In 2013, the Government of Japan issued “Japan Revitalization Strategy”, in which facilitation of overseas expansion of Japanese drugs, medical equipment, health services, and health system through Public Private Partnership (PPP) is included. In alignment with this strategy, ministries and agencies have initiated on various health project, one of which is “Project for global growth of medical technologies, systems and services through human resource development”funded by the Japan Ministry of Health, Labour, and Welfare from 2015. As an administrative organization of this project, National Center for Global Health and Medicine (NCGM) has organized 119 project for 4 years from 2015 to 2018. This report summarizes the experiences and the results of evaluation in terms of program management, expansion of introduced health technologies and the health impact. As the results, the overall project management was satisfactory from the viewpoints of varieties of project, the execution rates. Then, health technologies were adopted in the national guidelines or policies and 17 introduced medical products were purchased by local governments. When it comes to health impacts, 19646 health staffs were trained through this program for 4 years and 912334 persons were estimated as beneficiaries by 29 project in 2017. Based on data shown as above, the overall achievement of this program should be considered satisfactory. Since this program is unique among other PPP program in Japan as well as other countries as the program scheme to promote expansion of medical products through human resource development, the experiences should provide some insights about the ways to facilitate PPP in health sector. In order to extract the Tips of good practices for future activities, further analysis on each project is necessary.

Objectives : We analyzed the mortality and morbidity of congenital heart surgery in Japan by using Japan Cardiovascular Surgery Database (JCVSD). Methods : The congenital heart surgery performed between January 2017 to December 2018 were obtained from JCVSD. From the data obtained, the most frequent twenty procedures were selected, and the mortalities and major morbidities were analyzed. In addition, all the procedures were classified into STAT Mortality Categories and mortalities in each category were also analyzed. Results : The mortality of ASD repair and VSD repair were 0% and 0.2% respectively. The mortality of TOF repair, complete AVSD repair, Rastelli operation, CoA complex repair, bidirectional Glenn, TCPC were 2-3%. The mortality of systemic to pulmonary shunt was 4.9%, and the mortality of TAPVC repair and Norwood procedure were 11.1% and 15.7% respectively and not different from the results of 2015-2016. The mortalities according to the STAT categories 1-5 were 0.3%, 2.7%, 2.9%, 5.9% and 15.5% respectively and comparable to those of STS database (2013-2016). Conclusion : The analysis of the JCVSD-congenital data revealed the mortality rate of major surgical procedures for congenital heart disease performed in Japan in 2017-2018, the frequency of complications, and the mortality rate by STAT Mortality Categories. We believe that these statistics will play an important role as a basis for trends in Japan and for comparison of results with other countries.

Data on isolated coronary artery bypass grafting (CABG) performed in 2017 and 2018, 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). Isolated CABG was performed off-pump in 54.6% (n＝14,684) of all CABG cases (n＝26,913), and graft material for the LAD was left internal thoracic artery in 76.4% and right internal thoracic artery in 19.0%. Operative mortality was 1.5% in elective cases (On-pump CABG : ONCAB 1.9%, off-pump CABG : OPCAB 1.2%, p＜0.001), 7.4% in emergency cases (ONCAB 10.2%, OPCAB 4.3%, p＜0.001), and 2.5% overall. Postoperative morbidity was low in almost all aspects in OPCAB, and average JapanSCORE II is elevating every year. Overall short-term operative results for isolated CABG is stable, and operative candidates are shifting to higher-risk patients.

Objectives : We sought to present data relative to valvular heart surgeries from the Japan Cardiovascular Surgery Database in 2017 and 2018 to show current status and trend in Japan. Methods : We extracted data relative to cardiac valve surgeries performed in 2017 and 2018 from the Japan Cardiovascular Surgery Database. We obtained total number of aortic valve replacement procedures and showed trend for these 6 years from 2013 to 2018. The operative mortality rates were shown for representative valve procedures stratified by age group with the aim of showing a bench mark of Japan. Data regarding minimally invasive procedures and transcatheter aortic valve implantation which the Japan Cardiovascular Surgery Database can provide were also presented. Results : Despite dramatic increase of number of transcatheter aortic valve implantation in 2017 and 2018 compared to in 2015 and 2016, surgical aortic valve replacement also increased from 26,054 to 28,202. Regarding the operative mortality of first time valve procedures, it was 1.8% in isolated aortic valve replacement, 0.9% in isolated mitral valve repair, 8.2% in mitral valve replacement with biological prostheses, and 4.6% with mechanical prostheses. For first time valve procedures with concomitant coronary artery bypass, the operative mortality was 5.2% in aortic valve replacement, 4.9% in mitral valve repair. Regarding prosthetic valve selection, 72.6% of patients had biological prosthesis for aortic valve replacement procedures in their 60's, showing trend of increasing percentages of biological valve choice. Regarding minimally invasive procedure, 31.8% of first time isolated mitral valve plasty were performed via right thoracotomy. Though patients who underwent surgery via right thoracotomy had better clinical outcomes, it was also apparent that the patients who underwent surgery via right thoracotomy had lower operative risk profile. Aortic clamp time and cardiopulmonary bypass time were longer in the right thoracotomy patients. 6.3% of the patients who had isolated aortic valve replacement underwent surgery via right thoracotomy. The right thoracotomy aortic valve replacement patients had better clinical outcomes and had more percentage of lower risk profile. The overall mortality of transcatheter aortic valve implantation and surgical aortic valve replacement were 1.5% and 1.8%, respectively. Conclusion : We reported data related to heart valve surgery in 2017 and 2018 from the Japan Cardiovascular Surgery Database.

Purpose : The current status of treatment for thoracic/thoracoabdominal aortic diseases in Japan was analyzed. Methods : Using the Japan Cardiovascular Surgery Database (JCVSD), the number of cases, operative mortality and major morbidities (stroke, renal failure, pneumonia, paraplegia) of thoracic and thoracoabdominal aortic surgery in 2017 and 2018 were analyzed by surgical site (root-ascending, arch, descending, thoracoabdominal aorta), surgical procedure and age group. Results : The total number of cases was approximately 40,000 and aortic dissection and non-dissection were almost the same. The number of cases was highest in the 70s, and in the elderly, the rates of root replacement (particularly valve-sparing operation) in the root-ascending aorta and open-chest surgery (prosthetic graft replacement, OAR ; open stent graft, Open SG) in the arch, descending and thoracoabdominal aorta were lower. The outcome by procedure showed the lowest mortality and morbidity rate of valve-sparing in the root-ascending region, and lower mortality and morbidity (cerebral infarction, renal failure, and pneumonia) in non-open-chest procedures (TEVAR with/without branch reconstruction) than those in open-chest procedures in the arch, descending and thoracoabdominal regions. Unlike other complications, the incidence of paraplegia in the arch was lower in OAR than in non-open-chest procedures. With regards to age, the operative mortality in patients aged 80 or older was significantly higher than those under 80 for all surgical procedures in the root-ascending, arch and descending regions. Conclusions : Thoracic and thoracoabdominal aortic surgery in Japan was most often performed in elderly patients in their 70s with an overall good mortality rate of 5.3%. Mortality and postoperative morbidity in patients aged 80 or older were still high. Further improvement of surgical results is required.

Background/Aims: 5-Aminosalicylic acid (ASA) causes intolerance reactions in some patients. This study was performed to examine the prognosis of patients with ulcerative colitis (UC) and 5-ASA intolerance, and to evaluate the potential interaction between 5-ASA intolerance and the intestinal microbiota. Methods: We performed a retrospective cohort study of patients with UC who visited participating hospitals. The primary endpoint was to compare the incidence of hospitalization within 12 months between the 5-ASA intolerance group and the 5-ASA tolerance group. The secondary endpoint was to compare the risk of adverse clinical outcomes after the start of biologics between the 2 groups. We also assessed the correlation between 5-ASA intolerance and microbial change in an independently recruited cohort of patients with UC. Results: Of 793 patients, 59 (7.4%) were assigned to the 5-ASA intolerance group and 734 (92.5%) were assigned to the 5-ASA tolerance group. The admission rate and incidence of corticosteroid use were significantly higher in the intolerance than tolerance group (P< 0.001). In 108 patients undergoing treatment with anti-tumor necrosis factor biologics, 5-ASA intolerance increased the incidence of additional induction therapy after starting biologics (P< 0.001). The 5-ASA intolerance group had a greater abundance of bacteria in the genera Faecalibacterium, Streptococcus, and Clostridium than the 5-ASA tolerance group (P< 0.05). Conclusions In patients with UC, 5-ASA intolerance is associated with a risk of adverse clinical outcomes and dysbiosis. Bacterial therapeutic optimization of 5-ASA administration may be important for improving the prognosis of patients with UC.

Methods : We collated the nationwide data on congenital heart operations performed between January 2015 and December 2016 from the Japan Cardiovascular Surgery Database (JCVSD). The mortality and morbidity data for the 20 most-frequently performed procedures were analyzed. We also classified the surgical centers into three groups, according to the number of cardiopulmonary cases over a year and estimated the institution-wise distribution of major operations. Results : The mortality rate of the ASD and VSD repair procedures was ＜1%, while the mortality rate of procedures including TOF repair, complete AVSD repair, Rastelli operation, CoA complex repair, bidirectional Glenn and TCPC was found to be between 2-3%. The mortality rate of surgeries such as the Norwood procedure and TAPVC repair was comparably higher (＞10%). These complicated procedures were mainly performed at the surgical institutes handling a large volume of cases. Conclusion : Using the JCVSD, the nationwide data of congenital heart surgery, including postoperative complications, were analyzed.

Objectives : Data of valvular heart surgeries from the Japan Cardiovascular Surgery Database in 2015 and 2016 were analyzed to demonstrate the associated mortality and morbidity rates and choice of surgical procedures. Methods : We used the Japan Cardiovascular Surgery Database to extract data of cardiac valve replacement procedures performed in 2015 and 2016. The cases were further evaluated depending upon the type of procedure, and prosthesis used at each site. The rate of bio-prosthesis usage was derived for each valve position and age groups. The rates of operative mortality and morbidity were calculated for each valve position and type of procedures. Results : In total, 26,054 aortic valve replacements were performed in 2015 and 2016, showing a slight increase in number since the last report(2013-2014). A total of 3,305 transcatheter aortic valve replacements, 5,652 mitral valve replacements, and 12,024 mitral valve repair procedures were performed. The rate of bio-prosthesis usage in aortic valve replacement was 96.5%, 92.7% and 63.5% for patients in their 80s, 70s and 60s, respectively, demonstrating an increase in usage since 2013-2014. Mechanical valves were preferred in patients on chronic hemodialysis. The mortality rates of aortic valve replacement, mitral valve replacement, mitral valve repair, and tricuspid valve replacement procedures were 4.1%, 7.1%, 2.2%, and 10.5%, respectively. Conclusion : We evaluated recent trends in valvular heart surgery in Japan with respect to the type of procedure and prosthesis preferred and the postoperative outcomes. We found that bio-prosthesis usage was the most common.