Long-term outcomes using the stentless LivaNova-Sorin Pericarbon Freedom™ valve after aortic valve replacement

Abstract

OBJECTIVES: Information on the long-term safety, efficacy and durability of third-generation stentless aortic valves is lacking. METHODS: In this single-centre, single-surgeon retrospective observational study, between 2003 and 2015, consecutive, non-selected aortic valve replacement (AVR) patients were implanted with the LivaNova-Sorin Pericarbon FreedomTM, a third-generation stentless aortic xenograft. Changes in clinical and echocardiographic parameters were examined, as were mortality, structural valve deterioration and reoperation, according to age at 5, 10 and 14 years. RESULTS: The mean logistic EuroSCORE was 8.5% in 22 AVR patients (mean age 68.3 years; range 15-89 years). Many patients [n = 139 (43%)] underwent a concomitant procedure. Before AVR, 68.0% of patients were in New York Heart Association (NYHA) Class I or II, and at discharge, mean gradient was 10.0 ± 4.3 mmHg. Follow-up lasted up to 8.9 ± 2.8 years. At the last follow-up, 95.6% of patients were in New York Heart Association Class I or II, the mean gradient was 8.0 ± 3.5mmHg (P < 0.001) and reduction in interventricular septum thickness and improvement of ejection fraction were significant (both P > 0.001). Early 30-day in-hospital mortality was 1.6% overall and 0% in the AVR-only population. Overall survival probability was 99.9%, 87.9% and 82.7% at 5, 10 and 14 years. Freedom from structural valve deterioration at 14 years was 67.5%, 88.9% and 68.2% in AVR patients overall, in those aged <70 years and in those aged 60-70 years, respectively. Freedom from reoperation at 14 years was 70.3%, 88.3% and 78.0% in the corresponding groups. CONCLUSIONS: Sorin Pericarbon Freedom is a valuable aortic bioprosthesis with favourable haemodynamics, particularly in smaller annuli, and durability similar to that of stented valves, which make Sorin Pericarbon Freedom a useful option in AVR.