MEDTRONIC-INTACT PORCINE BIOPROSTHESIS - CLINICAL-PERFORMANCE TO 7 YEARS

The clinical performance of the Medtronic Intact porcine bioprosthesis was evaluated in 1,084 patients (mean age 66.4 years, range 9 to 91 years) who had a total of 1,099 implantations between 1985 and 1992, inclusive. There were 709 aortic valve replacements, 297 mitral valve replacements, and 80 multiple valve replacements. Concomitant procedures were performed in 432 (39.3%). The age group distribution (years) was 35 or younger in 20 patients, 36 to 50 in 64, 51 to 64 in 274, 65 to 69 in 225, 70 or older in 500. The total follow-up time was 2,741 patient-years (mean, 2.5 years) and was 97.5% complete. The early mortality rate was 7.1% and late mortality was 3.9% per patient-year. The overall patient survival at 7 years was 70% +/- 3%. The freedom from major thromboembolism was 94% +/- 1% at 7 years (p = not significant for valve positions). The freedom from reoperation at 7 years was 93% +/- 1%; freedom from valve-related mortality was 89% +/- 2%. The freedom from structural valve deterioration at 7 years was 97% +/- 1% (aortic valve replacement 97% +/- 1%; mitral valve replacement 97% +/- 2%). The freedom from structural valve deterioration among age groups was not different for the overall population, aortic valve replacement, or mitral valve replacement. Hemodynamic assessment revealed obstructive properties for aortic valve replacement sizes of 21 and 23 mm and for mitral valve replacement sizes of 25 and 27 mm. The Medtronic Intact porcine bioprosthesis shows excellent freedom from structural failure at 7 years for all valve positions and age groups, but obstructive properties for small aortic and mitral valve sizes.