TY - BOOK AU - Ben-Dor, Itsik AU - Buchanan, Kyle AU - Craig, Paige AU - Gai, Jiaxiang AU - Okubagzi, Petros AU - Pichard, Augusto D AU - Pokharel, Shreejana AU - Rogers, Toby AU - Satler, Lowell F AU - Torguson, Rebecca AU - Waksman, Ron TI - MynxGrip vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study SN - 1878-0938 PY - 2018/// KW - *Catheterization, Peripheral KW - *Femoral Vein KW - *Hemorrhage/pc [Prevention & Control] KW - *Hemostatic Techniques/is [Instrumentation] KW - *Vascular Closure Devices KW - Aged KW - Aged, 80 and over KW - Catheterization, Peripheral/ae [Adverse Effects] KW - Equipment Design KW - Female KW - Femoral Vein/dg [Diagnostic Imaging] KW - Hemorrhage/di [Diagnosis] KW - Hemorrhage/et [Etiology] KW - Hemostasis KW - Hemostatic Techniques/ae [Adverse Effects] KW - Humans KW - Male KW - Middle Aged KW - Pressure KW - Prospective Studies KW - Punctures KW - Time Factors KW - Treatment Outcome KW - MedStar Heart & Vascular Instituteon KW - Journal Article N1 - Available in print through MWHC library: 2002 - present N2 - CONCLUSIONS: The MynxGrip extravascular sealant is safe and effective for femoral venous access site closure; Copyright (c) 2018 Elsevier Inc. All rights reserved; 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; PURPOSE: Evaluate the safety of MynxGrip for common femoral vein closure; 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+/-1.38cm, 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+/-1.3g/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+/-5.7min, respectively (p<0.001) UR - https://dx.doi.org/10.1016/j.carrev.2018.03.007 ER -