Cg. Bjorck et al., INCREASED THROMBOGENICITY AFTER POLYMER COATING - EXPERIENCES WITH THE FIRST VERSION OF A NEW WOVEN DACRON GRAFT FOR AORTIC RECONSTRUCTION, The European journal of surgery, 160(1), 1994, pp. 9-14
Objective. To assess the initial results of insertion of a new woven D
acron graft coated with a polymer for occlusive and aneurysmal aortoil
iac disease. Design: Open study. Setting: Four Swedish vascular surgic
al units. Subjects: 28 patients who required aortoiliac or aortofemora
l reconstruction between September 1988 and June 1989. Main outcome me
asures: Incidence of, and time to, occlusion; type of intervention; wh
ether the graft needed to be replaced; and mortality. Results: Two pat
ients died in the postoperative period, and five during follow-up, giv
ing an overall mortality of 25%. None of the tube grafts occluded but
17 of 24 bifurcation grafts did (71%), the median time to occlusion be
ing 126 days (range 10-820). Our results have led to this graft being
removed from the market while modifications are made in the process of
impregonation of polymer. Conclusions: Strict protocols for the asses
sment of new graft materials should be introduced and enforced.