This presentation, delivered by Dr. Salvatore Giordano at EuroPCR 2026, detailed the results of the MELA Registry, a multicenter study comparing the performance of the Myval balloon-expandable valve series versus the self-expanding Evolut R valve in patients with large aortic annuli.
The study focused on patients with severe aortic stenosis and complex anatomies characterized by large aortic annuli (area ≥575 mm² or perimeter ≥85 mm). This population represents a clinical challenge due to the limited availability of prosthesis sizes, which may increase the risk of complications such as paravalvular leak, valve embolization, or mortality.
The primary objective was to compare early valve performance (30 days) and clinical outcomes between both devices.
This was a retrospective multicenter study conducted across five centers between January 2017 and December 2024. A total of 246 patients were included: 118 treated with Myval and 128 with Evolut R. To ensure group comparability, a propensity score weighted analysis was performed.
The primary endpoint was a composite of moderate or severe aortic regurgitation, permanent pacemaker implantation, and unsatisfactory valve performance according to VARC-3 criteria.
Postprocedural technical success rates were comparable between groups (96.6% for Myval versus 97.6% for Evolut R), as was device success at 30 days.
The Myval series demonstrated significantly shorter fluoroscopy and procedural times, along with a lower need for post-dilatation compared with Evolut R.
Regarding aortic regurgitation, Myval valves showed significantly lower rates of moderate or severe aortic regurgitation at 30 days (3.9% versus 11.0%; p=0.047).
No procedure-related deaths or strokes were reported in the Myval group at 30 days. In addition, major vascular complications and major bleeding events were numerically lower with Myval.
Conversely, Evolut R demonstrated a slightly lower mean aortic gradient at 30 days, although this difference was considered clinically insignificant.
Conclusions: Myval May Provide Better Early Outcomes in Patients With Large Aortic Annuli
The MELA Registry concluded that both Myval and Evolut R are safe and effective systems for treating patients with large aortic annuli. However, the Myval series demonstrated favorable early outcomes, including a significant reduction in moderate-to-severe aortic regurgitation and greater procedural efficiency due to shorter fluoroscopy and procedure times.
Original Title: TAVI Outcomes in Patients with Large Aortic Annuli.
Presented by Dr. Salvatore Giordano at EuroPCR 2026.
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