Midterm Follow-Up of the Stentless Freedom Solo Bioprosthesis in 350 Patients.

Abstract

The stentless Freedom Solo aortic bioprosthesis is implanted supraannularly using one running suture line in the sinuses of Valsalva. We report our 9-year experience with this bioprosthesis. From April 2005 to July 2014, 350 consecutive patients at our institution underwent aortic valve replacement with the Freedom Solo bioprosthesis. Follow-up and echocardiographic data were collected retrospectively from referring cardiology centers. The mean age was 76 ± 6 years, 48% were male, and 46% underwent a concomitant procedure. Median EuroSCORE II was 3.0 (interquartile range, 1.9 to 4.9). Operative mortality was 5.1% for all procedures and 2.1% for isolated aortic valve replacement. The 1-, 5-, and 9-year overall survival was 92%, 74%, and 47%, respectively. At 6 years, freedom from structural valve deterioration and freedom from aortic valve reoperation were 98% and 96%, respectively. Prosthetic valve endocarditis occurred at a rate of 0.8% per patient-year. Permanent pacemaker implantation was necessary in 2.3% (n = 8), and moderate and severe prosthesis-patient mismatch occurred in 30 patients overall (9.6%). Postoperative maximum and mean valvular gradients were 17 mm Hg and 10 mm Hg, respectively, and remained stable during follow-up. Aortic valve replacement with the Freedom Solo is safe and has a low rate of permanent pacemaker implantations and prosthesis-patient mismatch. Survival is comparable to that with other aortic bioprostheses, and structural valve deterioration and aortic valve reoperation are infrequent during midterm follow-up. Hemodynamic performance is excellent, with low valvular gradients that remain stable during follow-up.