title: Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients.
abstract: BACKGROUND
  There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the impact of sex on early and late mortality and safety end points after transcatheter aortic valve replacement using a collaborative meta-analysis of patient-level data.
  
  
  METHODS
  From the MEDLINE, Embase, and the Cochrane Library databases, data were obtained from 5 studies, and a database containing individual patient-level time-to-event data was generated from the registry of each selected study. The primary outcome of interest was all-cause mortality. The safety end point was the combined 30-day safety end points of major vascular complications, bleeding events, and stroke, as defined by the Valve Academic Research Consortium when available.
  
  
  RESULTS
  Five studies and their ongoing registry data, comprising 11,310 patients, were included. Women constituted 48.6% of the cohort and had fewer comorbidities than men. Women had a higher rate of major vascular complications (6.3% vs. 3.4%; p < 0.001), major bleeding events (10.5% vs. 8.5%; p = 0.003), and stroke (4.4% vs. 3.6%; p = 0.029) but a lower rate of significant aortic incompetence (grade ≥2; 19.4% vs. 24.5%; p < 0.001). There were no differences in procedural and 30-day mortality between women and men (2.6 % vs. 2.2% [p = 0.24] and 6.5% vs. 6.5% [p = 0.93], respectively), but female sex was independently associated with improved survival at median follow-up of 387 days (interquartile range: 192 to 730 days) from the index procedure (adjusted hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p = 0.001).
  
  
  CONCLUSIONS
  Although women experience more bleeding events, as well as vascular and stroke complications, female sex is an independent predictor of late survival after transcatheter aortic valve replacement. This should be taken into account during patient selection for this procedure.
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: O'Connor
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France. Electronic address: mc.morice@icps.com.fr.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Department of Cardiology, CHU de la Cavale Blanche, Brest, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Department of Cardiology, Columbia University Medical Center and New York Presbyterian Hospital, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Department of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Department of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.affiliation: Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, University of Catania, and the ETNA Foundation, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, University of Catania, and the ETNA Foundation, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.affiliation: Division of Cardiology, Città Della Salute e Della Scienza, University of Turin, Turin, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: D'Ascenzo
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Garot
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Division of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom.
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.affiliation: Department of Cardiology, Queen Elizabeth Hospital, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Ludman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery; D005260:Female; D006350:Heart Valve Prosthesis; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D011183:Postoperative Complications / Q000453:epidemiology*; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology; D016019:Survival Analysis; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods / Q000401:mortality
keywords: aortic stenosis; gender; transcatheter aortic valve implantation; transcatheter aortic valve replacement