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Chieffo, Alaide; Petronio, Anna Sonia; Mehilli, Julinda; Chandrasekhar, Jaya; Sartori, Samantha; Lefèvre, Thierry; Presbitero, Patrizia; Capranzano, Piera; Tchetche, Didier; Iadanza, Alessandro; Sardella, Gennaro; Mieghem, Nicolas M. van; Meliga, Emanuele; Dumonteil, Nicholas; Fraccaro, Chiara; Trabattoni, Daniela; Mikhail, Ghada W.; Sharma, Samin; Ferrer, Maria Cruz; Naber, Christoph; Kievit, Peter; Faggioni, Michela; Snyder, Clayton; Morice, Marie Claude; Mehran, Roxana (2016): Acute and 30-Day Outcomes in Women After TAVR Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry. In: Journal of the American College of Cardiology (Jacc): Cardiovascular interventions, Vol. 9, No. 15: pp. 1589-1600
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Abstract

OBJECTIVES The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. BACKGROUND Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. METHODS The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). RESULTS Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. Themean patient agewas 82.5 + 6.3 years, meanEuroSCOREI was 17.8 + 11.7% and mean Society of Thoracic Surgeons scorewas 8.3 +/- 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm(Edwards Lifesciences, Irvine, California) or Medtronic CoreValve <= 26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpointwere age (odds ratio [OR]: 1.04;95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02;95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62;95% CI: 1.07 to 6.40), new device generation (OR: 0.59;95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57;95% CI: 0.37 to 0.85). CONCLUSIONS Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy. (C) 2016 by the American College of Cardiology Foundation.