Five-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Heart Valve in Patients With Severe Aortic Stenosis.

BACKGROUND

Transcatheter aortic valve replacement (TAVR) has become the standard treatment for most patients with severe aortic stenosis. However, data on long-term mortality and durability of transcatheter heart valves (THVs) is limited. The Hydra CE study previously reported good early- and medium-term clinical performance and safety for TAVR with Hydra self-expanding THV (Vascular Innovations Co Ltd, Nonthaburi, Thailand, a subsidiary of Sahajanand Medical Technologies Limited, India).

AIMS: We herein report 5-year follow-up results from the long-term follow-up cohort of the Hydra CE study.

METHODS

The Hydra CE was a prospective, multicenter, single-arm study that enrolled 157 patients. Of these, 54 patients from two participating centers (Lithuania and Poland) provided consent for extended follow-up (up to 5 years), forming the long-term follow-up cohort. These patients were monitored for up to 5 years to assess the durability and sustained performance of the device. The primary endpoint of this cohort was all-cause mortality, with patients monitored for both clinical and echocardiographic outcomes throughout the follow-up period.

RESULTS

Among the 54 patients, the mean age was 81.0 ± 4.1 years. At 5-year follow-up, all-cause mortality was 24.3%, with cardiovascular deaths accounting for 6.0% of the patients. Effective orifice area increased from 0.68  ±  0.15 cm2 to 2.09  ±  0.57 cm2 (p < 0.001) and mean aortic valve gradient decreased from 53.4  ±  14.24 mmHg to 8.0 ±  3.14 mmHg at 5 years (p < 0.001). Improvement of at least one NYHA functional class from baseline to 5 years was observed in 65% of patients. New permanent pacemaker implantation rate at 5-year follow-up was 16.7%. There were no cases of valve endocarditis, thrombosis, or structural valve deterioration over 5 years.

CONCLUSION

The 5-year results from the long-term follow-up cohort of the Hydra CE study established excellent valve durability and sustained hemodynamic performance. The study demonstrated favorable long-term safety and clinical performance of the Hydra THV, with acceptable survival rates at 5-year follow-up.