University of Siena, Siena, Italy.
University of Siena, Siena, Italy.
Eur J Vasc Endovasc Surg. 2021 May;61(5):820-828. doi: 10.1016/j.ejvs.2021.01.004. Epub 2021 Feb 27.
The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce.
To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month.
One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively.
Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.
评估 Penumbra/Indigo 抽吸血栓切除术系统（Penumbra Inc.）在急性下肢缺血（ALLI）患者中的短期安全性和有效性。最近，类似于用于治疗急性缺血性中风的血管内真空辅助血栓切除术设备已可用于外周动脉，但数据仍然有限。
为了评估血管通畅性，提出了一种改良的血栓溶解治疗心肌梗死（TIMI）分类，称为 TIPI（外周缺血中的血栓抽吸）。TIPI 血流在就诊时、使用研究设备后立即以及所有辅助程序后进行评估。主要结局是使用研究系统进行血栓抽吸的技术成功率，定义为接近完全或完全再血管化 TIPI 2-3。在一个月时收集安全性和临床成功率。
共纳入 150 例患者。平均年龄为 72.4 岁，73.3%为男性。入组时的 Rutherford 分级为 I 级 16%、IIa 级 40.7%、IIb 级 43.3%，平均踝肱指数为 0.19。88.7%的患者达到主要技术成功（TIPI 2-3 级血流）。辅助程序包括慢性动脉粥样硬化病变的血管成形术/支架置入术（n=39）、溶栓（n=31）、带膜支架置入术（n=15）和补充性 Fogarty 血栓切除术（n=6）。在所有干预后，辅助性主要技术成功率为 95.3%（TIPI 2-3 级 143/150）。未报告全身性出血并发症或与器械相关的严重不良事件。在一个月的随访中，记录到 1 例死亡和 1 例膝下截肢。主要通畅率为 92%（150/150），再介入率为 7.33%，导致辅助性主要和次要通畅率分别为 94%和 99.33%。
INDIAN 登记处的结果表明，Indigo 系统的机械血栓切除术作为主要治疗方法，用于急性下肢缺血的血管再通是安全有效的。
