The medtronic intact porcine valve: ten-year clinical review

Our objective was to assess the long-term mortality and morbidity associated with the Medtronic Intact valve (Medtronic, Inc, Minneapolis, Minn).

Between 1983 and 1996, 447 patients (280 men and 167 women) received 466 Intact valves: 280 aortic, 156 mitral, and 30 tricuspid. The mean age was 57 years (median 63 years), with 45% younger than 60 years. The mean New York Heart Association class was 3.1. The follow-up was 98% complete and extended for 39 months (1-154 months) and 1324 patient-years. There were 32 valves at risk at 10 years after implantation. Doppler echocardiography was performed whenever possible in patients followed up for longer than 4 years (mean 8 years) after implantation.

Ten-year overall actuarial survival was 30% +/- 6% (14% +/- 7% for New York Heart Association classes IV-V and 39% +/- 8% for classes I-III). At 10 years freedom from infective endocarditis was 92% +/- 3%, freedom from thromboembolism was 80% +/- 5%, and freedom from nonstructural valve deterioration was 95% +/- 2%. Ten-year freedom from explantation was 64% +/- 6%, freedom from valve-related events was 51% +/- 6%, and freedom from valve-related death was 88% +/- 3%. There were 26 examples of structural valve deterioration, mainly caused by leaflet calcification (in 17 cases) and by buttress detachment (in 6 cases). In the aortic position at 10 years freedom from structural valve deterioration was 81% +/- 9%, but with only 1 event in patients older than 40 years (freedom 92% +/- 8%) and 100% freedom in patients older than 60 years. There was also 100% freedom from structural valve deterioration in the tricuspid position. In the mitral position freedom was 65% +/- 8%, with no significant difference between age groups.

The Intact valve provides superior results in the aortic position in patients older than 40 years and in the tricuspid position at all ages.