1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry

doi:10.1016/j.jcin.2017.09.034

JACC: Cardiovascular Interventions

Volume 11, Issue 1, 8 January 2018, Pages 1-12

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Abstract

Objectives

This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex–specific characteristics on composite 1-year clinical outcomes.

Background

Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex.

Methods

The WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods.

Results

A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.027) were independent predictors of the VARC-2 efficacy endpoint. Similarly, EuroSCORE I (HR: 1.02; 95% CI: 1.00 to 1.04; p = 0.013), baseline atrial fibrillation (HR: 1.58; 95% CI: 1.07 to 2.33; p = 0.022), and prior percutaneous coronary intervention (HR: 1.50; 95% CI: 1.03 to 2.19; p = 0.035) were independent predictors of 1-year death or stroke. After adjustment, no significant association was observed between history of pregnancy or any sex-specific factors and 1-year TAVR outcomes.

Conclusions

Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.

Graphical abstract

Key Words

female-specific characteristics

first female registry

transcatheter aortic valve replacement

1-year outcomes

Abbreviations and Acronyms

atrial fibrillation

aortic insufficiency

aortic stenosis

CAD

coronary artery disease

confidence interval

DAPT

dual-antiplatelet therapy

EuroSCORE

European System for Cardiac Operative Risk Evaluation

hazard ratio

LVEF

left ventricular ejection fraction

PCI

percutaneous coronary intervention

SAVR

surgical aortic valve replacement

TAVR

transcatheter aortic valve replacement

VARC

Valve Academic Research Consortium

Cited by (0)

: Dr. Petronio has served as a consultant for Boston Scientific, Medtronic, and Abbott Vascular. Dr. Mehilli has received lecture fees from Edwards Lifesciences, Abbott Vascular, Biotronik, Lilly/Daiichi-Sankyo, Terumo, and Bristol-Myers Squibb; and institutional research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Lefèvre has served as a proctor for Edwards Lifesciences. Dr. Sardella has received proctor fees for Edwards Lifesciences; and speaker fees from Direct Flow. Dr. Van Mieghem has received research grant support from Boston Scientific, Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Claret Medical. Dr. Dumonteil has received proctor fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular. Dr. Mikhail is the director of the Imperial Valve and Cardiovascular Course. Dr. S. Sharma has served on the Speakers Bureau for Boston Scientific, Abbott Vascular, Cardiovascular Systems Inc., and TriReme. Dr. Naber has received speaker fees from Edwards Lifesciences, Direct Flow Medical, Medtronic, and Claret; is a minor shareholder with Claret; and has served as an advisor for Direct Flow Medical. Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo Inc., AstraZeneca, The Medicines Company, Bristol-Myers Squibb, OrbusNeich, Beth Israel Deaconess, and Bayer; has served as a consultant for Boston Scientific, Cardiovascular Systems Inc., Medscape, and Shanghai BraccoSine Pharmaceutical; has received institutional advisory board funding from Bristol-Myers Squibb; has received institutional funding from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the data safety monitoring board for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and the Medicines Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.