Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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 (<= 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. CONCLUSIONS: 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.