Aortic valve replacement using the Freedom SOLO stentless bioprosthesis: clinical and haemodynamic performance in 625 patients at medium-term follow-up.

Abstract

Our goal was to analyse the haemodynamic and clinical results after implantation of the Freedom SOLO stentless aortic valve replacement by assessing the immediate postoperative results regarding mortality, discharge echocardiographic gradients and reoperation rates and by evaluating these results in the medium term. This study was designed as a single-centre retrospective observational trial. Clinical and echocardiographic data were collected retrospectively from 625 patients undergoing an aortic valve replacement using the Freedom Solo stentless valve (LivaNova, London, UK) at the Sint-Jan Hospital, Bruges, between May 2009 and May 2017. The mean age of the patient was 76 ± 6.9 years. Early operative (30-day) mortality was 3.5% overall and 0.8% (n = 2) in patients having isolated aortic valve replacement. Early reinterventions were necessary in 3% of patients (n = 19). Permanent pacemaker implantation was performed in 3%. The mean postoperative peak gradient was 14.3 ± 8.14 mmHg, and the mean gradient was 7.5 ± 4.46 mmHg. Fourteen patients underwent explantation, 2 of which were for structural valve deterioration and 8 for endocarditis. Overall survival at 7 years was 55% [95% confidence interval (CI) 47-62]. At 7 years, freedom from reoperation overall, freedom from operation for endocarditis and freedom from operation for structural valve deterioration were 94% (95% CI 88-97), 97% (95% CI 94-99) and 98% (95% CI 90-99), respectively. The Freedom Solo stentless aortic valve has proved to be safe, with excellent clinical and haemodynamic results. Structural valve degeneration and explantation occur infrequently, illustrating good durability in the medium term.