Cardiologia Clínica e Experimental
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Twenty Year Patient Survival and 17 Year Complications of Isolated Mitral Biocor Standard Porcine Valve

Giulio Rizzoli*, Tomaso Bottio, Marina Comisso, Giuseppe Faggian, Aldo Milano and Gino Gerosa

Objective: Performance of the prostheses must be verified in the time domain. We report the 20-year survival of 230 patients operated of mitral replacement with Biocor Standard prosthesis in Padova and Verona and the 17 year prosthetic failure and complications of the series of Padova.

Methods: 230 patients, 150 females and 80 males, aged 71 ± 6.3 received 235 isolated mitral Prostheses in Verona (67) and Padova (168), between June 1989 and August 2004. Twenty-year survival including 1698 patient-years was complete. Prosthesis survival was evaluated in the patients of Padova with a 90% goodness of follow-up and included 905 patient-years.

Results: Twenty-seven operations were done in the eighties, 168 in the nineties, 52 in this century. Three operations were emergent, 20 urgent. The indication was prosthetic malfunction in 50 cases (21.7%), regurgitation in 114 (49.6%), stenosis in 22 (9.7%), mixed lesion in 44 (19.1%), concomitant CABG (Coronary Artery Bypass Graft) was performed in 23%. Overall survival was 6% (2-13%), Thirty day mortality was 8.9% (5.6-13.3%). The early hazard phase extended to 2.5 years with a linearized rate 1.4%/patient-years vs. a late rate of 7.2%/patient-years. Seventeen years freedom from reoperation was 80.5% (55.3-92.3%), actual 92% (86.4-94.5%), from SVD (Structural Valve Degeneration) 85.2% (52.6-96.1%) actual 94% (88.2-96.7%), from perivalvular leak 92.6% (86.5- 96%), from embolism 83.1% (73-89.7%), from haemorrhage 83.8% (71.5-91.1%), from endocarditis 90.9% (82.4- 95.4%), from pacemaker 77% (60.2-87.5%).

Conclusion: Mitral Biocor has optimal durability and average complications. Premature mortality (6% vs. 30% survival of US (United States) matched population) is unrelated to prosthesis performance and suggest failure of our surgical strategy of the past century.

Ultra mini abstract: 20 year Survival of patients is disappointing (6%) when compared to the matched US population (30%). The 17 year performance of the Biocor standard device compares with the best available prostheses. This therefore suggests an overall failure of our surgical strategy of the past century.