Long-Term Durability of the Sorin Soprano Aortic Bioprosthetic Valve—A Swedish Nationwide Study

Abstract Objectives Structural valve deterioration is an inherent limitation of bioprosthetic valves; however, the time it takes to develop varies depending on the valve model. The Sorin Soprano aortic bioprosthetic valve (Sorin Group/LivaNova, Milan, Italy) lacks reported long-term results. This study aims to establish the long-term durability of this bioprosthetic valve in a nationwide cohort. Methods All patients who had received the Soprano bioprosthesis during aortic valve replacement in Sweden between 2005 and 2013 were included in the study. Patient characteristics, outcomes, and echocardiographic data were collected using national registries and electronic medical records. Standardized guidelines were used to assess echocardiographic data for the presence of severe structural valve deterioration. Results A total of 1054 patients (mean age 73.3 years) were included, with 14.0% being ≤65 years at surgery. The Soprano bioprosthesis represented 9.5% of all implanted bioprostheses. During a mean follow-up of 8.6 ± 4.5 years, 206 patients (19.5%) developed severe structural valve deterioration. The cumulative incidence of severe structural valve deterioration at 1, 5, 7, 10, and 15 years was 0.5%, 3.1%, 7.4%, 13.7%, and 22.1%, respectively, in the overall population. The cumulative incidence of structural valve deterioration-related reinterventions at 1, 5, 7, 10, and 15 years was 0%, 0.9%, 3.0%, 7.2%, and 11.5%, respectively. The 30-day mortality rate was 3.8%. Conclusions The Soprano bioprosthesis demonstrates high long-term rates of severe structural valve deterioration and deterioration-related reinterventions. These findings suggest the need for increased clinical vigilance and for more frequent echocardiographic monitoring in patients having received this bioprosthetic valve.