Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience

Abstract

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI’s procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Case report: Transcatheter aortic valve replacement in a large bicuspid anatomy using the XL-Myval 32 mm

“…The mean procedural time and contrast amounts were 36 min and 70 ml, respectively. These findings are consistent with the initial report on Myval’s safety and efficacy in BAV ( 10 ).…”

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

“…Data of patients with BAV treated with TAVI using the BE Myval THV and included in the first 30-day safety and efficacy report [ 10 ] were collected retrospectively from 10 centres in India ( n = 5), Denmark ( n = 2), Italy ( n = 2), and Croatia ( n = 1). A list of participating centres, collaborators, and numbers of patients included is mentioned previously [ 10 ]. The details of the included cohort, data collection, and procedural details were previously described [ 10 ].…”

“…Data about the feasibility of TAVI in BAV are obtained mainly from several observational cohort studies and registries among selected patients with different surgical risk groups and using various transcatheter heart valves (THV) [ 8 , 9 , 10 , 11 , 12 , 13 , 14 ].…”

“…The importance of such reports is to present the main long-term outcomes in terms of freedom from valve failure-related mortality, aortic valve re-intervention, and freedom from severe hemodynamic deterioration, in addition to freedom from stroke and significant bleeding secondary to the use of antithrombotic therapy [ 16 ]. In a recent paper by Elkoumy et al [ 10 ], the 30-day safety and performance of the balloon-expandable (BE) Myval THV (Meril Life Sciences Pvt. Ltd., Vapi, India) according to the updated valve academic research consortium-3 (VARC3) in patients with severe bicuspid AS was reported.…”

“…Ltd., Vapi, India) according to the updated valve academic research consortium-3 (VARC3) in patients with severe bicuspid AS was reported. The aim of this paper is to present the one-year clinical and hemodynamic outcomes of the previously published cohort of patients with BAV treated with Myval THV [ 10 ]. (Ref).…”