Replacement of the proximal aorta and aortic valve using a composite bileaflet prosthesis and gelatin-impregnated polyester graft (carbo-seal): Earlyresults in 143 patients

Objective: We report the combined early results from two centers in the Uni ted Kingdom using a composite conduit consisting of a bileaflet mechanical valve incorporated into a gelatin-impregnated, ultra-low porosity, woven po lyester graft (Carbo-Seal; Sulzer Carbomedics, Inc, Austin, Tex). Methods: Between August 1992 and March 1997, 143 patients underwent aortic root repl acement with the Carbo-Seal composite prosthesis. The indication for surger y was acute type A dissection in 31 (22%), chronic type A dissection in 9 ( 6%), ascending aortic aneurysm without dissection in 100 (70%), and false a neurysm of the ascending aorta in 3 (2%). Twenty-seven patients (19%) had u ndergone previous sternotomy, and 40 (28%) were seen as emergencies. Concom itant procedures were performed in 38 (27%), including 18 aortic arch or he miarch replacements. Total follow-up is 270 patient-years. Follow-up is 100 % complete. Results: The early (30-day) mortality was 7% (10 patients). Per manent neurologic events occurred in 2%. At a mean follow-up of 23 months, 94% of survivors were in New York Heart Association functional class I. Fre edom from reoperation was 97.2% +/- 1.6% (1 standard error [1 SE]) at 12 mo nths and 95.7% +/- 2.2% at 48 months. Including early mortality, survival w as 90.1% +/- 2.6% at 12 months and 83.1% +/- 3.5% at 48 months. Conclusions : Aortic root replacement with use of the Carbo-Seal prosthesis can be unde rtaken with a relatively low early mortality and morbidity. A low reoperati on rate and high intermediate-term survival can be expected, but continued follow-up is needed to determine the long-term efficacy of this prosthesis.