1.Current Status of Cardiovascular Surgery in Japan, 2013 and 2014 : A Report based on the Japan Cardiovascular Surgery Database (JCVSD)
Hideyuki Shimizu ; Norimichi Hirahara ; Noboru Motomura ; Hiroaki Miyata ; Shinichi Takamoto
Japanese Journal of Cardiovascular Surgery 2017;46(5):205-211
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.
2.A Report on the Distribution of "Lethal Dose/Pharmaceutical Product Strength” in High-Risk Drugs
Kazuki NAGASHIMA ; Hideyuki HIRAHARA ; Machiko WATANABE ; Fumio ITAGAKI
Japanese Journal of Drug Informatics 2022;24(1):30-37
Objective: This study assessed the distribution of "lethal dose/pharmaceutical product strength" in high-risk drugs.Methods: In 707 pharmaceutical products (312 ingredients) that had been defined as high-risk drugs in Japan, we collected acute toxicity information from these products on single dose toxicity studies conducted in mice, including median lethal dose (LD50) and approximate lethal dose (aLD). The LD50 and aLD were then divided by the strength (quantity of active ingredients) of the pharmaceutical product, after which the LD50or aLD values having an inequality sign was excluded.Results: We collected data on the acute lethal dose of 707 products (312 ingredients) from high-risk drugs. Data with an inequality sign, which was 143 of 495 products (28.9%) in tablets and capsules, then 43 of 212 items (20.3%) in injections, were excluded from the analysis. As observed, median (Q1, Q3) of "LD50/pharmaceutical product strength" and "aLD/pharmaceutical product strength" for tablets or capsules was 36.8 tablet/kg (11.5 tablet/kg, 144 tablet/kg) and 16.7 tablet/kg (6.9 tablet/kg, 65 tablet/kg), respectively. However, median (Q1, Q3) of "LD50/pharmaceutical product strength" and "aLD/pharmaceutical product strength" for injections were 1.3 bottle/kg (0.6 bottle/kg, 4.7 bottle/kg) and 0.8 bottle/kg (0.4 bottle/kg, 15 bottle/kg), respectively. In both cases, injections were distributed at a lower value than oral products.Conclusion: From this study, the distribution of "lethal dose/pharmaceutical product strength" in high-risk drugs was clarified. This information will therefore help pharmacists assess risks associated with individual pharmaceutical products.
3.Current Status of Cardiovascular Surgery in Japan : Analysis of Data from Japan Cardiovascular Surgery Database in 2015, 2016
Hideyuki SHIMIZU ; Norimichi HIRAHARA ; Noboru MOTOMURA ; Hiroaki MIYATA ; Shinichi TAKAMOTO
Japanese Journal of Cardiovascular Surgery 2019;48(1):18-24
Background : Thoracic and thoracoabdominal aortic diseases are treated using operative procedures like open aortic repair (OAR), thoracic endovascular aortic repair (TEVAR) or even hybrid aortic repair (HAR), a combination of OAR and TEVAR. The surgical approach to aortic repair is evolving over the decades. The purpose of this study was to examine the current trends in treatment. Methods : We extracted the nationwide data of aortic repair procedures performed between 2015 and 2016 from the Japan Cardiovascular Surgery Database (JCVSD). In addition to estimating the number of cases, we also classified the cases based on various criteria such as operative mortality, associated major morbidities (e.g. stroke, spinal cord insufficiency, renal failure), disease pathology (e.g. acute dissection, chronic dissection, ruptured aneurysm, unruptured aneurysm), site of operative repair (e.g. aortic root, ascending aorta, aortic root to arch, aortic arch, descending aorta, thoracoabdominal aorta) and the preferred surgical approach (i.e. OAR, HAR or TEVAR). Results : The total number of cases studied was 35,427, with an overall operative mortality rate of 7.3%. Among the 3 procedures, 64% of patients were treated with OAR. In comparison to the data in our previous report (also derived from the JCVSD in 2013 and 2014), the total number of cases and numbers of OAR, HAR, and TEVAR have increased by 17.0%, 2.4%, 126.1% and 34.9%, respectively. While the overall stroke rates following aortic arch surgical repair with HAR, OAR, and TEVAR were 10.1%, 8.4%, and 7.3% respectively. OAR was found to have the lowest stroke rate when limited to cases presenting with a non-dissected/unruptured aorta. The incidence rates of paraplegia following descending/thoracoabdominal aortic surgical repair using HAR, OAR, and TEVAR were 6.3%/10.4%, 4.3%/8.9% and 3.4%/4.6%, respectively. TEVAR was found to be associated with the lowest incidence of postoperative renal failure. Conclusions The number of operated thoracic and thoracoabdominal aortic diseases has increased, though the rate of operations using an OAR approach has decreased. While TEVAR showed the lowest mortality and morbidity rates, OAR demonstrated the lowest postoperative stroke rate for non-dissecting aortic arch aneurysms.
4.Current Status of Cardiovascular Surgery in Japan : A Report Based on the Japan Cardiovascular Surgery Database in 2017, 2018 4. Thoracic Aortic Surgery
Hideyuki SHIMIZU ; Norimichi HIRAHARA ; Noboru MOTOMURA ; Hiroaki MIYATA ; Shinichi TAKAMOTO
Japanese Journal of Cardiovascular Surgery 2020;49(4):169-179
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.