Late outcomes following freestyle versus homograft aortic root replacement: results from a prospective randomized trial

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. (J Am Coll Cardiol 2010; 55: 368-76) (C) 2010 by the American College of Cardiology Foundation