Impact of Baseline Left Ventricular Ejection Fraction on Midterm Outcomes in Women Undergoing Transcatheter Aortic Valve Implantation: Insight from the WIN-TAVI Registry

Abstract

Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group.