title: Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population.
abstract: This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes.
  
  
  
  No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population.
  
  
  
  The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries.
  
  
  
  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.
  
  
  
  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.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Sung-Han
authors.initials: SH
authors.lastname: Yoon
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Jung-Min
authors.initials: JM
authors.lastname: Ahn
authors.affiliation: Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Hayashida
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Watanabe
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Shirai
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Hsien-Li
authors.initials: HL
authors.lastname: Kao
authors.affiliation: Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
authors.forename: Wei-Hsian
authors.initials: WH
authors.lastname: Yin
authors.affiliation: Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.
authors.forename: Michael Kang-Yin
authors.initials: MK
authors.lastname: Lee
authors.affiliation: Department of Cardiology, National University Heart Centre, Singapore.
authors.forename: Edgar
authors.initials: E
authors.lastname: Tay
authors.affiliation: Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan.
authors.forename: Motoharu
authors.initials: M
authors.lastname: Araki
authors.affiliation: Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Yamanaka
authors.affiliation: Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Takahide
authors.initials: T
authors.lastname: Arai
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Mao-Shin
authors.initials: MS
authors.lastname: Lin
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
authors.forename: Jun-Bean
authors.initials: JB
authors.lastname: Park
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Duk-Woo
authors.initials: DW
authors.lastname: Park
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Soo-Jin
authors.initials: SJ
authors.lastname: Kang
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Seung-Whan
authors.initials: SW
authors.lastname: Lee
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
authors.forename: Seong-Wook
authors.initials: SW
authors.lastname: Park
authors.affiliation: Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan.
authors.forename: Toshiya
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Department of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan.
authors.forename: Michiya
authors.initials: M
authors.lastname: Hanyu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.affiliation: Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. Electronic address: sjpark@amc.seoul.kr.
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000208:ethnology / Q000401:mortality / Q000601:surgery*; D001208:Asia / Q000453:epidemiology; D044466:Asian People; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000208:ethnology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D016896:Treatment Outcome
keywords: Asia; aortic stenosis; transcatheter aortic valve replacement