BACKGROUND: The ideal substitute for aortic valve replacement in patients with aortic valve disease is not known. Our hypothesis was that the regulatory and adaptive properties of a living valve substitute could improve the long-term outcomes in patients. We therefore compared these outcomes after autograft aortic root replacement (Ross procedure) versus homograft aortic root replacement in adults. METHODS:Male and female patients (<69 years) requiring aortic valve surgery were randomly assigned in a one-to-one ratio to receive an autograft or a homograft aortic root replacement in one centre in the UK. The random allocation sequence was computer generated. Treatment was not masked. The primary endpoint was survival of patients at 10 years after surgery. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN03530985. FINDINGS:228 patients were randomly assigned to receive an autograft or a homograft aortic root replacement. 12 patients were excluded because they were younger than 18 years; 108 in each group received the surgery they were assigned to and were analysed. There was one (<1%) perioperative death in the autograft group versus three (3%) in the homograft group (p=0.621). At 10 years, four patients died in the autograft group versus 15 in the homograft group. Actuarial survival at 10 years was 97% (SD 2) in the autograft group versus 83% (4) in the homograft group. Hazard ratio for death in the homograft group was 4.61 (95% CI 1.71-16.03; p=0.0060). Survival of patients in the autograft group was similar to that in an age-matched and sex-matched British population (96%). INTERPRETATION: Our findings support the hypothesis that a living valve implanted in the aortic position can significantly improve the long-term outcomes in patients. FUNDING: Funding Magdi Yacoub Institute. Copyright 2010 Elsevier Ltd. All rights reserved.
RCT Entities:
BACKGROUND: The ideal substitute for aortic valve replacement in patients with aortic valve disease is not known. Our hypothesis was that the regulatory and adaptive properties of a living valve substitute could improve the long-term outcomes in patients. We therefore compared these outcomes after autograft aortic root replacement (Ross procedure) versus homograft aortic root replacement in adults. METHODS: Male and female patients (<69 years) requiring aortic valve surgery were randomly assigned in a one-to-one ratio to receive an autograft or a homograft aortic root replacement in one centre in the UK. The random allocation sequence was computer generated. Treatment was not masked. The primary endpoint was survival of patients at 10 years after surgery. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN03530985. FINDINGS: 228 patients were randomly assigned to receive an autograft or a homograft aortic root replacement. 12 patients were excluded because they were younger than 18 years; 108 in each group received the surgery they were assigned to and were analysed. There was one (<1%) perioperative death in the autograft group versus three (3%) in the homograft group (p=0.621). At 10 years, four patients died in the autograft group versus 15 in the homograft group. Actuarial survival at 10 years was 97% (SD 2) in the autograft group versus 83% (4) in the homograft group. Hazard ratio for death in the homograft group was 4.61 (95% CI 1.71-16.03; p=0.0060). Survival of patients in the autograft group was similar to that in an age-matched and sex-matched British population (96%). INTERPRETATION: Our findings support the hypothesis that a living valve implanted in the aortic position can significantly improve the long-term outcomes in patients. FUNDING: Funding Magdi Yacoub Institute. Copyright 2010 Elsevier Ltd. All rights reserved.
Authors: Donal MacGrogan; Guillermo Luxán; Anita Driessen-Mol; Carlijn Bouten; Frank Baaijens; José Luis de la Pompa Journal: Cold Spring Harb Perspect Med Date: 2014-11-03 Impact factor: 6.915
Authors: Amine Mazine; Rodolfo V Rocha; Ismail El-Hamamsy; Maral Ouzounian; Bobby Yanagawa; Deepak L Bhatt; Subodh Verma; Jan O Friedrich Journal: JAMA Cardiol Date: 2018-10-01 Impact factor: 14.676
Authors: Francesco Nappi; Sanjeet Singh Avtaar Singh; Mario Lusini; Antonio Nenna; Ivancarmine Gambardella; Massimo Chello Journal: Ann Transl Med Date: 2019-09
Authors: Angela McBrien; Milind Chaudhari; David S Crossland; Helen Aspey; Alison Heads-Baister; Massimo Griselli; John O'Sullivan; Asif Hasan Journal: Interact Cardiovasc Thorac Surg Date: 2012-02-22