Clinical Outcomes According to the Extent of Atherosclerotic Disease in Female Patients Undergoing Transcatheter Aortic Valve Replacement: An Analysis From the WIN-TAVI Registry.

Abstract

Background: Limited data exist on the impact of polyvascular disease (PolyVD) on clinical outcomes in female patients undergoing transcatheter aortic valve replacement (TAVR). We therefore sought to investigate clinical outcomes in women with versus without PolyVD undergoing TAVR.

Methods: Female participants from the multicentre Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized based on the presence or absence of PolyVD. The PolyVD population was defined as the presence of atherosclerotic disease affecting ≥ 2 arterial systems from coronary, cerebral, or lower limb peripheral vessels, whilst patients with either no atherosclerosis or atherosclerotic disease in one vascular system were included in the non-PolyVD population. The primary endpoint was the Valve Academic Research Consortium-2 consensus (VARC-2) efficacy endpoint at 1 year, whilst secondary endpoints included VARC-2 safety events, VARC-2 major bleeding and major vascular complications. Cox regression analysis were computed adjusting for various cofounders.

Results: Among 996 participants, 543 (54.5%) had PolyVD, while 453 (45.5%) did not. Across the subgroups no differences in age was noted, whilst patients with PolyVD were more likely to have a history of hypercholesterolemia and a previous cardiac surgery. The incidence of the primary endpoint was higher in the PolyVD group (19.4%) compared to the non-PolyVD group (13.3%, p_log-rank = 0.014), though the difference was attenuated after multivariable adjustments (p = 0.093). Of note, no statistically significant differences concerning incident VARC-2 safety events, VARC-2 major bleeding and major vascular complications were noted according to PolyVD status.

Conclusion: PolyVD is a common comorbidity and is associated with elevated rates of adverse clinical events, but no increase in safety events, vascular complications, or bleeding among women undergoing TAVR.