care remains unclear. Our aim was to clarify the clinicopathological characteristics, practical treatments, and prognosis of older Japanese breast cancer patients and discuss clinical issues. METHODS: We reviewed 132,240 cases, diagnosed between 2004 and 2011, from the Japanese Breast Cancer Registry. Focusing on older patients, we compared data among three age groups: 75 years and over (n = 27,385), 65-74 years (n = 43,839), and 55-64 years (n = 61,016). RESULTS: Data revealed the proportions of mucinous and apocrine carcinoma were higher in older patients, and they more frequently had clinical stage II and III cancer. Their ER-positive rates were higher, in contrast to the lower HER2-positive, breast-conserving surgery (BCS), post-BCS irradiation, and adjuvant chemotherapy rates. Almost half of the older patients who underwent chemotherapy received CMF or oral 5FU, during hormone therapy, Tamoxifen was administered more frequently. The overall survival rate decreased with age, but the breast cancer-specific survival (BCSS) at 5 years remained similar. The rate of other cause of death in the oldest group was about a half, and more than double that in those aged 55-64 years. CONCLUSIONS: We showed clinical data of older breast cancer patients in Japan. Their disease was more advanced at the time of diagnosis, post-BCS irradiation and primary systemic chemotherapy were omitted more frequently, and overall, BCSS was similar among age categories, although the rate of other causes of death was higher.

DOI： 10.1007/s12282-020-01188-8

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: The study objective was to report the clinical outcomes of open surgery for acute aortic dissection by using the Japan Cardiovascular Database. METHODS: Between 2013 and 2018, a total of 29,486 patients with acute aortic dissection who underwent open surgery were registered in the Japan Cardiovascular Database. Some 50% of patients were male. Age of patients at surgery was 59.8 ± 14.2 years; 61% of patients were aged less than 65 years, and 21% of patients were aged more than 75 years. Connective tissue disease was found in 1.2% of patients. Some 13% of patients had disturbed consciousness, and 12% of patients had cardiogenic shock. Some 11% of patients had moderate or severe aortic valve regurgitation, and 2.3% of patients had acute myocardial infarction. Some 94% of patients underwent surgery within 24 hours after diagnosis. Antegrade cerebral perfusion was used in 74% of patients, hypothermic circulatory arrest with retrograde cerebral perfusion was used in 17.1% of patients, and deep hypothermic circulatory arrest was used in 9.4% of patients. Cardiopulmonary bypass time was 216 ± 90 minutes, and cardiac ischemic time was 132 ± 60 minutes. Lowest body temperature was 24.6°C ± 3.2°C. Replacement of the ascending aorta (zone I) was performed in 69% of patients, and total arch replacement (zone 0 to zone II, III-) was performed in 29% of patients. The aortic valve was replaced in 7.9% of patients and repaired in 4.4% of patients. RESULTS: The 30-day mortality was 9.2%, and in-hospital mortality was 11%. The number of operations has increased through the study periods. The in-hospital mortality has been stable or in a decreasing trend. Major complications consisted of stroke in 12% of patients, new hemodialysis in 7.3% of patients, spinal cord ischemia in 3.9% of patients, and prolonged ventilation in 15% of patients. CONCLUSIONS: Approximately 30,000 patients with acute aortic dissection in the recent 6 years (2013 - 2018) underwent open surgery according to the nationwide Japanese database. The number of operations has increased, and in-hospital mortality has been stable or in a decreasing trend. Although the early outcomes are acceptable, there is still room for improvement in patients with preoperative comorbidities.

DOI： 10.1016/j.jtcvs.2020.09.147

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Breast cancer survival outcomes vary across different ethnic groups. We clarified the differences in clinicopathological and survival characteristics of breast cancer among Japanese, US residents with Japanese origin (USJ), and US residents with other origins (USO). METHOD: Using Surveillance, Epidemiology, and End Results (SEER) 18 dataset and Japanese Breast Cancer Society (JBCS) registry, we included patients first diagnosed with breast cancer between 2004 and 2015. We categorized the patients into three groups based on the database and the recorded ethnicity: Japanese (all those from the JBCS registry), USJ (those from SEER with ethnicity: Japanese), and USO (those from SEER with ethnicity other than Japanese). Excluding patients diagnosed after 2012, stage 0, and 4 patients, we examined the overall survival (OS) and breast cancer-specific survival (BCSS) using the Kaplan-Meier method and Cox proportional hazards models, adjusting for age, sex, cancer stage, and hormone receptor (HR) status. RESULTS: We identified 7362 USJ, 701,751 USO, and 503,013 Japanese breast cancer patients. The proportion of HR-positive breast cancer was the highest among USJ (71%). OS was significantly longer among Japanese and USJ than USO (Hazard ratio 0.46; 95% Confidence Interval [CI] 0.45-0.47 for Japanese and 0.66 [95% CI 0.59-0.74] for USJ) after adjusting for baseline covariates. BCSS was also significantly higher in the two groups (HR 0.53 [95% CI 0.51-0.55] for Japanese and 0.53 [95% CI 0.52-0.74] for USJ). CONCLUSIONS: In stage I-III breast cancer, Japanese and US residents with Japanese origin experienced significantly longer survival than US residents with non-Japanese origins.

DOI： 10.1007/s10549-020-05869-y

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Aim: The advantages of laparoscopic right hemicolectomy over open surgery for colon cancer in general clinical practice are debated, as evidenced by the continued use of open surgery in a significant proportion of patients worldwide. This study aimed to assess and compare the clinical outcome of laparoscopic and open right hemicolectomy for colon cancer using data from the Japanese National Clinical Database. Methods: A total of 72 299 patients who underwent laparoscopic (n = 46 084) and open (n = 26 215) right hemicolectomy for colon cancer between 2014 and 2018 were enrolled in this retrospective study. Short-term outcome was compared between groups using propensity score matching analysis. Results: The incidence of overall postoperative morbidity ≥ Clavien-Dindo classification grade 3 was significantly higher in the open surgery group than the laparoscopic group (4.7% vs 3.2%, P < .001). The incidence of most individual morbidities, including surgical site infection, anastomotic leakage, and ileus, was higher in the open surgery group. Short-term outcomes, including intraoperative blood loss, postoperative hospital stay, reoperation rate, 30-day mortality, and in-hospital mortality, were superior in the laparoscopic group, except for operative time. Subgroup analyses showed that the incidence of postoperative morbidity was lower in the laparoscopic group for all prespecified subgroups. Conclusion: Laparoscopic right hemicolectomy has an advantage over open surgery for colon cancer with respect to short-term outcome.

DOI： 10.1002/ags3.12381

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s11748-020-01460-w

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: To investigate the effect of geriatric variables on five newly added outcomes and create risk models for predicting these outcomes. SUMMARY BACKGROUND DATA: Because there is a current lack of geriatric research focusing on geriatric outcomes using a national surgical database in Japan, there is a need to investigate outcomes associated with major gastroenterological surgery using these data. METHODS: This multicenter prospective cohort study was conducted at 26 surgery departments across 21 institutions in Japan using the National Clinical Database (NCD) surgical registry. In total, 22 new geriatric variables were imported from the ACS NSQIP geriatric pilot study. The following five geriatric outcomes were defined: 1) postoperative delirium, 2) physical function on postoperative day 30, 3) fall risk on discharge, 4) discharge other than home with social service, and 5) functional decline on discharge, and geriatric risk prediction models for major gastroenterological surgery were created. RESULTS: Between January 2018 and December 2018, data on 3,981 procedures from seven major gastroenterological surgeries were collected and analyzed. Older age and preoperative geriatric variables (Origin status from home, History of dementia, Use of mobility aid, Fall history, and Not competent on admission) were strongly associated with postoperative outcomes. Geriatric risk prediction models for these outcomes were created, with C-statistic values ranging from 0.74 to 0.90, demonstrating model validity and sufficiency of fit. CONCLUSIONS: The risk models for the newly defined five geriatric outcomes that we created can be used in the decision-making process or provision of care in geriatric patients.

DOI： 10.1097/SLA.0000000000004308

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: We recently reported early postoperative results comparing use of anastomosis-assist device (Device) with side-biting clamp for ascending aorta during coronary artery bypass grafting (CABG) except for transient neurological complications that occurred less often with Device. Here, we evaluated perioperative safety of Device against aorta no-touch technique (No-touch). METHODS: We evaluated patients receiving isolated off-pump CABG with either Device or No-touch approach in 2014-2016 from Japan Adult Cardiovascular Surgery Database. We performed one-to-one matched analysis based on propensity score modeled from patient demographics, comorbidities, cardiac conditions and procedural characteristics. We compared early outcomes in both groups using Pearson's chi-square test/Wilcoxon rank sum test as appropriate with p<0.05 being statistically significant. RESULTS: Among 9,546 Device and 6,890 No-touch patients, we found 5,012 patient matches for each group. Device operation time significantly longer (293 versus 281 minutes; p<0.001) and homologous transfusion significantly greater (56.9% versus 51.0%; p<0.001) than No-touch. Thirty-day operative mortality (1.5% versus 1.7%; p=0.34), morbidity and mortality (6.8% versus 7.5%; p=0.17) and stroke (0.9% versus 1.1%; p=0.36) similar in both groups. New onset atrial fibrillation (11.9% versus 10.3%; p=0.01) occurred significantly more often with Device. Newly initiated dialysis (1.4% versus 1.9%; p=0.051) more frequent with No-touch while re-operation for graft occlusion more frequent with Device (1.0% versus 0.6%; p=0.06), but not significant for either outcome. CONCLUSIONS: Clinical safety of Device use in CABG comparable to No-touch for mortality and morbidity. Hemostasis may be a key issue for accomplishing higher level quality control when devices used in proximal anastomosis of CABG.

DOI： 10.1016/j.athoracsur.2020.08.016

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The Japanese Breast Cancer Society Registry started in 1975; it was transferred to the registry platform of the National Clinical Database in 2012. We provide the annual data and an analysis of the Breast Cancer Registry for 2017. METHODS: Patients' characteristics and pathological data of the 95,203 registered Japanese breast cancer patients from 1,427 institutes in 2017 were obtained. Trends in age at diagnosis and pathological stage were determined during the most recent 6 years (2012-2017). RESULTS: The mean onset age was 60.2 years with bimodal peaks at 45-49 years and 65-69 years. A short-term trend of the most recent 6 years of data caused the second, older peak. At diagnosis, 32.4% of breast cancer patients were premenopausal. The distribution of stages revealed that the proportion of early stage breast cancer (stage 0-I) increased up to 60%. At the initial diagnosis, 2.2% of patients presented with metastatic disease. Sentinel node biopsy without axillary node dissection was performed without neoadjuvant chemotherapy (NAC) in 68.8%, and with NAC in 31.1%, of patients. For patients without NAC, lymph node metastasis was less than 3% if the tumor size was less than 1 cm. The proportion of node-negativity decreased to 79.5% when tumor size was 2.1-5 cm. CONCLUSIONS: This analysis of the registry provides new information for effective treatment in clinical practice, cancer prevention, and the conduct of clinical trials. Further development of the registry and progress in collecting prognostic data will greatly enhance its scientific value.

DOI： 10.1007/s12282-020-01139-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been performed more and more frequently in elderly patients with aortic stenosis. We investigated the association of in-hospital availability of TAVR on outcomes of surgical aortic valve replacement (SAVR) in the era of TAVR.Methods and Results:We utilized data from the Japan Adult Cardiovascular Surgery Database. Between October 2013 and December 2016, 9,330 patients aged ≥80 years underwent isolated SAVR or SAVR with coronary artery bypass grafting in 557 centers in Japan. We assessed the associations of in-hospital TAVR availability with operative mortality and composite complications adjusting for each patient's characteristics, JapanSCORE predicted the risk scores, and hospital volumes of SAVR using generalized estimation equation methods. Observed operative mortality rates were 3.4% in all centers, 2.0% in TAVR centers and 4.0% in non-TAVR centers. The multivariable analyses showed that TAVR centers had statistically significantly lower operative mortality compared with non-TAVR centers among all patients (odds ratio 0.60, 95% confidence interval 0.41-0.89, P=0.01) and among intermediate/high-risk patients (odds ratio 0.52, 95% confidence interval 0.32-0.85, P<0.01) but not among low-risk patients (odds ratio 0.82, 95% confidence interval 0.44-1.51, P=0.52). CONCLUSIONS: In-hospital TAVR availability was associated with better outcomes of SAVR among elderly patients. This association was statistically significant among intermediate/high-risk patients but not significant among low-risk patients.

DOI： 10.1253/circj.CJ-20-0032

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To evaluate the impact of state-mandated policies for pulse oximetry screening on healthcare utilisation, with a focus on use of echocardiograms. DATA SOURCES/STUDY SETTING: Healthcare Cost and Utilisation Project, Statewide Inpatient Databases from 2008 to 2014 from six states. METHODS: We defined pre- and post-mandate cohorts based on dates when pulse oximetry became mandated in each state. Linear segmented regression models for interrupted time series assessed associations between implementation of the screening and changes in rate of newborns with Critical CHD-negative echocardiogram results. We also evaluated the changes in rate of newborns who underwent echocardiogram but were not diagnosed with any health issues that could cause hypoxemia. RESULTS: We identified 5967 critical CHD-negative echocardiograms (2847 and 3120 in the pre- and post-mandate periods, respectively). Our models detected a statistically significant increasing trend in rate of critical CHD-negative echocardiograms in the pre-mandate period (Incidence Rate Ratio: 1.08, p = 0.02), but did not detect any statistical differences in changes between pre- and post-mandate periods (Incidence Rate Ratio: 0.93, p = 0.14). Among non-Whites, an increasing trend of Critical CHD-negative echocardiogram during the pre-mandate period was detected (Incidence Rate Ratio 1.12, p < 0.01) and was attenuated during the post-mandate period (Incidence Rate Ratio 0.89, p = 0.02). Similar results were observed in the sensitivity analyses among both Whites and non-Whites. CONCLUSIONS: Results suggest that mandatory state screening policies are associated with reductions in false-positive screening rates for hypoxemic conditions, with reductions primarily attributed to trends among non-Whites.

DOI： 10.1017/S1047951120001742

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background In March 2011, the Fukushima Daiichi nuclear power plant disaster inflicted radiation damage across the Tohoku region of Northern Japan. The consequent harm to pregnant mothers and newborns was a matter of concern. We performed a registry-based analysis of the incidence of congenital heart disease during 2010 to 2013 using the Japan Cardiovascular Surgery Database. Methods and Results We selected patients who had complex congenital heart disease and who were born between January 1, 2010 and December 31, 2013 undergoing surgery, and assessed the trend in the number of first-time surgeries performed for patients aged 2 years and younger by birth year over time. The numbers of first-time surgeries for birth years 2010 to 2013 were 2978, 2924, 3077, and 2940, and no increasing trend was detected. Additionally, no increasing yearly trend was detected when the number of cases was divided by the total number of births in Japan in each birth month. The mortality of first-time surgeries performed for complex diseases, which often involves multiple subsequent surgeries, decreased from 4.7% in 2010 to 2.2% in 2013. Conclusions Our analyses showed no increase in the number of patients with congenital heart disease during 2010 to 2013. The yearly increase in the total number of surgeries following the Fukushima Daiichi nuclear disaster in a previous report can be explained by the decline in the mortality of first-time surgeries for complex cases. Such use of only the increase in the total yearly number of surgeries to claim the effects of a nuclear disaster on the incidence of congenital heart disease is a far too simplistic and dangerous proposition.

DOI： 10.1161/JAHA.119.014787

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Nonadherence to antihypertensive drugs is a primary reason for suboptimal clinical outcomes among hypertensive patients. We assessed adherence to newly initiated antihypertensive medications in non-elderly Japanese patients and examined which patient and facility characteristics were associated with low adherence. We selected new oral antihypertensive drug users, aged 30-74 years, between 2014 and 2016 from a large administrative claims database. We measured adherence as the proportion of days covered (PDC) during a 1-year follow-up and divided patients into three groups of low (PDC < 40%), intermediate (PDC ≥ 40% to <80%), and high (PDC ≥ 80%) adherence. Factors associated with low adherence were assessed by logistic regression analysis with generalized estimating equations. Among 31,592 patients (mean age, 51.7 years; 41.2% female), the median 1-year PDC was 88.5% (IQR: 41.9-98.1%). In total, 59.2%, 16.6%, and 24.2% of patients were categorized as having high, intermediate, and low adherence, respectively. Female sex (odds ratio [OR] 1.15, 95% confidential interval [95% CI] 1.08-1.22), younger age, and the initiation of angiotensin-converting enzyme inhibitors (OR 1.37, 95% CI 1.12-1.66), beta-blockers and thiazide diuretics (OR 4.82, 95% CI 4.34-5.36 and OR 3.91, 95% CI 2.79-5.46, respectively; compared with angiotensin II receptor blockers) were associated with low adherence. Patients initiating antihypertensives at larger hospitals (≥200 beds) were more likely to be adherent. While adherence to antihypertensive drugs in non-elderly Japanese patients was relatively high compared with that reported in previous studies in Western countries, patients with intermediate-low adherence may benefit from targeted interventions.

DOI： 10.1038/s41440-020-0440-2

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

The Japanese Breast Cancer Society (JBCS) registry began data collection in 1975, and it was integrated into National Clinical Database in 2012. As of 2016, the JBCS registry contains records of 656,896 breast cancer patients from more than 1400 hospitals throughout Japan. In the 2016 registration, the number of institutes involved was 1422, and the total number of patients was 95,870. We herein present the summary of the annual data of the JBCS registry collected in 2016. We analyzed the demographic and clinicopathologic characteristics of registered breast cancer patients from various angles. Especially, we examined the registrations on family history, menstruation, onset age, body mass index according to age, nodal status based on tumor size and subtype, and proportion based on ER, PgR, and HER2 status. This report based on the JBCS registry would support clinical management for breast cancer patients and clinical study in the near future.

DOI： 10.1007/s12282-020-01081-4

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Postoperative intra-abdominal infectious complication (PIIC) after gastrectomy for gastric cancer worsens in-hospital death or long-term survival. However, the methodology for PIIC preoperative risk assessment remains unestablished. We aimed to develop a preoperative risk model for postgastrectomy PIIC. METHODS: We collected 183,936 patients' data on distal or total gastrectomy performed in 2013-2016 for gastric cancer from the Japanese National Clinical Database and divided into development (2013-2015; n = 140,558) and validation (2016; n = 43,378) cohort. The primary outcome was the incidence of PIIC. The risk model for PIIC was developed using 18 preoperative factors: age, sex, body mass index, activities of daily living, 12 comorbidity types, gastric cancer stage, and surgical procedure in the development cohort. Secondarily, we developed another model based on the new scoring system for clinical use using selected factors. RESULTS: The overall incidence of PIIC was 4.7%, including 2.6%, 1.7%, and 1.3% in anastomotic leakage, pancreatic fistula, and intra-abdominal abscess, respectively. Among the 18 preoperative factors, male [odds ratio, (OR) 1.92], obesity (OR, 1.52-1.96), peripheral vascular disease (OR, 1.55), steroid use (OR, 1.83), and total gastrectomy (OR, 1.89) strongly correlated with PIIC incidence. The entire model using the 18 factors had good discrimination and calibration in the validation cohort. We selected eight relevant factors to create a simple scoring system, using which we categorized the patients into three risk groups, which showed good calibration. CONCLUSION: Using nationwide clinical practice data, we created a preoperative risk model for postgastrectomy PIIC for gastric cancer.

DOI： 10.1007/s10120-020-01083-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：WILEY  

Background Total pancreatectomy is required to completely clear tumours that are locally advanced or located in the centre of the pancreas. However, reports describing clinical outcomes after total pancreatectomy are rare. The aim of this retrospective observational study was to assess clinical outcomes following total pancreatectomy using a nationwide registry and to create a risk model for severe postoperative complications. Methods Patients who underwent total pancreatectomy from 2013 to 2017, and who were recorded in the Japan Society of Gastroenterological Surgery and Japanese Society of Hepato-Biliary-Pancreatic Surgery database, were included. Severe complications at 30 days were defined as those with a Clavien-Dindo grade III needing reoperation, or grade IV-V. Occurrence of severe complications was modelled using data from patients treated from 2013 to 2016, and the accuracy of the model tested among patients from 2017 using c-statistics and a calibration plot. Results A total of 2167 patients undergoing total pancreatectomy were included. Postoperative 30-day and in-hospital mortality rates were 1 center dot 0 per cent (22 of 2167 patients) and 2 center dot 7 per cent (58 of 167) respectively, and severe complications developed in 6 center dot 0 per cent (131 of 2167). Factors showing a strong positive association with outcome in this risk model were the ASA performance status grade and combined arterial resection. In the test cohort, the c-statistic of the model was 0 center dot 70 (95 per cent c.i. 0 center dot 59 to 0 center dot 81). Conclusion The risk model may be used to predict severe complications after total pancreatectomy.

DOI： 10.1002/bjs.11437

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Objective: To determine the pattern of antidiabetic drug use, with a particular focus on the metformin dose, among patients with type 2 diabetes mellitus (T2DM) in a Japanese working population.Methods: We used an administrative claims database linked to yearly health check-up data from large corporations. Data were collected for T2DM patients who began using an antidiabetic drug between 2014 and 2017 (n = 20,401). We evaluated the type of antidiabetic drug used and the characteristics of the patients using each type of drug. Among the metformin users, we assessed the titration in its dose or treatment during the 12 month period after initiation at 3 month intervals.Results: Among 20,401 new antidiabetic users, the most frequently used agents during the study period were dipeptidyl peptidase-4 inhibitors (DPP4is; 47.4%), followed by biguanides (18.5%) and sodium glucose cotransporter-2 inhibitors (SGLT2is; 6.7%). Most patients who initiated with metformin were prescribed 500 mg or less daily (72.9%); only 2.0% were prescribed a daily dose of >1000 mg. Moreover, 27% remained on the same daily dose during the 1 year follow-up, whereas another 29.9% discontinued their antidiabetic treatment altogether.Conclusions: A unique pattern of prescription was observed amongst Japanese patients with T2DM, and DPP4is, rather than metformin, were predominantly used as the first-line treatment. SGLT2is were infrequently prescribed. Metformin was prescribed at a daily dose of ≤500 mg in many patients. Greater efforts are needed to assess the comparative effectiveness of these treatment strategies.

DOI： 10.1080/03007995.2020.1729710

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Percutaneous coronary intervention (PCI) is performed in a wide range of institutions. We sought to assess the relationship between coronary artery bypass grafting (CABG) volume relative to PCI volume and clinical outcome using nationally representative PCI and CABG registries in Japan. METHODS: This was a collaborative, registry-based cohort study enrolling patients undergoing percutaneous coronary intervention in 2013-2014 using Japanese nationwide registry (J-PCI) with follow up until discharge. The absolute volume of CABG for each hospital was calculated using additional data from Japan CardioVascular Surgery Database (JCVSD). Patients undergoing their first PCI registered in the registry (N = 220,934), at 943 facilities were studied. Main outcomes were in-hospital mortality, and incidence of composite of in-hospital death and postprocedural complications. RESULTS: Among the 220,934 patients, 162,411 were men, with a mean age of 69.7 (SD 11.6) years. Patients underwent PCI at hospitals with varying CABG volume: The overall in-hospital mortality and composite event rate for PCI patients was 0.9% and 2.4%, respectively. CABG volume was associated with the in-hospital mortality of PCI at facilities performing less than 200 PCIs per year, but not at facilities performing 200 or more. Similarly, in-hospital mortality or complication was associated with PCI volume <200 only if no CABG is done at the facility. The result remained largely consistent in subgroup of patients presenting with acute coronary syndrome or even after excluding these institutions with extremely low number of PCI (<50 cases/year) or CABG (<15 cases / year). CONCLUSIONS: In a nationwide registry-based analysis, the surgical volume was associated with patients' clinical outcome after PCI, when limited number of PCIs were performed at the facility.

DOI： 10.3390/jcm9051267

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s11748-020-01298-2

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: International collaboration has an interest in health care quality evaluation. We compared characteristics and surgical outcomes between Asian patients in the United States and Japanese patients who undergo adult cardiac surgery. METHODS: Using the Japan Adult Cardiovascular Surgery Database (JCVSD) and The Society of Thoracic Surgeons (STS) National Database, we compared Asian patients undergoing isolated coronary artery bypass graft surgery between 2013 and 2016 in Japan and the United States. The STS had 16,903 Asian patients among 573,823 patients of all races undergoing isolated coronary artery bypass graft surgery (2.95%); the JCVSD had 55,570 patients, almost all of whom are Japanese. Descriptive statistics were analyzed independently, then the data were aggregated for comparison. RESULTS: The JCVSD patients were older (69 vs 65 years) with a smaller body surface area (1.65 m2 vs 1.81 m2) and body mass index (24 kg/m2 vs 26 kg/m2). The proportion of males (79% vs 78%), prevalence of chronic lung disease (82% vs 86%), and diabetes mellitus (54% vs 60%) were similar. The JCVSD had higher prevalence of renal disease requiring dialysis (11% vs 6%). The numbers of anastomoses were similar (3.1 vs 3.3); off-pump procedures and the usage of right internal mammary artery were more prevalent (60% vs 15% and 38% vs 7%, respectively) in the JCVSD. The unadjusted operative mortality was 2.7% in the JCVSD and 2.1% in the STS database. CONCLUSIONS: Comparisons of coronary artery bypass graft surgery characteristics and outcomes were conducted between the STS National Database and the JCVSD to illustrate the value of international collaboration on adult cardiac surgery databases.

DOI： 10.1016/j.athoracsur.2019.07.095

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To investigate the frequency of laparoscopic liver resection (LLR) nationwide in Japan. BACKGROUND: LLR was initially limited to basic liver resection, but is becoming more common in advanced liver resection. METHODS: Retrospective observational study of 148,507 patients registered in the National Clinical Database 2011-2017. Excluded: liver resection with biliary and vascular reconstruction. RESULTS: LLR or open liver resection (OLR) was performed in 1848 (9.9%) and 16,888 (90.1%) patients, respectively, in 2011, whereas in 2017, LLR had increased to 24.8% and OLR decreased to 75.2% of resections (5648 and 17,099 patients, respectively). There was an annual increasing trend of LLR, starting at 9.9%, then 13.8%, 17.3%, 21.2%, 18.1%, 21.0%, and finally 24.8% in 2017. Basic LLR became more common, up to 30.8% of LR in 2017. Advanced LLR increased from 3.3% of all resections in 2011 to 10.8% in 2017. Throughout the years observed, there were fewer complications in LLR than OLR. Operative mortality was 3.6% for both advanced LLR and OLR in 2011, and decreased to 1.0% and 2.0%, respectively, in 2017. Mortality for both basic LLR and basic OLR were low and did not change throughout the study, at 0.5% and 1.6%, respectively, in 2011 and 0.5% and 1.1%, in 2017. CONCLUSIONS: LLR has rapidly become widespread in Japan. Basic LLR is now a standard option, and advanced LLR, while not as common yet, has been increasing year by year. LLR has been safely developed with low mortality and complications rate relative to OLR.

DOI： 10.1097/SLA.0000000000003799

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Laparoscopic gastrectomy (LG) is an established minimally invasive procedure for gastric cancer. However, it is controversial whether LG is useful for patients with poor physical status classified into higher classes of the American Society of Anesthesiologists physical status (ASA-PS) classification. The aim of this study was to determine the feasibility of LG in patients with ASA-PS class ≥ 3. METHODS: We extracted data for a total of 28,160 patients with an ASA-PS class ≥ 3 who underwent distal or total gastrectomy for gastric cancer between January 2013 and December 2017 from the National Clinical Database Japan society for gastroenterological surgery registry. We developed a propensity score model from baseline demographics and comorbidities and matched patients undergoing LG to those undergoing open gastrectomy (OG) using a 1:1 ratio. Mortality and morbidities (within 30 days and in-hospital) were compared between the 6998 matched patient pairs. RESULTS: In-hospital mortality was significantly lower in patients undergoing LG than in those undergoing OG (2.3% vs. 3.0%, p = 0.01), while the 30-day mortality was similar (1.6% vs. 1.5%). The length of hospital stay was significantly shorter in the LG group (median, 14 days vs. 17 days, p < 0.001). The LG group had a significantly lower incidence of postoperative complications in patients with any grade complication (20.3% vs. 22.5%, p = 0.002) as well as those with ≥ grade 3 complications (8.7% vs. 9.8%, p = 0.03). CONCLUSION: LG was associated with decreased in-hospital mortality and a lower incidence of several postoperative complications when compared to OG among patients with poor physical condition.

DOI： 10.1007/s10120-019-00993-1

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Adding taxane to an anthracycline-based regimen improves survival in node-positive breast cancer patients, as shown by clinical trials and meta-analyses. However, no studies have analyzed the number of metastatic lymph nodes in patients with estrogen receptor (ER)-positive cancer. This study investigated whether adding a taxane to an anthracycline-based regimen improved prognosis in node-positive, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients in a real-world setting. METHODS: Using Japanese Breast Cancer Society registry data, we compared disease-free survival (DFS) of patients with ER-positive, HER2-negative breast cancer, excluding those receiving neoadjuvant chemotherapy, between those who received an anthracycline-based regimen followed by a taxane-based regimen (A + T) and those who received only an anthracycline-based regimen (A w/o T), stratified by lymph node status. A Cox proportional hazards model was used to evaluate DFS in both groups. RESULTS: There were 4566 eligible patients with ER-positive, HER2-negative breast cancer. During the median follow-up period of 60 months, there were 481 recurrences and 149 deaths. There was no significant difference in DFS between the A + T and A w/o T groups among patients with 1-3 positive nodes, while there was a significant difference among patients with ≥ 4 positive nodes. CONCLUSIONS: In patients with ER-positive, HER2-negative breast cancer, adding taxane to an anthracycline regimen did not improve DFS in patients with metastasis in 1-3 lymph nodes. We considered that the group without the addition of taxane might be present in patients with ER-positive, HER2-negative lymph node metastases.

DOI： 10.1007/s12282-019-00997-w

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The use of transcatheter or surgical aortic valve replacement (AVR) for severe aortic stenosis (AS) has considerably increased in recent years. However, the association between AS etiology and mid-term clinical outcomes after surgical AVR has not been fully investigated. METHODS AND RESULTS: We retrospectively included 201 patients (mean age, 75 years; 43%, men) who underwent surgical AVR for severe native AS (aortic valve area ≤1.0 cm2 on preoperative transthoracic echocardiography examination). The following valve etiologies were postoperatively identified on pathological examination: post-inflammatory (n = 28), congenital (n = 35), and calcific/degenerative (n = 138). The median follow-up interval was 4.1 years following surgical AVR. Of the 201 patients, 27% were asymptomatic, 40% had a history of heart failure, and 11% underwent previous heart surgery. The cumulative incidence of cardiac events (all-cause death, aortic valve deterioration requiring repeated AVR, and hospitalization for heart failure) and combined adverse events, which included non-fatal stroke, unplanned coronary revascularization, pacemaker implantation, and gastrointestinal bleeding along with cardiac events, was significantly higher in the calcific/degenerative group (p = 0.02 and p = 0.02, respectively). In multivariate analysis adjusted for age, sex, renal function, heart failure, atrial fibrillation, concomitant surgical procedures, and EuroSCORE II, AS etiology was independently associated with an increased risk of combined adverse events (congenital vs. post-inflammatory: hazard ratio [HR], 4.13; p = 0.02 and calcific/degenerative vs. post-inflammatory: HR, 5.69; p = 0.002). CONCLUSIONS: Pathology-proven AS etiology could aid in predicting the mid-term outcomes after surgical AVR, supporting the importance of accurate identification of severe AS etiology with or without postoperative pathological examination.

DOI： 10.1371/journal.pone.0229721

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Esophagectomy is a highly invasive procedure with a high incidence of complications. The objectives of this study were to create risk prediction models for postoperative morbidity associated with esophagectomy and to test their performance using a population-based large database. METHODS: A total of 10 862 patients who underwent esophagectomy between January 2011 and December 2012 derived from the Japanese national clinical database (NCD) were included. Based on the 148 preoperative clinical variables collected, risk prediction models for eight major postoperative morbidities were created using 80% (8715 patients) of the study population and validated using the remaining 20% (2147 patients) of the patients. RESULTS: The mortality rate was 3.1% and postoperative morbidity was observed in 42.6% of the patients. The c-statistics of the eight risk models established by the training set were surgical site infection (0.564), anastomotic leakage (0.531), need for transfusion (0.636), blood loss >1000 mL (0.644), pneumonia (0.632), unplanned intubation (0.607), prolonged mechanical ventilation over 48 hours (0.614), and sepsis (0.618) in the validation analysis. CONCLUSIONS: Risk prediction models for postoperative morbidity after esophagectomy using the population-based large database showed relatively fair performance. The current models may offer baseline information for risk stratification in clinical decision makings and help select more suitable surgical and nonsurgical treatment options and future clinical studies.

DOI： 10.1002/jso.25800

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.1007/s10549-019-05413-7

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: The incidence of thromboembolism in patients with cancer is approximately 11%, and the risk of thrombosis in patients with malignant tumors is 6-fold higher than that in healthy persons. Thrombosis not only disrupts the treatment of cancer but also induces deterioration of quality of life (QOL). Knowledge about thrombus treatment is limited, and evidence is scarce. Clarification of the status and safety of venous thromboembolism (VTE) treatment in patients with cancer will contribute to active intervention and improvement of prognosis and QOL. In this study, the therapeutic effects of a non-vitamin K antagonist oral anticoagulant for VTE and the prognosis of cancer after treatment will be examined to establish a therapeutic method for VTE in patients with cancer. Methods and Results: A multicenter, non-interventional, observational study will be conducted in patients with cancer who developed VTE and underwent anticoagulant therapy with rivaroxaban (group A) or warfarin (group B) for 24 weeks. The primary endpoint will be the recurrence/aggravation of symptomatic VTE or occurrence/aggravation of deep vein thrombosis. Registration of 500 patients is needed in order to calculate the 95% confidence interval of the event rate at ±1% precision. Conclusions: The investigation period will run from January 2019 to December 2023 with ongoing selection of patients. Trial registration: no. 5-18-32 (approved 1 August 2018).

DOI： 10.1253/circrep.CR-19-0078

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The aim of the present study was to clarify the association between preoperative liver function and complications after hepatectomy. METHODS: The study included 11,686 patients registered in the National Clinical Database for 2015 for whom data on indocyanine green at 15 min (ICG15) and hepatectomy were available. The patients were divided into four groups: group A (ICG15 <10%; n = 5,661), group B (ICG15 10% to <20%; n = 4,381), group C (ICG15 20% to <30%; n = 1,173) and group D (ICG15 >30%; n = 463). Hepatectomy procedures were classified as partial resection (n = 3,934), systematic subsegmentectomy (n = 2,055), monosectionectomy (n = 2,043), bisectionectomy (n = 2,993) and trisectionectomy (n = 208). Complications were classified using the Clavien-Dindo classification (CD) and evaluated by ICG15 category and procedure type. RESULTS: Complications more severe than CD III increased significantly as the operation time lengthened and the intraoperative bleeding volume increased (P < 0.001). ICG15 category was positively associated with operative death, >CD III complications, surgical site infection (SSI), liver failure, and intractable ascites for many of the major hepatectomy procedures, but not with bile leakage. More complications were observed in patients outside the Makuuchi criteria than in those within the criteria. CONCLUSIONS: Operation time and intraoperative bleeding volume are significantly associated with severe postoperative complications in patients undergoing hepatectomy. ICG15 is a good indicator predictive of operative death, >CD III complications, SSI, liver failure and intractable ascites.

DOI： 10.1002/jhbp.644

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: Regionalization directs patients to high-volume hospitals for specialized care. We investigated regionalization trends and outcomes in pediatric cardiac surgery. DATA SOURCES/STUDY SETTING: Statewide inpatient data from eleven states between 2000 and 2012. STUDY DESIGN: Mortality, length of stay (LOS), and cost were assessed using multivariable hierarchical regression with state and year fixed effects. Primary predictor was hospital case-volume, categorized into low-, medium-, and high-volume tertiles. DATA COLLECTION/EXTRACTION METHODS: We used Risk Adjustment for Congenital Heart Surgery-1 (RACHS-1) to select pediatric cardiac surgery discharges. PRINCIPAL FINDINGS: In total, 2841 (8.5 percent), 8348 (25.1 percent), and 22 099 (66.4 percent) patients underwent heart surgeries in low-, medium-, and high-volume hospitals. Mortality decreased over time, but remained higher in low- and medium-volume hospitals. High-volume hospitals had lower odds of mortality and cost than low-volume hospitals (odds ratio [OR] 0.59, P < 0.01, and relative risk [RR] 0.91, P < 0.01, respectively). LOS was longer for high- and medium-volume hospitals, compared to low-volume hospitals (high-volume: RR 1.18, P < 0.01; medium-volume: RR 1.05, P < 0.01). CONCLUSIONS: Regionalization reduced mortality and cost, indicating fewer complications, but paradoxically increased LOS. Further research is needed to explore the full impact on health care utilization.

DOI： 10.1111/1475-6773.13137

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: The role of postmastectomy radiotherapy (PMRT) in breast cancer patients receiving neoadjuvant chemotherapy (NAC) is controversial. We aimed to evaluate the effectiveness of radiotherapy in patients treated with NAC and mastectomy in the Japanese Breast Cancer Registry. METHODS: We enrolled patients who received NAC and mastectomy for cT1-4 cN0-2 M0 breast cancer. We evaluated the association between radiotherapy and outcomes, locoregional recurrence (LRR), distant disease-free survival (DDFS), and overall survival (OS) based on ypN status by multivariable analysis. RESULTS: Of the 145,530 patients, we identified 3226 who met the inclusion criteria. Among ypN1 patients, no differences were found in LRR, DDFS, or OS between groups with and without radiotherapy (p = 0.72, p = 0.29, and p = 0.36, respectively). Radiotherapy was associated with improved LRR-free survival (p < 0.001), DDFS (p = 0.01), and OS (p < 0.001) in patients with ypN2-3. Multivariable analysis demonstrated that use of radiotherapy was independently associated with improved LRR [hazard ratio (HR) 0.61, 95% confidence interval (CI) 0.45-0.82, p = 0.001] and OS [HR 0.69, 95% CI 0.53-0.89, p = 0.004) for ypN2-3 patients only. The association between radiotherapy and OS was not statistically significant among ypN0 (p = 0.22) and ypN1 patients (p = 0.51). CONCLUSIONS: The results from this nationwide database study did not show significant associations between PMRT and improved survival among ypN0 and ypN1 patients. Radiotherapy may be beneficial only for ypN2-3 breast cancer patients who receive NAC and mastectomy in the modern era.

DOI： 10.1245/s10434-019-07453-1

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: The aim of the present study was to develop a risk calculator predictive of postoperative pneumonia in patients undergoing gastroenterological surgery. Methods: We analyzed data from 382 124 patients undergoing eight main gastroenterological surgeries between 2011 and 2013 using the National Clinical Database in Japan. A risk model was developed using multivariate logistic regression analysis with patient data from 2011 to 2012 (n = 247 604) and validated using data from 2013 (n = 134 520). Results: Pneumonia was observed in 11 105 patients (2.9%). After the input of significant primary disease and surgical procedures, 18 patient characteristics including gender, chronic obstructive pulmonary disease, sepsis, and need for any assistance in the activities of daily living, six laboratory parameters, and two intraoperative factors were used for risk calculation. Area under the receiver-operating characteristic curve was 0.822 (95% confidence interval, 0.817-0.826) in the derivation group and 0.826 (0.819-0.832) in the validation group. Conclusion: The risk calculator accurately predicted the occurrence of pneumonia following gastroenterological surgery.

DOI： 10.1002/ags3.12248

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Laparoscopic gastrectomy (LG) might have greater clinical benefits for elderly patients as less invasive surgery; however, there is still little evidence to support its benefit. We evaluated the surgical outcomes of elderly patients in a nationwide prospective cohort study. METHODS: One hundred and sixty-nine participating institutions were identified by stratified random sampling, and were adjusted for hospital volume, type and location. During 1 year from 2014 to 2015, consecutive patients who underwent gastrectomy for gastric cancer were prospectively enrolled. 'Elderly' was defined as ≥ 75 years of age, based on the prevalence of comorbidities and the activities of daily living of patients of this age. We compared the surgical outcomes of LG to those of open gastrectomy (OG) in non-elderly and elderly patients. The primary outcome was the incidence of severe morbidities (Grade ≥ 3). RESULTS: Eight thousand nine hundred and twenty-seven patients were enrolled [non-elderly, n = 6090 (OG, n = 2602; LG, n = 3488); elderly, n = 2837 (OG, n = 1471; LG, n = 1366)]. Grade ≥ 3 complications occurred in 161 (10.9%) patients who underwent OG and 98 (7.2%) who underwent LG (p < 0.001). After adjusting for confounding factors, we confirmed that laparoscopic surgery was not an independent risk factor (odds ratio = 0.81, 0.60-1.09). OG was associated with a significantly longer median length of postoperative stay in comparison to LG (16 versus 12 days, p < 0.001). There were no significant differences in the incidence of other postoperative comorbidities. CONCLUSION: The safety of LG in elderly patients was demonstrated. LG shortened the length of postoperative hospital stay.

DOI： 10.1007/s10120-018-0898-7

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: To provide an accurate adjustment for mortality in a benchmark, developing a risk prediction model from its own dataset is mandatory. We aimed to develop and validate a risk model predicting in-hospital mortality in a broad spectrum of Japanese patients after percutaneous coronary intervention (PCI). DESIGN: A retrospective cohort study was conducted. SETTING: The Japanese-PCI (J-PCI) registry includes a nationally representative retrospective sample of patients who underwent PCI and covers approximately 88% of all PCIs in Japan. PARTICIPANTS: Overall, 669 181 patients who underwent PCI between January 2014 and December 2016 in 1018 institutes. MAIN OUTCOME MEASURES: In-hospital death. RESULTS: The study population (n=669 181; mean (SD) age, 70.1(11.0) years; women, 24.0%) was divided into two groups: 50% of the sample was used for model derivation (n=334 591), while the remaining 50% was used for model validation (n=334 590). Using the derivation cohort, both 'full' and 'preprocedure' risk models were developed using logistic regression analysis. Using the validation cohort, the developed risk models were internally validated. The in-hospital mortality rate was 0.7%. The preprocedure model included age, sex, clinical presentation, previous PCI, previous coronary artery bypass grafting, hypertension, dyslipidaemia, smoking, renal dysfunction, dialysis, peripheral vascular disease, previous heart failure and cardiogenic shock. Angiographic information, such as the number of diseased vessel and location of the target lesion, was also included in the full model. Both models performed well in the entire validation cohort (C-indexes: 0.929 and 0.926 for full and preprocedure models, respectively) and among prespecified subgroups with good calibration, although both models underestimated the risk of mortality in high-risk patients with the elective procedure. CONCLUSIONS: These simple models from a nationwide J-PCI registry, which is easily applicable in clinical practice and readily available directly at the patients' presentation, are valid tools for preprocedural risk stratification of patients undergoing PCI in contemporary Japanese practice.

DOI： 10.1136/bmjopen-2018-026683

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: The purpose of the study was to investigate variation in the use of in-hospital CT for venous thromboembolism (VTE) detection after total knee or hip replacement (TKR/THR) among surgical patients, using a nationwide Japanese in-hospital administrative database. METHODS: This retrospective study using a national administrative database (4/2012-3/2013) extracted patients who underwent TKR/THR surgeries at hospitals meeting the annual case-volume threshold of ≥ 30. Hospitals were categorized into three equally sized groups by frequency of postoperative CT use (low, middle, and high CT use group) to compare baseline patient-level and hospital-level characteristics. To further investigate between-hospital variation in CT usage, we fitted a hierarchical logistic regression model including hospital-specific random intercepts and fixed patient- and hospital-level effects. The intra class correlation coefficient was used to measure the amount of variability in CT use attributable to between-hospital variation. RESULTS: A total of 39,127 patients discharged from 447 hospitals met the inclusion criteria. The median hospital stay was 25 days (interquartile range, 20 - 32) and 7,599 (19.4%) patients underwent CT for VTE. CT utilization varied greatly among the hospitals; the crude frequency ranged from 0 to 100 % (median, 7.3 %; interquartile range, 1.8 - 18.3 %). After adjustment for known hospital- and patient-level factors related to CT use, 47 % of the variation in CT use remained attributable to the behavior of individual hospitals. CONCLUSION: We observed large inter hospital variability in the utilization of post-procedure CT for VTE detection in this Japanese TKR/THR cohort, suggesting that CT utilization is not optimized across the nation. ADVANCES IN KNOWLEDGE: We observed significant variability in the utilization of post-procedure CT for VTE detection among inpatients who underwent TKR/THR surgeries in a large sample of Japanese hospitals. The large variation suggests that CT utilization is not optimized across the nation, and that there may be potential overutilization of the technology in the highest CT use hospitals.

DOI： 10.1259/bjr.20180825

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Although laparoscopic total gastrectomy (LTG) is considered a technically demanding procedure with safety issues, it has been performed in several hospitals in Japan. Data from a nationwide web-based data entry system for surgical procedures (NCD) that started enrollment in 2011 are now available for analysis. METHODS: A retrospective cohort study was conducted using data from 32,144 patients who underwent total gastrectomy and were registered in the NCD database between January 2012 and December 2013. Mortality and morbidities were compared between patients who received LTG and those who underwent open total gastrectomy (OTG) in the propensity score-matched Stage I cohort and Stage II-IV cohort. RESULTS: There was no significant difference in mortality rate between LTG and OTG in both cohorts. Operating time was significantly longer in LTG while the blood loss was smaller. In the Stage I cohort, LTG, performed in 33.6% of the patients, was associated with significantly shorter hospital stay but significantly higher incidence of readmission, reoperation, and anastomotic leakage (5.4% vs. 3.6%, p < 0.01). In the Stage II-IV cohort, LTG was performed in only 8.8% of the patients and was associated with significantly higher incidence of leakage (5.7% vs. 3.6%, p < 0.02) although the hospital stay was shorter (15 days vs. 17 days, p < 0.001). CONCLUSION: LTG was more discreetly introduced than distal gastrectomy, but remained a technically demanding procedure as of 2013. This procedure should be performed only among the well-trained and informed laparoscopic team.

DOI： 10.1007/s10120-018-0795-0

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

PURPOSE: The aim of this study was to examine the quality of data from the National Clinical Database (NCD) via a comparison with regional government report data and medical charts. METHODS: A total of 1,165,790 surgical cases from 3007 hospitals were registered in the NCD in 2011. To evaluate the NCD's data coverage, we retrieved regional government report data for specified lung and esophageal surgeries and compared the number with registered cases in the NCD for corresponding procedures. We also randomly selected 21 sites for on-site data verification of eight demographic and surgical data components to assess the accuracy of data entry. RESULTS: The numbers of patients registered in the NCD and regional government report were 46,143 and 48,716, respectively, for lung surgeries and 7494 and 8399, respectively, for esophageal surgeries, leading to estimated coverages of 94.7% for lung surgeries and 89.2% for esophageal surgeries. According to on-site verification of 609 cases at 18 sites, the overall agreement between the NCD data components and medical charts was 97.8%. CONCLUSION: Approximately, 90-95% of the specified lung surgeries and esophageal surgeries performed in Japan were registered in the NCD in 2011. The NCD data were accurate relative to medical charts.

DOI： 10.1007/s00595-018-1700-5

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Objective: Severe aortic stenosis (AS) is one of the most serious valve conditions. Patient demography and the aetiology of AS have substantially changed in the past several decades along with a drastic improvement of surgical aortic valve replacement (SAVR) and its associated procedures. Contemporary patients with severe AS have multiple comorbidities and live much longer. We aimed to elucidate the treatment effects of SAVR on long-term outcome in propensity score (PS)-matched and the entire patient populations. Methods: We retrospectively reviewed 570 patients with severe AS defined as an aortic valve area of 1.0 cm2 or less. Systemic differences in 39 baseline characteristics between non-SAVR and SAVR groups were adjusted using PS matching method. The endpoints included all-cause mortality and cardiovascular events that included heart failure, non-fatal stroke, syncope and acute coronary syndrome. Results: Overall, 55% of the entire population (mean age 78 years; males 41%) were symptomatic. During 3.9 years of the median follow-up, 210 (36%) patients underwent SAVR and 231 (41%) died. Cumulative incidences of mortality and both mortality and cardiovascular events were significantly higher in the non-SAVR group than in the other group (p<0.001, each). Among 101 PS-matched pairs, SAVR correlated with a lower mortality risk (HR 0.35; 95% CI 0.21 to 0.59; p<0.001)) and mortality and cardiovascular events combined (HR 0.62; 95% CI 0.42 to 0.92; p=0.02). However, survival difference between both groups was markedly smaller among asymptomatic patients in the subgroup of matched patients. Conclusion: Patients with AS undergoing SAVR exhibit a lower incidence of all-cause mortality and major cardiovascular events than those not undergoing surgical interventions, even after the baseline characteristics are balanced by the PS matching. The correlation between SAVR and survival from cardiovascular events is less evident among asymptomatic patients.

DOI： 10.1136/openhrt-2018-000992

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Periprocedural stroke is a rare but life-threatening complication of percutaneous coronary intervention (PCI). Transradial intervention (TRI) is more beneficial than transfemoral intervention for periprocedural bleeding and acute kidney injuries, but its effect on periprocedural stroke has not been fully investigated. Our study aimed to assess risk predictors of periprocedural stroke according to PCI access site. METHODS AND RESULTS: Between 2008 and 2016, 17 966 patients undergoing PCI were registered in a prospective multicenter database. Periprocedural stroke was defined as loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours after onset. Periprocedural stroke was observed in 42 patients (0.3%). Stroke patients were older and had a higher incidence of chronic kidney disease, peripheral artery disease, and acute coronary syndrome but were less likely to undergo TRI. Multivariable logistic regression analysis revealed TRI (odds ratio; 0.33; 95% CI, 0.16-0.71; P=0.004) was significantly associated with a lower occurrence of periprocedural stroke. Finally, propensity score-matching analysis showed that TRI was associated with a reduced risk of periprocedural stroke compared with transfemoral intervention (0.1% versus 0.4%; P=0.014). According to our sensitivity analysis, this finding was robust to the presence of an unmeasured confounder in almost all plausible scenarios. CONCLUSIONS: TRI was associated with a reduced risk of periprocedural stroke compared with transfemoral intervention. Increased TRI use may reduce overall PCI complications and should be recommended as the optimal access site for both urgent/emergent and elective PCIs.

DOI： 10.1161/CIRCINTERVENTIONS.118.006761

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVES: The use of an anastomosis assist device during coronary artery bypass grafting (CABG) is considered less invasive for the ascending aorta than the use of a side-biting clamp (Side-clamp) and to possibly be associated with a lower incidence of postoperative stroke. However, this benefit has not yet been clearly demonstrated. This study was to evaluate whether the use of an anastomosis assist device will minimize the postoperative stroke and other complications in patients undergoing off-pump CABG in comparison with the use of the Side-clamp. METHODS: Patients undergoing isolated off-pump CABG were retrospectively reviewed using the Japan Adult Cardiovascular Surgery Database (2013-2016). We performed a one-to-one matched analysis based on the estimated propensity scores of those who underwent off-pump CABG with an anastomosis assist device (Device group, n = 14 213) or a side-biting clamp (Side-clamp group, n = 7374) and obtained 2 cohorts (n = 7348 each). We compared the early outcomes and the details of postoperative complications using the Pearson's χ2 test. P-values of <0.05 were considered to indicate statistical significance. RESULTS: No significant differences were observed in the rates of 30-day mortality (Side-clamp versus Device: 0.8% vs 0.8%, P = 0.93) or stroke (1.4% vs 1.4%, P = 0.46). Transient ischaemic attack/reversible ischaemic neurological deficit/delirium occurred more frequently in the Side-clamp group (1.3% vs 0.9%, P = 0.020), whereas new-onset atrial fibrillation (11.0% vs 12.8%, P < 0.001) and prolonged ventilation (2.0% vs 2.9%, P < 0.001) occurred more frequently in the Device group. There was no difference in the length of intensive care unit stay. CONCLUSIONS: The use of an anastomosis assist device partially provided better results with regard to the transient neurological complications; however, no overall benefit was observed in this study.

DOI： 10.1093/ejcts/ezy177

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Medication nonadherence is a major public health problem. Identification of patients who are likely to be and not be adherent can guide targeted interventions and improve the design of comparative-effectiveness studies. OBJECTIVE: To evaluate multiple measures of patient previous medication adherence in light of predicting future statin adherence in a large U.S. administrative claims database. METHODS: We identified a cohort of patients newly initiating statins and measured their previous adherence to other chronic preventive medications during a 365-day baseline period, using metrics such as proportion of days covered (PDC), lack of second fills, and number of dispensations. We measured adherence to statins during the year after initiation, defining high adherence as PDC ≥ 80%. We built logistic regression models from different combinations of baseline variables and previous adherence measures to predict high adherence in a random 50% sample and tested their discrimination using concordance statistics (c-statistics) in the other 50%. We also assessed the association between previous adherence and subsequent statin high adherence by fitting a modified Poisson model from all relevant covariates plus previous mean PDC categorized as < 25%, 25%-79%, and ≥ 80%. RESULTS: Among 89,490 statin initiators identified, a prediction model including only demographic variables had a c-statistic of 0.578 (95% CI = 0.573-0.584). A model combining information on patient comorbidities, health care services utilization, and medication use resulted in a c-statistic of 0.665 (95% CI = 0.659-0.670). Models with each of the previous medication adherence measures as the only explanatory variable yielded c-statistics ranging between 0.533 (95% CI = 0.529-0.537) for lack of second fill and 0.666 (95% CI = 0.661-0.671) for maximum PDC. Adding mean PDC to the combined model yielded a c-statistic of 0.695 (95% CI = 0.690-0.700). Given a sensitivity of 75%, the predictor improved the specificity from 47.7% to 53.6%. Patients with previous mean PDC < 25% were half as likely to show high adherence to statins compared with those with previous mean PDC ≥ 80% (risk ratio = 0.49, 95% CI = 0.46-0.50). CONCLUSIONS: Including measures of previous medication adherence yields better prediction of future statin adherence than usual baseline clinical measures that are typically used in claims-based studies. DISCLOSURES: This study was funded by the Patient-Centered Outcomes Research Institute (ME-1309-06274). Kumamaru, Kohsaka, and Miyata are affiliated with the Department of Healthcare Quality Assessment at the University of Tokyo, which is a social collaboration department supported by National Clinical Database. The department was formerly supported by endowments from Johnson & Johnson K.K., Nipro, Teijin Pharma, Kaketsuken K.K., St. Jude Medical Japan, Novartis Pharma K.K., Taiho Pharmaceutical, W. L. Gore & Associates, Olympus Corporation, and Chugai Pharmaceutical. Gagne has received grants from Novartis Pharmaceuticals and Eli Lilly and Company to the Brigham and Women's Hospital for unrelated work. He is a consultant to Aetion, a software company, and to Optum. Choudhry has received grants from the National Heart, Lung, and Blood Institute, PhRMA Foundation, Merck, Sanofi, AstraZeneca, CVS, and MediSafe. Schneeweiss is consultant to WHISCON and Aetion, a software manufacturer of which he also owns equity. He is principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, and Boehringer Ingelheim unrelated to the topic of this study. He does not receive personal fees from biopharmaceutical companies. No potential conflict of interest was reported by the other authors.

DOI： 10.18553/jmcp.2018.24.11.1146

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To apply a causal analysis approach to estimate the intent-to-treat and per-protocol effects in a safety outcome study of the 30-day risk of liver injury associated with antibiotic use (macrolides, penicillin-based antibiotics, and fluoroquinolones). RESEARCH DESIGN AND METHODS: For each antibiotic class, we constructed a pooled cohort of treated episodes matched with untreated episodes using an electronic medical record database from a university hospital. High-dimensional propensity scores were calculated using baseline patient characteristics, concomitant medications and medical history as surrogate confounders. Intent-to-treat hazard ratios (HRs) were estimated using inverse probability of treatment weighted discrete hazard models that ignored subsequent treatment changes. Per-protocol HRs were calculated using inverse probability of treatment and censoring weighted models after terminating each episode's observation at the first treatment change. RESULTS: For macrolides, the intent-to-treat HR (95% confidence interval) was 1.22 (0.75-1.98) and the per-protocol HR was 1.22 (0.67-2.22). For penicillin-based antibiotics, the intent-to-treat HR was 4.01 (3.16-5.08) and the per-protocol HR was 7.25 (5.58-9.41). For fluoroquinolones, the intent-to-treat HR was 1.60 (1.27-2.03) and the per-protocol HR was 1.69 (1.23-2.30). CONCLUSION: Researchers should clearly define the target estimands, and carefully estimate and interpret both effects.

DOI： 10.1080/14740338.2018.1528224

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Japanese Circulation Society  

BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results:The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30. CONCLUSIONS: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.

DOI： 10.1253/circj.CJ-18-0211

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Springer New York LLC  

BACKGROUND: Controversy persists regarding the technical feasibility of laparoscopic total gastrectomy (LTG), and to our knowledge, no prospective study with a sample size sufficient to investigate its safety has been reported. We aimed to compare the postoperative morbidity and mortality rates in patients undergoing LTG and open total gastrectomy (OTG) for gastric cancer in prospectively enrolled cohort using nationwide web-based registry. METHODS: From August 2014 to July 2015, consecutive patients undergoing LTG or OTG (925 and 1569 patients, respectively) at the participating institutions were enrolled prospectively into the National Clinical Database registration system. We constructed propensity score (PS) models separately in four facility yearly case-volume groups, and evaluated the postoperative morbidity and mortality in PS-matched 1024 patients undergoing LTG or OTG. RESULTS: The incidence of overall morbidity were 84 (16.4%) in the OTG and 54 (10.3%) in the LTG groups (p = 0.01).The incidence of anastomotic leakage and pancreatic fistula grade B or above were not significantly different between the two groups (LTG 5.3% vs. OTG 6.1%, p = 0.59, LTG 2.7% vs. OTG 3.7%, p = 0.38, respectively). There were also no significant differences in the 30-day and in-hospital mortality rates between the two groups (LTG 0.2% vs. OTG 0.4%, p = 0.56; LTG 0.4% vs. OTG 0.4%, p = 1.00, respectively). CONCLUSION: The results from our nationally representative data analysis showed that LTG could be a safe procedure to treat gastric cancer compared to OTG. The indication for LTG should be considered carefully in a clinical setting.

DOI： 10.1007/s00464-017-5976-0

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Objective: Nationwide databases are expected to provide critical data to improve medical practice. The present study used such data to develop risk models for clinically important outcomes after right hemicolectomy based on preoperative risk factors. Methods: Japan's National Clinical Database (NCD) identified 38 030 cases of right hemicolectomy in the years 2011 and 2012. These were used to analyze correlations between mortality and eight selected clinical outcomes of interest by Pearson's correlation coefficient (r). To construct risk models for the eight selected clinical outcomes, 80% of all the examined cases were extracted randomly as a development cohort, and preoperative risk factors for each clinical outcome were identified using a forward stepwise selection method. Morbidities predicted from the risk models were used to find areas under the receiver operator curves among the remaining 20% of the testing cohort. Results: The following clinical outcomes were identified as highly associated with operative mortality: systemic sepsis (r = .360), renal failure (r = .341), unplanned intubation (r = .316) and central nervous system (CNS) occurrences (r = .301). Risk models containing up to 21 preoperative variables were constructed for these eight postoperative clinical outcomes. Predictive values of the eight models were as follows: surgical site infections (0.634), anastomotic leakage (0.656), systemic sepsis (0.816), pneumonia (0.846), unplanned intubation (0.838), renal failure (0.883), CNS occurrences (0.833) and transfusion >5 units (0.846). Conclusions: This study indicated that the NCD-generated risk models for six of the eight selected critical postoperative outcomes had high discrimination among right hemicolectomy patients. These risk models can accurately identify high-risk patients prior to surgery.

DOI： 10.1002/ags3.12067

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Springer Verlag  

PURPOSE: To test the hypothesis that "acute-period" lumbar MRI in non-elderly patients with low back pain is less frequently performed at clinics/hospitals with greater involvement of full-time radiologists in the imaging workflow. METHODS: In a national-level claims database, we identified 14,819 non-elderly patients (mean age: 38.7±8.0 years) who visited clinics/hospitals for low back pain in 2013-2015. We classified the clinics/hospitals into four groups based on the level of full-time radiologist involvement and MRI ownership, and compared the frequency of acute-period lumbar MRI using hierarchical logistic regression analysis. RESULTS: Patients visiting facilities without a full-time radiologist (n=2105) were significantly (p<0.001) more likely to undergo acute-period MRI than those visiting facilities with ≥1 radiologist partially managing imaging workflow (level-1, n=491) or ≥1 radiologist intensively involved in imaging workflow (level-2, n=1190) (15.7% vs. 6.9% and 7.3%; adjusted odds ratio of no-radiologist versus level-2: 2.93, p=0.018). No difference was observed between level-1 and level-2 involvement. CONCLUSIONS: Facilities with no full-time radiologist were more likely to perform acute-period MRI to assess for low back pain, while no difference was seen between facilities with varying levels of radiologist involvement in the imaging workflow. Radiologist involvement may contribute to optimal utilisation of medical imaging. KEY POINTS: • Lumbar MRI was more frequently performed at facilities without full-time radiologists. • Full-time radiologists may play an important role in appropriate utilisation of imaging. • Frequency of MRI was similar between moderate and intensive radiologist involvement.

DOI： 10.1007/s00330-017-5086-3

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. METHODS: We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. RESULTS: We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. CONCLUSIONS: Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

DOI： 10.1177/2150135117745871

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

To clarify the safety profile of laparoscopic distal gastrectomy (LDG) for gastric cancer patients, the short-term outcome of LDG was compared to that of open distal gastrectomy (ODG) by propensity score matching using data from the Japanese National Clinical Database (NCD). We conducted a retrospective cohort study of patients undergoing distal gastrectomy between January 2012 and December 2013. Using the data for 70 346 patients registered in the NCD, incidences of mortality and morbidities were compared between LDG patients and ODG patients in the propensity score matched stage I patients (ODG: n = 14 386, LDG: n = 14 386) and stage II-IV patients (ODG: n = 3738, LDG: n = 3738), respectively. There was no significant difference in mortality rates between LDG and ODG at all stages. Operating time was significantly longer in LDG compared to ODG, whereas blood loss and incidences of superficial surgical site infection (SSI), deep SSI, and wound dehiscence were significantly higher in ODG at all stages. Interestingly, pancreatic fistula was found significantly more often in LDG (1%) compared to ODG (0.8%) (P = .01) in stage I patients; however, it was not different in stage II-IV patients. The length of postoperative stay was significantly longer in patients undergoing ODG compared to LDG at all stages. LDG in general practice might be a feasible therapeutic option in patients with both advanced gastric cancer and those with early gastric cancer in Japan.

DOI： 10.1002/ags3.12054

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

OBJECTIVE: To assess the use of laparoscopic surgeries (LS) and the association between its performance and hospitals' preference for LS over open surgeries. SUMMARY BACKGROUND DATA: LS is increasingly used in many abdominal surgeries, albeit both with and without solid guideline recommendations. To date, the hospitals' preference (LS vs. open surgeries) and its association with in-hospital outcomes has not been evaluated. METHODS: We enrolled patients undergoing 8 types of gastrointestinal surgeries in 2011-2013 in the Japanese National Clinical Database. We assessed the use of LS and the occurrences of surgery-related morbidity and mortality during the study period. Further, for 4 typical LS procedures, we assessed the hospitals' preference for LS by modeling the propensity to perform LS (over open surgeries) from patient-level factors, and estimating each institution's observed/expected (O/E) ratio for LS use. Institutions with O/E>2 were defined as LS-dominant. Using hierarchical logistic regression models, we assessed the association between LS preference and in-hospital outcomes. RESULTS: Among 1,377,118 patients undergoing gastrointestinal procedures in 2,336 participating hospitals, use of LS increased in all 8 procedures (35.1% to 44.7% for distal gastrectomy (DG), and 27.5% to 43.2% for right hemi colectomy (RHC)). Those operated at LS-dominant hospitals were at an increased risk of operative death (OR 1.83 [95%CI, 1.37-2.45] for DG, 1.79 [95%CI, 1.43-2.25] for RHC) compared to standard O/E level hospitals (0.5≤O/E<2.0). CONCLUSIONS: LS use widely increased during 2011-2013 in Japan. Facilities with higher than expected LS use had higher mortality compared to other hospitals, suggesting a need for careful patient selection and dissemination of the procedure.

DOI： 10.1371/journal.pone.0193186

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：Japanese Circulation Society  

BACKGROUND: The trend of the initial treatment strategy for pulmonary arterial hypertension (PAH) has changed from monotherapies to upfront combination therapies. This study analyzed treatments and outcomes in Japanese patients with PAH, using data from the Japan PH Registry (JAPHR), which is the first organized multicenter registry for PAH in Japan.Methods and Results:We studied 189 consecutive patients (108 treatment-naïve and 81 background therapy patients) with PAH in 8 pulmonary hypertension (PH) centers enrolled from April 2008 to March 2013. We performed retrospective survival analyses and analyzed the association between upfront combination and hemodynamic improvement, adjusting for baseline NYHA classification status. Among the 189 patients, 1-, 2-, and 3-year survival rates were 97.0% (95% CI: 92.1-98.4), 92.6% (95% CI: 87.0-95.9), and 88.2% (95% CI: 81.3-92.7), respectively. In the treatment-naïve cohort, 33% of the patients received upfront combination therapy. In this cohort, 1-, 2-, and 3-year survival rates were 97.6% (95% CI: 90.6-99.4), 97.6% (95% CI: 90.6-99.4), and 95.7% (95% CI: 86.9-98.6), respectively. Patients on upfront combination therapy were 5.27-fold more likely to show hemodynamic improvement at the first follow-up compared with monotherapy (95% CI: 2.68-10.36). CONCLUSIONS: According to JAPHR data, initial upfront combination therapy is associated with improvement in hemodynamic status.

DOI： 10.1253/circj.CJ-17-0139

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：WILEY  

BACKGROUND: The morbidity rate after pancreaticoduodenectomy remains high. The objectives of this retrospective cohort study were to clarify the risk factors associated with serious morbidity (Clavien-Dindo classification grades IV-V), and create complication risk calculators using the Japanese National Clinical Database. METHODS: Between 2011 and 2012, data from 17,564 patients who underwent pancreaticoduodenectomy at 1,311 institutions in Japan were recorded in this database. The morbidity rate and associated risk factors were analyzed. RESULTS: The overall and serious morbidity rates were 41.6% and 4.5%, respectively. A pancreatic fistula (PF) with an International Study Group of Pancreatic Fistula (ISGPF) grade C was significantly associated with serious morbidity (P < 0.001). Twenty-one variables were considered statistically significant predictors of serious complications, and 15 of them overlapped with those of a PF with ISGPF grade C. The predictors included age, sex, obesity, functional status, smoking status, the presence of a comorbidity, non-pancreatic cancer, combined vascular resection, and several abnormal laboratory results. C-indices of the risk models for serious morbidity and grade C PF were 0.708 and 0.700, respectively. CONCLUSIONS: Preventing a PF grade C is important for decreasing the serious morbidity rate and these risk calculations contribute to adequate patient selection.

DOI： 10.1002/jhbp.438

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記述言語：英語   出版者・発行元：WILEY-BLACKWELL  

DOI： 10.1111/pai.12624

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：RADIOLOGICAL SOC NORTH AMERICA  

Purpose To evaluate the variation among U.S. hospitals in overall use and yield of in-hospital computed tomographic (CT) pulmonary angiography (PA) in patients undergoing total hip replacement (THR) or total knee replacement (TKR) surgery. Materials and Methods Patients in the Premier Research Database who underwent elective TKR or THR between 2007 and 2011 were enrolled in this HIPAA-compliant, institutional review board-approved retrospective observational study. The informed consent requirement was waived. Hospitals were categorized into low, medium, and high tertiles of CT PA use to compare baseline patient- and hospital-level characteristics and pulmonary embolism (PE) positivity rates. To further investigate between-hospital variation in CT PA use, a hierarchical logistic regression model that included hospital-specific random effects and fixed patient- and hospital-level effects was used. The intraclass correlation coefficient (ICC) was used to measure the amount of variability in CT PA use attributable to between-hospital variation. Results The cohort included 205 198 patients discharged from 178 hospitals (median of 734.5 patients discharged per hospital; interquartile range, 316-1461 patients) with 3647 CT PA studies (1.8%). The crude frequency of CT PA scans among the hospitals ranged from 0% to 6.2% (median, 1.6%); more than 90% of the hospitals performed CT PA in less than 3% of their patients. The mean hospital-level PE positivity rate was 12.3% (median, 9.1%); there was no significant difference in PE positivity rate across low through high CT PA use tertiles (11.3%, 11.9%, 12.9%, P = .37). After adjustment for hospital- and patient-level factors, the remaining amount of interhospital variation was relatively low (ICC, 9.0%). Conclusion Limited interhospital variation in use and yield of in-hospital CT PA was observed among patients undergoing TKR or THR in the United States. © RSNA, 2016 Online supplemental material is available for this article.

DOI： 10.1148/radiol.2016152765

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記述言語：日本語   掲載種別：研究論文（学術雑誌）  

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：SPRINGER  

PURPOSE: The aim of this study was to investigate whether young age at onset of breast cancer is an independent prognostic factor in patients from the Japanese Breast Cancer Registry, after adjustment of known clinicopathological prognostic factors. METHODS: Of the 53,670 patients registered between 2004 and 2006 and surveyed after a 5-year follow-up prognosis, 25,898 breast cancer patients (48.3 %), who were obtained prognostic data, were examined. Clinicopathological factors were compared between young adult (YA; <35 years), middle-aged adult (MA; 35-50 years), and older adult (OA; >50 years) patients. Five-year disease-free survival (DFS) and overall survival (OS) rates were studied. RESULTS: YA patients were associated with an advanced TNM stage and aggressive characteristics (e.g. human epidermal growth factor receptor 2 (HER2)-positive or oestrogen receptor (ER)-negative breast cancers) compared to MA and OA patients (P < 0.001). The 5-year DFS and OS rates were 79.4 % and 90.8, 88.5 and 95.0 %, and 87.8 % and 91.6 % for YA, MA, and OA patients, respectively. From the multivariable regression analysis, young age at onset was confirmed as an independent prognostic factor for both DFS (hazard ratio 1.73, 95 % confidence interval 1.42-2.10; P < 0.001) and OS (hazard ratio 1.58, 95 % confidence interval 1.16-2.15; P = 0.004). CONCLUSIONS: Young age at onset is an independent negative prognostic factor in breast cancer. Further studies are required to develop new therapeutic strategies for YA breast cancer patients.

DOI： 10.1007/s10549-016-3984-8

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：ELSEVIER SCIENCE INC  

OBJECTIVE: To compare confounding adjustment by high-dimensional propensity scores (hdPSs) and historically developed high-dimensional disease risk scores (hdDRSs) in three comparative study examples of newly marketed medications: (1) dabigatran vs. warfarin on major hemorrhage; (2) on death; and (3) cyclooxygenase-2 inhibitors vs. nonselective nonsteroidal anti-inflammatory drugs on gastrointestinal bleeds. STUDY DESIGN AND SETTING: In each example, we constructed a concurrent cohort of new and old drug initiators using US claims databases. In historical cohorts of old drug initiators, we developed hdDRS models including investigator-specified plus empirically identified variables and using principal component analysis and lasso regression for dimension reduction. We applied the models to the concurrent cohorts to obtain predicted outcome probabilities, which we used for confounding adjustment. We compared the resulting estimates to those from hdPS. RESULTS: The crude odds ratio (OR) comparing dabigatran to warfarin was 0.52 (95% confidence interval: 0.37-0.72) for hemorrhage and 0.38 (0.26-0.55) for death. Decile stratification yielded an OR of 0.64 (0.46-0.90) for hemorrhage using hdDRS vs. 0.70 (0.49-1.02) for hdPS. ORs for death were 0.69 (0.45-1.06) and 0.73 (0.48-1.10), respectively. The relative performance of hdDRS in the cyclooxygenase-2 inhibitors example was similar. CONCLUSION: hdDRS achieved similar or better confounding adjustment compared to conventional regression approach but worked slightly less well than hdPS.

DOI： 10.1016/j.jclinepi.2016.02.011

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

BACKGROUND: Effectiveness of carotid artery stenting (CAS) relative to carotid endarterectomy (CEA) among Medicare patients has not been established. We compared effectiveness of CAS versus CEA among Medicare beneficiaries. METHODS AND RESULTS: We linked Medicare data (2000-2009) to the Society for Vascular Surgery's Vascular Registry (2005-2008) and the National Cardiovascular Data Registry's (NCDR) Carotid Artery Revascularization and Endarterectomy Registry (2006-2008/2009). Medicare patients were followed up from procedure date until death, stroke/transient ischemic attack, periprocedural myocardial infarction, or a composite end point for these outcomes. We derived high-dimensional propensity scores using registry and Medicare data to control for patient factors and adjusted for provider factors in a Cox regression model comparing CAS with CEA. Among 5254 Society for Vascular Surgery's Vascular Registry (1999 CAS; 3255 CEA) and 4055 Carotid Artery Revascularization and Endarterectomy Registry (2824 CAS; 1231 CEA) Medicare patients, CAS patients had a higher comorbidity burden and were more likely to be at high surgical risk (Society for Vascular Surgery's Vascular Registry: 96.7% versus 44.5%; Carotid Artery Revascularization and Endarterectomy Registry: 71.3% versus 44.7%). Unadjusted outcome risks were higher for CAS. Mortality risks remained elevated for CAS after adjusting for patient-level factors (hazard ratio, 1.24; 95% confidence interval, 1.06-1.46). After further adjustment for provider factors, differences between CAS and CEA were attenuated or no longer present (hazard ratio for mortality, 1.13; 95% confidence interval, 0.94-1.37). Performance was comparable across subgroups defined by sex and degree of carotid stenosis, but there was a nonsignificant trend suggesting a higher risk of adverse outcomes in older (>80) and symptomatic patients undergoing CAS. CONCLUSIONS: Outcomes after CAS and CEA among Medicare beneficiaries were comparable after adjusting for both patient- and provider-level factors.

DOI： 10.1161/CIRCOUTCOMES.115.002336

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DOI： 10.1161/CIRCOUTCOMES.115.002336

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：SPRINGER  

The rate of breast cancer screening for women of all ages in Japan is increasing. However, little is known about the biological differences between screen- and self-detected tumors. We used data from the Japanese Breast Cancer Registry (JBCR), a nationwide registry of newly diagnosed breast cancer cases in Japan, to investigate patients diagnosed between January 1, 2004 and December 31, 2011. We compared the clinicopathological features of tumors and assessed yearly trends regarding the proportion of screen-detected cases during the study period. We found that 31.8 % (65,358/205,544) of cancers were detected by screening. Asymptomatic tumors detected by screening (asymptomatic) were more likely to have favorable prognostic features than those that were self-detected (ductal carcinoma in situ [DCIS]: 19.8 versus 4.1 %, node-negative: 77.0 versus 61.6 %, and estrogen receptor-positive [ER+]: 82.0 versus 72.9 %, respectively). All these findings were statistically significant (p < .001). The proportion of breast cancers detected by screening among all cases increased from 21.7 % in 2004 to 37.1 % in 2011. During the same time period, the proportion of screen-detected DCIS increased from 41.5 to 66.0 % and that of ER+ cancers increased from 23.2 to 39.7 %. This study demonstrated that low-risk tumors, including DCIS, ER+, and lower TNM stage, account for a substantial proportion of clinical screening-detected cancers. The differences in biological characteristics between screen- and self-detected cancers may account in part for the limited efficacy of breast cancer screening programs aimed at improving breast cancer mortality.

DOI： 10.1007/s10549-016-3770-7

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：WILEY-BLACKWELL  

OBJECTIVE: To investigate the effect of pediatrician supply on under-5 mortality over the period 2000-2010. DATA SOURCES: Multiple publicly available data sources were used. STUDY DESIGN: Japan's 366 "Secondary Tier of Medical Care Units" (STMCU) were used as study units. To evaluate the association between under-5 mortality and pediatrician supply, we explored time and area fixed-effects Poisson regression model. The following factors were introduced into the models as time-varying controls: (1) number of physicians other than pediatricians per total population except for under-5-year-old population, and (2) income per total population by year and STMCU. Extensive sensitivity analyses were conducted to assess robustness of results. PRINCIPAL FINDINGS: Pediatrician density was inversely associated with under-5 mortality. We estimated that a unit increase in pediatrician density was associated with a 7 percent (95 percent CI: 2-12 percent) reduction in the child mortality rate after adjustment for all other variables. The results were consistent and robust across all specifications tested. CONCLUSIONS: The results suggest that increasing human health resources can have positive effects on child health, even in settings where child mortality of less than 5 per 1,000 has been achieved.

DOI： 10.1111/1475-6773.12354

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：BioMed Central Ltd.  

BACKGROUND: Multivariable confounder adjustment in comparative studies of newly marketed drugs can be limited by small numbers of exposed patients and even fewer outcomes. Disease risk scores (DRSs) developed in historical comparator drug users before the new drug entered the market may improve adjustment. However, in a high dimensional data setting, empirical selection of hundreds of potential confounders and modeling of DRS even in the historical cohort can lead to over-fitting and reduced predictive performance in the study cohort. We propose the use of combinations of dimension reduction and shrinkage methods to overcome this problem, and compared the performances of these modeling strategies for implementing high dimensional (hd) DRSs from historical data in two empirical study examples of newly marketed drugs versus comparator drugs after the new drugs' market entry-dabigatran versus warfarin for the outcome of major hemorrhagic events and cyclooxygenase-2 inhibitor (coxibs) versus nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) for gastrointestinal bleeds. RESULTS: Historical hdDRSs that included predefined and empirical outcome predictors with dimension reduction (principal component analysis; PCA) and shrinkage (lasso and ridge regression) approaches had higher c-statistics (0.66 for the PCA model, 0.64 for the PCA + ridge and 0.65 for the PCA + lasso models in the warfarin users) than an unreduced model (c-statistic, 0.54) in the dabigatran example. The odds ratio (OR) from PCA + lasso hdDRS-stratification [OR, 0.64; 95 % confidence interval (CI) 0.46-0.90] was closer to the benchmark estimate (0.93) from a randomized trial than the model without empirical predictors (OR, 0.58; 95 % CI 0.41-0.81). In the coxibs example, c-statistics of the hdDRSs in the nsNSAID initiators were 0.66 for the PCA model, 0.67 for the PCA + ridge model, and 0.67 for the PCA + lasso model; these were higher than for the unreduced model (c-statistic, 0.45), and comparable to the demographics + risk score model (c-statistic, 0.67). CONCLUSIONS: hdDRSs using historical data with dimension reduction and shrinkage was feasible, and improved confounding adjustment in two studies of newly marketed medications.

DOI： 10.1186/s12982-016-0047-x

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

Background- Clinical trials demonstrated the efficacy of carotid artery stenting (CAS) relative to carotid endarterectomy when performed by physicians with demonstrated proficiency. It is unclear how CAS performance may be influenced by the diversity in CAS and non-CAS provider volumes in routine clinical practice. Methods and Results- We linked Medicare claims to the Centers for Medicare and Medicaid Services' CAS Database (2005-2009). We assessed the association between 30-day mortality and past-year physician (0, 1-4, 5-9, 10-19, &gt;= 20) and hospital (&lt; 10, 10-19, 20-39, &gt;= 40) CAS volumes and past-year hospital coronary and peripheral stenting volumes (&lt; 200, 200-399, 400-849, &gt;= 850) among beneficiaries at least 66 years of age. Unadjusted 30-day mortality risk was 1.8% (95% confidence interval [CI], 1.6-2.0) for 19 724 patients undergoing CAS by 2045 physicians in 729 hospitals. Median past-year CAS volume was 9 (interquartile range, 4-19) for physicians and 23 (interquartile range, 12-41) for hospitals. Compared to physicians performing &gt;= 20 CAS in the past year, lower CAS volumes were associated with higher adjusted risks of 30-day morality (P value for trend &lt; 0.05): 1.4 (95% CI, 0.9-2.3) for 0 past-year CAS, 1.3 (95% CI, 0.9-1.8) for 1 to 4, 1.1 (95% CI, 0.8-1.6) for 5 to 9, and 0.9 (95% CI, 0.7-1.4) for 10 to 19. An inverse relationship between 30-day mortality and past-year CAS hospital volume as well as past-year hospital non-CAS volume, past-year hospital non-CAS volume, and 30-day mortality was also noted. Conclusions- Among Medicare patients, an inverse relationship exists between physician and hospital CAS volumes and hospital non-CAS stenting volume and 30-day mortality, even after adjusting for all pertinent patient- and hospital-level factors.

DOI： 10.1161/CIRCOUTCOMES.114.001668

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

BACKGROUND: Clinical trials demonstrated the efficacy of carotid artery stenting (CAS) relative to carotid endarterectomy when performed by physicians with demonstrated proficiency. It is unclear how CAS performance may be influenced by the diversity in CAS and non-CAS provider volumes in routine clinical practice. METHODS AND RESULTS: We linked Medicare claims to the Centers for Medicare and Medicaid Services' CAS Database (2005-2009). We assessed the association between 30-day mortality and past-year physician (0, 1-4, 5-9, 10-19, ≥20) and hospital (<10, 10-19, 20-39, ≥40) CAS volumes and past-year hospital coronary and peripheral stenting volumes (<200, 200-399, 400-849, ≥850) among beneficiaries at least 66 years of age. Unadjusted 30-day mortality risk was 1.8% (95% confidence interval [CI], 1.6-2.0) for 19 724 patients undergoing CAS by 2045 physicians in 729 hospitals. Median past-year CAS volume was 9 (interquartile range, 4-19) for physicians and 23 (interquartile range, 12-41) for hospitals. Compared to physicians performing ≥20 CAS in the past year, lower CAS volumes were associated with higher adjusted risks of 30-day morality (P value for trend < 0.05): 1.4 (95% CI, 0.9-2.3) for 0 past-year CAS, 1.3 (95% CI, 0.9-1.8) for 1 to 4, 1.1 (95% CI, 0.8-1.6) for 5 to 9, and 0.9 (95% CI, 0.7-1.4) for 10 to 19. An inverse relationship between 30-day mortality and past-year CAS hospital volume as well as past-year hospital non-CAS volume, past-year hospital non-CAS volume, and 30-day mortality was also noted. CONCLUSIONS: Among Medicare patients, an inverse relationship exists between physician and hospital CAS volumes and hospital non-CAS stenting volume and 30-day mortality, even after adjusting for all pertinent patient- and hospital-level factors.

DOI： 10.1161/CIRCOUTCOMES.114.001668

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

BACKGROUND AND PURPOSE: After the 2005 National Coverage Determination to reimburse carotid artery stenting (CAS) for Medicare beneficiaries, the number of CAS procedures increased and carotid endarterectomy (CEA) decreased. We evaluated trends in surgeons' past-year CEA case-volume and 30-day mortality after CEA, and their association before and after the National Coverage Determination. METHODS: In a retrospective cohort study of patients undergoing CEA (2001-2008) and CAS (2005-2008) using Medicare data, we described yearly trends of CEA and CAS rates, patient characteristics, and 30-day mortality after CEA. We used logistic regression adjusting for patient- and surgeon-level factors to assess the effect of surgeon case volume on 30-day mortality after CEA. RESULTS: We identified 454 717 CEA and 27 943 CAS patients. Patients undergoing CEA in recent years were older and had more comorbidities than earlier years. CEA rates per 10 000 beneficiaries declined from 18.1 in 2002 to 12.7 in 2008, whereas median surgeon past-year case-volume declined from 27 to 21. The CAS rates peaked at 2.3 per 10 000 beneficiaries in 2006 but declined to 1.8 in 2008, resulting in declining overall revascularization procedure rates during 2005 to 2008. Thirty day post-CEA mortality was 1.40% (95% confidence interval, 1.34-1.47) in 2001 to 2002 and 1.17% (1.10-1.24) in 2007 to 2008. Surgeon's past-year case-volume of <10 was associated with higher 30-day mortality consistently during 2001 to 2008. CONCLUSIONS: The rate of CEA procedures decreased substantially during 2001 to 2008, as did surgeon past-year case-volume. The postprocedural mortality in Medicare beneficiaries was high compared with trial patients but somewhat improved over time. Those operated by lower past-year case-volume surgeons had increased mortality.

DOI： 10.1161/STROKEAHA.114.006276

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：ELSEVIER SCIENCE BV  

BACKGROUND: Severe aortic stenosis (AS) is now predominantly a disease of the elderly, with significant mortality and morbidity. In order to investigate the burden of severe AS in the current population, we assessed mortality, causes of death, clinical event rates, and prognostic factors of patients diagnosed with severe AS. METHODS: A total of 519 consecutive patients (mean age, 78±9 years) with severe AS (aortic valve area <1.0 cm(2)) were retrospectively analyzed. All-cause mortality and clinical events including aortic valve replacement, heart failure requiring admission, acute coronary syndrome, and syncope were measured as main outcome. RESULTS: During a median follow-up of 3.5 years, 167 patients (32%) died. Overall survival rates at 1 and 3 years were 86% and 70%, respectively. Of all deaths, 101 (61%) were cardiovascular-related and 56 (33%) were non-cardiovascular. Syncope occurred in only 18 (4%) patients, while heart failure requiring admission occurred in 188 (43%) patients as the most frequent event. Male, severe symptoms (New York Heart Association functional class, III/IV), inactive state, previous history of heart failure, renal insufficiency, hemodialysis treatment, peripheral vascular disease, malignancy, and statin use at enrollment were significantly and independently associated with death among the patients. CONCLUSIONS: Among the one-third of severe AS patients who died during follow-up, 61% of deaths were cardiovascular-related. Cardiovascular death may be the leading, but not the only, cause of death for contemporary severe AS patients. Factors such as severe symptomatic status, lower daily activity level, and chronic kidney diseases were strong predictive factors of worse survival in this population.

DOI： 10.1016/j.jjcc.2015.02.011

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：AMER MEDICAL ASSOC  

IMPORTANCE: Despite increased carotid artery stenting (CAS) dissemination following the 2005 National Coverage Determination, to our knowledge, periprocedural and long-term outcomes have not been described among Medicare beneficiaries. OBJECTIVE: To describe the incidence of outcomes during and after the periprocedural period among Medicare beneficiaries undergoing CAS. DESIGN, SETTING, AND PARTICIPANTS: Observational study with a mean follow-up time of approximately 2 years among 22,516 fee-for-service Medicare beneficiaries at least 66 years old undergoing CAS (2005-2009) who were linked to the Centers for Medicare & Medicaid Services' CAS database. Database procedure dates were required to fall during a Medicare hospitalization for CAS. MAIN OUTCOMES AND MEASURES: Periprocedural (30-day) and long-term risks of mortality and stroke or transient ischemic attack, as well as periprocedural myocardial infarction. Subgroups were based on sociodemographic, clinical, and center-level factors, as well as the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial or Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) enrollment criteria. RESULTS: The mean patient age was 76.3 years, 60.5% were male, 93.8% were of white race, 91.2% were at high surgical risk, 47.4% were symptomatic, and 97.4% had carotid stenosis of at least 70%. Crude 30-day mortality, stroke or transient ischemic attack, and myocardial infarction risks were 1.7% (95% CI, 1.5%-1.8%), 3.3% (95% CI, 3.0%-3.5%), and 2.5% (95% CI, 2.3%-2.7%), respectively. Mortality during a mean follow-up time of 2 years was 32.0% (95% CI, 31.0%-33.0%), with rates of 37.3% (95% CI, 35.8%-38.7%) among symptomatic patients and 27.7% (95% CI, 26.4%-28.9%) among asymptomatic patients. Older age, symptomatic carotid stenosis, and nonelective hospital admission were associated with increased adjusted hazards of mortality and stroke or transient ischemic attack during and after the periprocedural period. The presence of a stroke center, government ownership, and a hospital bed capacity of 500 or more were associated with increased adjusted hazards of periprocedural mortality and stroke or transient ischemic attack. Few patients met the SAPPHIRE trial or CREST enrollment criteria primarily because physicians did not meet proficiency requirements either due to exceeding periprocedural complication trial thresholds or not meeting minimum CAS volume requirements. CONCLUSIONS AND RELEVANCE: Competing risks may limit the benefits of CAS in certain Medicare beneficiaries, particularly among older and symptomatic patients who have higher periprocedural and long-term mortality risks. The generalizability of trials like the SAPPHIRE or CREST to the Medicare population may be limited, underscoring the need to evaluate real-world effectiveness of carotid stenosis treatments.

DOI： 10.1001/jamaneurol.2014.3638

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

BACKGROUND: ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography (AUC2010) does not incorporate prior coronary computed tomographic angiography (CCTA) results in the appropriateness of a CCTA examination. The purpose of this study was to explore the criteria for forgoing repeat CCTA among patients with clinical scenarios suggesting CCTA as appropriate after prior CCTA excluding coronary artery disease. METHODS AND RESULTS: Among patients from a single center (February 2006 to April 2013) who underwent appropriate CCTA based on AUC2010, consecutive 555 CCTAs, which had a prior CCTA excluding significant stenosis (>50% stenosis in diameter), were selected. The median time difference between the studies was 34.2 (Q1-Q3, 22.9-50.1) months. Significant stenosis was detected at the time of repeat scan (by CCTA or subsequent catheter angiography) in 13.3% (74 of 555). A multivariable logistic model (C-statistic, 0.74; bootstrapped overfitting bias, 0.8%) identified 3 predictors of significant stenosis: time difference between the studies >3 years (adjusted odds ratio, 2.1; 95% confidence interval, 1.2-3.5), diabetes mellitus (odds ratio, 2.4; 95% confidence interval,1.4-4.3), and 26% to 50% stenosis on the initial CCTA (odds ratio, 5.6; 95% confidence interval, 3.2-9.6). When these 3 factors were all absent (corresponding to 31.9% of the population), the probability of significant stenosis was 4.5% (95% confidence interval, 2.7-7.4%), whereas 17.1% of patients had significant stenosis among those with at least 1 positive variable. When coronary arteries were completely normal at the initial scan, the prevalence of significant stenosis was only 1.8% irrespective of other factors, and no patient underwent revascularization. CONCLUSIONS: Nondiabetic patients with a prior CCTA <3 years showing no or ≤25% stenosis had a <5% prevalence of significant stenosis. The value of repeat CCTA in this group is likely small, especially when the prior CCTA demonstrated normal coronaries, even if the clinical scenario considered a CCTA appropriate.

DOI： 10.1161/CIRCIMAGING.113.001549

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：BIOMED CENTRAL LTD  

BACKGROUND: The characteristics and aetiology of pneumonia in the non-elderly population is distinct from that in the elderly population. While a few studies have reported an inverse association between hospital case volume and clinical outcome in elderly pneumonia patients, the evidence is lacking in a younger population. In addition, the relationship between volume and outcome may be different in severe pneumonia cases than in mild cases. In this context, we tested two hypotheses: 1) non-elderly pneumonia patients treated at hospitals with larger case volume have better clinical outcome compared with those treated at lower case volume hospitals; 2) the volume-outcome relationship differs by the severity of the pneumonia. METHODS: We conducted the study using the Japanese Diagnosis Procedure Combination database. Patients aged 18-64 years discharged from the participating hospitals between July to December 2010 were included. The hospitals were categorized into four groups (very-low, low, medium, high) based on volume quartiles. The association between hospital case volume and in-hospital mortality was evaluated using multivariate logistic regression with generalized estimating equations adjusting for pneumonia severity, patient demographics and comorbidity score, and hospital academic status. We further analyzed the relationship by modified A-DROP pneumonia severity score calculated using the four severity indices: dehydration, low oxygen saturation, orientation disturbance, and decreased systolic blood pressure. RESULTS: We identified 8,293 cases of pneumonia at 896 hospitals across Japan, with 273 in-hospital deaths (3.3%). In the overall population, no significant association between hospital volume and in-hospital mortality was observed. However, when stratified by pneumonia severity score, higher hospital volume was associated with lower in-hospital mortality at the intermediate severity level (modified A-DROP score = 2) (odds ratio (OR) of very low vs. high: 2.70; 95% confidence interval (CI): 1.12-6.55, OR of low vs. high: 2.40; 95% CI:0.99-5.83). No significant association was observed for other severity strata. CONCLUSIONS: Hospital case volume was inversely associated with in-hospital mortality in non-elderly pneumonia patients with intermediate pneumonia severity. Our result suggests room for potential improvement in the quality of care in hospitals with lower volume, to improve treatment outcomes particularly in patients admitted with intermediate pneumonia severity.

DOI： 10.1186/1472-6963-14-302

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担当区分：筆頭著者   記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

Background-The accuracy of stroke diagnosis in administrative claims for a contemporary population of Medicare enrollees has not been studied. We assessed the validity of diagnostic coding algorithms for identifying stroke in the Medicare population by linking data from the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study to Medicare claims.
Methods and Results-The REGARDS Study enrolled 30 239 participants &gt;= 45 years in the United States between 2003 and 2007. Stroke experts adjudicated suspected strokes, using retrieved medical records. We linked data for participants enrolled in fee-for-service Medicare to claims files from 2003 through 2009. Using adjudicated strokes as the gold standard, we calculated accuracy measures for algorithms to identify incident and recurrent strokes. We linked data for 15 089 participants, among whom 422 participants had adjudicated strokes during follow-up. An algorithm using primary discharge diagnosis codes for acute ischemic or hemorrhagic stroke (International Classification of Diseases, Ninth Revision, Clinical Modification codes: 430, 431, 433. x1, 434. x1, 436) had a positive predictive value of 92.6% (95% confidence interval, 88.8%-96.4%), a specificity of 99.8% (99.6%-99.9%), and a sensitivity of 59.5% (53.8%-65.1%). An algorithm using only acute ischemic stroke codes (433. x1, 434. x1, 436) had a positive predictive value of 91.1% (95% confidence interval, 86.6%-95.5%), a specificity of 99.8% (99.7%-99.9%), and a sensitivity of 58.6% (52.4%-64.7%).
Conclusions-Claims-based algorithms to identify stroke in a contemporary Medicare cohort had high positive predictive value and specificity, supporting their use as outcomes for etiologic and comparative effectiveness studies in similar populations. These inpatient algorithms are unsuitable for estimating stroke incidence because of low sensitivity.

DOI： 10.1161/CIRCOUTCOMES.113.000743

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：AMER COLL CHEST PHYSICIANS  

BACKGROUND: Despite a general consensus that rapid communication of critical radiology findings from radiologists to referring physicians is imperative, a possible association with superior patient outcomes has not been confirmed. The objective of this study was to evaluate the correlation between early direct communication of CT image findings by radiologists to referring physicians and better clinical outcomes in patients with acute pulmonary embolism (PE). METHODS: This was a retrospective, single-institution, cohort study that included 796 consecutive patients (February 2006 to March 2010) who had acute PE confirmed by CT pulmonary angiography (CTPA) and whose treatment had not been initiated at the time of CTPA acquisition. The time from CTPA to direct communication of the diagnosis was evaluated for its association with time from CTPA to treatment initiation and with 30-day mortality. Cox regression analysis was performed with inverse probability weighting by propensity scores calculated using 20 potential confounding factors. RESULTS: In 93.4% of patients whose first treatment was anticoagulation, the referring physicians started treatment after receiving direct notification of the diagnosis from the radiologist. Late communication (&gt; 1.5 h after CTPA; n = 291) was associated with longer time to treatment initiation (adjusted hazard ratio [HR], 0.714; 95% CI, 0.610-0.836; P &lt; .001) and higher all-cause and PE-related 30-day mortality (HR, 1.813; 95% CI, 1.163-2.828; P = .009; and HR, 2.625; 95% CI, 1.362-5.059; P = .004, respectively). CONCLUSIONS: Delay (&gt; 1.5 h of CTPA acquisition) in direct communication of acute PE diagnosis from radiologists to referring physicians was significantly correlated with a higher risk of delayed treatment initiation and death within 30 days.

DOI： 10.1378/chest.13-0308

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記述言語：英語   掲載種別：研究論文（学術雑誌）   出版者・発行元：LIPPINCOTT WILLIAMS & WILKINS  

BACKGROUND: The association between hospital volume and patient outcomes remains unclear for stroke. Little is known about whether these relationships differ by stroke subtypes. OBJECTIVES: To examine the association of hospital volume with in-hospital mortality and costs of care for stroke. RESEARCH DESIGN: Secondary data analysis of national hospital database. SUBJECTS: A total of 66,406 patients admitted between July 1 and December 31, 2010 with primary diagnosis of stroke at 796 acute care hospitals in Japan were included. MEASURES: We used a locally weighted scatter-plot smoothing method to test the relationship between hospital volume and outcomes. On the basis of these results, we categorized patient volume into 3 groups (10-50, 51-100, and >100 discharges/6 mo). We tested the volume-outcome relationship using multivariable regression models adjusting for patient and hospital characteristics. Subgroup analysis was conducted by stratifying on stroke subtype. RESULTS: Compared with those treated at high-volume hospitals (>100 discharges), patients admitted to low-volume hospitals (10-50 discharges) had higher in-hospital mortality (adjusted odds ratio, 1.45; 95% CI, 1.23-1.71, P<0.0001). In the lowest volume hospitals, adjusted costs of care per discharge were 8.0% lower (95% CI, -14.1% to -1.8%, P=0.01) compared with the highest volume hospitals. The volume-mortality association was significant across all stroke subtypes. Highest volume hospitals had higher costs than lowest volume hospitals for subarachnoid hemorrhage, but this association was nonsignificant for ischemic and hemorrhagic stroke. CONCLUSIONS: Highest volume hospitals had lower mortality than the lowest volume hospitals for stroke in Japan. Highest volume hospitals had higher costs for subarachnoid hemorrhage, but not for ischemic and hemorrhagic stroke.

DOI： 10.1097/MLR.0b013e31829c8b70

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記述言語：日本語   出版者・発行元：(株)南江堂  

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その他リンク： https://search.jamas.or.jp/default/link?pub_year=2024&ichushi_jid=J00349&link_issn=&doc_id=20240416060012&doc_link_id=issn%3D0021-5252%26volume%3D77%26issue%3D3%26spage%3D197&url=http%3A%2F%2Fwww.pieronline.jp%2Fopenurl%3Fissn%3D0021-5252%26volume%3D77%26issue%3D3%26spage%3D197&type=PierOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00005_2.gif

記述言語：日本語   出版者・発行元：(一社)日本消化器外科学会  

目的:術後早期回復プログラムの普及にともない,周術期管理に関する診療報酬算定が可能となったが,算定による合併症抑制効果を臨床データと紐づけて解析した大規模な報告は少ない.今回,上部消化管手術を対象とした.周術期管理に関連する診療報酬加算の算定状況をアンケート調査し,National Clinical Database(以下,NCDと略記)と紐付けたうえで合併症抑制効果を解析することを目的とした.方法:日本消化器外科学会認定施設のうち上部消化管手術を実施している診療科を対象にアンケートを行い,周術期管理に関連する診療報酬8項目の算定の有無を調査した.NCDの術後アウトカム(術後合併症発症率,術後30日以内の死亡率,術後在院日数)と紐づけし統計学的解析を行った.結果:認定施設884施設のうち633施設(71.6%)から回答を得た.栄養サポートチーム加算+歯科医師連携加算は算定ありが,幽門側胃切除術および胃全摘術で有意に短い術後在院日数を示し,食道切除再建術では術後30日以内の死亡率が有意に低かった.周術期口腔機能管理後手術加算は算定ありが,いずれの術式でも術後在院日数が有意に短く,食道切除再建術では術後30日以内の死亡率が有意に低かった.結語:胃癌手術,食道癌手術において,診療報酬の算定状況と術後合併症の相関が明らかとなった.(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本乳癌学会  

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記述言語：日本語   出版者・発行元：(一社)日本乳癌学会  

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記述言語：日本語   出版者・発行元：(一社)日本先天性心疾患インターベンション学会  

一般社団法人日本先天性心疾患インターベンション学会(JCIC学会)では,カテーテル治療の手技・件数・有害事象に関して,1993年からの全国アンケート集計にはじまり,2013年よりインターネットでの日本先天性心疾患インターベンション学会レジストリー(JCIC-R)の運用を開始している.本稿では,完全オンライン移行4年目の2019年の1年間における4,805セッションの集計について報告する.本レジストリーの特徴として,登録対象が小児期から成人期にかけての先天性心疾患のみならず,川崎病心血管後遺症や,正常心構造を含む小児期頻拍性不整脈に対するアブレーションを含め,あらゆるカテーテル治療手技と有害事象を含めるという,一国家における包括的リアルワールドデータであることが挙げられる.ベンチマーキング,多施設共同研究のみならず,市販後調査を中心とする新規医療機器導入事業,申請と承認事業等,多方面で有効活用が始まっている.(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本外科学会  

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記述言語：日本語   出版者・発行元：(公社)日本透析医会  

近年では我が国でも様々な大規模データベースが上梓され、その利活用が進められている。そして、新たな選択肢として大規模データの種類の増加により、これまで精緻な解析が難しかった研究課題についても実施可能になっている。本研究課題では、日本の外科手術の現状を示すNational Clinical Databaseの呼吸器外科領域のデータと、診療報酬データとして広く利活用の進むDPCデータの二つの大規模データを使用し、肺癌に対して肺葉切除術を実施した際の、術前透析や術後腎不全が周術期入院医療費や術後在院日数に与える影響の評価を行った。409施設より10,326症例を対象症例として同定したところ、術前透析・術後腎不全はそれぞれ54例(0.52%)・5例(0.05%)に観察された。術前透析例では非実施例と比べ、術後在院日数は同等で、入院医療費は若干増加がみられたが、それは入院中の透析関連費用で説明できる程度であった。術後腎不全では術後在院日数・入院医療費のいずれも増加がみられ、その他の術後合併症の中でも影響の大きなグループに分類された。以上より、現状の術前透析例の手術・周術期管理は安全・適正に実施されていることが示唆され、術後腎不全は本術式では頻度は少ないが、医療資源の観点よりも重要な合併症であることが確認された。これらの情報は周術期の腎不全の診療報酬上の取り扱いを考えるうえで重要な情報と考えられた。(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本消化器外科学会  

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記述言語：日本語   出版者・発行元：(一社)日本乳癌学会  

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記述言語：日本語   出版者・発行元：(一社)日本乳癌学会  

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記述言語：日本語   出版者・発行元：医学図書出版(株)  

NCD泌尿器領域は詳細データ収集開始より時間も経過し、そのデータの利活用のフェーズに入りつつある。本稿では、NCD泌尿器領域のデータの成り立ちや構造について俯瞰し、そのうえで、これまで泌尿器領域で使用されてきたビッグデータとの相違点について概観する。そして、NCD泌尿器領域でこれからどのような利活用の展開が期待できるかについて解説し、将来的な期待について述べていきたい。(著者抄録)

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記述言語：日本語   出版者・発行元：(NPO)日本心臓血管外科学会  

[目的]2017、2018年のJCVSDの集計を記述し、本邦の弁膜症手術の現状と傾向を理解する一助となることを目指す。指標となる代表的術式の手術成績を示し、今後の弁膜症治療を考えるうえで重要と思われる経カテーテル的大動脈弁置換術、右開胸での弁膜症手術についてもJCVSDのデータから提供できる統計を記述する。[方法]JCVSDデータベースより2017年と2018年の心臓弁膜症手術データを抽出した。本報告が始まってからの大動脈弁手術数6年間の推移を示した。弁膜症の代表的な術式について、年代別に、手術死亡率を示した。小切開弁手術と経カテーテル的大動脈弁置換術の手術成績につきJCVSDから提供できるデータを記載した。[結果]2015〜2016年の2年間と比較して2017〜2018年は経カテーテル的大動脈弁置換術の著しい増加がみられたが外科的大動脈弁置換術も26,054例から28,202例に増加がみられた。弁膜症初回手術の手術死亡率は、大動脈弁置換単弁で生体弁機械弁とも1.8%、僧帽弁形成0.9%など良好であった。初回生体弁僧帽弁置換は8.2%、機械弁で4.6%であった。冠動脈バイパス術を併施した症例では大動脈弁置換初回単弁で5.2%、僧帽弁形成で4.9%であった。人工弁選択では大動脈弁位では60代でも72.6%の患者に生体弁が用いられており、より生体弁が多く用いられる傾向が明らかであった。右開胸での手術について、初回単弁僧帽弁形成では31.8%の症例が右開胸でなされていた。手術成績について多くの転帰で右側開胸が良好であったが、同時に右開胸の症例のほうがJapan Scoreでリスクの低い症例の割合が大きいことが分かった。大動脈遮断時間、人工心肺時間は側開胸で長かった。大動脈弁置換術では右側開胸で行われているのは6.3%、やはり右側開胸で多くの転帰で手術成績が良好であったが、これも側開胸でJapan Scoreで低リスク症例の割合が大きかった。経カテーテル的大動脈弁置換術と外科的大動脈弁置換全体の手術死亡率は、それぞれ1.5%と1.8%であった。[結語]2017〜2018年のJCVSDによる弁膜症手術の集計を報告した。(著者抄録)

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その他リンク： https://search.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2020&ichushi_jid=J01122&link_issn=&doc_id=20200730330003&doc_link_id=10.4326%2Fjjcvs.49.160&url=https%3A%2F%2Fdoi.org%2F10.4326%2Fjjcvs.49.160&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_3.gif

記述言語：日本語   出版者・発行元：(NPO)日本心臓血管外科学会  

2017年および2018年の日本心臓血管外科手術データベースに登録された単独冠動脈バイパス術症例について術前状態および術後短期成績、グラフト選択の現況、前下行枝血行再建へのグラフト選択(年齢別)について分析した。単独冠動脈バイパス術については54.6%(26,913例中14,684例)に人工心肺非使用で施行された。左前下行枝の血行再建にはLITAが76.4%、RITAが19.0%に使用された。手術死亡率は待機的手術では1.5%(On-pump CABG:ONCAB 1.9%、off-pump CABG:OPCAB 1.2%、p<0.001)、緊急手術では7.4%(ONCAB 10.2%、OPCAB 4.3%、p<0.001)、全体では2.5%であった。周術期合併症・手術死亡率ともにOPCABで有意に成績が良好であった。2013年以降のJapanSCORE IIは年次ごとに上昇しており症例の重症化がうかがわれた。*手術死亡率:術後30日以内の死亡または在院中の死亡(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本先天性心疾患インターベンション学会  

一般社団法人日本先天性心疾患インターベンション学会(JCIC学会)(旧日本Pediatric Interventional Cardiology(JPIC)学会)では,1993年よりカテーテル治療の手技・件数・有害事象に関する全国アンケート集計が継続されてきた.2013年より日本先天性心疾患インターベンション学会レジストリー(JCIC-R)(旧JPICデータベース(JPIC-DB))の実運用を開始し,3年の移行期間を経て,2016年からすべてJCIC-Rに登録されている.本稿では3年目の2018年における4,909件の集計について報告する.2020年1月より学会名称変更に伴い本レジストリーの名称も変更となった後も,登録対象を小児期から成人期にかけての先天性心疾患のみならず,川崎病心血管後遺症や,正常心構造を含む小児期頻拍性不整脈に対するあらゆるカテーテル治療手技と有害事象を含めるという,一国の包括的リアルワールドデータであることには変わりない.今後も,ベンチマーキング,リスク層別化,多施設共同研究,新規医療機器導入および認定事業等,多方面に有効活用して頂けるよう更新を重ねていく.(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本外科学会  

1975年より乳癌研究会の事業として開始された乳がん登録は,2004年にweb登録システムに移行し,2011年までに255,519例が登録された.2012年1月1日よりNCD(National Clinical Database)登録と合体し,NCD乳がん登録となった.その結果,登録症例数は,著明に増加し,本邦の乳がん罹患数の80%以上をカバーするがん登録となった.また,2004年から2011年の登録症例の93%がNCD乳がん登録に移管された.しかも,5年予後調査結果も登録されており,NCD移管後も引き続き5年,10年の予後登録,解析が可能なシステムとなっている.現時点での5年予後調査回答率は,2004年75%,2012年61%であり,2004年の10年予後は,56%である.2016年全国がん登録が開始され,2016年の罹患数合計値による本登録のカバー率は84%であった.本稿では,NCDシステムでの乳がん登録の現状を紹介するとともに,Quality Indicator(医療の質指標:QI)の実施率によるわが国の乳がん治療の実態を明らかにする.さらにビッグデータの予後解析を用いた臨床研究の成果を紹介する.(著者抄録)

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記述言語：日本語   出版者・発行元：(NPO)日本医師事務作業補助研究会  

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記述言語：日本語   出版者・発行元：(NPO)日本医師事務作業補助研究会  

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記述言語：日本語   出版者・発行元：(一社)日本消化器外科学会  

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記述言語：日本語   出版者・発行元：(株)篠原出版新社  

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記述言語：日本語   出版者・発行元：(一社)日本医療情報学会  

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記述言語：日本語   出版者・発行元：(一社)日本内科学会  

PubMed

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その他リンク： https://search.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2016&ichushi_jid=J01159&link_issn=&doc_id=20161128030010&doc_link_id=10.2169%2Fnaika.105.2183&url=https%3A%2F%2Fdoi.org%2F10.2169%2Fnaika.105.2183&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_3.gif

記述言語：日本語   出版者・発行元：(一社)日本医療情報学会  

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記述言語：日本語   出版者・発行元：(一社)日本薬剤疫学会  

National Clinical Database(NCD)は2011年に登録を開始した分野横断的な症例レジストリープラットフォームである。年間150万件を超える症例がウェブシステムを介して登録されており、参加学会の増加とともにその規模は拡大してきている。全国規模の臨床学会の専門医制度との連携のもと、NCDに登録されるデータは高い悉皆性が特徴である。本稿ではNCDデータの利活用の例として、1)医療の質の評価および向上に向けた利活用、2)clinical questionに対する観察研究利用、3)ヘルスサービスリサーチ利用、4)産官学連携プロジェクトにおける利用の4つを紹介する。また、NCDが機関の最重要業務の一つと位置づけるデータの質の管理についても、そのための取組み例として、収集データ項目の定義・設計、事務局機能の整備、ウェブシステムを利用した登録データチェック、そして監査・データ検証のプロセスを紹介する。(著者抄録)

DOI： 10.3820/jjpe.21.27

J-GLOBAL

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：(株)南江堂  

ビッグデータの活用は,医療においても活発である.国が主導する診断群分類(Diagnosis Procedure Combination:DPC)やNational Database(NDB)以外に,「保健医療2035提言書」では,National Clinical Database(NCD)などの医療現場主導の取り組みによる臨床データベースの充実を積極的に支援することが明示されており,関連学会などのみで活動されていた事業に国レベルで注力されている.これまで独立して実施されてきたデータベース事業を横断的に活用することで,より強固なエビデンスを創出することが可能であり,それらを整備することが今後の日本における課題となる.(著者抄録)

DOI： 10.15106/J00393.2016229897

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記述言語：日本語   出版者・発行元：日本診療情報管理学会  

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