Objective To report on an electronic database with longitudinal information on the use of bare platinum coils for the endovascular occlusion of cerebral aneurysms. We report here the final analysis of the data.
Methods From 1 May 2004 to 10 July 2007, a global registry was conducted at 36 centers in the USA, Europe and Latin America. 303 patients were enrolled, of whom 299 patients were treated with bare detachable platinum coils (mostly Trufill Detachable Coil System (DCS) Orbit coils). Short and long term anatomical and clinical data were collected. Logistic regression analysis was used to examine the association of selected patient characteristics to outcomes of recanalization and retreatment.
Results 313 aneurysms, ruptured and unruptured, were treated in the 299 patients. Follow-up data were available on 185 patients: 150 (81%) had a 3–6 month follow-up, 63 (34%) had a 1 year follow-up and five (3%) had a 2 year follow-up. This paper reviews the status of 185 patients with follow-up data available at this time. Immediately postprocedure, 114 (58%) aneurysms were completely obliterated, 40 (20%) residual neck, 23 (12%) residual aneurysm and 19 (10%) dog ear. Of 174 aneurysms in 167 patients with angiographic follow-up, 137 (79%) remained stable or improved, nine (5%) showed aneurysm regrowth, 26 (15%) showed compaction and two (1%) had migrated. At 3–6 months, 11 of the 174 (6%) aneurysms were re-treated.
Conclusion These results confirm previous outcome data of endovascular occlusion of cerebral aneurysms with Trufill DCS Orbit complex shaped detachable platinum coils. Complications related to the device were rare.
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* Participating centers and investigators are listed at the end of the manuscript (please see the Appendix).
Funding This study was supported by Cordis Neurovascular.
Competing interests Dr. Bernard R. Bendok has research grants from MicroVention, Inc., NIH and the Erika Keeny Foundation.
Ethics approval Each center obtained local approval or a waiver/exemption from its institutional review board or ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All clinical data obtained in the course of conducting the COMPLEX E-registry is the property of Codman Neurovascular.