Aortic valve replacement, using either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) approaches appear to be similarly effective for males and females at intermediate surgical risk, a post-hoc analysis of the randomised SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial has concluded. The analysis, which was conducted by Nicolas van Mieghem (Erasmus University Medical Centre, Rotterdam, The Netherlands) and colleagues, was published online ahead of print in EuroIntervention.
van Mieghem and colleagues note that female sex is a risk factor for mortality after surgical valve replacement according to the Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) calculator, and add that in previous studies TAVI appeared to have a favourable efficacy and safety profile compared to SAVR, particularly in females at high operative risk. Through the analysis, they sought to identify sex-specific differences in outcome for patients at intermediate surgical risk in the international SURTAVI trial, which saw 1,746 patients with symptomatic, severe aortic stenosis randomised in a 1:1 ratio to TAVI with a self-expanding valve (CoreValve or Evolut R device) or surgical valve replacement.
Outcomes were analysed for 1,660 intermediate-risk patients (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438), with the primary endpoint defined as a composite of all-cause mortality or disabling stroke at two years. Compared to males, Van Mieghem et al find that females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs. 4.3±1.6%, p<0.01) and more frailty. Men required more concomitant revascularization (23% vs. 16%), they noted. All-cause mortality or disabling stroke at two years was similar between TAVI and surgical valve replacement for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs. 14.4%, p=0.99); the difference between females and males was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI for females than males, they noted.
Discussing the findings, van Mieghem et al note that there are no sex-specific differences in the two-year rate of all-cause death or disabling stroke in elderly patients after TAVI using a self-expanding or surgical valve replacement. Furthermore, concomitant coronary revascularization is found to be more common in men with more comorbidities than females who are frailer, whilst females had more TAVI procedure-related complications than males without any early or late survival penalty. And, functional capacity improves more quickly with TAVI than surgical valve replacement in both sexes with a greater incremental improvement in females at 30 days and one year, the study finds. Additionally, rehospitalisation for valve or heart failure related symptoms after TAVI was more frequent in males than in females, and was more frequent compared to surgery only in men.
In conclusion, the paper notes: “Aortic valve replacement, either by surgical or transcatheter approach, is equally effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI.”