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水凝胶涂层与非水凝胶栓塞线圈在外周动脉应用中闭塞血管的前瞻性、多中心、随机试验。

Vessel Occlusion using Hydrogel-Coated versus Nonhydrogel Embolization Coils in Peripheral Arterial Applications: A Prospective, Multicenter, Randomized Trial.

机构信息

Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.

Department of Radiology, Oita University Faculty of Medicine, Oita, Japan.

出版信息

J Vasc Interv Radiol. 2021 Apr;32(4):602-609.e1. doi: 10.1016/j.jvir.2020.12.001. Epub 2021 Mar 4.

Abstract

PURPOSE

To evaluate the safety and effectiveness of hydrogel-coated coils for vessel occlusion in the body trunk.

MATERIALS AND METHODS

A total of 77 patients with various peripheral vascular lesions, treatable by embolization with coils, were randomized (hydrogel group, n = 38; nonhydrogel group, n = 39). In the hydrogel group, embolization of the target vessel was conducted using 0.018-inch hydrogel-coated coils (AZUR 18; Terumo Medical Corporation, Tokyo, Japan) with or without bare platinum coils. The nonhydrogel group received both bare platinum coils and fibered coils without the use of hydrogel-coated coils.

RESULTS

Complete target vessel occlusion was accomplished in 36 patients in the hydrogel group and 37 patients in the nonhydrogel group. No major adverse events were observed in either group. The median number of coils/vessel diameter and the median total coil length/vessel diameter were significantly larger in the nonhydrogel group than in the hydrogel group (P = .005 and P = .004, respectively). The median embolization length was significantly longer in the nonhydrogel group (31.95 mm) than in the hydrogel group (23.43 mm) (P = .002). If no expansion was assumed, the median packing density in the hydrogel group was 44.9%, which was similar to that in the nonhydrogel group (46.5%) (P = .79). With full expansion assumed, the median packing density in the hydrogel group was 125.7%.

CONCLUSIONS

Hydrogel-coated coils can be safely used for peripheral vascular coil embolization, and hydrogel-coated and conventional coils in combination allow for a shorter embolization segment and shorter coil length.

摘要

目的

评估水凝胶涂层线圈用于体腔血管闭塞的安全性和有效性。

材料与方法

共纳入 77 例接受线圈栓塞治疗的各种外周血管病变患者,随机分为水凝胶组(n=38)和非水凝胶组(n=39)。水凝胶组采用 0.018 英寸水凝胶涂层(AZUR 18;日本 Terumo 医疗公司)线圈或联合裸铂线圈栓塞目标血管;非水凝胶组仅采用裸铂线圈和纤维线圈,不使用水凝胶涂层线圈。

结果

水凝胶组 36 例、非水凝胶组 37 例患者完全闭塞靶血管。两组均未发生重大不良事件。非水凝胶组线圈/血管直径中位数和总线圈长度/血管直径中位数均显著大于水凝胶组(P=0.005 和 P=0.004)。非水凝胶组栓塞长度中位数显著长于水凝胶组(31.95 mm 比 23.43 mm)(P=0.002)。如果不考虑扩张,水凝胶组的中位堆积密度为 44.9%,与非水凝胶组(46.5%)相似(P=0.79)。如果假设完全扩张,水凝胶组的中位堆积密度为 125.7%。

结论

水凝胶涂层线圈可安全用于外周血管线圈栓塞,水凝胶涂层线圈与传统线圈联合使用可使栓塞段和线圈长度更短。

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