Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
Five-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Heart Valve in Patients With Severe Aortic Stenosis.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Bajoras Vilhelmas, Dabrowski Maciej, Davidavicius Giedrius, Cesna Sigitas, Peciuraite Dovile, Witkowski Adam, Stoklosa Patrycjusz, Sudhir Krishnankutty, Aidietis Audrius
Аннотация
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.
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.