Business Wire India
- Valve gradient was in single digit and remained consistent at 6-month follow-up.
- Effective orifice area was consistently above 2 cm2 up to 6-month follow-up.
- The need for permanent pacemaker rates were similar to the current generation devices.
- Moderate-to-severe paravalvular leaks were 0%.
SMT (Sahajanand Medical Technologies Limited) today announces publication of the Genesis study in CCI (Catheterization and Cardiovascular Intervention) journal evaluating 6 months results of its self-expanding transcatheter aortic valve, Hydra.
Genesis study was a multicentre, prospective, single-arm, non-randomized investigational study performed at 11 sites across India. The objective of the study was to assess the safety and performance of the Hydra transcatheter aortic valve in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk.
Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in the Genesis trial and the device success defined by the VARC-II criteria was achieved in 92.5% of the cases. The analysis showed that post-procedure reduction in aortic pressure gradient [from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < 0.0001)] and improvement in aortic valve area [from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p < 0.0001)] were significant and were maintained at 6 months.
Also, the rate of new permanent pacemaker implantation was 7.5% at 30 days and paravalvular leak of more than mild severity was not observed in any patients at the end of the procedure and this persisted up to 6-months follow-up. There were no cases of bioprosthetic valve embolization, stroke, or conversion to open heart surgery for a failed valve implantation.
The Genesis study was chaired by the Principal Investigator Dr. Praveen Chandra from Medanta – The Medicity, Gurugram, India and co-chaired by Prof. Lars Søndergaard from Rigshospitalet, Copenhagen, Denmark.
Speaking about the trial, Principle Investigator Dr. Praveen Chandra said, “Hydra Valve, a self-expanding repositionable device has shown excellent echocardiographic and clinical outcomes at acute and long term follow-up. It showed good durability and no increase in pacemaker implantation rates. The repositionability and flexibility of the valve are one of the best.”
Elaborating more on the study, Prof Lars Sondergaard added,” The novel Hydra transcatheter heart valve is designed to optimize outcomes when treating patients with severe aortic stenosis. This was tested in the Genesis trial, which recently was published in the American medical journal Catheterization and Cardiovascular Interventions. The Genesis study revealed an excellent hemodynamic performance with large effective orifice area and low transvalvular gradient when using the Hydra heart valve. Furthermore, the unique design of this heart valve also led to a very flexible system even in challenging patient anatomies, easy access to the coronary arteries and low rate of new permanent pacemakers. These findings are important for treating physicians when choosing the best heart valve prosthesis for patients undergoing transcatheter aortic valve replacement."
Overall, these findings demonstrate favourable and sustained 6-month safety and performance outcomes of the self-expanding Hydra transcatheter aortic valve in patients with symptomatic severe aortic stenosis who were at high or extreme surgical risk.
Hydra valve shows high efficacy and safety profile in the Genesis study which was used for the regulatory approval in India.
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