Ben-Dor Itsik, Craig Paige, Torguson Rebecca, Rogers Toby, Buchanan Kyle D, Pokharel Shreejana, Gai Jiaxiang, Okubagzi Petros G, Satler Lowell F, Pichard Augusto D, Baker Nevin C, Waksman Ron
Division of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States.
Interventional Cardiology, Excela Health Heart and Vascular Center, Greensburg, PA, United States.
Cardiovasc Revasc Med. 2018 Jun;19(4):418-422. doi: 10.1016/j.carrev.2018.03.007. Epub 2018 Mar 12.
Evaluate the safety of MynxGrip® for common femoral vein closure.
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.
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).
The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.
评估MynxGrip®用于股总静脉闭合的安全性。
这是一项多中心、随机、前瞻性研究，纳入208例计划通过股静脉途径进行诊断/介入操作的患者。患者按1:1随机分组，分别接受MynxGrip®（n = 104）或手法压迫（n = 104）进行静脉止血，使用5、6和7F鞘管。连续测量双侧小腿和大腿周长。患者随访至出院。两组基线特征无差异。
两组在静脉血栓形成方面无差异（0%，p = 1）。总体而言，穿刺部位小腿直径（-0.18±1.38cm，p = 0.18）或大腿直径（0.33±2.86，p = 0.81）均无显著变化。两组患者均未发生严重或轻微血管并发症、穿刺部位感染、神经损伤或需要输血的穿刺部位出血。手法压迫组和MynxGrip®组术后血红蛋白下降分别为-0.51±1.1与-0.64±1.3g/dL，p = 0.59。与手法压迫组相比，MynxGrip®组止血时间显著缩短，分别为0.12±0.89与7.6±5.7分钟（p < 0.001）。
MynxGrip®血管外密封剂用于股静脉穿刺部位闭合安全有效。
