First-in-Human Evaluation of Balloon Expandable Transcatheter Heart Valve in the Treatment of Severe Symptomatic Native Aortic Stenosis: The MyVal-1 Study.

AIMS: To demonstrate safety and efficacy of the next-generation balloon-expandable Myval™ transcatheter heart valve (THV) in intermediate or high-risk patient population with severe symptomatic native aortic stenosis. METHODS AND RESULTS: MyVal-1 was first-in-human, prospective, multicentre, single-arm, open-label study. Between June 2017 and February 2018, a total of 30 patients were enrolled at 14 sites across India. Mean age was 75.5±6.7 years; 43.3% had coronary artery disease. The mean Society of Thoracic Surgeons score was 6.4±1.8% and 100% patients were in New York Heart Association (NYHA) functional class II/III/IV at pre-procedure. The six-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) score were recorded. After successful implantation of Myval THV, 96.6% and 100% were in NYHA functional class I/II at 30-day and 12-month follow-up, respectively. Outcomes of six-minute walk test (148.0±87.4 vs. 336.0±202.9meter) and KCCQ score (36.6±11.0 vs. 65.9±11.4) improved from baseline to 12-month follow-up. The effective orifice area (0.6±0.2cm2 vs. 1.8±0.3cm2, p<0.0001), mean aortic-valve gradient (47.4±8.8mmHg vs. 12.0±3.3mmHg, p<0.0001), peak aortic-valve gradient (71.7±13.0mmHg vs. 20.3±5.9mmHg, p<0.0001) and trans-aortic velocity (4.5±0.4m/s vs. 2.2±0.4m/s, p<0.0001) improved substantially from baseline to 12-month post-procedure. Four all-cause mortality were reported through 12 months. Moreover, there was no other moderate/severe paravalvular leak, aortic regurgitation or need for new permanent pacemaker (PPM) through 12-month follow-up. CONCLUSIONS: The MyVal-1 study demonstrated the primary safety and efficacy of Myval THV with no new PPM requirement through 12-month follow-up. However, future trials with larger number of patients and long-term follow-up are warranted to establish the safety and efficacy.