Balloon-Expandable Myval Octacor Versus Self-Expanding Evolut PRO/PRO+ and Acurate Neo2: Short-Term Outcomes From...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Engineering

Background:

• Transcatheter aortic valve implantation (TAVI) is expanding to younger, lower-risk patients, necessitating optimized procedural and hemodynamic outcomes.
• The Myval Octacor balloon-expandable valve (BEV) aims to reduce paravalvular regurgitation (PVL), pacemaker implantation (PPI), and improve hemodynamics.
• Limited comparative data exist for Myval Octacor against contemporary self-expanding supra-annular valves (SEVs) like Evolut PRO/PRO+ and Acurate Neo2.

Purpose of the Study:

• To compare the safety, efficacy, and short-term clinical outcomes of the Myval Octacor BEV versus SEVs in transfemoral TAVI.
• To evaluate device success, technical success, valve performance, and early safety endpoints at 30 days post-TAVI.

Main Methods:

• Prospective, multicenter registry of Myval Octacor patients compared with SEV recipients from the NEOPRO2 registry.
• Propensity score matching was used to adjust for baseline differences between the groups.
• Primary endpoint: 30-day Valve Academic Research Consortium-3 (VARC-3) device success. Secondary endpoints: technical success, valve performance, and early safety.

Main Results:

• Myval Octacor demonstrated higher 30-day VARC-3 device success (97% vs. 88%, p=0.024) compared to SEVs.
• A trend towards lower moderate-to-severe PVL was observed in the Myval Octacor group (1% vs. 7%, p=0.06).
• Indexed effective orifice areas were larger with Myval Octacor; mortality, stroke, PPI, and MI rates were similar at 30 days.

Conclusions:

• Myval Octacor shows comparable early safety and efficacy to supra-annular SEVs in TAVI.
• The Myval Octacor offers potential advantages in device success and hemodynamic performance.
• Larger randomized trials are warranted to validate these findings for TAVI procedures.