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

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 Freedom™, 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 ± 3.5 mmHg (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.