Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT
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 characte...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-03-01
|
| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.121.023848 |
| _version_ | 1797859011080486912 |
|---|---|
| author | Tsuyoshi Kaneko Sreekanth Vemulapalli Shun Kohsaka Kazuo Shimamura Amanda Stebbins Hiraku Kumamaru Adam J. Nelson Andrzej Kosinski Koichi Maeda Joseph E. Bavaria Shigeru Saito Michael J. Reardon Toru Kuratani Jeffrey J. Popma Taku Inohara Vinod H. Thourani John D. Carroll Hideyuki Shimizu Morimasa Takayama Martin B. Leon Michael J. Mack Yoshiki Sawa |
| author_facet | Tsuyoshi Kaneko Sreekanth Vemulapalli Shun Kohsaka Kazuo Shimamura Amanda Stebbins Hiraku Kumamaru Adam J. Nelson Andrzej Kosinski Koichi Maeda Joseph E. Bavaria Shigeru Saito Michael J. Reardon Toru Kuratani Jeffrey J. Popma Taku Inohara Vinod H. Thourani John D. Carroll Hideyuki Shimizu Morimasa Takayama Martin B. Leon Michael J. Mack Yoshiki Sawa |
| author_sort | Tsuyoshi Kaneko |
| collection | DOAJ |
| description | 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; P<0.001), were more frequently women (45.9% versus 68.1%; P<0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P<0.001) than patients in the United States. Japan had lower unadjusted 30‐day mortality (1.3% versus 3.2%; P<0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P<0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P<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. |
| first_indexed | 2024-04-09T21:22:35Z |
| format | Article |
| id | doaj.art-44f5071606a24a2bbb656550c056e6ed |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-09T21:22:35Z |
| publishDate | 2022-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-44f5071606a24a2bbb656550c056e6ed2023-03-28T04:20:50ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802022-03-0111610.1161/JAHA.121.023848Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVTTsuyoshi Kaneko0Sreekanth Vemulapalli1Shun Kohsaka2Kazuo Shimamura3Amanda Stebbins4Hiraku Kumamaru5Adam J. Nelson6Andrzej Kosinski7Koichi Maeda8Joseph E. Bavaria9Shigeru Saito10Michael J. Reardon11Toru Kuratani12Jeffrey J. Popma13Taku Inohara14Vinod H. Thourani15John D. Carroll16Hideyuki Shimizu17Morimasa Takayama18Martin B. Leon19Michael J. Mack20Yoshiki Sawa21Division of Cardiac Surgery Brigham and Women’s Hospital Boston MADuke Clinical Research Institute Durham NCDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiovascular Surgery Osaka University Hospital Osaka JapanDuke Clinical Research Institute Durham NCDepartment of Healthcare Quality Assessment Graduate School of Medicine Faculty of Medicine The University of Tokyo JapanDuke Clinical Research Institute Durham NCDuke Clinical Research Institute Durham NCDepartment of Cardiovascular Surgery Osaka University Graduate School of Medicine Suita City JapanDivision of Cardiac Surgery University of Pennsylvania Philadelphia PADivision of Cardiology Shonan Kamakura Hospital Kamakura JapanDivision of Cardiac Surgery Houston Methodist Hospital Houston TXDepartment of Cardiovascular Surgery Osaka University Hospital Osaka JapanMedtronic Santa Rosa CADuke Clinical Research Institute Durham NCDepartment of Cardiac Surgery Piedmont Heart Institute Atlanta GADivision of Cardiology University of Colorado Aurora CODepartment of Cardiovascular Surgery Keio University School of Medicine Tokyo JapanDepartment of Cardiology Sakakibara Heart Institute Fuchu JapanDivision of Cardiology Columbia University Irving Medical CenterNew York‐Presbyterian Hospital New York NYCardiovascular Service line Baylor Scott & White HealthBaylor Scott & White Research Institute Dallas TXDepartment of Cardiovascular Surgery Osaka University Hospital Osaka JapanBackground 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; P<0.001), were more frequently women (45.9% versus 68.1%; P<0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P<0.001) than patients in the United States. Japan had lower unadjusted 30‐day mortality (1.3% versus 3.2%; P<0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P<0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P<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.https://www.ahajournals.org/doi/10.1161/JAHA.121.023848aortic stenosisbioprosthetic aortic valveTAVR |
| spellingShingle | Tsuyoshi Kaneko Sreekanth Vemulapalli Shun Kohsaka Kazuo Shimamura Amanda Stebbins Hiraku Kumamaru Adam J. Nelson Andrzej Kosinski Koichi Maeda Joseph E. Bavaria Shigeru Saito Michael J. Reardon Toru Kuratani Jeffrey J. Popma Taku Inohara Vinod H. Thourani John D. Carroll Hideyuki Shimizu Morimasa Takayama Martin B. Leon Michael J. Mack Yoshiki Sawa Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease aortic stenosis bioprosthetic aortic valve TAVR |
| title | Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT |
| title_full | Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT |
| title_fullStr | Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT |
| title_full_unstemmed | Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT |
| title_short | Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT |
| title_sort | practice patterns and outcomes of transcatheter aortic valve replacement in the united states and japan a report from joint data harmonization initiative of sts acc tvt and j tvt |
| topic | aortic stenosis bioprosthetic aortic valve TAVR |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.121.023848 |
| work_keys_str_mv | AT tsuyoshikaneko practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT sreekanthvemulapalli practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT shunkohsaka practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT kazuoshimamura practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT amandastebbins practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT hirakukumamaru practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT adamjnelson practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT andrzejkosinski practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT koichimaeda practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT josephebavaria practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT shigerusaito practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT michaeljreardon practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT torukuratani practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT jeffreyjpopma practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT takuinohara practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT vinodhthourani practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT johndcarroll practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT hideyukishimizu practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT morimasatakayama practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT martinbleon practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT michaeljmack practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt AT yoshikisawa practicepatternsandoutcomesoftranscatheteraorticvalvereplacementintheunitedstatesandjapanareportfromjointdataharmonizationinitiativeofstsacctvtandjtvt |