Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve.

Abstract

Objectives: Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is a novel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve.

Methods: In this prospective single-centre study, 120 consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30 days and 6 months using Valve Academic Research Consortium‑2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for a permanent pacemaker implantation (PPI) were investigated.

Results: At 6‑month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30 days. An intermediate valve size was selected in 51% of the patients.

Conclusions: The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6‑month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve.