Audrius Aidietis1, Suphot Srimahachota2, Maciej Dabrowski3, Vaildas Bilkis1, Wacin Buddhari2, Gary S H Cheung4, Rajesh K Nair5, Abdurashid A Mussayev6, Shafeeq Mattummal7, Praveen Chandra8, Ajay U Mahajan9, Zbigniew Chmielak3, Sajeev C Govindan10, John Jose11, Murugesh S Hiremath12, Sharad Chandra13, Ranjan Shetty14, Sandeep Mohanan15, John F John16, Sanjay Mehrotra17, Lars Søndergaard18. 1. Cardiology and Angiology Centre, Vilnius University Hospital Santaros Clinics, Vilnius, Lithuania. 2. Cardiac Center and Division of Cardiovascular Disease, Department of Medicine, King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand. 3. Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland. 4. Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong SAR. 5. Department of Cardiology, Waikato Hospital, Hamilton, New Zealand. 6. Catheterization Laboratory, National Research Center for Cardiac Surgery, Astana, Kazakhstan. 7. Department of Adult Cardiology, ASTER MIMS Hospital, Kozhikode, India. 8. Division of Interventional Cardiology, Medanta The Medicity Hospital, Gurgaon, India. 9. Department of Cardiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, India. 10. Department of Cardiology, Government Medical College, Calicut, India. 11. Department of Cardiology, Cardiology Unit 2, Christian Medical College Hospital, Vellore, India. 12. Department of Cardiology, Ruby Hall Clinic, Pune, India. 13. Department of Cardiology (Lari Heart Center), King George's Medical University, Lucknow, India. 14. Department of Cardiology, Manipal Hospital, Bengaluru, India. 15. KMCT Heart Institute, KMCT Medical College Hospital, Kozhikode, India. 16. Department of Cardiology, Baby Memorial Hospital, Calicut, India. 17. Department of Cardiology, NH Institute of Cardiac Sciences, Bangalore, India. 18. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: lars.soendergaard.01@regionh.dk.
Abstract
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).
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).