Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Kiel, Germany.
Department of Radiology and Neuroradiology, University Hospital of Schleswig-Holstein, Kiel, Germany.
Eur J Vasc Endovasc Surg. 2020 Jun;59(6):983-989. doi: 10.1016/j.ejvs.2020.01.016. Epub 2020 Feb 13.
To compare the percutaneous Rotarex and Angiojet thrombectomy devices with regard to effectiveness and in vitro safety.
The Rotarex and Angiojet devices were evaluated in an established in vitro pulsatile flow model with a human femoropopliteal vessel phantom. First pass recanalisation and thrombus weight were assessed after thrombectomy, as well as micro- and macro-emboli. Further, histological evaluation of the vascular phantom was performed to analyse vascular injuries.
Thrombus weight did not differ significantly prior to the thrombectomy between the groups, but the Rotarex showed slight advantages in thrombus removal vs. the Angiojet regarding first pass recanalisation. Micro- and macro-emboli occurred in most of the endovascular manoeuvres performed; however, significantly more macro-emboli (2.37 ± 1.51 vs. 0.87 ± 0.83; p = .048) were observed using the Rotarex than the Angiojet. Macroscopic dissections were detected in the Rotarex group (n = 3) but not in the Angiojet group. Microscopic vascular injuries were detected significantly more often in the Rotarex group (Rotarex: 531.61 μm ± 102.81 μm; Angiojet: 705.42 μm ± 61.68 μm [p = .001]).
Both devices showed a comparable performance, with a slight advantage for the Rotarex regarding first pass recanalisation. Significantly more thrombo-emboli, and vascular injuries were observed in the Rotarex group with the latter being obviously the more tissue preserving procedure but potentially with a lower rate of recanalisation. Based on the present results, clinical randomised trials, including long term follow up, are needed to optimise and improve the use of catheter based procedures, taking into account the thrombus entity, localisation, and clinical history.
比较经皮旋切 Rotarex 和 Angiojet 血栓切除术设备的有效性和体外安全性。
在一个使用人股腘血管模型的既定脉动流模型中评估 Rotarex 和 Angiojet 设备。血栓切除术后评估初次再通率和血栓重量，以及微栓子和栓子。此外，对血管模型进行组织学评估，以分析血管损伤。
血栓切除术前，两组血栓重量无显著差异，但 Rotarex 在初次再通方面稍优于 Angiojet。在大多数血管内操作中都发生了微栓子和栓子；然而，使用 Rotarex 时，栓子明显多于 Angiojet（2.37±1.51 比 0.87±0.83；p=0.048）。Rotarex 组（n=3）检测到宏观夹层，但 Angiojet 组未检测到。Rotarex 组的微观血管损伤明显多于 Angiojet 组（Rotarex：531.61μm±102.81μm；Angiojet：705.42μm±61.68μm [p=0.001]）。
两种设备的性能相当，Rotarex 在初次再通方面略有优势。Rotarex 组观察到的血栓栓子和血管损伤明显更多，但后者显然是一种保留组织的更有效方法，但再通率可能较低。基于目前的结果，需要进行包括长期随访在内的临床随机试验，以优化和改进基于导管的治疗方法，同时考虑到血栓实体、定位和临床病史。
