The Sorin Freedom Stentless Pericardial Valve: Clinical and Echocardiographic Performance at 10 years

OBJECTIVE: The Sorin Pericarbon Freedom (SPF) is a stentless valve made of pericardium clinically available in 1990. We report the clinical and hemodynamic performance of the SPF at 10 years. METHODS: From April 2000 to December 2005, 85 patients with a mean age of 75 ± 6 years (range 57-86), underwent aortic valve replacement (AVR) with an SPF. Mean left ventricular ejection fraction was 58 ± 10% (range 29-86%) and mean peak transvalvular gradient (PG) 86 ± 24 mmHg. Clinical evaluation was performed at 3, 6, 12 months, and yearly thereafter. RESULTS: There were 2 operative deaths (2.4%). Follow-up ranged from 2 to 135 months (mean 78 ± 32 months) and was 99% complete. There were 35 late deaths, 7 of which were valve-related, with an actuarial survival of 45 ± 8% at 10 years. Structural SPF deterioration occurred in 2 patients, with an actuarial freedom of 96 ± 3%. A total of 4 patients were re-operated, 2 because of structural deterioration, 1 because of endocarditis, and 1 because of sinotubular junction dilatation; freedom from reoperation was 93 ± 4% at 10 years. At last clinical control, 41 patients (89%) were in NYHA class I or II. Mean SPF effective orifice area varied from 1.55 ± 0.66 cm2 for size 21 mm to 2.33 ± 0.86 cm2 for size 27 mm; PG varied from 19 ± 10 mmHg for size 21 mm to 11 ± 6 mmHg for size 27 mm. Left ventricular mass index decreased from 213 ± 51 gm/m2 to 157 ± 436 gm/m2 (p<0.001). CONCLUSIONS: The SPF has demonstrated overall good results in terms of valve durability and freedom from valve-related complications up to 10 years, with excellent hemodynamic performance.