Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population

Asian TAVR Investigators

Research output: Contribution to journalArticle

28 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)926-933
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number9
DOIs
Publication statusPublished - 2016 May 9

Fingerprint

Population
Registries
Observational Studies
Stroke
Mortality
Aortic Valve Stenosis
Acute Kidney Injury
Multicenter Studies
Blood Vessels
Transcatheter Aortic Valve Replacement
Diabetes Mellitus
Body Mass Index
Hemorrhage
Safety
Equipment and Supplies
Survival

Keywords

  • aortic stenosis
  • Asia
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. / Asian TAVR Investigators.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 9, 09.05.2016, p. 926-933.

Research output: Contribution to journalArticle

@article{d8b84eec3197442d92ffea8fe953ac83,
title = "Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population",
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).",
keywords = "aortic stenosis, Asia, transcatheter aortic valve replacement",
author = "{Asian TAVR Investigators} and Yoon, {Sung Han} and Ahn, {Jung Min} and Kentaro Hayashida and Yusuke Watanabe and Shinichi Shirai and Kao, {Hsien Li} and Yin, {Wei Hsian} and Lee, {Michael Kang Yin} and Edgar Tay and Motoharu Araki and Futoshi Yamanaka and Takahide Arai and Lin, {Mao Shin} and Park, {Jun Bean} and Park, {Duk Woo} and Kang, {Soo Jin} and Lee, {Seung Whan} and Kim, {Young Hak} and Lee, {Cheol Whan} and Park, {Seong Wook} and Toshiya Muramatsu and Michiya Hanyu and Ken Kozuma and Kim, {Hyo Soo} and Shigeru Saito and Park, {Seung Jung}",
year = "2016",
month = "5",
day = "9",
doi = "10.1016/j.jcin.2016.01.047",
language = "English",
volume = "9",
pages = "926--933",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "9",

}

TY - JOUR

T1 - Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population

AU - Asian TAVR Investigators

AU - Yoon, Sung Han

AU - Ahn, Jung Min

AU - Hayashida, Kentaro

AU - Watanabe, Yusuke

AU - Shirai, Shinichi

AU - Kao, Hsien Li

AU - Yin, Wei Hsian

AU - Lee, Michael Kang Yin

AU - Tay, Edgar

AU - Araki, Motoharu

AU - Yamanaka, Futoshi

AU - Arai, Takahide

AU - Lin, Mao Shin

AU - Park, Jun Bean

AU - Park, Duk Woo

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Kim, Young Hak

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Muramatsu, Toshiya

AU - Hanyu, Michiya

AU - Kozuma, Ken

AU - Kim, Hyo Soo

AU - Saito, Shigeru

AU - Park, Seung Jung

PY - 2016/5/9

Y1 - 2016/5/9

N2 - 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).

AB - 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).

KW - aortic stenosis

KW - Asia

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=84965161686&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84965161686&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2016.01.047

DO - 10.1016/j.jcin.2016.01.047

M3 - Article

C2 - 27151607

AN - SCOPUS:84965161686

VL - 9

SP - 926

EP - 933

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 9

ER -