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Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

ABSTRACT: Transcatheter aortic valve implantation (TAVI) performed using femoral arterial access is now a guideline recommended treatment for severe calcific aortic stenosis (AS) in elderly patients. Technological advancements and procedural refinements have focused on making TAVI simpler, safer, more effective and durable. Myval (Meril Lifesciences) is a new generation balloon-expandable transcatheter heart valve (THV) developed in India that possesses novel features to improve deliverability and aid precise deployment. Following the first-in-human study, Myval was approved in India for commercial implantation in October 2018 and was subsequently given a CE mark in April 2019. This article reviews the science, technology and up-to-date clinical evidence for the Myval THV.

SUBMITTER: Seth A

PROVIDER: S-EPMC10311401 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

Seth Ashok A Kumar Vijay V Singh Vivudh Pratap VP Kumar Dhananjay D Varma Puneet P Rastogi Vishal V

Interventional cardiology (London, England) 20230410

Transcatheter aortic valve implantation (TAVI) performed using femoral arterial access is now a guideline recommended treatment for severe calcific aortic stenosis (AS) in elderly patients. Technological advancements and procedural refinements have focused on making TAVI simpler, safer, more effective and durable. Myval (Meril Lifesciences) is a new generation balloon-expandable transcatheter heart valve (THV) developed in India that possesses novel features to improve deliverability and aid pre ...[more]

PMID: 37398875

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Project description:Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33-0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42-1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17-0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14-0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14-0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31-11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33-9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41-1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53-1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43-1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

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

Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

Publications

Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

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