Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study

Abstract

Aim

The Hydra THV incorporates an active release mechanism designed to facilitate the deployment of the supra-annular valve. The aim of the GENESIS-II study was to assess the safety and performance of Hydra THV at 6 months follow-up after treating severe aortic stenosis in patients at high surgical risk.

Methods

This prospective, multicenter, non-randomized, investigational study was conducted between November 2021 and November 2023. The study enrolled 40 patients with high surgical risk and symptomatic severe aortic stenosis from 19 sites across India. The primary safety endpoint of the study was cardiovascular mortality at 30 days, while the primary performance endpoint was device success, as defined by VARC-2.

Results

Among the 40 patients, the mean age was 74.4 ± 6.7 years, 65% were male, and the mean Society of Thoracic Surgeons (STS) risk score was 3.5 ± 1.6%. The device had a success rate of 95%. At 6 months, there was one cardiovascular death (2.5 %). All-cause death was observed in 5% patients. The incidence of new permanent pacemaker implantation was 7.9%. There was a progressive enhancement in effective orifice area, from 0.6 ± 0.2 cm² at baseline to 1.9 ± 0.4 cm² at 6 months (p < 0.001). Similarly, the mean aortic valve gradient significantly improved from 53.1 ± 12.5 mm Hg at baseline to 8.7 ± 3.3 mmHg at 6 months (p < 0.001) post-intervention.

Conclusion

The results of 6 months follow-up after implantation of the Hydra THV with an active release mechanism in the GENESIS-II study demonstrated a high device success rate with favorable safety and performance of the device.