Background: The study aim was to investigate the hemodynamic behavior over time and ease of implant and durability of the Sorin Pericarbon Freedom (SPF)® stentless pericardial aortic xenograft.
Methods: Between March 2003 and April 2010, a total of 251 consecutive, non-selected patients (mean age 70.1 years; range: 17-89 years; 17.1% aged >80 years) received a SPF bioprosthesis as an aortic valve substitute at the authors' institution. All implantations were performed by a single surgeon using a classical, double-line, subcoronary implant technique. Of these patients. 108 (43%) underwent a concomitant procedure. The mean logistic EuroSCORE was 8.3. Patients were followed for complications and hemodynamic evaluation. Echocardiographic controls and clinical data were obtained at discharge, and at six months' and eight years' follow up.
Results: The in-hospital/30-day mortality was 1.2% for the entire group, but 0% for patients with isolated valve replacement. A total of 27 deaths had occurred at the time of the last follow up (22 were due to non-cardiac causes). At follow up (mean 3.7 years; range: 0-7.8 years), 91.1% of survivors were in NYHA classes I or II. Freedom from reoperation and from structural valve deterioration was 96.0% and 96.8%, respectively, at 7.8 years. The mean pressure gradient of the series (measured using echocardiography) was 10.3 ± 4.5 mmHg at discharge, and 8.3 ± 4.5mmHg at the time of the last follow up. The mean effective orifice area was 1.85 ± 0.70 cm2 for the entire series, and there was an absence of prosthesis-patient mismatch in 90% of patients.
Conclusions: The study results confirmed the favourable hemodynamic behavior, low risk of implantation and acceptable durability of the pericardial stentless SPF aortic prosthesis. The data also endorsed use of the SPF as an aortic valve substitute, even in a young and active population, and particularly in the presence of a small aortic annulus. The accuracy of implantation remains a crucial factor for durability and subsequent satisfactory hemodynamic performance. A longer follow up would provide further information with regards to complications and durability of the SPF prosthesis.