Three‐Year Clinical and Hemodynamic Evaluation of the Hydra Self‐Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT Background The Hydra CE study revealed 1‐year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates. Aims We evaluated the 3‐year clinical and hemodynamic outcomes of Hydra self‐expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk. Methods The Hydra CE study was a prospective, multicenter, single‐arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long‐term follow‐up at recruitment, with a planned 5‐year follow‐up period. The primary endpoint was all‐cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes. Results Among the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all‐cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device‐related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3‐year follow‐up was 12.9%. Conclusion The 3‐year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.
DOI: 10.1002/ccd.31285
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4404229367