Bridging the gender gap in TAVI: real-world evidence from a single-centre study

Background Women are commonly underrepresented in clinical trials, raising concerns about the applicability of data to the female population. In this analysis, we sought to address whether the results observed in clinical trials align with real-world practice and whether women face distinct challenges or benefits following TAVI compared to men. Methods This retrospective analysis assessed 300 TAVI patients from a single centre, without surgical backup. We aimed to assess in-hospital outcomes: periprosthetic leak, high-grade atrioventricular block, vascular and haemorrhagic complications, stroke, acute kidney injury, and death within 7 days. At 1 year follow-up (FUP) outcomes were cardiovascular death, readmission for cardiovascular causes, and clinical improvement following TAVI. Results From a total of 300 patients undergoing TAVI, 139 were male and 161 were women. Regarding baseline characteristics, women were older than men. Diabetes was more prevalent in men, as was current smoking. Men had a higher prevalence of coronary artery disease (CAD), previous PCI and previous CABG. Renal dysfunction was more common in women. About clinical presentation, women had higher risk scores, higher mean aortic valve gradients, lower aortic valve area, higher left ventricular ejection fraction and higher median calcium score. Men and women had no significant differences in in-hospital complications, except for acute kidney injury more frequent in women. At 1-year follow-up, no significant differences were found according to sex concerning cardiovascular death, readmissions due to cardiovascular causes, or clinical improvement (p > 0.05 for all). Conclusions In contrast to clinical trials, women were well-represented in our study population. Women tended to present with more severe valvular disease and higher surgical risk scores compared to men. However, men exhibited a higher prevalence of comorbidities such as coronary artery disease and previous revascularization procedures (PCI and CABG). Despite these baseline differences, no significant disparities were observed between genders in most in-hospital complications and 1-year follow-up outcomes, except for acute kidney injury, which was more frequent in women. This suggests that, despite their higher initial surgical risk, women achieve similar clinical outcomes to men after TAVI.