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PVSS23.  Propaten® Graft Generates No Systemic Effect On Markers Of Haemostasis Activation Or Detectable HIT-Inducing Antibodies In Humans

Jan M. M. Heyligers, Ton Lisman, Hence J. M. Verhagen, Cees Weeterings, Philip G. de Groot, Frans L. Moll.
University Medical Center Utrecht, Departments of Vascular Surgery and Haematology, Utrecht, Intl., Netherlands.

OBJECTIVES: Almost a third of patients do not have suitable veins making the use of prosthetic materials necessary in peripheral arterial bypass procedures. Prosthetic materials might cause platelet adhesion and activation of coagulation on the graft. One potential strategy to reduce this thrombogenicity is to covalently bind heparin to the endoluminal surface of grafts. The human in vivo study described here examines the systemic effects of the recently FDA approved Propaten® heparin coated graft, and addresses whether graft implantation results in: 1)A measurable reduction of systemic markers of haemostasis activation as compared to control grafts. 2) Antibody formation against heparin, potentially responsible for HIT (= heparin-induced thrombocytopenia), and if so, is the antibody titre of clinical relevance.

METHODS: Twenty patients undergoing femoro-popliteal bypass grafting were included in the study. Ten patients received a standard ePTFE Vascular Graft and 10 received a Heparin-bonded ePTFE Graft (Propaten® WL Gore) . Blood samples were drawn pre- and directly postoperatively and at days 1, 3, 5 and week 6 after surgery. Established markers of in vivo activation of platelets and blood coagulation (F1+2, FPA, sGPV, and D-Dimers) were measured using standard commercially available techniques. Furthermore, anti-PF4/heparin antibody titres were measured using a commercially available ELISA.

RESULTS: No statistical differences were observed in any of the markers of in vivo activation of platelets and blood coagulation between patients receiving Propaten® or control ePTFE. Moreover, no antibodies against heparin could be demonstrated up to six weeks after implantation.

CONCLUSIONS: No measurable effect of heparin immobilization on systemic markers of haemostasis were found using the Propaten® graft in vivo. Also, no auto-antibodies against heparin could be detected up to 6 weeks after implantation.