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Long-term survival after xenograft versus homograft aortic root replacement: Results from a prospective randomized trial
Authors:Giovanni Melina  Fabio De Robertis  Jullien A Gaer  Emiliano Angeloni  Ismail El-Hamamsy  Toufan Bahrami  John R Pepper  Johanna JM Takkenberg  Magdi H Yacoub
Institution:1. Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom;2. Department of Cardiac Surgery, Ospedale Sant''Andrea, “Sapienza” Università di Roma, Rome, Italy;3. Division of Cardiac Surgery, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada;4. Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands;5. Imperial College, London, United Kingdom;1. Department of Orthopedic Surgery, NYU Langone Health, NYU Langone Orthopedic Hospital, New York, NY;2. Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY;1. Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China;2. Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China;1. Department of Cardiothoracic Surgery, Royal Melbourne Hospital, Melbourne, Australia;2. Department of Cardiothoracic Surgery, Epworth Hospital, Melbourne, Australia;3. Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands;4. Department of Cardiology, Royal Melbourne Hospital, Melbourne, Australia;1. Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, New York;2. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York;3. Department of Surgery, Stony Brook University Hospital, Stony Brook, New York
Abstract:ObjectiveThe study objective was to investigate the long-term survival of patients undergoing xenograft versus homograft full root aortic valve replacement.MethodsA total of 166 patients requiring aortic valve surgery were randomized to undergo the Freestyle (Medtronic Inc, Minneapolis, Minn) bioprosthesis (N = 90) or a homograft (N = 76) full root aortic valve replacement between 1997 and 2005 in a single institution. Six patients randomly assigned to the homograft crossed over to the Freestyle bioprosthesis because of the unavailability of suitably sized homografts. All surgeons were required to adhere to the standard surgical technique for homograft root implantation previously described. Follow-up was 98.5% complete.ResultsThe mean age of the study population was 65 ± 8 years. Coronary artery bypass grafting was associated with root aortic valve replacement in 76 of 166 patients (46%, P = not significant between groups), and overall hospital mortality was 4.8% (8/166, P = not significant between groups). Median follow-up was 13.8 years (range, 0-21.8 years; 2033 patient-years). The Kaplan–Meier survival analysis showed that there was no significant difference in overall survival between the 2 arms at 5, 10, and 15 years. Twenty-year survival was 28.3% ± 5% for the Freestyle group versus 25.1% ± 5.7% for the homograft group (P = .90), which was comparable to the age- and sex-matched UK general population. The freedom from aortic valve reoperation at 20 years was comparable for the Freestyle group versus the homograft group (67.9% ± 8.8% vs 67.2% ± 10.3%, respectively; P = .74).ConclusionsThis is the first study to investigate the long-term survival of xenograft versus homograft full root aortic valve replacement from a prospective randomized trial. The observed 20-year overall survival and freedom from aortic valve reoperation serve as a benchmark for future studies on interventions for aortic valve disease in the elderly.
Keywords:aortic valve surgery  xenografts  homografts  survival  CABG"}  {"#name":"keyword"  "$":{"id":"kwrd0020"}  "$$":[{"#name":"text"  "_":"coronary artery bypass grafting  CI"}  {"#name":"keyword"  "$":{"id":"kwrd0030"}  "$$":[{"#name":"text"  "_":"confidence interval  HR"}  {"#name":"keyword"  "$":{"id":"kwrd0040"}  "$$":[{"#name":"text"  "_":"hazard ratio  TAVI"}  {"#name":"keyword"  "$":{"id":"kwrd0050"}  "$$":[{"#name":"text"  "_":"transcatheter aortic valve implantation
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