2. Eternal Heart Care Centre & Research Institute Pvt., Ltd., India
3. Medanta- The Medicity, Haryana, India
4. Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, India
5. Military Hospital Cardio Thoracic Centre, Maharashtra, India
6. Christian Medical College & Hospital, Tamil Nadu, India
7. Lokmanya Tilak Municipal Medical College & General Hospital, Maharashtra, India
8. Narayana Institute of Cardiac Sciences, Karnataka, India
9. Apollo Hospital Enterprise Limited, Tamil Nadu, India
10. Sree Chitra Tirunal Institute for Medical Sciences & Technology, Kerala, India
11. Sri Jayadeva Institute of Cardiovascular Sciences & Research, Karnataka, India
12. G. Kuppuswamy Naidu Memorial Hospital, Tamil Nadu, India
13. Fortis Escorts Heart Institute, New Delhi, India
14. Christian Medical College & Hospital, Tamil Nadu, India
15. Lari Cardiology Centre, King George’s Medical University, Lucknow, Uttar Pradesh, India
As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention - has been published immediately upon acceptance as it was received. The content of this article is the sole responsibility of the authors, and not that of the journal or its publishers.
To read the full content of this article, please download the PDF. Download full article (PDF)
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.
Sign in to read and download the full articleForgot your password?
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com