Clinical experience with the Carpentier-Edwards porcine xenograft

The first 101 patients to undergo aortic, mitral or double valve replacement with a Carpentier-Edwards bioprosthesis at the National Heart Hospital are reviewed. A total of 112 valves were replaced (69 aortic, 43 mitral), with an operative mortality of 12.9%. The 88 operative survivors were followed for up to 52 months. There were 9 thromboembolic episodes (3.9% per patient year), most of which were not confined to the early postoperative months. They were most common after mitral valve replacement (6.3% per patient year), particularly in the presence of atrial fibrillation. A low incidence of prosthetic endocarditis was noted, principally involving the valve in the aortic position. Three valves were removed for calcific degeneration and small structural defects were noted incidentally in 3 valves removed for other reasons. The possible etiology and significance of these is discussed. Seven of the 10 reoperations and 5 of the 9 late deaths were considered to be xenograft-related. Over a 4-year follow-up period there was a 9% incidence of valve-related deaths, an overall survival of 87% and a complication-free survival of 73%.