Masanori Yamamoto1, Yusuke Watanabe2, Norio Tada3, Toru Naganuma4, Motoharu Araki5, Futoshi Yamanaka6, Kazuki Mizutani7, Minoru Tabata8, Hiroshi Ueno9, Kensuke Takagi10, Akihiro Higashimori11, Shinichi Shirai12, Kentaro Hayashida13. 1. Department of cardiology, Toyohashi Heart Center, Toyohashi, Japan; Department of cardiology, Nagoya Heart Center, Nagoya, Japan. Electronic address: yamamoto@heart-center.or.jp. 2. Department of cardiology, Teikyo University School of Medicine, Tokyo, Japan. 3. Department of cardiology, Sendai Kosei Hospital, Sendai, Japan. 4. Department of cardiology, New Tokyo Hospital, Chiba, Japan. 5. Department of cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. 6. Department of cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan. 7. Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan. 8. Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa Medical Center, Chiba, Japan. 9. Toyama University Hospital, Toyama, Japan. 10. Ogaki Municipal Hospital, Gifu, Japan. 11. Kishiwada Tokushukai Hospital, Osaka, Japan. 12. Department of cardiology, Kokura Memorial Hospital, Kokura, Japan. 13. Department of cardiology, Keio University School of Medicine, Tokyo, Japan.
Abstract
OBJECTIVES: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. BACKGROUND: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. METHODS: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). RESULTS: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. CONCLUSIONS: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.
OBJECTIVES: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. BACKGROUND: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. METHODS: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). RESULTS: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. CONCLUSIONS: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.
Authors: Neel M Butala; David A Wood; Haiyan Li; Khaja Chinnakondepalli; Sandra B Lauck; Janarthanan Sathananthan; John A Cairns; Elizabeth A Magnuson; Madeleine Barker; John G Webb; Robert Welsh; Anson Cheung; Jian Ye; James L Velianou; Harindra C Wijeysundera; Anita Asgar; Susheel Kodali; Vinod H Thourani; David J Cohen Journal: Circ Cardiovasc Interv Date: 2022-10-18 Impact factor: 7.514