Background and aim of the study: The Sorin Freedom SOLO valve is a third-generation stentless aortic valve which shows beneficial hemodynamic performance compared to stented bioprostheses. Long-term results regarding hemodynamics, the durability of the valve, and patient outcome are scarce, and their acquisition was the aim of this single-center study.
Methods: Between 2005 and 2006, a total of 68 consecutive patients (30 males, 38 females; mean age at surgery 76.1 ± 6.3 years) underwent aortic valve replacement with a Sorin Freedom SOLO prosthesis. Indications were aortic stenosis (n = 50), aortic regurgitation (n = 1) and mixed lesions (n = 17). Associated procedures were performed in 31 patients (45.6%), most of which were coronary artery bypass grafting (68.8 %). The follow up was performed by telephone interviews, and clinical and echocardiographic examinations. Morbidity, mortality and echocardiographic data were analyzed.
Results: The total follow up was 501.1 patient-years, with a mean follow up of 7.4 ± 3.4 years (maximum 11.2 years). The follow up was 100% complete. Hospital mortality was 4.4% (n = 3). Actuarial survival at five and 10 years was 76.5 ± 5.1% and 41.5 ± 6.5%, respectively. Reinterventions were performed in eight patients; these included three reoperations due to endocarditis, four transcatheter aortic valve implantations, and one reoperation due to structural valve deterioration (SVD). The overall freedom from valve reintervention due to SVD at five and 10 years was 97.8 ± 2.2% and 82.9 ± 7.5%, respectively. After eight years, echocardiography demonstrated peak and mean transvalvular gradients of 18 ± 11 and 10 ± 7 mmHg, respectively. The overall effective and indexed aortic valve orifice areas were 1.73 ± 0.58 cm2 and 0.92 ± 0.33 cm2/m2, respectively.
Conclusions: At long-term follow up the Sorin Freedom SOLO bioprosthesis was associated with favourable hemodynamic results and survival. Freedom from SVD was not superior to that occurring with stented bioprostheses.