Sung-Han Yoon1, Jung-Min Ahn1, Kentaro Hayashida2, Yusuke Watanabe3, Shinichi Shirai4, Hsien-Li Kao5, Wei-Hsian Yin6, Michael Kang-Yin Lee7, Edgar Tay8, Motoharu Araki9, Futoshi Yamanaka10, Takahide Arai2, Mao-Shin Lin5, Jun-Bean Park11, Duk-Woo Park1, Soo-Jin Kang1, Seung-Whan Lee1, Young-Hak Kim1, Cheol Whan Lee1, Seong-Wook Park1, Toshiya Muramatsu9, Michiya Hanyu12, Ken Kozuma3, Hyo-Soo Kim11, Shigeru Saito10, Seung-Jung Park13. 1. Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. 2. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. 3. Division of Cardiology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan. 4. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. 5. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 6. Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan. 7. Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong. 8. Department of Cardiology, National University Heart Centre, Singapore. 9. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan. 10. Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan. 11. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea. 12. Department of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan. 13. Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. Electronic address: sjpark@amc.seoul.kr.
Abstract
OBJECTIVES: This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes. BACKGROUND: No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population. METHODS: The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries. RESULTS: In total, 848 patients with mean STS score of 5.2 ± 3.8% were enrolled between March 2010 and September 2014 at 11 centers in 5 countries. The Edwards Sapien or Medtronic CoreValve was implanted in 64.7% and 35.3% of patients, respectively. The procedural success rate was 97.5%. The 30-day and 1-year mortality rates were 2.5% and 10.8%, respectively. There was no difference in 1-year mortality between devices (Sapien: 9.4%; CoreValve: 12.2%; log-rank p = 0.40). The rates of stroke, life-threatening bleeding, major vascular complications and acute kidney injury (stage 2 to 3) were 3.8%, 6.4%, 5.0% and 3.3%, respectively. Moderate or severe paravalvular leakage was significantly more common with the CoreValve than Sapien (14.4% vs. 7.3%; p = 0.001). According to the multivariate model, a higher STS score, lower body mass index, New York Heart Association functional class III-IV symptoms, diabetes mellitus, prior cerebrovascular accident, low mean gradient at baseline, and moderate or severe paravalvular leakage were significantly associated with reduced survival. CONCLUSIONS: Despite anatomical features of concern, the clinical outcomes of TAVR in our Asian population were favorable in comparison with those of previously published trials and observational studies. (The Asian Transcatheter Aortic Valve Replacement Registry [Asian TAVR]; NCT02308150).
OBJECTIVES: This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes. BACKGROUND: No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population. METHODS: The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries. RESULTS: In total, 848 patients with mean STS score of 5.2 ± 3.8% were enrolled between March 2010 and September 2014 at 11 centers in 5 countries. The Edwards Sapien or Medtronic CoreValve was implanted in 64.7% and 35.3% of patients, respectively. The procedural success rate was 97.5%. The 30-day and 1-year mortality rates were 2.5% and 10.8%, respectively. There was no difference in 1-year mortality between devices (Sapien: 9.4%; CoreValve: 12.2%; log-rank p = 0.40). The rates of stroke, life-threatening bleeding, major vascular complications and acute kidney injury (stage 2 to 3) were 3.8%, 6.4%, 5.0% and 3.3%, respectively. Moderate or severe paravalvular leakage was significantly more common with the CoreValve than Sapien (14.4% vs. 7.3%; p = 0.001). According to the multivariate model, a higher STS score, lower body mass index, New York Heart Association functional class III-IV symptoms, diabetes mellitus, prior cerebrovascular accident, low mean gradient at baseline, and moderate or severe paravalvular leakage were significantly associated with reduced survival. CONCLUSIONS: Despite anatomical features of concern, the clinical outcomes of TAVR in our Asian population were favorable in comparison with those of previously published trials and observational studies. (The Asian Transcatheter Aortic Valve Replacement Registry [Asian TAVR]; NCT02308150).
Authors: Tian-Yuan Xiong; Walid Ben Ali; Yuan Feng; Kentaro Hayashida; Hasan Jilaihawi; Azeem Latib; Michael Kang-Yin Lee; Martin B Leon; Raj R Makkar; Thomas Modine; Christoph Naber; Yong Peng; Nicolo Piazza; Michael J Reardon; Simon Redwood; Ashok Seth; Lars Sondergaard; Edgar Tay; Didier Tchetche; Wei-Hsian Yin; Mao Chen; Bernard Prendergast; Darren Mylotte Journal: Nat Rev Cardiol Date: 2022-06-20 Impact factor: 32.419
Authors: Edgar Tay; Thet Khaing; Wei Hsian Yin; Enrique Fabio Posas; Paul Hsien-Li Kao; Wacin Buddhari; Kentaro Hayashida; Kay Woon Ho; Mao Shin Lin; Jonathan Yap; Jun Jie Zhang; Paul Tonn Lim Chiam; Mohd Ali Rosli; Seung-Jung Park; Wasan Udayacherm; Ryo Yanagisawa; Huay Cheem Tan; Michael K Y Lee Journal: AsiaIntervention Date: 2021-07