The new Labcor-Santiago pericardial bioprosthesis

The Labcor-Santiago pericardial valve has been designed to minimize mechanical stress and to avoid abrasion wear, at the same time preserving the concept of mounting the pericardium outside the posts for full orifice opening. The new design has preserved the traditional superior hemodynamic performance of pericardial valves, avoiding abrasion by careful padding of the stents and introducing a new concept of cusp attachment in order to increase mechanical durability. Since June 1990, 40 patients received 46 Labcor-Santiago valves: 29 in the aortic position and 17 in the mitral position. Mean age was 65.6 years. Eighty percent of the patients were women. New York Heart Association Functional Class III-IV was present in 76% of patients. Hospital mortality has been 12.5%, with 31% undergoing concomitant procedures. No anticoagulation was administered and there has been one thromboembolic event. Echo-Doppler assessment yielded the following in the aortic position: effective orifice area for 19-mm size = 1 cm2; for 21-mm size = 1.2 cm2. Mean systolic gradient for 19-mm size = 14.7 mmHg; for 21-mm size = 11.2 mmHg. In the mitral position: effective orifice area for 27-mm size = 2 cm2; for 29-mm size = 2.3 cm2. Mean diastolic gradients for 27-mm size = 4.6 mmHg; for 29-mm size = 3.3 mmHg. The low-profile flexible stent, the streamlined shape without outside prosthetic material, and the anatomical sewing rim allow a comfortable implantation of the Labcor-Santiago valve, particularly in the small aortic annulus. It is hoped that this new design will contribute to an increase in in vivo mechanical durability.