Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison.

Background: Heavy calcifications in severe aortic stenosis (AS) pose a major challenge in patients undergoing transcatheter aortic valve replacement (TAVR). Only a few studies have addressed the performance of different transcatheter heart valves (THV) in this subgroup of patients.

Objective: We aimed to investigate the outcomes of the self-expanding Medtronic CoreValve Evolut valve frame and the balloon-expandable Edwards SAPIEN-3/3 Ultra THV in this challenging patient population.

Methods: This was a multicenter registry including a total of 1513 patients with heavily calcified AS undergoing TAVR. The primary endpoint was the incidence and degree of paravalvular leak (PVL) after TAVR. Secondary endpoints were post-implant hemodynamics as well as clinical endpoints according to the VARC-3 definitions.

Results: The CoreValve Evolut R but not the Evolut PRO showed significantly higher rates of PVL compared to the SAPIEN-3/3 Ultra (44.8% vs. 29.5% for mild PVL, p < 0.001), while there was no significant difference in ≥ moderate PVL between both groups (p = 0.399). The CoreValve Evolut R and Evolut PRO showed superior THV hemodynamics compared to the SAPIEN-3/3 Ultra group. These findings were confirmed in a propensity score-matched analysis. There were no significant differences regarding short-term outcomes including permanent pacemaker implantation and all-cause mortality between the three groups.

Conclusions: In patients with severely calcified AS, both CoreValve Evolut PRO and SAPIEN-3/3 Ultra THV showed lower rates of PVL than the CoreValve Evolut R. The self-expanding CoreValve platform had superior post-implant hemodynamics than the SAPIEN-3/3 Ultra system.