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CARDIAC SURGERY

Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement

Results From a Prospective Randomized Trial

Ismail El-Hamamsy, MD^_*, Lucy Clark, PhD^_*, Louis M. Stevens, MD, Zubair Sarang, BSc^_*, Giovanni Melina, MD^_*, Johanna J.M. Takkenberg, MD, PhD and Magdi H. Yacoub, MD^_*,_*

^_* Department of Cardiac Surgery, Harefield and Royal Brompton NHS Trust, National Heart and Lung Institute, Imperial College London, London, United Kingdom
Harvard School of Public Health, Harvard University, Boston, Massachusetts
Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands

Manuscript received May 26, 2009; revised manuscript received September 28, 2009, accepted September 30, 2009.

^_* Reprint requests and correspondence: Sir Magdi H. Yacoub, Harefield Heart Science Center, Harefield Hospital, Hill End Road, Harefield UB9 6JH, United Kingdom (Email: m.yacoub{at}imperial.ac.uk).

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.

Key Words: homografts • xenografts • survival • structural valve degeneration

Abbreviations and Acronyms   AI = aortic insufficiency   AV = aortic valve   CI = confidence interval   EF = ejection fraction   HR = hazard ratio   NYHA = New York Heart Association

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