Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement: Results From a Prospective Randomized Trial

• Published in: Journal of the American College of Cardiology 2010-01, Vol.55 (4), p.368-376
• Main Authors: EL-HAMAMSY, Ismail, CLARK, Lucy, STEVENS, Louis M, SARANG, Zubair, MELINA, Giovanni, TAKKENBERG, Johanna J. M, YACOUB, Magdi H
• Format: Article
• Language: English
• Subjects: Age; Aged; Antibiotics; Aortic Valve - physiology; Aortic Valve - surgery; Aortic Valve - transplantation; Biological and medical sciences; Bioprosthesis; Cardiology; Cardiology. Vascular system; Confidence intervals; Coronary vessels; Diabetes; Echocardiography; Female; Heart; Heart Valve Diseases - etiology; Heart Valve Diseases - surgery; Heart Valve Prosthesis; Humans; Male; Medical sciences; Middle Aged; Mortality; Postoperative Complications - mortality; Prospective Studies; Prostheses; Reoperation; Surgery; Surgical techniques; Survival analysis; Transplantation, Homologous; Transplants & implants; Treatment Outcome; Variables; Veins & arteries
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2009.09.030

The aims of this study were to compare long-term results after homograft versus Freestyle (Medtronic Inc., Minneapolis, Minnesota) aortic root replacement. The ideal substitute for aortic root replacement remains undetermined. 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. 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). 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.