Gender-Specific Outcomes in TAVI with Self-Expandable Valves: Insights from a Large Real-World Registry.

Background/Objectives: Aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and imposes an increasing burden on aging populations. Although transcatheter aortic valve implantation (TAVI) has transformed the treatment of severe AS, current guidelines do not differentiate management based on gender. This study aimed to investigate gender-based differences in procedural complications and one-year clinical outcomes in patients treated with next-generation self-expandable TAVI devices. Methods: This retrospective, multicenter international registry included 3862 consecutive patients who received either the ACURATE neo or Evolut R/Pro valve. Patients were stratified by gender; propensity score matching (PSM) adjusted for baseline differences. The primary endpoint was a composite of all-cause mortality or stroke at one year. Secondary endpoints included major vascular complications, major or life-threatening bleeding and acute kidney injury (AKI). Results: Of 3353 patients included (64.5% female), women were older (82.3 ± 5.6 vs. 81.1 ± 6.2 years, p < 0.001) and had higher STS scores (5.2 ± 3.9 vs. 4.5 ± 3.4%, p < 0.001). In the unmatched population, major vascular complications occurred in 7.7% of females versus 4.1% of males (p < 0.001), life-threatening bleeding in 2.8% vs. 1.4% (p = 0.016) and AKI in 8.5% vs. 5.7% (p = 0.009). After PSM, the primary endpoint was more frequent in females (9.4% vs. 6.0%, p = 0.014), largely driven by stroke (2.8% vs. 1.2%, p = 0.024), while overall mortality was similar (11.3% vs. 9.5%, p = 0.264). Conclusions: Despite comparable long-term survival, female patients undergoing TAVI with self-expandable valves experience higher rates of procedural complications, notably stroke and major vascular events. These findings underscore the need for tailored procedural strategies to improve outcomes in female patients.