Document Detail

Late outcomes following freestyle versus homograft aortic root replacement: results from a prospective randomized trial.
MedLine Citation:
PMID:  20117443     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The aims of this study were to compare long-term results after homograft versus Freestyle (Medtronic Inc., Minneapolis, Minnesota) aortic root replacement. BACKGROUND: The ideal substitute for aortic root replacement remains undetermined. METHODS: Between 1997 and 2005, 166 patients (age 65 +/- 8 years) undergoing total aortic root replacement were randomized to receive a homograft (n = 76) or a Freestyle bioprosthesis (n = 90). Six patients randomly assigned to homograft crossed over to Freestyle because of unavailability of suitably sized homografts. Median follow-up was 7.6 years (maximum 11 years; 1,035 patient-years). "Evolving" aortic valve dysfunction was defined as aortic regurgitation >/=2/4 and/or peak gradient >20 mm Hg. RESULTS: Patient characteristics were comparable between groups. Concomitant procedures were performed in 44% and 47% of Freestyle and homograft patients, respectively (p = 0.5). Overall hospital mortality was 4.8% (1% for isolated root replacement). Eight-year survival was 80 +/- 5% in the Freestyle group versus 77 +/- 6% in the homograft group (p = 0.9). Freedom from need for reoperation at 8 years was significantly higher after Freestyle root replacement (100 +/- 0% vs. 90 +/- 5% after homograft replacement; p = 0.02). All reoperations were secondary to structural valve deterioration (n = 6). At last echocardiographic follow-up, actuarial freedom from evolving aortic valve dysfunction was 86 +/- 5% for Freestyle bioprostheses versus 37 +/- 7% for homografts (p < 0.001). Clinically, freedom from New York Heart Association functional class III to IV and freedom from valve-related complications were similar between groups (p = 0.7 and p = 0.9, respectively). CONCLUSIONS: In this patient group, late survival is similar after homograft versus Freestyle root replacement. However, Freestyle aortic root replacement is associated with significantly less progressive aortic valve dysfunction and a lower need for reoperations.
Ismail El-Hamamsy; Lucy Clark; Louis M Stevens; Zubair Sarang; Giovanni Melina; Johanna J M Takkenberg; Magdi H Yacoub
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  55     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-03-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  368-76     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Department of Cardiac Surgery, Harefield and Royal Brompton NHS Trust, National Heart and Lung Institute, Imperial College London, London, United Kingdom.
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MeSH Terms
Aortic Valve / physiology,  surgery*,  transplantation
Heart Valve Diseases / etiology,  surgery
Heart Valve Prosthesis*
Middle Aged
Postoperative Complications / mortality
Prospective Studies
Transplantation, Homologous
Treatment Outcome
Comment In:
J Am Coll Cardiol. 2010 Jan 26;55(4):377-8   [PMID:  20117444 ]

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