The Medtronic Intact bioprosthesis: clinical and hemodynamic performance over 13 years

Abstract

We evaluated our results over 13 years with the aortic-position Medtronic Intact bioprosthesis. Our study involved 91 consecutive patients with isolated aortic valve replacement with the Medtronic Intact bioprosthesis. The follow-up was complete for 95%. Mean follow-up was 6.61 years (range 16 days-13 years), 590 patient years. Early mortality rate was 3.3%. Late mortality was 23 patients. Survival at 13 years was 53.52% (SD = 7.63%). The linearized rate of major thromboembolism was 0.34% per patient year; rate of major bleeding events was 0.33% per patient year. The rate of nonstructural dysfunction was 0.16% per patient year. Rate of reoperation was 0.53% and rate of structural valve deterioration was 0.16% per patient year. New York Heart Association (NYHA) postoperative classes were I to II in 92.21%. Gradients were as follows: 21 to 23.87 mm Hg, 23 to 18 mm Hg, 25 to 15.5 mm Hg, and 27 to 16.50 mm Hg. Structural valve deterioration was low during the 13 years of follow-up. Valve gradients and areas remained the same over the follow-up period. The Medtronic Intact bioprosthesis shows excellent clinical and hemodynamic performance at 13 years of follow up.