The mitral medical pericardial bioprosthesis: new generation bovine pericardial prosthesis.

Abstract

The Mitral Medical Mitroflow pericardial bioprosthesis was implanted in 99 operations (99 patients with 104 valves) between 1984 and 1987. The mean age of the patients was 62.8 years (range 28 to 94 years). The early mortality was 6.1% (including patients with concomitant procedures--coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 2.3% per patient-year. The total cumulative follow-up was 172 years. Thromboembolism (TE) was 4.1% per patient-year (fatal 1.2% per patient-year) (minor 2.3%; major 1.8%); antithromboembolic therapy-related hemorrhage (ATH) 0.6% (fatal 0.6%); prosthetic valve endocarditis (PVE) 0.6% (fatal 0%); periprosthetic leak (PPL) 0.6% (fatal 0%); clinical valve dysfunction (CVD) 1.2% (fatal 0%); and structural valve deterioration/primary tissue failure (SVD) 1.2% per patient-year (fatal 0% per patient-year). Thromboembolism was the significant complication. SVD occurred in two patients during the third year of evaluation. The overall patient survival was 89.2 +/- 3.3% at four years. The patients were classified as 91.9% NYHA functional Class III and IV preoperatively and 97.7% Class I and II postoperatively. The freedom at four years from TE was 88.5% +/- 4.9%; SVD 92.5 +/- 5.1%; and reoperation 89.8% +/- 5.3%. Freedom from all valve-related complications at four years was 76.8% +/- 6.6%; valve-related mortality 97.2 +/- 2.0%; mortality and reoperation (valve failure) 87.3% +/- 5.5%; mortality and residual morbidity (treatment failure) 95.5% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 85.6% +/- 5.7%. There were three valve-related deaths of a total of ten deaths (early 2; late 1) (TE 2; ATH 1; CVD 0; PVE 0; PPL 0; and SVD 0). Valve-related reoperation was performed in four patients (TE 0; CVD 0; PVE 1; PPL 1; and SVD 2). The Mitral Medical Mitroflow pericardial bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life.