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. 2025 May 26;8(5):e70808.
doi: 10.1002/hsr2.70808. eCollection 2025 May.

Single-Center Evaluation of the Myval Balloon-Expandable Transcatheter Heart Valve: A Follow-Up Study: A Retrospective Cohort Study

Mohammadreza Baay  1 , Ata Firouzi  1 , MohammadHossein MozafaryBazargany  2 , Amir Azimi  2 , Armin Elahifar  1 , Mohammad Javad Alemzadeh-Ansari  1 , Zahra Hosseini  1 , Seifollah Abdi  1 , Amineh Safairad  1 , Peyman Bashghareh  1 , Ehsan Khalilipur  1
Affiliations

Single-Center Evaluation of the Myval Balloon-Expandable Transcatheter Heart Valve: A Follow-Up Study: A Retrospective Cohort Study

Mohammadreza Baay et al. Health Sci Rep. .

Abstract

Background and aims: Our objective is to report our single-center experience with the novel balloon-expandable Myval Transcatheter Heart Valve (THV) system in Transcatheter Aortic Valve Replacement (TAVR) procedures.

Methods: We conducted a retrospective study on a cohort of consecutive patients who underwent TAVR utilizing Myval THV from September 2021 to August 2023 at a tertiary care cardiac center. We collected baseline characteristics, pre- and post-procedural echocardiographic findings, procedural details, in-hospital outcomes, VARC-3 technical success, and complications. Additionally, patients were followed up for 3 months concerning their clinical outcomes.

Results: The study population comprised 92 TAVR patients with a mean age of 76.8 ± 7.3 years, 66.3% were male, and the mean STS score was 5.9 ± 3.2%. The most common valve sizes used were 24.5 mm (30.4%), 23 mm (26.1%), and 27.5 mm (17.4%). Pre-dilation was performed in 32 cases (34.8%), achieving a 93.5% technical success rate. In-hospital mortality occurred in three patients (3.3%), which included one annulus rupture. Permanent pacemaker implantation was required in six patients (6.5%). Three patients (3.3%) exhibited 3+ paravalvular leakage demonstrated by angiography. The New York Heart Association (NYHA) functional class showed significant improvement from baseline to discharge (p < 0.0001). At the 3-month follow-up, five patients encountered mortality (5.4), and three experienced an episode of stroke or transient ischemic attack (3.2%). Two other patients were hospitalized due to cardiovascular events during the 3-month follow-up.

Conclusion: The Myval THV shows a favorable safety and efficacy profile in TAVR, with low mortality and complications at 3 months.

Keywords: Myval; aortic stenosis; balloon‐expandable; transcatheter aortic valve replacement; transcatheter heart valve.

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Conflict of interest statement

S. Abdi has a role as a clinical proctor for the Sapien 3 valve by Edwards Lifesciences. E. Khalilipur is certified as an independent operator in transcatheter heart valve replacements with the Myval THV system. A. Firouzi is an international proctor for Myval THV. The remaining authors declare no conflicts of interest. Supporting sources were not involved in study design, data collection, analysis, interpretation, writing the report, or deciding to submit the report for publication.

Figures

Figure 1
Figure 1
Deployment of the Myval valve in a patient with aortic stenosis. Positioning of the Myval Valve. The central dense marker band of the crimped prosthesis is aligned with the plane of the aortic valve annulus to ensure accurate placement. (A) Postimplantation result. (B) Successful deployment of the Myval THV within the aortic annulus, with no evidence of PVL or malposition.
Figure 2
Figure 2
The violin plot compares the impact of transcatheter aortic valve replacement using Myval on various echocardiographic parameters: ejection fraction, left ventricular end‐diastolic volume index, mean aortic valve gradient, peak aortic valve gradient, and peak aortic valve velocity. The plots (A–E) display the medians as well as the 25th and 75th percentiles. Additionally, improvements in mitral valve regurgitation, assessed echocardiographically before and after the procedure, are shown in plot (F).
Figure 3
Figure 3
Clinical status of patients before and following the procedure, categorized according to the New York Heart Association Functional Classification.
See this image and copyright information in PMC

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