Acute and 30-Day Outcomes in Women After TAVR Results From the WIN-TAVI (Women%26apos;s INternational Transcatheter Aortic Valve Implantation) Real-World Registry

作者：Chieffo Alaide; Petronio Anna Sonia; Mehilli Julinda; Chandrasekhar Jaya; Sartori Samantha; Lefevre Thierry; Pre**itero Patrizia; Capranzano Piera; Tchetche Didier; Iadanza Alessandro; Sardella Gennaro; Van Mieghem Nicolas M; 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

来源：JACC: Cardiovascular Interventions , 2016, 9(15): 1589-1600.

DOI：10.1016/j.jcin.2016.05.015

• early outcomes
• first female registry
• mortality
• transcatheter aortic valve replacement

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.

• 出版日期2016-8-8