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J Am Coll Cardiol. 2015 Jul 21;66(3):221-228. doi: 10.1016/j.jacc.2015.05.024.

Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients.

Author information

1
Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France.
2
Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris - Hôpital Privé Jacques Cartier, Massy, France. Electronic address: mc.morice@icps.com.fr.
3
Department of Cardiology, CHU de la Cavale Blanche, Brest, France.
4
Department of Cardiology, Columbia University Medical Center and New York Presbyterian Hospital, New York, New York.
5
Department of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
6
Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
7
Department of Cardiology, Ferrarotto Hospital, University of Catania, and the ETNA Foundation, Catania, Italy.
8
Division of Cardiology, Città Della Salute e Della Scienza, University of Turin, Turin, Italy.
9
Division of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom.
10
Department of Cardiology, Queen Elizabeth Hospital, University of Birmingham, Birmingham, United Kingdom.

Abstract

BACKGROUND:

There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement.

OBJECTIVES:

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.

KEYWORDS:

aortic stenosis; gender; transcatheter aortic valve implantation; transcatheter aortic valve replacement

PMID:
26184614
DOI:
10.1016/j.jacc.2015.05.024
[Indexed for MEDLINE]
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