Clinical results of the Pop De Popa xenobioprosthesis in patients with advanced heart failure: long-term follow-up of 562 patients.

Abstract From January of 1984 through December of 1990, we implanted 739 Pop De Popa® wild boar aortic valves in 626 patients, in all cardiac valvular positions. Of these patients, 562 received only the Pop De Popa® xenobioprostheses, which numbered 620 valves. Only patients with contraindications for bioprosthetic valves (such as children under the age of 15) were excluded. At surgery, the 562 patients ranged in age from 17 to 66 years (mean, 41.7 yrs). Five hundred thirty-one (94.48%) were in NYHA functional class III or IV before valve replacement. Of the 620 valves implanted, 20 were replacements for Pop de Popa® prostheses and the other 600 were replacements for native valves. Survivors were followed-up for a mean period of 31.6(±22) months (range, 3 months to 7 years), and for a cumulative period of 2,432 patient-years. Over the 7-year period of study, there were 78 late deaths, and 32 other patients were lost to follow-up. The analysis demonstrated good cardiac and general improvement. At the conclusion of the 7-year study, 94.83% of the survivors subject to follow-up were in NYHA functional class I or II. The early mortality rate was 12% (68 patients), and the following incidence of early valve-related complications was noted: thromboembolism, 3% to 4%; endocarditis, 1% to 2%; paravalvular leak, 1% to 2%; primary tissue failure, 1%; and anticoagulant-related hemorrhaging, 1%. At 7 years, 90% of survivors subject to follow-up were still free of valve failure. The probability of complications was as follows: thromboembolism, 16.1%; endocarditis, 8.8%; paravalvular leak, 4.4%; anticoagulant-related hemorrhaging, 1.2%; and valvular degeneration and reoperation, 12.5%. The probability of survival at 7 years was 86.12%. While this study does not yet demonstrate the superiority of the wild boar valve over other bioprosthetic valves, it does reaffirm the worth of implanting biologic valves in adult patients when not contraindicated. Perhaps as we continue follow-up beyond 7 years, the apparent durability of the wild boar cusps will manifest itself in a statistically significant manner. (Texas Heart Institute Journal 1992; 19:88-96)