Health science reports · 2025
Single-Center Evaluation of the Myval Balloon-Expandable Transcatheter Heart Valve: A Follow-Up Study: A Retrospective Cohort Study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Baay Mohammadreza, Firouzi Ata, MozafaryBazargany MohammadHossein, Azimi Amir, Elahifar Armin, Alemzadeh-Ansari Mohammad Javad, Hosseini Zahra, Abdi Seifollah, Safairad Amineh, Bashghareh Peyman, Khalilipur Ehsan
Аннотация
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.
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.