Gender Equality and TAVR Outcomes

Jul 13, 2015
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Authors:
O’Connor SA, Morice MC, Gilard M, et al.
Citation:
Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients. J Am Coll Cardiol 2015;66:221-228.
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the impact of gender on early and late mortality and safety endpoints after transcatheter aortic valve replacement (TAVR)?

Methods:

The authors obtained data from five studies using the Medline, EMBASE, and Cochrane library databases, and a database containing individual patient-level time-to-event data was generated from the registries of each selected study. The primary outcome of interest was all-cause mortality. The safety endpoint was the combined 30-day safety endpoints of major vascular complications, bleeds, and stroke, as defined by the Valve Academic Research Consortium where available.

Results:

A total of 11,310 patients were included from the five studies and their ongoing registry data. Women comprised 48.6% of the cohort and had less comorbidities than men. Women had a higher rate of major vascular complications (6.3% vs. 3.4%, p < 0.001), major bleeding (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 was no difference in procedural or 30-day mortality between women and men (2.6 % vs. 2.2%, p = 0.24 and 6.5% vs. 6.5%, p = 0.93), but female sex was independently associated with improved survival at median follow-up of 387 days (interquartile range, 192-730 days) from the index procedure (adjusted hazard ratio, 0.79; 95% confidence interval, 0.73-0.86; p = 0.001).

Conclusions:

The authors concluded that female gender is an independent predictor of late survival after TAVR.

Perspective:

This patient-level pooled meta-analysis reports that female sex was associated with survival advantage over male patients even after adjustment for baseline demographic and clinical factors and valve type. There was, however, no difference observed between males and females with respect to 30-day mortality despite women having a higher rate of major vascular, bleeding, and stroke events. If future prospective studies confirm that conventional surgery has worse outcomes in women than in men, these findings may have significant implications for future patient selection for TAVR.

Keywords: Aortic Valve Insufficiency, Cardiac Surgical Procedures, Comorbidity, Female, Heart Valve Diseases, Incidence, Registries, Stroke, Transcatheter Aortic Valve Replacement


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