Medtronic intact porcine bioprosthesis: 10 years’ experience

Background. The Medtronic Intact porcine bioprosthesis experience was evaluated over a period of 10 years to determine the influence of structural valve deterioration by valve position in various age groupings. Methods. From 1986 to 1996 inclusive, at three centers, 1,272 patients had the prosthesis implanted in 1,296 procedures. The mean age of the population was 67 years (range, 9 to 91 years). There were 836 aortic valve replacements (AVR) (64.5%), 333 mitral valve replacements (MVR) (25.7%), and 110 multiple valve replacements (MR) (8.5%). Results. The early mortality was 7.3% (94 of 1,296 procedures). The early mortality with concomitant procedures (primarily coronary artery bypass grafting) was 9.8% (52 of 528) and without, 5.5% (42 of 768). The late mortality was 4.25%/patient-year. The linearized rate of major thromboembolism was 0.86%/patient-year. The rate of reoperation was 1.19%/patient-year and valve-related mortality, 1.06%/patient-year. There were 36 cases of structural valve deterioration for aortic valve replacement (16), mitral valve replacement (15), tricuspid valve replacement (2), and multiple valve replacement (3). The freedom from structural valve deterioration for aortic valve replacement was in patients 21 to 40 years, 62.5% ± 25.8% at 7 years; 41 to 50 years, 75.0% ± 15.3% at 7 years; 51 to 60 years, 91.0% ± 4.5% at 8 years; 61 to 70 years, 98.7% ± 0.7% at 10 years; and older than 70 years, 98.3% ± 1.0% at 10 years (p< 0.05). The freedom from structural valve deterioration for mitral valve replacement was for patients 41 to 50 years, 91.7% ± 8.0% at 7 years; 51 to 60 years, 85.9% ± 9.9% at 8 years; 61 to 70 years, 86.3% ± 6.8% at 8 years; and older than 70 years, 93.9% ± 4.8% at 8 years (not significant). Conclusions. The Medtronic Intact porcine bioprosthesis has acceptable freedom from structural valve deterioration in both the aortic and mitral positions approaching 10 years of evaluation.