title: Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry.
abstract: 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.
  
  
  
  Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined.
  
  
  
  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).
  
  
  
  Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 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 endpoint were 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).
  
  
  
  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.
authors: Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy.
authors: Alaide
authors: A
authors: Chieffo
authors: Department of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy.
authors: Anna Sonia
authors: AS
authors: Petronio
authors: Department of Cardiology, Ludwig-Maximilians-University of Munich, Munich, Germany.
authors: Julinda
authors: J
authors: Mehilli
authors: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Jaya
authors: J
authors: Chandrasekhar
authors: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Samantha
authors: S
authors: Sartori
authors: Department of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France.
authors: Thierry
authors: T
authors: Lefèvre
authors: Department of Cardiology, Istituto Clinico Humanitas; Milan, Italy.
authors: Patrizia
authors: P
authors: Presbitero
authors: Department of Cardiology, University of Catania, Catania, Italy.
authors: Piera
authors: P
authors: Capranzano
authors: Department of Cardiology, Clinique Pasteur, Toulouse, France.
authors: Didier
authors: D
authors: Tchetche
authors: Department of Cardiology, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy.
authors: Alessandro
authors: A
authors: Iadanza
authors: Department of Cardiology, Policlinico "Umberto I", "Sapienza" University of Rome, Rome, Italy.
authors: Gennaro
authors: G
authors: Sardella
authors: Department of Cardiology, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands.
authors: Nicolas M
authors: NM
authors: Van Mieghem
authors: Department of Cardiology, Mauriziano Hospital, Turin, Italy.
authors: Emanuele
authors: E
authors: Meliga
authors: Department of Cardiology, Rangueil University Hospital, Toulouse, France.
authors: Nicholas
authors: N
authors: Dumonteil
authors: Department of Cardiology, University of Padova, Padova, Italy.
authors: Chiara
authors: C
authors: Fraccaro
authors: Department of Cardiology, Centro Cardiologico Monzino, Milan, Italy.
authors: Daniela
authors: D
authors: Trabattoni
authors: Department of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom.
authors: Ghada W
authors: GW
authors: Mikhail
authors: Department of Cardiology, Mount Sinai Hospital, New York, New York.
authors: Samin
authors: S
authors: Sharma
authors: Department of Cardiology, Hospital Universitario Miguel Servet, Zaragoza, Spain.
authors: Maria Cruz
authors: MC
authors: Ferrer
authors: Department of Cardiology, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany.
authors: Christoph
authors: C
authors: Naber
authors: Department of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands.
authors: Peter
authors: P
authors: Kievit
authors: Department of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Michela
authors: M
authors: Faggioni
authors: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Clayton
authors: C
authors: Snyder
authors: Department of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France.
authors: Marie Claude
authors: MC
authors: Morice
authors: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.
authors: Roxana
authors: R
authors: Mehran
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D016009:Chi-Square Distribution; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D015999:Multivariate Analysis; D009656:North America; D016017:Odds Ratio; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000401:mortality; D016896:Treatment Outcome
keywords: early outcomes; first female registry; mortality; transcatheter aortic valve replacement