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 a...

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Veröffentlicht in:	JACC. Cardiovascular interventions 2016-05, Vol.9 (9), p.926-933
Hauptverfasser:	Yoon, Sung-Han, MD, Ahn, Jung-Min, MD, Hayashida, Kentaro, MD, PhD, Watanabe, Yusuke, MD, PhD, Shirai, Shinichi, MD, Kao, Hsien-Li, MD, Yin, Wei-Hsian, MD, Lee, Michael Kang-yin, MD, Tay, Edgar, MD, Araki, Motoharu, MD, Yamanaka, Futoshi, MD, Arai, Takahide, MD, Lin, Mao-Shin, MD, Park, Jun-Bean, MD, Park, Duk-Woo, MD, PhD, Kang, Soo-Jin, MD, PhD, Lee, Seung-Whan, MD, PhD, Kim, Young-Hak, MD, PhD, Lee, Cheol Whan, MD, PhD, Park, Seong-Wook, MD, PhD, Muramatsu, Toshiya, MD, Hanyu, Michiya, MD, PhD, Kozuma, Ken, MD, Kim, Hyo-Soo, MD, PhD, Saito, Shigeru, MD, Park, Seung-Jung, MD, PhD
Format:	Artikel
Sprache:	eng
Schlagworte:	Aged Aged, 80 and over aortic stenosis Aortic Valve Stenosis - diagnostic imaging Aortic Valve Stenosis - ethnology Aortic Valve Stenosis - mortality Aortic Valve Stenosis - surgery Asia Asia - epidemiology Asian Continental Ancestry Group Cardiovascular Chi-Square Distribution Female Heart Valve Prosthesis Humans Kaplan-Meier Estimate Male Multivariate Analysis Postoperative Complications - ethnology Proportional Hazards Models Prospective Studies Prosthesis Design Registries Risk Assessment Risk Factors Time Factors transcatheter aortic valve replacement Transcatheter Aortic Valve Replacement - adverse effects Transcatheter Aortic Valve Replacement - instrumentation Transcatheter Aortic Valve Replacement - mortality Treatment Outcome
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Zusammenfassung:	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 )
ISSN:	1936-8798 1876-7605
DOI:	10.1016/j.jcin.2016.01.047