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.