Aortic valve replacement with the Mitroflow pericardial bioprosthesis: Durability results up to 21 years

Objective

The study aim was to analyze the performance profile of a large series of Mitroflow pericardial valves (Sorin Group Canada Inc. Mitroflow Division) in the very long term.

Methods

Data from 1513 patients with isolated aortic valve replacement who received pericardial bioprostheses between 1986 and 2007 were analyzed. Cumulative duration of follow-up was 6164 patient-years with a maximum duration of 21 years. Actuarial rates of valve-related events were calculated by the Kaplan–Meier method and the Cox multivariate analysis to identify independent determinants of outcome.

Results

Hospital mortality for elective surgery was 2.5%. Late death was 40.6%. Reoperation was required in 86 (5.7%) patients and was valve related in 83: structural valve deterioration in 64 (4.2%) patients, prosthetic valve endocarditis in 17 patients (1.1%), valve thrombosis in 1, and periprosthetic leak in 1. Rates of 20-year actuarial freedom from valve-related morbidity were as follows: structural valve deterioration 84.8% (actual 96.6%) in patients 70 years of age or older; thromboembolism 94.1%; and prosthetic valve endocarditis 96.8%. Twenty-year actual risk of reoperation for structural valve deterioration was 11.4% in all patients and 3.4%, in patients 70 years or age or older. Advanced age, renal insufficiency, pulmonary disease, and low body mass index were independent risk factors for late outcome (P < .001).

Conclusions

After 2 decades of follow-up, the Mitroflow pericardial aortic valve continues to be a valve of choice with a predictable low rate of valve-related events, particularly for patients over the age of 65 to 70 years and others with comorbidities.

Abbreviations and Acronyms: NYHA, New York Heart Association, CI, confidence interval, CL, confidence limits, OR, odds ratio, PVE, prosthetic valve endocarditis, SVD, structural valve deterioration, TE, thromboembolism

CTSNet classification: 35