Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis.

Porcine bioprostheses provide an excellent alternative to mechanical prostheses for heart valve replacement in patients unable to comply with systemic anticoagulation and in the elderly. Long-term results of this prosthesis, however, demonstrated identical survival and parallel event-free status, albeit at a lower rate than the mechanical valves. Some discrepancy exists as to the need for and duration of systemic anticoagulation in the bioprosthesis, and some evidence exists to contraindicate anticoagulation due to a higher late mortality rate in patients with an aortic bioprosthesis. The records of 561 patients having the Carpentier-Edwards bioprosthesis in the aortic position as an isolated valve procedure were reviewed. The overall rate of bioprosthetic failure events was low (0.23%/patient year) and the survival (5 year, 74.8 +/- 2.4%; 10 year, 52.9 +/- 4.9%) and event-free statistics (5 year, 67.9 +/- 2.6%; 10 year, 42.4 +/- 5.1%) were excellent. No gender difference was present. A vulnerable period for neurologic events was identified by hazard function whereby the incidence of stroke was high; these were increased in the patient variables of compromised ejection fraction (0.54; p < or = 0.003), older age (< or = 73 years; p < or = 0.02), and preoperative atrial fibrillation or paced rhythm (p < or = 0.01). This pattern was similar for both transient ischemic events and strokes and rapidly decreased over the first few months of the first year and the first few years of the 12-year follow-up. These patients were not routinely anticoagulated.(ABSTRACT TRUNCATED AT 250 WORDS)