[Evaluation of a hemostatic device with percutaneous collagen application (VasoSeal) compared to a mechanical compression system (Compressar) after transfemoral catheterization of patients suffering from arterial occlusive disease]

Abstract

Purpose: Comparison of the efficacy of VasoSeal and a mechanical compression system (Compressar) for percutaneous hemostasis after femoral arterial catheterization of patients with arterial occlusive disease.

Materials and methods: 60 patients underwent either diagnostic angiography or interventional procedures. The level of anticoagulation, blood pressure, and activation clotting time were recorded, and the time to hemostasis after sheath removal was measured. VasoSeal application was considered "successful" if the compression time was less than two minutes. On the subsequent day as well as 4 months later, color coded Doppler ultrasound was performed to register treatment success and potential (late) complications.

Results: 57 patients qualified for inclusion in this study. In 21 of the 26 patients who underwent the procedure with the VasoSeal, immediate hemostasis was achieved within 1.75 minutes. In all 31 patients who had the Compressar applied, hemostasis was successful with a mean compression time of 17.4 minutes. Thus, VasoSeal significantly reduced hemostasis time irrespective of anticoagulation status, but it had a much higher incidence of minor local complications (bleeding, hematoma) compared to the control group (34.6 % vs. 5.8 %). The technical success was lower with VasoSeal than with Compressar (81 % vs. 100 %). Both groups had no severe or late complications.

Conclusion: According to our results, VasoSeal does not provide a suitable alternative compared to the effective, safe and cheap application of Compressar as a hemostatic device.