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

Abstract

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. 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. 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). 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.