Chait Jesse, Aurshina Afsha, Marks Natalie, Hingorani Anil, Ascher Enrico
1 Vascular Institute of New York, Brooklyn, NY, USA.
Vasc Endovascular Surg. 2019 Oct;53(7):558-562. doi: 10.1177/1538574419861768. Epub 2019 Jul 21.
Thrombolytic therapy is widely used in the treatment of arterial occlusions causing acute limb ischemia (ALI); however, knowledge regarding the efficacy of the different catheter systems available is scarce. The objective of this study was to compare the safety and efficacy of 2 catheter-directed infusion systems for intra-arterial thrombolysis in the setting of ALI.
A retrospective analysis was conducted to study all catheter-directed thrombolysis procedures performed over 32 months in patients diagnosed with ALI. Patients with thrombosis in both native arteries and bypass grafts were included. Patients with contraindications to thrombolysis, or those receiving thrombolysis for deep venous thrombosis, were excluded. The duration of thrombolysis, amount of thrombolytic agent, and technical success rate were recorded. Technical success was defined as complete or near-complete resolution of thrombus burden, allowing for further intervention. Data were stratified to include location of thrombus, procedural complications, mortality, and rates of limb loss.
Ninety-one patients met inclusion criteria. Among them, Uni-Fuse and EKOS catheters were used in 69 and 22 patients, respectively. The mean age of the population was 71 (standard deviation [SD]: ±1.5) for patients treated with the EKOS catheter and 70 years (SD: ±2.6) for patients receiving thrombolysis with Uni-Fuse. There was no significant difference in the mean infusion duration (1.65 vs 1.9 days), volume of tissue plasminogen activator (44.6 vs 48.2 mg), or technical success rate (72% vs 86%) between the Uni-Fuse and EKOS cohorts ( > .3). Furthermore, there was no difference in major limb loss or compartment syndrome between each group ( > .4). The overall complication rate was 14% in both groups, with a 30-day mortality rate of 4% when treated with either catheter system.
This study suggests that a standard multi-hole infusion catheter demonstrates similar clinical safety and efficacy as the ultrasound-accelerated EKOS system in the treatment of ALI.
溶栓疗法广泛应用于治疗导致急性肢体缺血（ALI）的动脉闭塞；然而，关于现有不同导管系统疗效的了解却很少。本研究的目的是比较两种导管定向输注系统在ALI情况下进行动脉内溶栓的安全性和疗效。
进行回顾性分析，研究在32个月内对诊断为ALI的患者进行的所有导管定向溶栓程序。纳入天然动脉和旁路移植物均有血栓形成的患者。排除有溶栓禁忌症的患者，或接受深静脉血栓形成溶栓治疗的患者。记录溶栓持续时间、溶栓剂用量和技术成功率。技术成功定义为血栓负荷完全或接近完全消退，以便进行进一步干预。数据分层包括血栓位置、手术并发症、死亡率和肢体丢失率。
91例患者符合纳入标准。其中，分别有69例和22例患者使用了Uni-Fuse导管和EKOS导管。接受EKOS导管治疗的患者平均年龄为71岁（标准差[SD]：±1.5），接受Uni-Fuse溶栓治疗的患者平均年龄为70岁（SD：±2.6）。Uni-Fuse组和EKOS组在平均输注持续时间（1.65天对1.9天）、组织纤溶酶原激活剂用量（44.6毫克对48.2毫克）或技术成功率（72%对86%）方面无显著差异（P>.3）。此外，两组之间在主要肢体丢失或骨筋膜室综合征方面也无差异（P>.4）。两组的总体并发症发生率均为14%，使用任一导管系统治疗时30天死亡率均为4%。
本研究表明，在治疗ALI时，标准的多孔输注导管与超声加速EKOS系统具有相似的临床安全性和疗效。
