Division of Cardiac Surgery Brigham and Women's Hospital Boston MA.
Duke Clinical Research Institute Durham NC.
J Am Heart Assoc. 2022 Mar 15;11(6):e023848. doi: 10.1161/JAHA.121.023848. Epub 2022 Mar 4.
Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; <0.001), were more frequently women (45.9% versus 68.1%; <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.
医疗器械在获得监管批准后的实际应用情况和结果可能因国家而异。本研究旨在通过两国间的合作项目(Harmonization-by-Doing),比较美国和日本在经导管主动脉瓣置换术(TAVR)方面的国家临床注册数据,以评估两国间患者特征、围手术期结局以及结局变化的可变性。
从美国胸外科医师学会/美国心脏病学会经导管瓣膜治疗(STS/ACC TVT)注册中心和日本经导管瓣膜治疗(J-TVT)注册中心分别提取患者水平数据,以分析 2013 年至 2019 年 TAVR 结果。这些注册中心的数据录入均由联邦监管机构强制要求,且多数变量定义已实现标准化,以便于直接进行数据比较。共分析了来自美国 646 家机构的 244722 例 TAVR 和来自日本 171 家机构的 26673 例 TAVR。美国的中位数每站点量为 65(四分位距,45-97),日本为 28(四分位距,19-41)。总体而言,J-TVT 中的患者年龄更大(美国:平均年龄 80.1±8.7 岁,日本:84.4±5.2 岁;<0.001),女性更多(45.9%,68.1%;<0.001),STS 预测死亡率更高(5.27%,6.20%;<0.001)。与美国患者相比,日本患者的 30 天死亡率(1.3%,3.2%;<0.001)和死亡、卒中和出血的复合结局(17.5%,22.5%;<0.001)更低,但中转开胸手术率(0.94%,0.56%;<0.001)更高。
本研究通过使用按共同变量定义编码的国家登记处进行国际比较,证明了美国和日本之间开展合作分析的可行性。尽管日本的 30 天死亡率和主要发病率较低,但两国均获得了良好的结果。通过实践进行协调是建立全球学习以改善患者结局所需的关键步骤之一。