30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study

Aidietis A. Srimahachota S. Dabrowski M. Bilkis V. Buddhari W. Cheung G.S.H. Nair R.K. Mussayev A.A. Mattummal S. Chandra P. Mahajan A.U. Chmielak Z. Govindan S.C. Jose J. Hiremath M.S. Chandra S. Shetty R. Mohanan S. John J.F. Mehrotra S. Søndergaard L.
10 January 2022 Elsevier Inc.

JACC: Cardiovascular Interventions
2022 #15 Issue 1 93 - 104 pp.

Objectives: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. Background: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. Methods: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. Results: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm² to 1.9 ± 0.6 cm²) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. Conclusions: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263)

aortic stenosis , extreme surgical risk , high surgical risk , self-expanding aortic valve transcatheter aortic valve replacement , transcatheter aortic valve replacement

Text of the article Перейти на текст статьи

Cardiology and Angiology Centre, Vilnius University Hospital Santaros Clinics, Vilnius, Lithuania
Cardiac Center and Division of Cardiovascular Disease, Department of Medicine, King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand
Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong SAR
Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
Catheterization Laboratory, National Research Center for Cardiac Surgery, Astana, Kazakhstan
Department of Adult Cardiology, ASTER MIMS Hospital, Kozhikode, India
Division of Interventional Cardiology, Medanta The Medicity Hospital, Gurgaon, India
Department of Cardiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, India
Department of Cardiology, Government Medical College, Calicut, India
Department of Cardiology, Cardiology Unit 2, Christian Medical College Hospital, Vellore, India
Department of Cardiology, Ruby Hall Clinic, Pune, India
Department of Cardiology (Lari Heart Center), King Georges Medical University, Lucknow, India
Department of Cardiology, Manipal Hospital, Bengaluru, India
KMCT Heart Institute, KMCT Medical College Hospital, Kozhikode, India
Department of Cardiology, Baby Memorial Hospital, Calicut, India
Department of Cardiology, NH Institute of Cardiac Sciences, Bangalore, India
Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Cardiology and Angiology Centre
Cardiac Center and Division of Cardiovascular Disease
Department of Interventional Cardiology and Angiology
Department of Medicine and Therapeutics
Department of Cardiology
Catheterization Laboratory
Department of Adult Cardiology
Division of Interventional Cardiology
Department of Cardiology
Department of Cardiology
Department of Cardiology
Department of Cardiology
Department of Cardiology (Lari Heart Center)
Department of Cardiology
KMCT Heart Institute
Department of Cardiology
Department of Cardiology
Department of Cardiology

10 лет помогаем публиковать статьи Международный издатель

Книга Публикация научной статьи Волощук 2026 Book Publication of a scientific article 2026