Safety and performance parameters of the Myval transcatheter aortic valve bioprosthesis: The SAPPHIRE prospective registry.

Background: TAVR is an established treatment for patients with severe symptomatic aortic stenosis. Different THV platforms are nowadays available, each of them with its inherent limitations and others are under development aiming at overcoming such limitations. We thus sought to investigate the performance and 1-year clinical outcome of a new generation, balloon expandable, THV: the Myval™ (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India).

Methods: This registry included the first 100 consecutive patients (mean age 80.7 ± 7.7; STS 4.3 ± 3.3 %), who underwent transcatheter aortic valve implantation for severe stenosis of the native aortic valve from May 2020 to December 2020, in two Italian Centers. Clinical and procedural outcomes were defined according to VARC-3 criteria.

Results: Transfemoral Myval THV was successfully implanted in all patients, with no intra-hospital mortality (technical success 100 %): vascular access complications were all "minor" (16 %), and managed by compression/balloon inflation; no cases of annular rupture or coronary obstruction occurred; 5 % of patients required an in-hospital pacemaker implantation (PM). Device success was 99 %. Overall and cardiovascular mortality were 6 % (CI 5 %-7 %) and 4 % (CI 2 %-5 %) at 1- year, while 12 % (CI 9 %-14 %) and 7 % (6-9 %) at 2 years. A total of 9 % of the patients required a PM within 12 months, and no further PM implantation occurred afterwards. No cerebrovascular events, renal failure and myocardial infarction occurred between discharge and 2-year follow-up. No events of structural valve deterioration but a sustained improvement of echocardiographic parameters were observed.

Conclusion: The Myval THV has a promising safety/efficacy profile at 2 year follow up. This performance should be further evaluated in the context of randomized trials to better elucidate its potential.