Hirsch Joshua A, Bendok Bernard R, Paulsen Richard D, Cognard Christophe, Campos Jorge, Cronqvist Mats
Department of Radiology, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02214, USA.
J Vasc Interv Radiol. 2007 Dec;18(12):1487-94. doi: 10.1016/j.jvir.2007.07.020.
To report an interim analysis of the registry data and evaluate the performance of Trufill DCS Orbit coils in terms of the stability of initial aneurysmal occlusion.
From May 1, 2004, to February 1, 2006, 291 patients with ruptured or unruptured aneurysms were enrolled in a multiple-center global registry from 37 centers in the United States, Europe, and Latin America to be treated via endovascular embolization with Trufill DCS Orbit detachable platinum coils. Acute and long-term anatomic and clinical data were collected and evaluated.
Initially, complete obliteration was reported in 187 of 300 treated aneurysms (62.3%) for which data were available; one treated aneurysm had no initial occlusion data. At follow-up (<or=1 year), 99 aneurysms were assessed. For 56 aneurysms with initial complete obliteration, 49 (87.5%) remained stable. The overall grade of occlusion of 99 aneurysms remained stable or improved in 81 cases (81.8%). Recanalization was seen in 16.2% of aneurysms (15 cases of coil compaction and one case of aneurysm growth); two aneurysms (2.0%) had coil migration. Five aneurysms (5.1%) underwent repeat treatment.
The use of Trufill DCS Orbit coils for the endovascular occlusion of aneurysms allowed a favorable rate of initial complete obliteration, high packing density, and aneurysmal stability at follow-up as long as 1 year. Longer-term follow-up is needed to determine the long-term stability of aneurysmal occlusion.
报告登记数据的中期分析，并根据初始动脉瘤闭塞的稳定性评估Trufill DCS Orbit线圈的性能。
2004年5月1日至2006年2月1日，来自美国、欧洲和拉丁美洲37个中心的291例破裂或未破裂动脉瘤患者被纳入一项多中心全球登记研究，通过使用Trufill DCS Orbit可脱卸铂金线圈进行血管内栓塞治疗。收集并评估急性和长期的解剖学及临床数据。
最初，在有数据的300个治疗动脉瘤中，187个（62.3%）报告为完全闭塞；1个治疗动脉瘤无初始闭塞数据。在随访（≤1年）时，评估了99个动脉瘤。对于56个初始完全闭塞的动脉瘤，49个（87.5%）保持稳定。99个动脉瘤的总体闭塞等级在81例（81.8%）中保持稳定或改善。16.2%的动脉瘤（15例线圈压缩和1例动脉瘤增大）出现再通；2个动脉瘤（2.0%）发生线圈移位。5个动脉瘤（5.1%）接受了再次治疗。
使用Trufill DCS Orbit线圈进行动脉瘤的血管内闭塞，初始完全闭塞率良好，填塞密度高，随访长达1年时动脉瘤稳定性良好。需要更长时间的随访来确定动脉瘤闭塞的长期稳定性。
