A novel balloon-expandable transcatheter aortic valve bioprosthesis: Myval and Myval Octacor

ABSTRACT

Introduction

Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis.

Areas covered

This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs’ performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures.

Expert opinion

Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.

KEYWORDS:

• Aortic stenosis
• transcatheter aortic valve replacement
• balloon-expandable valve
• Myval
• Octacor
• paravalvular leaks
• permanent pacemaker implantation

Article highlights

• Myval and the new generation Myval Octacor are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis.

• Both THVs demonstrated comparable valve academic research consortium (VARC)-3 device success, early safety, and clinical efficacy compared to the primary contemporary THV systems (e.g. Sapien 3 and Evolut R/Pro).

• Low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI) have been reported in non-randomized and randomized studies using these THVs.

• The intermediate and extra-large sizes of Myval present a promising option for widening the range of patients suitable for transcatheter aortic valve replacement (TAVR), of whom those with large annuli and non-calcified aortic regurgitation.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer is a proctor for Meril Life. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.