Ten year durability and performance of porcine bioprostheses

The results presented herein describe the prognosis over the first 10 postoperative years for patients operated upon at Stanford University Medical Center who received a first generation, commercially-manufactured porcine bioprosthetic valve. Extrapolation of these results to 15 and 20 years cannot be justified at this time. Conversely, newer tissue valves are believed to be superior, in terms of both hemodynamic performance and long-term durability. Indeed, the newer pericardial valves (Hancock Laboratories and American-Edwards Laboratories) have hemodynamic characteristics that do not differ markedly from those of the tilting disk and bi-leaflet mechanical valves. This promise of potential superior durability in terms of resistance to fibrocalcification will only be able to be determined after patients with these second and third generation tissue valves have been followed for 10 to 15 years postoperatively. Speculation regarding the comparative performance between a durable mechanical valve and a bioprosthesis in the 10 to 15 year time frame is also probably not prudent at this time. We continue to submit, however, that the balance between lower cumulative complication and death rates and finite durability--which currently favors the tissue valve at 10 years--will continue to predominate beyond ten years. This is due for the most part to the constant rate of serious (and frequently fatal) valve-related complications which occur in patients with mechanical valves over the years; having 20 to 40% of patients with mechanical valves succumb within 10 to 15 years due to the complications of TE, ACH, and valve thrombosis is not acceptable, in our opinion, as the magnitude of the risk associated with porcine valve PTF and resultant REOP is lower.(ABSTRACT TRUNCATED AT 250 WORDS)