Immediate and Early Outcomes Following Myval Octacor Transcatheter Heart Valve Implantation for the Treatment of Patients With Severe Aortic Valve Stenosis: The OCTACOR-EU Study.

Background: THV is a standard treatment for elderly patients with severe AS, using either BE or self-expanding (SE) THVs. While the Myval BE THV has demonstrated safety and efficacy, data on its latest iteration, the Octacor, are limited.

Objective: To evaluate the clinical performance of the next-generation Myval Octacor balloon-expandable (BE) transcatheter heart valve (THV) in patients with severe, symptomatic native aortic valve stenosis (AS).

Methods: This observational, real-world, multicenter study involved patients deemed suitable for TAVR and treated with Octacor BE THV at 15 European centers. The primary endpoint was the rate of technical success (exit from procedure room) per VARC-3 criteria. Secondary endpoints included overall mortality, stroke, moderate-to-severe paravalvular leak (PVL), and need for permanent pacemaker (pPM) at 30-day and the longest available follow-up. An analysis by THV sizes (standard -20 to 29 mm vs. XL sizes -30.5 and 32 mm) was performed.

Results: From January to December 2023, 252 patients with severe AS underwent TAVR with the Octacor THV. The average age was 80.6 ± 6.7 years, and the mean STS score was 3.45%. Bicuspid anatomy was reported in 7.1% of cases (standard group 5.4% vs. XL group 20%, p = 0.004). Technical success was achieved in 98.8% of procedures (standard group 99.1% vs. XL group 96.7%, p = 0.2). At 30 days, overall mortality was 1.2%, stroke 3.2%, moderate-to-severe PVL 0.8%, and pPM 16.3%.

Conclusions: The novel BE Myval Octacor THV showed high technical success and favorable early clinical outcomes. Longer follow-up and a head-to-head comparison versus other commercially available THVs are awaited.