Single-center experience using the Freedom SOLO aortic bioprosthesis

Objective: This study reviews a single institution experience with the Freedom SOLO (Sorin Group, Saluggia, Italy) aortic bioprosthesis. Methods: Between October 2006 and February 2010, 128 patients (64 men, 64 women; mean age, 75.8 +/- 5.1 years) underwent aortic valve replacement using the Freedom SOLO stentless aortic valve. The follow-up time was 36.7 +/- 1.2 months and 100% complete. Results: Concomitant procedures were performed in 77 patients (60%). The mean standard European System for Cardiac Operative Risk Evaluation was 9 +/- 2.7. Grade 3 aortic stenosis was present in 73% of patients, mixed aortic stenosis and regurgitation were present in 40% of patients, and mitral regurgitation was present in 46% of patients. The mean crossclamp time was 53 +/- 12 minutes for isolated Freedom SOLO aortic valve implantation and 80 +/- 28 minutes for concomitant procedures, and the mean cardiopulmonary bypass time was 103 +/- 31 minutes. The mean implanted valve size was 22.6 +/- 1.4 mm. The mean intensive care unit and hospital stays were 2.4 +/- 1.1 days and 8.8 +/- 2.6 days, respectively. Three patients underwent reoperation for bleeding. The 15-day, 30-day, and perioperative mortality were all 4.6%. The 36-month survival was 95.4% +/- 1.6% for the cohort with a low European System for Cardiac Operative Risk Evaluation (<9) and 88.6% +/- 1.7% for the cohort with a high European System for Cardiac Operative Risk Evaluation (>9). Echocardiographic data preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively showed peak transvalvular gradients of 75 +/- 23, 17 +/- 6, 18 +/- 6.5, 16 +/- 6, and 16 +/- 9 mm Hg, respectively (P < .001), and a mean left ventricular end-diastolic diameter of 51 +/- 7, 50 +/- 6, 48 +/- 8, 47 +/- 6, and 46.5 +/- 7.5 mm, respectively (P < .05). There were only 3 cases of early mild aortic regurgitation (grade 1), which remained stable at 12 months. Conclusions: The Freedom SOLO stentless aortic valve has excellent early and intermediate-term results.