Ten-year results of the Freedom Solo stentless heart valve: excellent haemodynamics but progressive valve dysfunction in the long term.

OBJECTIVES

Freedom Solo (FS) is a pericardial stentless heart valve showing excellent haemodynamic performance at mid-term. The aim of this study was to evaluate the long-term performance of such bioprostheses.

METHODS

Between December 2004 and November 2009, 109 patients (31 men; mean age 76 ± 6 years) underwent aortic valve replacement with FS. Preoperatively, the mean NYHA class was 2.5 ± 0.7, the mean EuroSCORE II, 2.8 ± 2.5. Mean prosthesis size was 22.7 ± 1.9 mm; concomitant procedures were performed in 65 patients. Structural valve deterioration (SVD) was diagnosed according to the Valve Academic Research Consortium-2 definition.

RESULTS

Two patients (1.8%) died within 30 days. Follow-up (72 ± 36 months) was 100% completed. The 1-, 5- and 10-year actuarial survival rates were 89, 73 and 42%, respectively, with 8 valve-related deaths; the actuarial freedom from SVD was 99, 93 and 76%. During 61 ± 39 months of follow-up, echocardiographic findings worsened progressively: At discharge, 3-5 and 7-9 years, the mean gradient was 8 ± 4, 12 ± 11 and 19 ± 19 mmHg ( P  < 0.01); the indexed effective orifice area was 1.0 ± 0.2, 0.9 ± 0.2 and 0.8 ± 0.3 cm 2 /m 2 ( P  < 0.01). Of the 13 patients who developed SVD, it was due to aortic stenosis in 11. SVD was a predictor of cardiovascular mortality at univariate analysis (HR 2.87, 1.12-7.29); 2 explanted prostheses showed massive calcium deposits with mean calcium and phosphorus contents of 234 ± 16 and 116 ± 7 mg/g dry weight, respectively.

CONCLUSIONS

The FS bioprosthesis shows excellent mid-term clinical and haemodynamic results and offers an alternative to other valves, particularly in the case of a small aortic annulus. Worsening of FS performance was observed at late follow-up because of progressive SVD with stenosis, questioning whether it should be used in patients with a long life expectancy.