Clinical evaluation of the Hydra self-expanding THV: 30-day results from the GENESIS-II study.

Background: The Hydra transcatheter heart valve (THV) utilised in the GENESIS-II study is equipped with an active release mechanism for tentacle deployment, distinguishing it from the Hydra THV used in earlier studies. Aims: The primary objective of the GENESIS-II study is to assess the ongoing safety and performance of the Hydra THV in treating severe aortic stenosis in patients deemed at high surgical risk. Methods: This is a prospective, multicentre, non-randomised, investigational study conducted between November 2021 and November 2023. The study enrolled a total of 40 patients exhibiting 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 Valve Academic Research Consortium-2. The 6-month follow-up of the GENESIS-II study is ongoing. Results: Among the 40 patients, the average age was 74.4±6.7 years, and 65% were male. The rate of device success was 95%. At 30 days, 2.5% of patients experienced cardiovascular mortality, and the incidence of new permanent pacemaker implantation was 7.9%. There was a progressive enhancement in the effective orifice area, transitioning from 0.6±0.2 cm² at baseline to 1.9±0.6 cm² at 30 days (p<0.001). Similarly, the mean aortic valve gradient demonstrated significant improvement from 53.1±12.5 mmHg at baseline to 8.4±4.0 mmHg at 30 days (p<0.001) post-intervention. Conclusions: The Hydra THV is the first device with an active release mechanism for deploying the supra-annular valve. The observed high rates of device success and procedural safety in the GENESIS-II study may support the continued safety and performance of the device.