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

OBJECTIVES: We compared the clinical outcomes of mitral valve (MV) repair for mitral regurgitation via robot-assisted approach (ROBO) and small right thoracotomy approach (MINI) three years after the reimbursement of ROBO in Japan. METHODS: Patients who underwent isolated MV repair by minimally invasive approach between 2018 and 2020 from the Japanese Cardiovascular Surgery Database were included. Patients in the ROBO group were matched to the MINI group based on propensity scores estimated from patient and surgical characteristics. Perioperative outcomes were compared among all as well as in subgroups categorized based on the yearly number of ROBO or MINI cases (≥10 or not) at the hospital. RESULTS: We identified 2,443 patients who had undergone isolated MV repair at 250 institutions in the database, and analysis of propensity matched 577 patient-pairs demonstrated that operation time, cardiopulmonary bypass time, and aortic cross clamp time were significantly shorter in ROBO. Although the ICU stay was longer in ROBO, the time to discharge was significantly shorter in ROBO. There was no meaningful difference in in-hospital mortality. The incidence of postoperative stroke, renal failure, prolonged ventilation, and the number of patients who cinverted to MV 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 ROBO is just as effective as MINI. The introduction of robot-assisted MV repair in Japan has been successful.

Descriptive analysis of long-term survival after aortic valve replacement for dialysis patients: importance of renal pathologies and age.

OBJECTIVES: This study analyzed the long-term survival of dialysis patients undergoing AVR using the Japanese National Clinical Database with additional survival data. METHODS: De-novo AVR for dialysis-dependent patients between 2010 and 2012 who were registered in the Japan Cardiovascular Surgery Database were included. Concomitant aortic surgery and transcatheter aortic valve replacement were excluded. An additional questionnaire was sent to each hospital regarding the underlying kidney disease, the duration of dialysis initiation to the surgery, and clinical outcomes. The Kaplan-Meier survival curve was descriptively shown for all cohorts and each renal pathology. Furthermore, we compared the incidence of bioprosthetic valve failure in patients who were < 65 years old (group Y) and ≧65 years old (group O). RESULTS: Of these 1529 patients, diabetic nephropathy was 517, chronic glomerulonephritis was 437, and renal sclerosis was 210, regarding renal pathology. 1, 3, and 5-year survival in each pathology was 78.4%, 58.6%, 45.9% in diabetic nephritis, 78.8%, 68.4%, 58.2% in chronic glomerulonephritis, 79.0%, 67.8%, 52.1% in renal sclerosis, and 74.4%, 62.6%, 49.2% in others. Active infectious endocarditis was more prevalent in group Y (O 2.7% vs. Y 9.6%). The incidence of bioprosthetic valve failure requiring re-hospitalization was too small to analyze. 1, 3, and 5-year survival was 76.0%, 63.4%, 49.2% in group O and 74.3%, 64.2%, and 47.7% in group Y. CONCLUSIONS: Long-term survival of AVR for dialysis-dependent was higher in patients with chronic glomerulonephritis and lower in patients with diabetic nephritis than in other pathologies.

Time course changes in insulin sensitivity during cardiac surgery: A retrospective study on intraoperative glycemic management using an artificial pancreas.

INTRODUCTION: Glycemic control is essential for improving the prognosis of cardiac surgery, although precise recommendations have not yet been established. Under a constant blood glucose level, the insulin infusion rate correlates with insulin resistance during glycemic control using an artificial pancreas (AP). We conducted this retrospective study to elucidate changes in intraoperative insulin sensitivity as a first step to creating glycemic control guidelines. METHODS: Fifty-five cardiac surgery patients at our hospital who underwent intraoperative glycemic control using an AP were enrolled. Twenty-three patients undergoing surgical procedures requiring cardiac arrest under hypothermic cardiopulmonary bypass (CPB) with minimum rectal temperatures lower than 32°C, 13 patients undergoing surgical procedures requiring cardiac arrest under hypothermic CPB with minimum rectal temperatures of 32°C, eight patients undergoing on-pump beating coronary artery bypass grafting and 11 patients undergoing off-pump coronary artery bypass were assigned to groups A, B, C and D, respectively. We analyzed the time course of changes in the data derived from glycemic control using the AP. RESULTS: Significant time course changes were observed in groups A and B, but not in groups C and D. Insulin resistance was induced after the start of hypothermic CPB in groups A and B, and the induced change was not resolved by the rewarming procedure, remaining sustained until the end of surgery. CONCLUSIONS: Hypothermia is the predominant factor of the induced insulin resistance during cardiac surgery. Thus, careful glycemic management during hypothermic CPB is important. Prospective clinical studies are required to confirm the findings of this study.

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.

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.

Late outcome of coronary artery bypass grafting with or without mitral repair for moderate or moderate-severe ischemic mitral regurgitation.

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.

Mechanical vs Bioprosthetic Aortic Valve Replacement in Patients on Dialysis: Long-term Outcomes.

BACKGROUND: Using the Japan National Clinical Database and additional data, this study is an analysis of long-term survival of dialysis-dependent patients who underwent aortic valve replacement (AVR). METHODS: Dialysis-dependent patients who underwent de novo AVR between 2010 and 2012 and who were registered in the database were included. Concomitant aortic surgery and transcatheter aortic valve replacement were excluded. Additional data on the underlying kidney disease, the duration of dialysis, and clinical outcomes were registered between October 29, 2019, and August 30, 2020. The primary outcome was all-cause mortality. The secondary outcomes were cerebral infarction, cerebral bleeding, gastrointestinal bleeding, and prosthetic valve failure. RESULTS: After propensity score matching, 1016 cases (508 each in the bioprosthetic and mechanical valve groups) were matched. The median follow-up period was 3.29 years (interquartile range [IQR], 0.59 years, 6.25 years). The median survival time was 5.38 years (IQR, 1.20 and 9.26 years) in the mechanical valve group and 4.98 years (IQR, 1.69 and 9.62 years) in the bioprosthetic valve group. The Cox regression model showed no significant difference in long-term survival between the groups (mechanical valve: hazard ratio [HR], 0.895; 95% CI, 0.719-1.113; P = .318). The incidences of cerebral infarction and prosthetic valve failure requiring admission were similar between the groups. Cerebral bleeding (HR, 2.143; 95% CI, 1.125-4.080; P = .002) and gastrointestinal bleeding (HR, 2.071; 95% CI, 1.243-3.451; P = .0005) were more frequent in the mechanical valve group. CONCLUSIONS: Long-term survival of dialysis-dependent patients was similar regardless of whether mechanical valves or bioprosthetic valves were implanted. The incidences of cerebral and gastrointestinal bleeding were 2-fold higher in the mechanical valve group.

Incidence and outcomes of surgical site infection after cardiovascular surgery (complete republication).

OBJECTIVES: Surgical site infection in cardiovascular surgery had a great effect on postoperative outcomes. This study examined the current status of surgical site infection and postoperative outcomes used the registered data of the Japan Cardiovascular Surgery Database. METHODS: From the registry, we extracted 53,186 cases of thoracic cardiovascular surgery performed under median sternotomy in 2018. According to Japanese Healthcare Associated Infections Surveillance (JHAIS), patients were divided into three groups: coronary artery bypass graft (CABG) with saphenous vein graft (SVG) (SVG+ ; n = 14,246), CABG without SVG (SVG-; n = 5535), and operations other than CABG (no CABG; n = 33,405). The incidence of deep sternal wound infection, leg wound infection, hospital death, and hospitalization more than 90 days was examined. RESULTS: The incidence of deep sternal wound infection is 1.4% in all cases and 1.7% in SVG+ , 1.2% in SVG-, and 1.4% in no CABG. In deep sternal wound infection cases, incidence of hospital death was 24.7% and was higher than no infection cases. Especially, in no CABG group, incidence of hospital death was 30.1%. The long-term hospitalization rate and readmission rate within 30 days of patients with deep sternal wound infection were also high. CONCLUSIONS: The incidence of deep sternal wound infection was low, but it has not decreased. Postoperative outcomes in patients with surgical site infection were still bad.

Postoperative outcomes of valve reoperation are associated with the number of previous cardiac operations.

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.

Contemporary surgical management of complete atrioventricular septal defect with tetralogy of Fallot in Japan.

OBJECTIVES: Complete atrioventricular septal defect with tetralogy of Fallot is a rare and complex heart disease. This study aimed to describe contemporary management approaches for this heart disease and the outcomes. METHODS: Data were obtained from 46 domestic institutions in the Japan Cardiovascular Database (2011-2018). Patients with a fundamental diagnosis of complete atrioventricular septal defect with tetralogy of Fallot, without other complex heart diseases, were included. The primary outcome was operative mortality (30-day or in-hospital mortality). RESULTS: A total of 119 patients underwent initial surgery for a complete atrioventricular septal defect with tetralogy of Fallot during this study period. Primary repair was performed in 40 (34%) patients (primary repair group), and palliative procedure was performed in 79 (66%) patients as part of a planned staged approach (staged group). Forty institutions (87%) experienced at least one case of staged repair. No institution experienced more than or equal to two cases/year on average during the study period. Overall, 11 operative mortalities occurred (9.2%). Operative mortality rates in the primary and staged groups were comparable (p = 0.5). Preoperative catecholamine use, repeat palliative surgeries, and emergency admission were significant risk factors for operative mortality in multivariate analysis (odds ratio, 95% confidence interval: 8.58, [0-0.11]; 12.65, [1.28-125.15]; 8.64, [1.87-39.32, respectively]). CONCLUSIONS: Staged approach for complete atrioventricular septal defect with tetralogy of Fallot was the preferred option. The outcomes of this complex disease were favorable for patients in centers with low cases of complete atrioventricular septal defect with tetralogy of Fallot.

Association between prehospital transfer distance and surgical mortality in emergency thoracic aortic surgery.

OBJECTIVE: To examine whether there is an association between prehospital transfer distance and surgical mortality in emergency thoracic aortic surgery. METHODS: A retrospective cohort study using a national clinical database in Japan was conducted. Patients who underwent emergency thoracic aortic surgery from January 1, 2014, to December 31, 2016, were included. Patients with type B dissection were excluded. A multilevel logistic regression analysis was performed to examine the association between prehospital transfer distance and surgical mortality. In addition, an instrumental variable analysis was performed to address unmeasured confounding. RESULTS: A total of 12,004 patients underwent emergency thoracic aortic surgeries at 495 hospitals. Surgical mortality was 13.8%. The risk-adjusted mortality odds ratio for standardized distance (mean 12.8 km, standard deviation 15.2 km) was 0.94 (95% confidence interval, 0.87-1.01; P = .09). Instrumental variable analysis did not reveal a significant association between transfer distance and surgical mortality as well. CONCLUSIONS: No significant association was found between surgical mortality and prehospital transfer distance in emergency thoracic aortic surgery cases. Suspected cases of acute thoracic aortic syndrome may be transferred safely to distant high-volume hospitals.

Sociodemographic and work-related factors influencing long working hours among cardiovascular surgeons in Japan: a cross-sectional study.

The maximum limit on overtime working hours for physicians will be applied from 2024. To explore sociodemographic and work-related factors influencing overtime work among cardiovascular surgeons (CS) in Japan. This cross-sectional study included 607 CS who responded to an online survey. Working hours were categorized into ≤60 hours, 60-79 hours, and ≥80 hours per week according to Japan Ministry of Health, Labour and Welfare. Adjusted odds ratios (aOR) were calculated using a multinomial analysis with stepwise reduction after adjustment for potential confounders. Compared to ≤60 hours, significant factors related to 60-79 hours and ≥80 hours per week were age groups of 30s to 50s versus 60s (aOR: 7.48-3.22 and 23.64-4.87), management with cardiovascular drugs (aOR: 1.87 and 5.80), and postoperative wound management (aOR: 0.47 and 0.16), respectively. Significantly related informed consent for surgery (aOR: 3.29) was seen in 60-79 hours. Contrarily, CS who worked for ≥80 hours took on-duty 5 times or more per month (aOR: 3.89), performed night or holiday calls 20 times or more per month (aOR: 2.26), and attended the intensive care unit (aOR: 3.12). These findings suggest that younger, and some non-surgical work-related factors could influence long working hours among CS.

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

Comparison of long-term outcomes between off-pump and on-pump coronary artery bypass grafting using Japanese nationwide cardiovascular surgery database.

OBJECTIVES: In Japan, off-pump coronary artery bypass (OPCAB) is more common than on-pump coronary artery bypass. Superior early results of OPCAB have been reported; however, long-term results were still unclear. Purpose of this study is to evaluate the clinical outcomes of OPCAB in Japan using Japan Adult Cardiovascular Surgery Database. METHODS: Between 2008 and 2010, 23,633 patients who underwent isolated coronary artery bypass were reported in database. We selected the cases from the hospital with mean annual coronary surgery volume of more than 50. Among the total of 7724 cases at 41 institutions, 2150 (31.2%) on-pump coronary artery bypass (ONCAB) and 5574 (68.8%) OPCAB cases were included. Propensity score (PS) matching was performed using PS developed from patient characteristics and preoperative factors resulting in 2007 cases matched pairs. Long-term follow-up data on patients' mortality and stroke were collected. RESULTS: In-hospital mortality was significantly lower in OPCAB (ONCAB 1.1%, OPCAB 0.4% p = 0.01). Stroke was low in OPCAB group (ONCAB 1.7%, OPCAB 0.8%, p = 0.01). There was no statistically significant difference between OPCAB and ONCAB regarding 7-year overall survival (86.1% vs 88.1% respectively), composite outcomes (72.0% vs 73.9% respectively), or cardiac deaths (97.3% vs 97.1% respectively). Subgroup analysis (more than 75 years old) showed a worse trend in OPCAB group. Only in OPCAB group, incomplete revascularization significantly influenced 7-year survival. CONCLUSIONS: OPCAB is associated with early prognostic benefits; however, it might be less favorable outcomes in the long term when patients are older or with incomplete revascularization.