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

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.