Minimally invasive cardiac surgeries in 2021: annual report by Japanese society of minimally invasive cardiac surgery.

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.

Impact of immediate breast reconstruction on perioperative therapy: insights from a Japanese Nationwide Registry.

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.

Successful launch of robot-assisted mitral valve repair in Japan under universal health coverage.

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.

Survival trends and patient characteristics between 2004 and 2016 for breast cancer in Japan based on the National Clinical Database-Breast Cancer Registry.

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.

The accuracy and characteristics of gastric cancer treatment information in the national data of the hospital-based cancer registry.

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.

Prognostic factors after open and endovascular repair for infected native aneurysms of the abdominal aorta and common iliac artery.

OBJECTIVE: Infected 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. However, owing to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-open repair and post-EVAR outcomes and to clarify factors affecting the short-term and late prognosis after each treatment. METHODS: Using a nationwide clinical registry, we investigated 600 patients treated with open repair and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative or operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent or recurrent aneurysm-related infection, were examined. RESULTS: Prosthetic grafts were used in >90% of patients treated with open repair, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Preoperative 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 = .046, and HR, 2.24; 95% CI, 1.12-4.46; P = .022, respectively) and persistent or recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P = .039, and OR, 4.96; 95% CI, 1.81-13.55; P = .002, respectively) after open repair, whereas omental wrapping or 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 = .019, and HR, 0.53; 95% CI, 0.32-0.88; P = .014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent or recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P = .034), whereas an elevated preoperative white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P = .048). CONCLUSIONS: Profiles of prognostic factors differed between open repair and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. Open repair may be more suitable than EVAR for patients with concurrent abscess formation.

2020 Annual Report of National Clinical Database-Breast Cancer Registry: 10-year mortality of elderly breast cancer patients in Japan.

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.

Annual report of the Japanese Breast Cancer Registry for 2019.

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.

No difference in the incidence of postoperative pulmonary complications between abdominal laparoscopy and laparotomy for minimally invasive thoracoscopic esophagectomy: a retrospective cohort study using a nationwide Japanese database.

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.

Open Versus Zone 0/1 Endovascular Aortic Repair for Arch Aneurysm: A Propensity Score-Matched Study from the National Clinical Database in Japan.

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.

Current status of surgical treatment for acute aortic dissection in Japan: Nationwide database analysis.

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.

The volume-outcome relationship in free-flap reconstruction: A nationwide study based on the Clinical Database.

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.

Analysis of prognosis in different subtypes of invasive lobular carcinoma using the Japanese National Cancer Database-Breast Cancer Registry.

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.

Surgical Repair of Abdominal Aorto-Iliac Prosthetic Graft Infections: A Nationwide Japanese Cohort Study.

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.

One-year outcome of transcatheter aortic valve replacement for bicuspid aortic valve stenosis: a report from the Japanese Nationwide registry (J-TVT registry).

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.

Annual Report for 2019 by the Japanese Association for Coronary Artery Surgery.

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.

The utility of the self-controlled study design for pharmacoepidemiological studies without an active comparator medication using a medical information database: An application to assess the risk of varenicline on cardiovascular outcomes.

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.