Long-Term Safety and Performance of a National Pericardium Organic Valvular Bioprosthesis in the Brazilian Public Health System: Retrospective Analysis Up To 26 Years of Follow-up.

Objective: To evaluate the long-term performance of a bovine pericardium valve prosthesis in individuals who required valve replacement in the Brazilian public health system.

Methods: Medical records of patients having mitral or aortic valve replacement with bovine pericardium valve prostheses between 1978 and 1994 at a Brazilian hospital were reviewed in this retrospective study. Safety was assessed through the complications and serious adverse events rates in the early and long terms. Successful valve replacement was defined by absence of complications and serious adverse events up to 30 days after surgery.

Results: A total of 439 surgeries were performed in 382 patients with a mean age of 46.45 ± 13.93 years. Mean follow-up time was 6.26 years (up to 26.13 years). Rheumatic etiology was present in 83.5% of the cases. Mitral valve replacement was the most performed surgery. Five complications in five patients were recorded up to 30 days after surgery, and the rate of serious adverse events for the same period was 10.3%. Successful valve replacement rate was 90.7%. Postoperative complications were reported during the follow-up period in 29.6% of the procedures, being calcification the most common with 17.3%.

Conclusions: Despite the young age of the patients, safety outcomes were in accordance with what is reported in the literature for bioprostheses, with acceptable complication, serious adverse events, and freedom from reintervention rates.