Aortic leaflet replacement with the new 3F stentless aortic bioprosthesis.

Abstract

Clinical trials with the new 3F stentless aortic bioprosthesis began October 2001, and as one of the first centers to implant this prosthesis in humans, we would like to present our experiences with this new device. The 3F aortic bioprosthesis is a stentless biological heart valve fabricated from three equal leaflets of equine pericardium, assembled in a tubular shape, and implanted in the native aortic root to replace the patient's diseased aortic leaflets. Between January 2002 and August 2002, 24 3F aortic bioprostheses were implanted at our institution. Effective orifice area, mean gradients, and ejection fraction were evaluated by echocardiography at discharge and at 12-month follow-ups after surgery. At 12-month follow-ups, the 3F bioprosthesis showed a good hemodynamic performance with a significant drop of mean gradients to 10.3 mm Hg, a mean effective orifice area of 1.7 cm2, and a mean ejection fraction of 61.5%. The clinical performance of the new 3F aortic bioprosthesis is comparable with regular stentless aortic valves. However its unique design facilitates implantation.