068-I * Clinical and Haemodynamic Outcomes in 804 Patients Receiving the Freedom Solo Stentless Aortic Valve: Results From an International Prospective Multicentre Study

Objectives: The aim of this prospective, non-randomised, multicentre trial was to demonstrate the safety and effectiveness of the Freedom SOLO valve. Methods: From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.6 ± 6.3 years; 45.1% females; 91.4% in NYHA class II–III) underwent aortic valve replacement in 30 centres in Europe (18) and North America (6 US, 6 Canada). The cumulative follow-up was 1102 patient-years (mean 16.5 ± 10.8 months; range: 0–40.5 months). A total of 376 patients underwent concomitant procedures, with the majority of procedures being CABG (264 patients). Results: Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were classified as valve-related. The actuarial freedom from valve-related death was 99.0%, 98.8%, 98.3% and 95.5% at 6 months, 1, 2 and 3 years, respectively. At 3 years, hazard rates were 1.55%/patient-year for endocarditis, 0.73%/patient-year for non-structural valve dysfunction, 0.55%/patient-year for SVD, 1.27%/patient-year for major thromboembolisms, 1.73%/patient-year for valve explants. No cases of valve thrombosis were observed. NYHA class I and II was observed in 95.7%, 97%, 95.5% and 91.4% of patients at 3–6 months, 1, 2 and 3 years postoperatively, respectively. Mean gradients and increase in effective orifice area for each valve size were stable over the follow-up period (Table 1). The mean left ventricular mass index decreased from 137.6 g/m2 at discharge to 127.1 g/m2 at 3–6 months, 121.8 g/m2 at 12 months, 120.5 g/m2 and 126.4 g/m2 at 2 and 3 years. Postoperative echocardiographic data by valve size Conclusion: The excellent clinical and haemodynamic results confirm the safety and effectiveness of the Freedom SOLO valve.