GENESIS-II Study reveals exceptional 30-day results for the Hydra self-expanding transcatheter aortic valve

Findings presented at EuroPCR 2024 showcase the exceptional safety and efficacy of the Hydra THV, offering renewed hope for patients with severe aortic stenosis

New Delhi: A study, known as GENESIS-II, has unveiled promising 30-day results for the Hydra self-expanding transcatheter aortic valve (THV). Presented at EuroPCR 2024 by Dr. Nagendra Boopathy Senguttuvan of Sri Ramachandra Hospital, Chennai, Tamil Nadu, the study showcased the remarkable performance of the Hydra THV, marking an important advancement in transcatheter aortic valve technology.
Dr. John Jose, Study lead & Principal investigator on the trial stated, “GENESIS II demonstrated impressive safety and efficacy results for the Hydra THV, with low mortality, significant reductions in valve gradients, and minimal paravalvular leak at 30 days. We look forward to the longer-term results from this trial, an important addition to available data on this promising TAVI technology from India.” 
The GENESIS-II study, conducted by Sahajanand Medical Technologies (SMT) across 19 sites in India, enrolled 40 patients diagnosed with severe aortic stenosis and classified as high surgical risk. Over a period from November 01, 2021, to November 10, 2023, the study aimed to evaluate the continuous safety and performance of the Hydra THV. 
Key findings from the study revealed exceptional safety and efficacy of the Hydra THV at 30 days post-intervention. Notably, the cardiovascular mortality rate stood at 2.5%, with a new permanent pacemaker implantation incidence of 7.9%. The device success rate impressively reached 95%, with no clinical events related to secondary endpoints observed. 
Furthermore, significant improvements were noted in parameters such as effective orifice area and mean aortic valve gradient, along with favorable enhancements in New York Heart Association (NYHA) functional class. Dr. Anmol Sonawane from Breach Candy Hospital, a prominent TAVR specialist and principal proctor in the study, commented on the ease of device deployment and improved clinical outcomes with the Hydra THV.
Elaborating on the results, prominent TAVR specialist, Dr Anmol Sonawane from Breach Candy Hospital, who played a pivotal role as principal proctor in this study, remarked, “The modification of the Hydra delivery system with a novel active release mechanism has significantly eased device deployment. Clinical outcomes have notably improved, with lower 30-day mortality compared to the earlier GENESIS trial, and acceptable complication rates. The Hydra THV represents a promising new technology in patients with severe aortic stenosis.”
Dr. Krishna Sudheer, Chief Medical Officer at SMT, emphasized the excellent clinical outcomes, “At 30-day follow up, the GENESIS II trial showed excellent clinical outcomes for the Hydra THV, now with a novel active release mechanism for deploying the valve. These results add to earlier data from the GENESIS and the CE Mark trials, confirming the safety and performance of SMT’s TAVI device in the treatment of severe aortic stenosis in patients at high surgical risk.”