Abstract
Background: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort. Methods: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics. Results: Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, p < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001) but had less previous cardiovascular events (all p < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, p < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, p < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, p < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, p = 0.012 and 2.5% vs. 1.4%, p = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, p = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18–1.82, p < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21–1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching. Conclusion: Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.
Highlights
Transcatheter aortic valve replacement (TAVR) has been proven to be an effective treatment for inoperable, high, intermediate, and even low-risk symptomatic severe aortic stenosis (AS) [1,2,3,4,5,6,7]
Women were older (83 ± 6 vs. 81 ± 6, p < 0.001), with higher prevalence of severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001)
AS compared with males, clearly statistically significant at 1- and 3-year; (2) a significant reduced rate of MACCE according to female sex at 1- and 3-year, a higher numerical increase in stroke/TIA in women; (3) diabetes mellitus (DM) and peripheral artery disease (PAD), beyond male sex, remained significant predictors of death and major vascular complications, respectively; and (4) a preserved renal function, defined by eGFR > 60 mL/min, represents one of the most important predictors of survival
Summary
Transcatheter aortic valve replacement (TAVR) has been proven to be an effective treatment for inoperable, high-, intermediate-, and even low-risk symptomatic severe aortic stenosis (AS) [1,2,3,4,5,6,7]. Despite the fact that several studies have explored female-specific factors in TAVR and their association with protection from future cardiovascular events, the results are still debated [11,12] The understanding of these risk differences is essential to better individualize TAVR treatment and to investigate whether female sex–specific characteristics contribute to TAVR outcomes. Three-year mortality was significantly lower in women compared with men (19.8% vs 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21–1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching. Conclusion: Despite higher rates of peri-procedural complications, women presented better survival than men
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