The Myval Balloon-Expandable Transcatheter Heart Valve Implant in Aortic and Mitral Interventions: A Single-Center Experience.

BACKGROUND

Balloon-expandable valve implants are widely used for percutaneous aortic and mitral valve replacement. This study presents our experience with the Myval implant (Meril Life Sciences, Vapi, India) in these positions.

METHODS

This is a retrospective single-cohort observational study. Between March 2019 and August 2024, 15 patients underwent Myval implantation; out of them, 14 patients (93.33%) underwent transcatheter aortic valve implant (TAVI), and one underwent transcatheter mitral-valve-in-ring implant (TMViR). The mean age of our patients was 75.87±7.51 years (range: 64-90 years), with a slightly higher proportion of females (53.33%). All the patients were symptomatic and presented in New York Heart Association (NYHA) functional class II to IV. The mean EuroSCORE II was 7.99±5.64%, indicating more higher operative risk patients. Fourteen patients who underwent TAVI had severe aortic stenosis with varying degrees of regurgitation. The mean aortic annulus area in these patients was 390.20±74.49 mm², with a mean area-derived diameter of 22.19±2.17 mm. The most commonly used Myval implant sizes were 23 mm (33.33%) and 24.5 mm (33.33%). The procedures were conducted under deep conscious sedation unless general anesthesia was specifically necessary. All cases were performed through the femoral route, with three patients (20%) requiring a femoral arterial cut-down approach and the remaining 12 (80%) cases utilizing the percutaneous Seldinger technique, guided by an angiographic roadmap. Pre-ballooning was not mandatory and was required in only five of the TAVI cases and the TMViR case.

RESULTS

In our study, no instances of valve migration, embolization, or deformation were reported. Coronary protection was required in four patients (28.6%) of TAVI procedures, while none required coronary stenting post-valve deployment. One patient underwent emergency coronary stenting under extracorporeal membrane oxygenation support before valve deployment as guide-induced left-main coronary dissection during a coronary protection procedure. Post-procedure, two patients had significant paravalvular leak, and two had residual stenosis against Myval, but both improved by post-ballooning with additional volume. The failure rate of the ProGlide percutaneous closure device was 13.3%. One patient had a navigator balloon rupture below the rated burst pressure, and one had a Python sheath tear during retrieval of the delivery system. No patients required permanent pacemakers (PPMs). The mean post-procedural hospital stay was 2.9 days. There were no procedural or 30-day mortalities. During a mean follow-up of 22 months, two patients (13.4%) died, one of them attributed to non-cardiac causes.

CONCLUSION

Our experience with Myval has shown it to be an effective and user-friendly option for both aortic and mitral interventions, demonstrating good procedural success rates and a favorable safety profile despite some minor concerns, making it a cost-effective choice for balloon-expandable transcatheter heart valves, particularly in developing countries like India.