Objective: Despite proven safety of endovascular coil embolization of intracranial aneurysms, the potential need for retreatment remains criticized. The goal of this prospective study was to assess the safety, durability, and effect on recanalization rates of the Cerecyte (Micrus Corp., Sunnyvale, CA) bioactive coil.
Methods: Two hundred twelve ruptured and unruptured aneurysms in 176 patients were prospectively enrolled in a database registry during a 12-month period. Adverse clinical outcomes directly attributed to the use of the Cerecyte coil were documented. Angiographic outcomes were determined immediately after coil embolization and during follow-up studies. All patients who received stent assistance or a non-Cerecyte coil were excluded. Two independent endovascular surgeons reviewed follow-up films. Any discrepancy was deemed a recurrence.
Results: After exclusion criteria, 81 patients with 89 aneurysms were available for a minimum of 6 months of follow-up. Of those 89 aneurysms, 65% were ruptured aneurysms and were treated in the acute setting. The mean size of the aneurysm was 7 mm. The mean angiographic follow-up period was 11.2 months. Recurrences requiring retreatment as a result of dome filling were identified in six aneurysms (6.7%). Four aneurysms (4%) developed compaction of more than 20%, which was defined as interstitial filling of the fundus. There was one thromboembolic event leading to permanent neurological deficit. No cases of chemical meningitis or delayed hydrocephalus occurred.
Conclusion: The Cerecyte bioactive coil seems to be safe and effective for use in both ruptured and unruptured aneurysms. The bioactive polymer within the coils allows similar handling characteristics of a bare platinum coil. Studies to assess long-term outcomes with direct comparison to platinum coils and alternative bioactive coils are warranted.