15-year experience with the Carpentier-Edwards pericardial bioprosthesis

Background. The aim of the study was to evaluate the late results of the Ca rpentier-Edwards pericardial bioprosthesis, which we have been implanting s ince 1981. Methods. The 812 patients who underwent heart valve replacement with a Carp entier-Edwards pericardial bioprosthesis between 1981 and 1996 were reviewe d. Their clinical, operative, and follow-up data were prospectively recorde d in a computerized database. All but 29 patients were available for follow -up (96% completeness), which averaged 58 months and totaled 3,000 patient- years. Results. There were 598 aortic valve replacements (74%), 149 mitral valve r eplacements (18%), and 65 double valve replacements (8%). The mean age at t he time of surgery was 65 years (range, 18 to 88 years), with 24% of the pa tients under the age of 60 years. Preoperatively, 558 patients (69%) were i n New York Heart Association functional class III or IV. Associated surgica l procedures included coronary artery bypass grafting in 219 patients (27%) and tricuspid or mitral valve repair in 40 (5%). Previous cardiac operatio ns had been performed in 149 patients, including 134 valve-related procedur es. There were 49 early deaths overall (6%): 29 after aortic valve replacem ent (4.8%), 11 after mitral valve replacement (7.4%), and 9 with double val ve replacement (13.8%). There were 120 late deaths for a 10-year actuarial survival rates of 69% +/- 3%, 58% +/- 7%, and 38% +/- 10% for aortic, mitra l, and double valve replacement, respectively. The 14-year survival rate fo r aortic valve replacement patients is 68% +/- 3%. The 10-year and 14-year actuarial freedom rates from events after aortic valve replacement are 92% +/- 2% and 88% +/- 4% for thromboembolism, 96% +/- 1% and 92% +/- 4 for end ocarditis, 91% +/- 2 and 72% +/- 6% for reoperation, and 93% +/- 2% and 80% +/- 5% for structural dysfunction of the valve. The 10-year actuarial free dom rates from events after mitral and double valve replacement are 93% +/- 3% and 89% +/- 4% for thromboembolism, 95% +/- 3% and 88% +/- 5% for endoc arditis, 76% +/- 7% and 70% +/- 14% for reoperation, and 81% +/- 7% and 72% +/- 15% for structural dysfunction. No primary tissue failure of the prost hesis in any position was observed in the 357 patients aged 70 years or mor e at the time of valve implantation. Conclusions. The Carpentier-Edwards pericardial valve offers excellent clin ical results and durability, particularly in the aortic position and for pa tients older than 70 years of age. (C) 1998 by The Society of Thoracic Surg eons.