The Sorin Freedom Stentless Pericardial Valve: A Valid Benchmark For Current Percutaneous Devices

Objectives: Trans-catheter aortic valve implantation (TAVI) has emerged as an alternative to aortic valve replacement (AVR) for severe aortic stenosis. The majority of TAVI systems currently available incorporate pericardial stentless bioprostheses, with only short follow-up data available. Therefore information on long-term results of AVR with a stentless pericardial valve, such as the Sorin Freedom (SF), represents a valid benchmark. In this study we report the clinical and hemodynamic performance of SF with a 10-year follow-up. Methods: From January 2000 to December 2004, 78 patients, mean age 5.6±5.8 years, underwent AVR with SF. Sixteen (20.5%) were in NYHA class IV, 18 (23.1%) in III, 44 (56.4%) in class I or II. Mean ejection fraction (LVEF) was 58.11±11.16%. Echocardiographic evaluation was performed at 3, 12 months and yearly thereafter assessing effective orifice area (EOA), gradients (PG) and regression of left ventricular mass index (LVMi). Results: There was 1 operative death (1.2%). A total of 77 patients were discharged and followed for total follow-up of 5602 months (mean 70±25 months). There were 24 late deaths with an actuarial survival of 56±8.8% at 10 years. Three patients were reoperated, with a freedom from reoperation of 95±3% at 10 years, because of structural deterioration, endocarditis and dilatation of sinotubular junction, respectively. At last clinical control 47 patients (90%) were in NYHA class I or II and 5 patients (9%) were in NYHA class III. Mean EOA varied from 1.8±0.8cm2 for valve size21 to 2.3±0.6 cm2 for size27 and mean PG varied from 22±9 mmHg for valve size21 to 13±4 mm Hg for size27. LVMi decreased from 182.9±39.6gm/m2 to 142.1±42.6gm/m2 (p<0.001). Conclusions: SF stentless bioprosthesis has provided good results in terms of valve durability and freedom from valve-related complications with excellent hemodynamic performance at 10-year follow-up. These data represent important reference point against which performance of current TAVI systems must be compared.