Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study

Area of Science:

• Cardiology
• Interventional Cardiology
• Biomaterials Science

Background:

• The Myval balloon-expandable (BE) valve demonstrates promising early clinical results.
• Comparative studies with established valves are limited.
• This research compares the Myval BE valve against the Evolut self-expanding (SE) valve.

Purpose of the Study:

• To compare the clinical performance of the Myval BE valve and the Evolut SE valve.
• To evaluate safety and efficacy outcomes in patients with severe aortic stenosis.
• To assess differences in procedural complications and long-term results.

Main Methods:

• A retrospective single-center study included 223 patients with severe aortic stenosis.
• Patients received either the Myval BE valve (n=120) or the Evolut SE valve (n=103).
• 91 matched pairs were analyzed for outcomes at 30 days and 1 year, with echocardiography at 30 days.

Main Results:

• Procedural complications were infrequent in both groups.
• No significant differences were observed in cardiac death or stroke at 30 days and 1 year.
• The Myval BE valve group required significantly less permanent pacemaker implantation (PPI) (4% vs. 15%, p=0.01).
• Moderate-severe paravalvular leakage (PVL) rates were comparable (1% vs. 4%, p=0.17).

Conclusions:

• The Myval BE valve and Evolut SE valve exhibit comparable safety and efficacy up to 1 year.
• A notable difference was the lower rate of permanent pacemaker implantation with the Myval BE valve.
• Both valves demonstrated excellent hemodynamics and low rates of moderate-severe paravalvular leakage.