Balloon-Expandable Myval Valve Four-Year Outcomes

The expanding indication of transcatheter aortic valve replacement (TAVR) to younger patients or those at lower surgical risk has driven research towards providing stronger evidence as regards long-term durability.

The Myval valve (Meril Life Sciences), a balloon-expandable system developed as an alternative to SAPIEN valves, has sparked growing interest, especially following the LANDMARK data.

A multicenter study led by Jain et al. has contributed with important evidence on Myval performance and durability at 4 years. The study included 366 patients with severe aortic stenosis treated between 2017 and 2020, and assessed parameters defined by VARC-3, including hemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF), and patient-prosthesis mismatch (PPM).

Patient mean age was 75.9 and they were predominantly male, with significant comorbidity burden: 55.2% with coronary artery disease and 37.4% with chronic kidney disease. The transfemoral approach was used in 98.9% of cases, with 7.9% post-dilatation rate. 

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After four years, overall survival was 81.8%, with 98.5% stroke-free survival rate. BVF Incidence was 3.3% (criterion 1), with no need for reintervention and no valve-related deaths. Mean aortic gradients remained stable at 11.96 mmHg, with mean effective orifice area 1.66 cm². 

Grade 2 HVD was seen in 9.7% and grade 3 in 0.7%. Moderate or greater aortic regurgitation reached 9.2%, while severe PPM was reported in 2.1%. These results are comparable to contemporary series of both balloon-expandable and self-expanding valves.

Conclusions

They study by Jain et al. supports Myval durability in a real population, with comparable results to those obtained with other prosthesis normally used. Sustained hemodynamic stability and low complications incidence reinforce Myval as a valid alternative in the context of TAVR.

Original Title: Four-year durability of the Myval balloon-expandable transcatheter aortic valve.

Reference: Jain A, Jose J, Montorfano M, Nissen H, Martin P, Seth A, Stambuk K, Sengottuvelu G, Abdurashid M, García-Gómez M, Fernandez-Cordón C, Rodriguez M, Jorgensen MD, Campo A, Serrador A, Vallinas-Hernandez S, Carrasco-Moraleja M, San Román A, Amat-Santos IJ. Four-year durability of the Myval balloon-expandable transcatheter aortic valve. EuroIntervention. 2025 Jul 7;21(13):e758-e765. doi: 10.4244/EIJ-D-24-01112. PMID: 40627005; PMCID: PMC12207338.