Taqi M Asif, Quadri Syed A, Puri Ajit S, Fitzsimmons Brian F, Jin Jianhua Nancy, Rai Ansaar T, Given Curtis A, Masso Javier, Powers Ciaran J, English Joey D, Zaidat Osama O
California Institute of Neuroscience and Los Robles Hospital and Medical Center, Thousand Oaks, California, USA.
Department of Radiology, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Interv Neurol. 2018 Feb;7(1-2):53-64. doi: 10.1159/000481518. Epub 2017 Nov 15.
Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC.
The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients.
The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use.
BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.
球囊辅助弹簧圈栓塞术（BACE）和支架辅助弹簧圈栓塞术等辅助治疗在宽颈和大型颅内动脉瘤的治疗中发挥着重要作用。Transform™ 封堵球囊导管（TOBC）注册研究旨在评估使用TOBC进行BACE的安全性、有效性和效率。
TOBC注册研究是一项前瞻性多中心注册试验。美国的7个地点和西班牙的1个地点参与并纳入了81名患者。
基于对不同变量的评分评估了TOBC的性能和安全性。评分采用半定量评定量表（1 = 优秀，5 = 差）。这些变量的平均评分如下：透视下可见度为1.8；到达预定部位的能力为1.6；首次定位时的稳定性为1.5；充盈时的稳定性为1.6；放气时的稳定性为1.6；暂时阻断血流的能力为1.6；辅助弹簧圈栓塞的能力为1.7。平均充盈和放气时间分别为4.9秒和5.6秒。69.4%的BACE病例实现了动脉瘤的完全闭塞（Raymond I级）。4/81（4.8%）的病例发生了血栓形成。在所有病例中，血栓通过药物溶解，无患者发生梗死，蛛网膜下腔出血导致的潜在高凝状态被认为是一个促成因素。1/81（1.2%）的病例发生了血管破裂，但与TOBC的使用无关。
使用TOBC进行BACE是安全有效的。评估性能的所有变量均显示出良好至优秀的结果。
