MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study

Abstract

Purpose: Evaluate the safety of MynxGrip® for common femoral vein closure.

Methods and materials: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups.

Results: There was no difference between the groups for venous thrombosis, (0%, p = 1). Overall, there was no significant change in access site calf (-0.18 ± 1.38 cm, p = 0.18) or thigh diameter (0.33 ± 2.86, p = 0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51 ± 1.1 vs. -0.64 ± 1.3 g/dL, p = 0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12 ± 0.89 vs. 7.6 ± 5.7 min, respectively (p < 0.001).

Conclusions: The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.

Keywords: Randomized clinical trial; Vascular closure devices; Venous closure.