Yasuaki Takeji1, Tomohiko Taniguchi2, Takeshi Morimoto3, Naritatsu Saito1, Kenji Ando2, Shinichi Shirai2, Genichi Sakaguchi4, Yoshio Arai4, Yasushi Fuku5, Yuichi Kawase5, Tatsuhiko Komiya6, Natsuhiko Ehara7, Takeshi Kitai7, Tadaaki Koyama8, Shin Watanabe1, Hirotoshi Watanabe1, Hiroki Shiomi1, Eri Minamino-Muta1, Shintaro Matsuda1, Hidenori Yaku1, Yusuke Yoshikawa1, Kazuhiro Yamazaki9, Masahide Kawatou9, Kazuhisa Sakamoto9, Toshihiro Tamura10, Makoto Miyake10, Hisashi Sakaguchi11, Koichiro Murata12, Masanao Nakai13, Norio Kanamori14, Chisato Izumi15, Hirokazu Mitsuoka16, Masashi Kato17, Yutaka Hirano18, Tsukasa Inada19, Kazuya Nagao19, Hiroshi Mabuchi20, Yasuyo Takeuchi21, Keiichiro Yamane22, Takashi Tamura23, Mamoru Toyofuku23, Mitsuru Ishii24, Moriaki Inoko25, Tomoyuki Ikeda26, Katsuhisa Ishii27, Kozo Hotta28, Toshikazu Jinnai29, Nobuya Higashitani29, Yoshihiro Kato30, Yasutaka Inuzuka31, Yuko Morikami32, Kenji Minatoya9, Takeshi Kimura1. 1. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University. 2. Division of Cardiology, Kokura Memorial Hospital. 3. Department of Clinical Epidemiology, Hyogo College of Medicine. 4. Division of Cardiovascular Surgery, Kokura Memorial Hospital. 5. Department of Cardiology, Kurashiki Central Hospital. 6. Department of Cardiovascular Surgery, Kurashiki Central Hospital. 7. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital. 8. Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital. 9. Department of Cardiovascular Surgery, Graduate School of Medicine, Kyoto University. 10. Department of Cardiology, Tenri Hospital. 11. Department of Cardiovascular Surgery, Tenri Hospital. 12. Department of Cardiology, Shizuoka City Shizuoka Hospital. 13. Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital. 14. Division of Cardiology, Shimada Municipal Hospital. 15. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center. 16. Division of Cardiology, Nara Hospital, Kindai University Faculty of Medicine. 17. Department of Cardiology, Mitsubishi Kyoto Hospital. 18. Department of Cardiology, Kindai University Hospital. 19. Department of Cardiovascular Center, Osaka Red Cross Hospital. 20. Department of Cardiology, Koto Memorial Hospital. 21. Department of Cardiology, Shizuoka General Hospital. 22. Department of Cardiology, Nishikobe Medical Center. 23. Department of Cardiology, Japanese Red Cross Wakayama Medical Center. 24. Department of Cardiology, National Hospital Organization Kyoto Medical Center. 25. Cardiovascular Center, The Tazuke Kofukai Medical Research Institute, Kitano Hospital. 26. Department of Cardiology, Hikone Municipal Hospital. 27. Department of Cardiology, Kansai Electric Power Hospital. 28. Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center. 29. Department of Cardiology, Japanese Red Cross Otsu Hospital. 30. Department of Cardiology, Saiseikai Noe Hospital. 31. Department of Cardiology, Shiga Medical Center for Adults. 32. Department of Cardiology, Hirakata Kohsai Hospital.
Abstract
BACKGROUND: There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. METHODS AND RESULTS: We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). CONCLUSIONS: These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.
BACKGROUND: There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. METHODS AND RESULTS: We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). CONCLUSIONS: These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.