Recently, the use of databases for clinical trials is being promoted. We used the Japan Adult Cardiovascular Surgery Database (JACVSD) data was used as a historical control in a clinical trial, and we analyzed following : the processes of using data and the efficiency of data collection, available variables for statistical analysis, and query functions for missing and invalid data. We chose available variables of JACVSD data and created rules for merging JACVSD data with interventional group data, in addition to analyzing the data collection processes for clinical trials. Subjects were selected from cases registered in the JACVSD. On statistical analysis, 63% of 76 variables were used ; variables related to the patients' symptoms had to be collected separately. Missing and invalid data were effectively excluded. We could conduct data collection efficiently by using the JACVSD as a historical control for clinical trials. Selecting subjects from the JACVSD could reduce the burden of selecting subjects from hospitals and prevent selection bias.

In the year 2000, the Japan Cardiovascular Surgery Database (JCVSD) was created with the support of the Society of Thoracic Surgeons (STS). STS database software was translated to Japanese with the same definitions and in 2001, the data entry of adult cardiac surgeries was initiated online using University Hospital Medical Information Network, UMIN. In 2008, entry of the data of congenital heart surgeries was initiated in the congenital section of JCVSD and preoperative expected mortality (JapanSCORE) in adult cardiovascular surgeries was first calculated using the risk model of JCVSD. In 2011, the Japan Surgical Board system merged with JCVSD and all cardiovascular surgical data could be registered in JCVSD from 2012. The reports resulting from the analyses of data from JCVSD (Current Status of Cardiovascular Surgery in Japan, 2013 and 2014 : A report based on the JCVSD) will encourage further improvements in the quality of cardiovascular surgeries, patient safety, and medical care for patients in Japan.

Objective and Methods : Data on isolated coronary artery bypass grafting (CABG) performed in 2013 and 2014, and registered in the Japan Cardiovascular Surgery Database were reviewed for preoperative characteristics, postoperative outcomes, and choice of graft material for the left anterior descending artery (LAD). Results : Isolated CABG was performed off-pump in 54.7% of cases, and graft material for the LAD was left internal thoracic artery in 74.3% and right internal thoracic artery in 15.6%. Operative mortality was 2.0% in elective cases, 8.2% in emergency cases, and 3.0% overall. In elective cases, operative mortality was 1.1% for off-pump CABG compared with 3.0% for on-pump CABG. Conclusions : Clinical results of our isolated CABG was reasonable and acceptable.

Objective : To demonstrate the mortality rate and the choice of surgical procedures, especially the selection of the valve prosthesis, in each position of the valve in each age of the patients and the effects of the preoperative complications to the mortality and prosthetic valve selection, the data from JCVSD in 2013 and 2014 are analyzed. Methods : The proportion of each surgical procedure is compared in each age of the patients in the aortic, the mitral and the tricuspid position. Results : The proportion of the mechanical valve prostheses was 23.1, 40.5 and 11.4% in the aortic, mitral and tricuspid position respectively and it was higher in hemodialysis patients than in non-hemodialysis patients. The operative mortality rate was 4.3, 11.7, 15.8 and 5.6% in all cases, the hemodialysis patients, the patients with liver dysfunction and the patients with atrial fibrillation and flutter, respectively in AVR, and 4.0, 14.4, 11.2 and 4.1%, respectively in each group listed above after mitral surgery. Conclusion : These results clarify the status of cardiac valvular surgery in Japan.

Background : Although open aortic repair (OAR) is still considered to be a standard treatment for thoracic aortic diseases, recently the indication of thoracic endovascular treatment (TEVAR) /hybrid aortic repair (HAR) is expanding. The purpose of this study is to review the current status of treatment of thoracic aortic diseases. Methods : The data concerning surgery for diseases in thoracic/thoracoabdominal aorta in 2013 and 2014 are extracted from the Japan Cardiovascular Surgery Database (JCVSD). The number of cases and operative mortality are evaluated for pathology (acute dissection, chronic dissection, ruptured aneurysm, un-ruptured aneurysm), treatment modality (OAR, HAR, TEVAR), JapanSCORE (＜5%, 5 to 10%, 10 to 15%, 15%≦) and their combination. Results : The total number of cases included in this study was 30,271 and the overall operative mortality was 5.9%. Among 3 types of treatment, 73.2% of patients underwent OAR (root, 98.3% ; ascending, 97.4% ; root to arch, 95.5% ; arch, 81.7% ; descending, 34.2% ; thoracoabdominal, 64.4%). Although the rate of OAR was in negative correlation with JapanSCORE (JS) in treatment for thoracoabdominal region (JS＜5%, 80.4% ; 5%≦JS＜10%, 67.6% ; 10%≦JS＜15%, 58.8% ; 15%≦JS, 55.7%), such relation was not observed in other regions. The operative mortality of OAR was well reflected by JS (JS＜5%, 2.1% ; 5%≦JS＜10%, 5.5% ; 10%≦JS＜15%, 10.2% ; 15%≦JS, 20.3%), however, those of TEVAR/HAR was less than the range of JS. Conclusions : The distribution of treatment differs depending on site of diseases and is not much influenced by JS. It has become clear that JapanSCORE is a reliable tool for estimating operative mortality in OAR. However, the observed operative mortality was lower than JS in TEVAR/HAR and a new risk score for TEVAR/HAR should be established.

National Clinical Database (NCD) is a multidisciplinary clinical registry platform collecting patient case information throughout Japan in close linkage with the board certification systems for various Japanese professional medical societies. Since its initiation of data collection in 2011, NCD has grown in its size as more national level professional societies joined its activity. Its current case registration volume is above 150 million cases per year. In this commentary, we will introduce four patterns of utilization examples of NCD: 1) data use for the assessment and improvement of healthcare quality in Japan, 2) data use for conducting observational studies to answer physician generated clinical questions, 3) data use for health services research, and 4) Use of the registry platform for industry-government-academia collaboration. We will also go over some of the data quality management and improvement activities at NCD, which they regard as one of the top priority issues in the operation of the institution. These include: defining and designing of the data elements, administrative support from the office staffs, data error checking using the web based registration system, and data audit and validation.

Objectives : We analyzed the mortality and morbidity of congenital heart surgery in Japan by using the Japan Cardiovascular Surgery Database (JCVSD). Methods : Data regarding congenital heart surgery performed between January 2013 and December 2014 were obtained from JCVSD. The 20 most frequent procedures were selected and the mortality rates and major morbidities were analyzed. Results : The mortality rates of atrial septal defect (ASD) repair and ventricular septal defect (VSD) repair were less than 1%, and the mortality rates of tetralogy of Fallot (TOF) repair, complete atrioventricular septal defect (AVSD) repair, bidirectional Glenn, and total cavopulmonary connection (TCPC) were less than 2%. The mortality rates of the Norwood procedure and total anomalous pulmonary venous connection (TAPVC) repair were more than 10%. The rates of unplanned reoperation, pacemaker implantation, chylothorax, deep sternal infection, phrenic nerve injury, and neurological deficit were shown for each procedure. Conclusion : Using JCVSD, the national data for congenital heart surgery, including postoperative complications, were analyzed. Further improvements of the database and feedback for clinical practice are required.

In Japan, few surveys have evaluated the structure and clinical process of cardiovascular surgery programs. We mailed a questionnaire to all 149 facilities participating in the Japan Adult Cardiovascular Database as of April 1st 2007. We received responses from 129 facilities (response rate 86.6%). For CABG surgery, many facilities regard “IMA use (95.3%) ” and “off-pump surgery” is the first choice as a facility and recommend “discharge antiplatelets (89.9%) ” and “discharge antilipid (47.3%) ”. On the other hand most facilities did not made any recommendation regarding “preoperative beta blockers (72.9%) ” and “discharge beta blockers (60.5%) ”. The usage rates of preoperative beta blockers and discharge beta blockers were very low in Japan though their usage rates were relatively high in the United States.

An 84-year-old man with a thoracic aortic aneurysm underwent total arch replacement with selective antegrade cerebral perfusion. Immediately after the operation, respiratory distress and hypotension developed and Chest X-ray films and computed tomography showed bilateral lung edema. Echocardiography showed a small, underfilled left ventricle, but with preserved systolic function. We suspected transfusion-related acute lung injury (TRALI), and started sivelestat and steroid pulse therapy. His respiratory condition gradually improved, and he was discharged on postoperative day 78. The diagnosis of TRALI was confirmed by positive test results of an HLA class I antibody in the transfused fresh frozen plasma and T- and B-cells of the patient. TRALI should be considered as a cause of acute lung injury after surgery with blood transfusion.

We investigated tte effects of Bukuryoshigyaku-to on cxperimental hemorrhagic shock. Twelve mongrel dogs, which were anesthetized with 26mg/kg of pentobarbital were used, Bukuryoshigyaku-to was given to six dogs and saline solution alone was given to six dogs as a control. Under artificial respiration management, a hemorrhagic shock model was created by modified Wiggers method. The drug was administered by enema immediately after the compensatory phase. Bukuryoshigyaku-to, consistied of 4g Bukuryo (Hoelen), 2g of Kanzo (Glycyrrhizae Radix), 2g Kankyo (Zingiberis Siccatum Rhizoma), 2g of Ninjin (Ginseng Radix) and 2g of Bushi (Aconiti Tuber), which were extracted by boiling for approximately 30 minutes.
The results showed no statistical differences in the changes in the mean arterial pressure and central venous pressure between the two groups. However, the cardiac index was significantly higher in the observation phase in the Bukuryoshigyaku-to group than in the control group. A drop in body pressure was prevented in the traditional Bukuryoshigyaku-to group.
These findings suggest the effectiveness of Bukuryoshigyaku-to in the treatment of hemorrhagic shock.