Dataset Information

The Myval Transcatheter Heart Valve System for the Treatment of Severe Aortic Stenosis - Current Evidence and Future Directions.

ABSTRACT: Transcatheter aortic valve replacement has revolutionised the treatment of aortic valve disease. The Myval™ device (Meril Life Sciences Pvt. Ltd., Gujarat, India) is a CE-marked, next-generation balloon-expandable transcatheter heart valve, designed for the treatment of severe aortic valve stenosis. This review illustrates the salient technical features of this transcatheter valve, pre-clinical studies and evidence from the first-in-human trial. We also provide a brief overview of planned clinical trials and registries.

SUBMITTER: Sengottuvelu G

PROVIDER: S-EPMC9524723 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The Myval Transcatheter Heart Valve System for the Treatment of Severe Aortic Stenosis - Current Evidence and Future Directions.

Sengottuvelu Gunasekaran G Kumar Vijay V Seth Ashok A

Heart international 20201223 2

Transcatheter aortic valve replacement has revolutionised the treatment of aortic valve disease. The Myval™ device (Meril Life Sciences Pvt. Ltd., Gujarat, India) is a CE-marked, next-generation balloon-expandable transcatheter heart valve, designed for the treatment of severe aortic valve stenosis. This review illustrates the salient technical features of this transcatheter valve, pre-clinical studies and evidence from the first-in-human trial. We also provide a brief overview of planned clinic ...[more]

PMID: 36276512

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Project description:BackgroundStudies assessing outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (AS) with hemodynamic subtypes have demonstrated mixed results with respect to outcomes and periprocedural complications. This study aimed to assess the outcomes of TAVR in patients across various hemodynamic subtypes of severe AS.MethodsPubMed, Embase, and Cochrane databases were searched through September 2023 to identify all observational studies comparing outcomes of TAVR in patients with paradoxical low flow low gradient (pLFLG), classic LFLG, and high gradient AS (HGAS). The primary outcome was major adverse cardiovascular events (MACE). The secondary outcomes were components of MACE (mortality, myocardial infarction [MI], stroke). A bivariate, influential, and frequentist network meta-analysis model was used to obtain the net odds ratio (OR) with a 95% CI.ResultsA total of 21 studies comprising 17,298 (8742 experimental and 8556 HGAS) patients were included in the quantitative analysis. TAVR was associated with a significant reduction in the mean aortic gradient, and an increase in the mean aortic valve area irrespective of the AS type. Compared with HGAS, TAVR in classic LFLG had a significantly higher (OR, 1.68; 95% CI, 1.04-2.72), while pLFLG (OR, 0.98; 95% CI, 0.72-1.35) had a statistically similar incidence of MACE at a median follow-up of 1-year. TAVR in LFLG also had a significantly higher need for surgery (OR, 3.57; 95% CI, 1.24-10.32), and a greater risk of periprocedural (OR, 2.00; 95% CI, 1.17-3.41), 1-month (OR, 1.69; 95% CI, 1.08-2.64), and 12-month (OR, 1.41; 95% CI, 1.05-1.88) mortality compared with HGAS. The incidence of MI, major bleeding, vascular complications, paravalvular leak, pacemaker implantation, and rehospitalizations was not significantly different between all other types of AS (HGAS vs LFLG, pLFLG).ConclusionsTAVR is an effective strategy in severe AS irrespective of the hemodynamic subtypes. Relatively, pLFLG did not have significantly different risk of periprocedural complications compared with HGAS, while classical LFLG AS had higher risk of MACE, primarily driven by the greater mortality risk.

Dataset Information

The Myval Transcatheter Heart Valve System for the Treatment of Severe Aortic Stenosis - Current Evidence and Future Directions.

Publications

The Myval Transcatheter Heart Valve System for the Treatment of Severe Aortic Stenosis - Current Evidence and Future Directions.

Similar Datasets

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