Abstract
OBJECTIVES: This study reports the initial clinical and echocardiographic results of the Premium bioprosthetic aortic valve up to 4 years of follow-up. METHODS: Between October 2007 and July 2011, 121 consecutive patients were submitted for aortic valve replacement with the Premium bioprosthetic valve. The mean age was 68 ± 9 years and 64 patients were males. The patients were periodically evaluated by clinical and echocardiographic examinations. The mean follow-up was 21 months (min = 2, max = 48), yielding 217 patients/year for the analysis. RESULTS: The hospital mortality was 8%. Late survival at 3 years was 89% (95% CI: 81.9-93.3%), and 80% of the patients were in NYHA functional class I/II. The rates of valve-related complications were low, with a linearized incidence of 0.9%/100 patients/year for thromboembolic complications, 0% for haemorrhagic events and 0.9%/100 patients/year of bacterial endocarditis. There was no case of primary structural valve dysfunction. The mean effective orifice area was 1.61 ± 0.45 cm(2); mean gradient 13 ± 5 mmHg and peak gradient 22 ± 9 mmHg. Significant patient-prosthesis mismatch was found in only 11% of the cases. CONCLUSIONS: The Premium bioprosthetic aortic valve demonstrated very satisfactory clinical and echocardiographic results up to 4 years, similar to other commercially available, third-generation bioprosthetic valves.