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Real-World Performance and Mid-Term Durability of the Myval Transcatheter Heart Valve in Patients Undergoing
Alberto Colella Cervone1, Dimytri Alexandre de Alvim Siqueira1, Tacianne Rolemberg Braga Delamain1
1Interventional Cardiology Department, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
Background:
The Myval Transcatheter Heart Valve (THV) was designed to address limitations of earlier devices, such as paravalvular leak and sizing restrictions. The LANDMARK trial showed non-inferior short-term outcomes versus established valves in a randomized population of patients with severe aortic stenosis eligible for TAVR with the compared devices. However, confirmation of these findings in routine clinical practice remains important. This study evaluates the real-world safety, efficacy, and mid-term durability of Myval in severe aortic stenosis.
Aims:
This study evaluates the real-world safety, efficacy, and mid-term durability of the Myval THV in patients with severe symptomatic aortic stenosis undergoing TAVR in a consecutive single-center registry.
Methods:
We conducted a retrospective, single-center, single-arm study including 214 consecutive patients who underwent Myval THV implantation between December 2020 and February 2025, with at least 30-day follow-up. Clinical events were reported as incidence rates per 100 patient-years, and hemodynamic performance was assessed using mean profile charts with 95% confidence intervals.
Results:
Among 214 patients (mean age 77 years; 41% female), procedural success was 97.7%. Aortic valve area increased from 0.68 cm2 at baseline to 1.79 cm2 at 30 days, with mean gradients falling from 55.6 mmHg to 10.2 mmHg and remaining stable at 3 years. At 1 year, all-cause mortality was 9.0%, stroke 2.7%, and new pacemaker implantation 11.8%, while structural valve deterioration was rare (3.4%).
Conclusion:
In this real-world cohort, TAVR with the Myval THV showed high procedural success, sustained mid-term hemodynamic improvement, and complication rates comparable to benchmark devices. These findings support its potential as a safe and effective option for severe aortic stenosis, although confirmation in larger, multicentre studies with extended follow-up is warranted.
