What question did this study set out to answer?

March 6, 2025IJC Heart & VasculatureOpen Access

A systematic review and meta-analysis of the hemodynamics and outcomes of the Myval balloon-expandable valve in patients with severe aortic stenosis and with aortic regurgitation

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Why the study?

With the rapid growth of TAVI, the authors aimed to evaluate the performance and outcomes of the Myval transcatheter heart valve in severe aortic stenosis and its use in quantitative videodensimetry, transcatheter ViV, and NCAR.

Does the Myval THV provide safe and effective hemodynamic outcomes in patients with severe aortic stenosis and aortic regurgitation?

Key Points

To evaluate the hemodynamic performance and clinical outcomes of the Myval transcatheter heart valve in severe aortic stenosis, valve-in-valve procedures, and non-calcified aortic regurgitation.
Systematic search across PubMed, Scopus, Web of Science, Embase, and Cochrane up to October 2024.
Identified studies reporting outcomes of Myval transcatheter heart valve implantation in patients with severe aortic stenosis or off-label use in valve-in-valve and non-calcified aortic regurgitation.
Included 29 studies and synthesized hemodynamic outcomes using R software.
Pooled mean aortic gradients were 9.25 mmHg (95% CI [8.20, 10.29]) at discharge, 8.46 mmHg (95% CI [7.57, 9.34]) at 30 days, 10.63 mmHg (95% CI [9.12, 12.14]) at 1 year, and 7.20 mmHg (95% CI [6.78, 7.63]) at 2 years.
Rates of moderate or greater aortic regurgitation were 1% (95% CI [1, 2]) at discharge, 3% (95% CI [2, 4]) at 30 days, 4% (95% CI [2, 7]) at 1 year, and 5% (95% CI [3, 8]) at 2 years.
Off-label use in transcatheter valve-in-valve procedures reduced mean aortic gradients, and its application in non-calcified aortic regurgitation reduced regurgitation incidence.

Structured PICO

Does the Myval THV provide safe and effective hemodynamic outcomes in patients with severe aortic stenosis and aortic regurgitation?

Population

Patients with severe aortic stenosis, non-calcified aortic regurgitation (NCAR), or requiring transcatheter valve-in-valve (ViV) procedures (29 studies included)

Intervention

Myval transcatheter heart valve (THV)

Outcome

Mean aortic gradient and incidence of ≥ moderate aortic regurgitation at discharge, 30-day, 1-year, and 2-year follow-upsurrogate

The Myval THV demonstrates favorable short- and long-term hemodynamic outcomes and low rates of moderate or greater aortic regurgitation in patients with severe aortic stenosis, as well as promising results for valve-in-valve and non-calcified aortic regurgitation.

Implication

Supports the safety and efficacy of this newer balloon-expandable valve across diverse anatomies;.

Abstract

Introduction: Transcatheter aortic valve implantation (TAVI) has been growing rapidly. We aim to evaluate the performance and outcomes of the Myval transcatheter heart valve (THV) in patients with severe aortic stenosis and its use in quantitative videodensimetry, transcatheter valve-in-valve (ViV), and non-calcified aortic regurgitation (NCAR). Methods: A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to October 2024. We used the relevant keywords to include studies that reported the outcomes of patients with severe aortic stenosis who underwent TAVI using the Myval THV and off-label usage in transcatheter ViV and NCAR. Data analysis was done using R software. Results: A total of 29 studies were included in this study. The results of the mean aortic gradient at discharge, 30-day, one-year, and 2-year were 9.25 mmHg (95 % CI [8.20, 10.29]), 8.46 (95 % CI [7.57, 9.34]). 10.63 (95 % CI [9.12, 12.14]), and 7.2 (95 % CI [6.78, 7.63]), respectively. Additionally, the pooled percentages of patients with ≥ moderate aortic regurgitation were found in 1 % (95 % CI [1,2]) at discharge, 3 % (95 % CI [2,4]) at 30-day, 4 % (95 % CI [2,7]) at one-year follow-up and 5 % (95 % CI [3,8]) at 2-year. Furthermore, usage of the Myval THV in transcatheter ViV and NCAR led to a reduction in mean aortic gradient and incidence of aortic regurgitation, respectively. Conclusion: The Myval THV showed good safety and efficacy outcomes in short- and long-term follow-ups following the TAVI. Also, it showed promising results during transcatheter ViV and NCAR.