Cerebrovascular events with self-expanding versus balloon-expandable valves in patients with or without peripheral arterial disease.

Abstract

Objectives: The authors compared the risk of cerebrovascular events (CVE) with self-expanding vales (SEV) vs balloon-expandable valves (BEV) in patients with or without peripheral artery disease (PAD), stratified by the access route and the complexity of PAD (Hostile score).

Methods: The PAD-related risk of CVE between SEV vs BEV was investigated using data from the HOSTILE Registry, an observational study including 1707 patients with severe PAD undergoing transcatheter aortic valve replacement (TAVR) via different access routes. The relative risk of CVE with SEV vs BEV in patients without PAD was investigated in a meta-analysis of randomized controlled transfemoral access (TFA)-TAVR trials of patients with normal femoral arteries. The primary endpoint was the risk of 30-day CVE.

Results: Among the 1021 patients undergoing TAVR through TFA or transaxillary access (TAxA), 674 (66.0%) received SEVs and 329 (32.2%) received BEVs. The 30-day propensity-adjusted risk of CVE was higher for SEV compared with BEV (adjusted hazard ratio [HR], 2.70; 95% CI, 1.16-6.23), with no significant interaction between the transcatheter heart valve and either the access route or the Hostile score. Similar results were apparent at 1 year (adjusted HR, 2.98; 95% CI, 1.30-6.83). In contrast, in a meta-analysis of 4 RCTs and 2131 patients with femoral arteries suitable for TAVR, there were no significant differences in the 30-day rates of CVE between SEV and BEV (odds ratio, 0.58; 95% CI, 0.24-1.40).

Conclusions: Compared with BEVs, SEVs were associated with higher 30-day and 1-year rates of CVE in patients with PAD, a finding not apparent in patients with suitable femoral arteries enrolled in RCTs.