Publications by authors named "Hiraku Kumamaru"

80 Publications

Association between age and short-term outcomes of gastroenterological surgeries in older patients: an analysis using the National Clinical Database in Japan.

Langenbecks Arch Surg 2021 Aug 11. Epub 2021 Aug 11.

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.

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.
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http://dx.doi.org/10.1007/s00423-021-02296-5DOI Listing
August 2021

Systemic therapy and prognosis of older patients with stage II/III breast cancer: A large-scale analysis of the Japanese Breast Cancer Registry.

Eur J Cancer 2021 Sep 19;154:157-166. Epub 2021 Jul 19.

Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ejca.2021.06.006DOI Listing
September 2021

Profiles of institutional departments affect operative outcomes of eight gastroenterological procedures.

Ann Gastroenterol Surg 2021 May 20;5(3):304-313. Epub 2021 Feb 20.

The Japanese Society of Gastroenterological Surgery Tokyo Japan.

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.
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http://dx.doi.org/10.1002/ags3.12431DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164461PMC
May 2021

Real-World Evidence of the Incidence of and Risk Factors for Type 1 Diabetes Mellitus and Hypothyroidism as Immune-Related Adverse Events Associated With Programmed Cell Death-1 Inhibitors.

Endocr Pract 2021 Jun 24;27(6):586-593. Epub 2020 Dec 24.

Research Support Center, Shizuoka General Hospital, Shizuoka, Japan; Department of Health Policy and Management, School of Medicine, Keio University, Tokyo, Japan.

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.
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http://dx.doi.org/10.1016/j.eprac.2020.12.009DOI Listing
June 2021

Transcatheter Aortic Valve Replacement in Patients With a Small Annulus - From the Japanese Nationwide Registry (J-TVT).

Circ J 2021 Jun 27;85(7):967-976. Epub 2021 Feb 27.

Department of Cardiovascular Medicine, Kitasato University.

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 mm) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm/m[0.92-1.35] vs. 1.16 cm/m[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 cm/m[0.78-1.06] vs. 1.07 cm/m[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.
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http://dx.doi.org/10.1253/circj.CJ-20-1084DOI Listing
June 2021

Sodium-glucose cotransporter-2 inhibitors and the risk of urinary tract infection among diabetic patients in Japan: Target trial emulation using a nationwide administrative claims database.

Diabetes Obes Metab 2021 06 8;23(6):1379-1388. Epub 2021 Mar 8.

Department of Biostatistics, School of Public Health, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.

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.
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http://dx.doi.org/10.1111/dom.14353DOI Listing
June 2021

Sodium-glucose cotransporter-2 inhibitors and the risk of urinary tract infection among diabetic patients in Japan: Target trial emulation using a nationwide administrative claims database.

Diabetes Obes Metab 2021 06 8;23(6):1379-1388. Epub 2021 Mar 8.

Department of Biostatistics, School of Public Health, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.

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.
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http://dx.doi.org/10.1111/dom.14353DOI Listing
June 2021

Multi-Institutional Prospective Cohort Study of Patients With Pulmonary Hypertension Associated With Respiratory Diseases.

Circ J 2021 03 2;85(4):333-342. Epub 2021 Feb 2.

Department of Respirology, Graduate School of Medicine, Chiba University.

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.
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http://dx.doi.org/10.1253/circj.CJ-20-0939DOI Listing
March 2021

Improvements in French risk stratification score were correlated with reductions in mean pulmonary artery pressure in pulmonary arterial hypertension: a subanalysis of the Japan Pulmonary Hypertension Registry (JAPHR).

BMC Pulm Med 2021 Jan 14;21(1):28. Epub 2021 Jan 14.

Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan.

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.
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http://dx.doi.org/10.1186/s12890-021-01398-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7809781PMC
January 2021

Status of cardiovascular surgery in Japan between 2017 and 2018: A report based on the Cardiovascular Surgery Database. 2. Isolated coronary artery bypass surgery.

Asian Cardiovasc Thorac Ann 2021 May 10;29(4):294-299. Epub 2021 Jan 10.

Department of Health Policy and Management, Keio Q1 University, Japan.

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% ( = 14,684) of all coronary artery bypass cases ( = 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%,  < 0.001), 7.4% in emergency cases (on-pump 10.2% and off-pump 4.3%,  < 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.
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http://dx.doi.org/10.1177/0218492320981499DOI Listing
May 2021

Status of cardiovascular surgery in Japan between 2017 and 2018: A report based on the Japan Cardiovascular Surgery Database. 3. Valvular heart surgery.

Asian Cardiovasc Thorac Ann 2021 May 10;29(4):300-309. Epub 2021 Jan 10.

Department of Health Policy and Management, School of Medicine, Keio University, Tokyo, Japan.

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.
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http://dx.doi.org/10.1177/0218492320981459DOI Listing
May 2021

Incidence of adverse cardiovascular events in type 2 diabetes mellitus patients after initiation of glucose-lowering agents: A population-based community study from the Shizuoka Kokuho database.

J Diabetes Investig 2021 Aug 28;12(8):1452-1461. Epub 2021 Jan 28.

Research Support Center, Shizuoka General Hospital, Shizuoka, Japan.

Aims/introduction: Increased incidence of hospitalization for heart failure (HHF) among patients with diabetes is increasingly being reported. We investigated the incidence of adverse cardiovascular events including HHF among patients with type 2 diabetes mellitus, and the potential clinical improvement with sodium-glucose cotransporter 2 inhibitors (SGLT2i) using a contemporary administrative claims database from a large governmental district of Japan.

Materials And Methods: We included initiators of any oral glucose-lowering drugs between 2013 and 2018. We estimated the 5-year cumulative incidence of hospitalization for HF, myocardial infarction 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 Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) trials, assuming the same risk reduction as theirs.

Results: Among 23,340 drug initiators (54.0% men, and 6.4% aged >85 years), the 5-year cumulative incidence was 5.4% (95% confidence interval 4.9-5.9%) for HHF, 1.9% (95% confidence interval 1.7-2.2%) for myocardial infarction admission and 6.1% (95% confidence interval 5.7-6.6%) for stroke admission. Among 6,192 patients with laboratory test data, 651 (10.5%) and 2,680 (43.3%) patients met the EMPA-REG-like and DECLARE-like criteria, respectively. The 5-year cumulative incidence among the 2,849 patients meeting either of the criteria was estimated to decrease from 97.1 to 75.6 events through 75% adoption of SGLT2i.

Conclusions: The incidence of HHF was similar to that of stroke. A 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.
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http://dx.doi.org/10.1111/jdi.13485DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354514PMC
August 2021

Current status of open surgery for acute type A aortic dissection in Japan.

J Thorac Cardiovasc Surg 2020 Nov 11. Epub 2020 Nov 11.

Keio University, Tokyo, Japan.

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.
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http://dx.doi.org/10.1016/j.jtcvs.2020.09.147DOI Listing
November 2020

Clinical outcome of laparoscopic vs open right hemicolectomy for colon cancer: A propensity score matching analysis of the Japanese National Clinical Database.

Ann Gastroenterol Surg 2020 Nov 1;4(6):693-700. Epub 2020 Aug 1.

The Japan Society for Endoscopic Surgery Tokyo Japan.

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%,  < .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.
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http://dx.doi.org/10.1002/ags3.12381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726676PMC
November 2020

Evaluation of postoperative outcomes of valve reoperation: a retrospective study.

Eur J Cardiothorac Surg 2021 04;59(4):869-877

Japan Cardiovascular Surgery Database Organization, Tokyo, Japan.

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.
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http://dx.doi.org/10.1093/ejcts/ezaa384DOI Listing
April 2021

Clinicopathological characteristics, practical treatments, prognosis, and clinical issues of older breast cancer patients in Japan.

Breast Cancer 2021 Jan 21;28(1):1-8. Epub 2020 Nov 21.

Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan.

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.
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http://dx.doi.org/10.1007/s12282-020-01188-8DOI Listing
January 2021

Geriatric Risk Prediction Models for Major Gastroenterological Surgery using the National Clinical Database in Japan: A Multicenter Prospective Cohort Study.

Ann Surg 2020 Oct 15. Epub 2020 Oct 15.

Department of Hepato-Biliary-Pancreatic and Transplant Surgery, Fukushima Medical University.

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.
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http://dx.doi.org/10.1097/SLA.0000000000004308DOI Listing
October 2020

Device Use for Proximal Anastomosis on Ascending Aorta in Off-Pump Coronary Artery Bypass Grafting.

Ann Thorac Surg 2021 06 13;111(6):1909-1915. Epub 2020 Oct 13.

Division of Cardiovascular Surgery, Sakura Medical Center, Toho University, Chiba, Japan.

Background: We recently reported early postoperative results comparing the use of an anastomosis-assist device with a side-biting clamp for ascending aorta during coronary artery bypass grafting (CABG). Transient neurological complications occurred less often with the device. Here, we evaluated the perioperative safety of the device compared with the aorta no-touch technique (no-touch).

Methods: We evaluated patients listed in the Japan Adult Cardiovascular Surgery Database who received isolated off-pump CABG with either the device or the no-touch approach from 2014 to 2016. We performed a one-to-one matched analysis based on a propensity score modeled from patient demographics, comorbidities, cardiac conditions, and procedural characteristics. We compared early outcomes in both groups using Pearson's chi-square or Wilcoxon rank sum test as appropriate; P less than .05 was statistically significant.

Results: Among 9546 device and 6890 no-touch patients, we found 5012 patient matches for each group. The device operation time was significantly longer (293 versus 281 minutes; P < .001) and homologous transfusion was significantly greater (56.9% versus 51.0%; P < .001) than with no-touch. Thirty-day operative mortality (1.5% versus 1.7%; P = .34), morbidity and mortality (6.8% versus 7.5%; P = .17), and stroke (0.9% versus 1.1%; P = .36) were similar in both groups. New-onset atrial fibrillation (11.9% versus 10.3%; P = .01) occurred significantly more often with the device. Newly initiated dialysis (1.4% versus 1.9%; P = .051) was more frequent with no-touch whereas reoperation for graft occlusion was more frequent with the device (1.0% versus 0.6%; P = .06) but was not significant for either outcome.

Conclusions: The clinical safety of use of the device in CABG was comparable to no-touch for mortality and morbidity. Hemostasis may be a key issue for accomplishing higher-level quality control when devices are used in proximal anastomosis of CABG.
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http://dx.doi.org/10.1016/j.athoracsur.2020.08.016DOI Listing
June 2021

Breast cancer survival among Japanese individuals and US residents of Japanese and other origins: a comparative registry-based study.

Breast Cancer Res Treat 2020 Nov 20;184(2):585-596. Epub 2020 Aug 20.

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.

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.
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http://dx.doi.org/10.1007/s10549-020-05869-yDOI Listing
November 2020

Annual report of the Japanese Breast Cancer Registry for 2017.

Breast Cancer 2020 Sep 24;27(5):803-809. Epub 2020 Jul 24.

Department of Breast Surgery, Kyorin University Hospital, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.

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.
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http://dx.doi.org/10.1007/s12282-020-01139-3DOI Listing
September 2020

The Association of In-Hospital Transcatheter Aortic Valve Replacement Availability on Outcomes of Surgical Aortic Valve Replacement in Elderly Patients.

Circ J 2020 08 16;84(9):1599-1604. Epub 2020 Jul 16.

Japan Cardiovascular Surgery Database Organization.

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.
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http://dx.doi.org/10.1253/circj.CJ-20-0032DOI Listing
August 2020

Congenital Heart Disease After the Fukushima Nuclear Accident: The Japan Cardiovascular Surgery Database Study.

J Am Heart Assoc 2020 07 2;9(13):e014787. Epub 2020 Jul 2.

The Japanese Association for Thoracic Surgery Tokyo Japan.

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.
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http://dx.doi.org/10.1161/JAHA.119.014787DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670522PMC
July 2020

Effect of newborn screening for critical CHD on healthcare utilisation.

Cardiol Young 2020 Aug 2;30(8):1157-1164. Epub 2020 Jul 2.

Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.

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.
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http://dx.doi.org/10.1017/S1047951120001742DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096776PMC
August 2020

Preoperative risk factors for postoperative intra-abdominal infectious complication after gastrectomy for gastric cancer using a Japanese web-based nationwide database.

Gastric Cancer 2021 Jan 21;24(1):205-213. Epub 2020 May 21.

Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.

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.
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http://dx.doi.org/10.1007/s10120-020-01083-3DOI Listing
January 2021

Annual report of the Japanese Breast Cancer Society registry for 2016.

Breast Cancer 2020 Jul 11;27(4):511-518. Epub 2020 May 11.

Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8606, Japan.

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.
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http://dx.doi.org/10.1007/s12282-020-01081-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297705PMC
July 2020

Outcome of Percutaneous Coronary Intervention in Relation to the Institutional Volume of Coronary Artery Bypass Surgery.

J Clin Med 2020 Apr 27;9(5). Epub 2020 Apr 27.

Scientific and Registry Committee, Japanese Association of Cardiovascular Intervention and Therapeutics, Tokyo 104-0033, Japan.

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.
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http://dx.doi.org/10.3390/jcm9051267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287823PMC
April 2020

Adherence to antihypertensive medication and its predictors among non-elderly adults in Japan.

Hypertens Res 2020 07 20;43(7):705-714. Epub 2020 Apr 20.

Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo City, Tokyo, Japan.

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.
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http://dx.doi.org/10.1038/s41440-020-0440-2DOI Listing
July 2020

Safe Dissemination of Laparoscopic Liver Resection in 27,146 Cases Between 2011 and 2017 From the National Clinical Database of Japan.

Ann Surg 2020 Mar 20. Epub 2020 Mar 20.

Japanese Society of Hepato-Biliary-Pancreatic Surgery, Tokyo, Japan.

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.
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http://dx.doi.org/10.1097/SLA.0000000000003799DOI Listing
March 2020
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