Bendszus M, Solymosi L
Department of Neuroradiology, University of Würzburg, Würzburg, Germany.
AJNR Am J Neuroradiol. 2006 Nov-Dec;27(10):2053-7.
Recanalization remains a major drawback in the endovascular treatment of intracranial aneurysms. Here, we report on our preliminary clinical experience with a new bioactive coil.
In a prospective study, 25 aneurysms were treated in 24 patients. Endovascular occlusion of the aneurysm was performed by using a novel polyglycol acid-loaded coil (Cerecyte). Mean aneurysm volume was 114.7 mm(3), with a mean dome height of 5.2 mm and a neck width of 2.8 mm. The primary goal of this study was to assess the safety of this new polymer-loaded coil in terms of periprocedural, technical, or angiographic complications. The secondary scope was to evaluate treatment efficacy regarding primary aneurysm occlusion, packing attenuation, and recanalization at follow-up angiography at 6 months.
There were no major technical or angiographic complications resulting in permanent morbidity. Complete initial occlusion of the aneurysm was accomplished in 17 patients, and a neck remnant was present in 8 patients. All aneurysms with complete initial occlusion remained stable at 6 months. Progression of a neck remnant without need for retreatment was noted in 2 patients, whereas 5 neck remnants turned to complete occlusion. Thus, complete occlusion rate at 6 months was 88%.
In this preliminary study the use of Cerecyte coils was safe, with an incidence of procedural complications comparable with that of bare platinum coils. Although most of the aneurysms in this study were small, the immediate and 6-month follow-up angiographic results are encouraging so that in our opinion, a larger clinical trial is warranted.
再通仍然是颅内动脉瘤血管内治疗的一个主要缺陷。在此,我们报告我们使用一种新型生物活性线圈的初步临床经验。
在一项前瞻性研究中,对24例患者的25个动脉瘤进行了治疗。使用新型载聚乙醇酸线圈(Cerecyte)对动脉瘤进行血管内闭塞。动脉瘤平均体积为114.7立方毫米,平均瘤顶高度为5.2毫米,颈部宽度为2.8毫米。本研究的主要目的是评估这种新型载聚合物线圈在围手术期、技术或血管造影并发症方面的安全性。次要目的是在6个月的随访血管造影中评估关于原发性动脉瘤闭塞、填塞衰减和再通的治疗效果。
未发生导致永久性致残的重大技术或血管造影并发症。17例患者实现了动脉瘤的完全初始闭塞,8例患者存在颈部残余。所有初始完全闭塞的动脉瘤在6个月时均保持稳定。2例患者颈部残余进展但无需再次治疗,而5处颈部残余转变为完全闭塞。因此,6个月时的完全闭塞率为88%。
在这项初步研究中,使用Cerecyte线圈是安全的,手术并发症发生率与裸铂线圈相当。尽管本研究中的大多数动脉瘤较小,但即时和6个月随访血管造影结果令人鼓舞,因此我们认为有必要进行更大规模的临床试验。