在治疗外周血管疾病中使用 5×300mm Proteus 栓塞捕获扩张球囊的初步经验。

Initial experience with the 5 × 300-mm Proteus embolic capture angioplasty balloon in the treatment of peripheral vascular disease.

机构信息

Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.

出版信息

J Endovasc Ther. 2012 Dec;19(6):826-33. doi: 10.1583/JEVT-12-3960MR.1.

DOI:10.1583/JEVT-12-3960MR.1

PMID:23210883

Abstract

PURPOSE

To describe the use of the 5 × 300-mm Proteus embolic capture angioplasty (ECA) balloon catheter to reduce embolic burden in complex TASC II (TransAtlantic Inter-Society Consensus) C and D femoropopliteal interventions.

METHODS

A non-randomized safety and feasibility study was conducted at 2 centers enrolling 15 subjects (9 women; mean age 72.5 ± 9.5 years, range 53-85) suffering from Rutherford-Becker category 2 to 4 occlusive disease. Of the 20 lesions in 15 limbs, 16 were TASC II D and 4 were TASC II C. Average baseline stenosis was 95%± 12%; 16 lesions were totally occluded. Half of the lesions were de novo, 5 were restenotic, and 5 were in-stent stenoses. Average lesion length was 284 ± 50 mm. In addition to using the ECA device, 18 of the target lesions were treated with stents and 4 with rotational thrombectomy devices. Distal angiography was performed before and after use of the ECA device to locate any periprocedural embolic events.

RESULTS

Procedural success was achieved in 100% lesions. The ECA balloon was used for predilation in 11 lesions and for postdilation in 9. No distal embolization or flow-limiting vessel dissections were observed despite the complex nature of the cases. Three non-device-related complications were reported (pseudoaneurysm, myocardial infarction, acute renal failure) and resolved without sequelae within 30 days. Analysis of the particles recovered from 5 ECA balloons demonstrated a mean 257 ± 185 particles, with a mean major axial dimension of 0.54 ± 0.04 mm (range 0.11-7.54). There were a mean 7.67 ± 6.03 particles >2 mm in diameter, and all samples contained 1 to 3 particles >4 mm in diameter.

CONCLUSION

In this small series, the 5 × 300-mm ECA embolic capture balloon catheter was an effective tool for avoiding embolic events in long peripheral lesions, with a good safety profile. The device might be considered as part of routine clinical practice for complex TASC II C/D femoropopliteal lesions.

摘要

目的

描述使用 5×300mm Proteus 栓塞捕获球囊导管减少复杂 TASC II（跨大西洋血管外科学会共识）C 和 D 股腘动脉病变介入治疗中的栓塞负荷。

方法

在 2 个中心进行了一项非随机安全性和可行性研究，共纳入 15 名受试者（9 名女性；平均年龄 72.5±9.5 岁，范围 53-85 岁），患有 Rutherford-Becker 2-4 级闭塞性疾病。在 15 条肢体的 20 个病变中，16 个为 TASC II D，4 个为 TASC II C。平均基线狭窄率为 95%±12%；16 个病变完全闭塞。一半的病变为新发，5 个为再狭窄，5 个为支架内狭窄。平均病变长度为 284±50mm。除使用 ECA 装置外，18 个目标病变还使用了支架，4 个使用了旋转血栓切除术装置。在使用 ECA 装置前后进行远端血管造影，以定位任何围手术期栓塞事件。

结果

100%的病变均获得了手术成功。ECA 球囊用于预扩张 11 个病变，后扩张 9 个病变。尽管病例复杂，但未观察到远端栓塞或限制血流的血管夹层。报告了 3 例与器械无关的并发症（假性动脉瘤、心肌梗死、急性肾衰竭），并在 30 天内无后遗症消退。对 5 个 ECA 球囊回收的颗粒进行分析，平均每个球囊有 257±185 个颗粒，平均主要轴向直径为 0.54±0.04mm（范围 0.11-7.54）。平均有 7.67±6.03 个直径大于 2mm 的颗粒，所有样本均含有 1-3 个直径大于 4mm 的颗粒。