模拟器训练在实施股动脉穿刺点ExoSealTM封堵止血系统操作的多中心对照研究

背景与目的：介入手术已成为血管外科的主要治疗手段，对于手术直接相关的股动脉穿刺点封堵处理是手术操作收尾的一个重要环节。鉴于国内外目前尚缺乏关于封堵止血系统模拟器训练应用效果的高级别证据，本研究旨在评估模拟器训练在实施股动脉穿刺点ExoSealTM封堵止血系统操作的临床应用效果以及在血管介入操作基础教学培训中的应用价值。方法：采用前瞻性对照设计，选择2020年5月—2020年10月7个中心的8名血管介入医师分别用两种不同方式进行封堵操作培训。4名血管介入医师通过阅读ExoSealTM说明书和观看视频进行培训（对照组），另4名血管介入医师的培训方式为在前者基础上增加专业人员指导下的模拟器使用（研究组）。培训结束后，在主诊医师监管下，每名医师对接受血管介入手术，并在股总动脉使用6 F鞘管的患者，采用ExoSealTM封堵止血系统对穿刺点进行封堵。两组医师各操作50例患者，比较两组的操作时间、出血量、器械成功率、股动脉栓塞发生率、二次干预率、24 h内发生血肿率。结果：研究组在ExoSealTM封堵止血系统操作中，所需的操作时间和出血量均少于对照组（24.50 s vs. 30.00 s，P=0.003；8.60 mL vs. 11.22 mL，P=0.019）。研究组的器械成功率（98.0%）高于对照组（96.0%），但差异无统计学意义（P=0.558）。两组均无动脉栓塞、二次干预和24 h内发生血肿情况。结论：ExoSealTM封堵止血系统模拟器的训练能够提高股动脉封堵的安全性和有效性。该模拟器的训练应常规用于血管介入操作的基础教学培训中。

Simulator training for femoral artery puncture site closure using ExoSealTM vascular closure device: a multicenter controlled study

Background and Aims: Interventional procedures have become the main part of vascular surgery practice. The closure of the femoral arterial puncture site directly related to the operation is an essential step at the end of surgical procedures. Considering the lack of high-level evidence on the application effect of the simulator training for occlusion and hemostasis system at home and abroad, this study aimed to evaluate the clinical application effect of the simulator training in implementation of femoral arterial puncture point closure using ExoSealTM vascular closure device and the application value of the simulator training in the basic teaching and training of vascular intervention operation. Methods: Using a prospective controlled design, 8 interventional vascular surgeons from 7 centers were selected during May 2020 to October 2020 to receive two different approaches for closure operation training. Four interventional surgeons were trained by reading the instructions of ExoSealTM vascular closure device and watching the videos (control group), and the training method for the other 4 interventional surgeons was the use of simulator under the guidance of professionals in addition to the training for control group (study group). After completion of the training, under the supervision of the attending surgeons, each participant performed puncture site closure using the ExoSealTM vascular closure device in patients undergoing endovascular interventional procedures and with 6-F sheaths in the common femoral artery. After this operation was performed in 50 cases by each group, the operative time, blood loss, equipment success rate, incidence of femoral artery embolism, secondary intervention rate and incidence of 24-h hematoma formation were compared between the two groups. Results: During the operation of ExoSealTM vascular closure device, the operative time and blood loss in study group were significantly less than those in control group (24.50 s vs. 30.00 s, P=0.003; 8.60 mL vs. 11.22 mL, P=0.019). The equipment success rate in study group (98%) was higher than that in control group (96%), but it did not reach a statistical significance (P=0.558). There were no arterial embolism, second intervention 24-h hematoma formation in both groups. Conclusion: The training of ExoSealTM vascular closure device simulator can improve the safety and effectiveness of femoral arterial puncture site sealing. The training of the simulator is recommended to be routinely used in the basic teaching and training of vascular intervention operation.