RESUMEN
BACKGROUND AND AIM OF THE STUDY: The BioPhysio bioprosthesis (Edwards Lifesciences LLC, Irvine, CA, USA) was designed to further improve the hemodynamic performance currently achieved by stented valves. A flexible Nitinol stent that preserves aortic root dynamics, thus maximizing the effective orifice area (EOA), is a key innovation of this prosthesis. The study aim was to provide a clinical evaluation of this new device. METHODS: Between December 2004 and August 2005, a total of 50 patients (27 males, 23 females; mean age 75.8 +/- 5.1 years; range: 55-84 years) received a BioPhysio aortic bioprosthesis. Clinical outcomes, EOAs, mean gradients and regression of left ventricular hypertrophy were evaluated echocardiographically at discharge, and at six, 12, 24, 36, 48, and 60 months after surgery. RESULTS: The 60-month follow up was complete for all patients. No patients died within 30 days of surgery, but the late mortality was 14% (n = 6). There was one sudden unexplained death. One patient developed endocarditis at two years after surgery and underwent reoperation. There were no cases of stroke or renal failure. The BioPhysio prosthesis showed a good hemodynamic performance, with a significant fall in mean gradient to 15.1 +/- 8.3 mmHg, a mean EOA of 1.5 +/- 0.7 cm2, and a mean ejection fraction of 61 +/- 7.2%. There were no cases of aortic regurgitation. The NYHA functional class was improved in all patients, and there was a significant reduction in the left ventricular mass index to 185.7 +/- 49.6 g/m2 at 24 months. CONCLUSION: The clinical performance of the BioPhysio aortic bioprosthesis is comparable to that of regular stentless aortic valves. However, clinical approval for the widespread use of this bioprosthesis was not obtained.