MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study
MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study
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DOI：
10.1016/j.carrev.2018.03.007
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发表时间：
2018-06-01
影响因子：
1.7
通讯作者：
Waksman, Ron
中科院分区：
文献类型：
--
作者：
Ben-Dor, Itsik;Craig, Paige;Waksman, Ron
目的：评估 MynxGrip (R) 用于股总静脉闭合的安全性。方法和材料：这是一项多中心、随机、前瞻性研究，纳入了 208 名计划通过股静脉通路接受诊断/介入手术的患者。患者按照 1:1 的比例随机分配，接受通过 MynxGrip (R) (n = 104) 进行静脉止血或使用 5、6 和 7 Fr 鞘管进行手动压迫 (n = 104)。连续测量双侧小腿和大腿周长。对患者出院期间进行随访。两组之间的基线特征没有差异。结果：两组之间的静脉血栓形成没有差异（0%，p = 1）。总体而言，小腿入路部位（-0.18 +/- 1.38 cm，p = 0.18）或大腿直径（0.33 +/- 2.86，p = 0.81）没有显着变化。两组患者均未出现严重或轻微血管并发症、通路部位感染、神经损伤或需要输血的通路部位出血。手动加压组和 MynxGrip (R) 组的术前至术后血红蛋白下降分别为 -0.51 +/- 1.1 与 -0.64 +/- 1.3 g/dL，p = 0.59。与手动加压组相比，MynxGrip (R) 组的止血时间显着缩短，分别为 0.12 +/- 0.89 和 7.6 +/- 5.7 分钟 (p < 0.001)。结论：MynxGrip (R) 血管外密封剂对于股静脉通路部位闭合是安全有效的。 (C) 2018 Elsevier Inc. 保留所有权利。
Purpose: Evaluate the safety of MynxGrip (R) 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 (R) (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 themanual compression group and MynxGrip (R) group, respectively. Time to hemostasis, was significantly lower in the MynxGrip (R) group compared to themanual compression group with 0.12 +/- 0.89 vs. 7.6 +/- 5.7 min, respectively (p < 0.001).Conclusions: The MynxGrip (R) extravascular sealant is safe and effective for femoral venous access site closure. (C) 2018 Elsevier Inc. All rights reserved.