title: Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial.
abstract: OBJECTIVE
  To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device.
  
  
  METHODS
  The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0-43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0-40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms).
  
  
  CONCLUSIONS
  Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.
authors.affiliation: Department of Neurological Surgery, University of Washington, Seattle 98195, USA. jesk@u.washington.edu
authors.forename: J M
authors.initials: JM
authors.lastname: Eskridge
authors.forename: J K
authors.initials: JK
authors.lastname: Song
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017542:Aneurysm, Ruptured / Q000503:physiopathology / Q000628:therapy; D001488:Basilar Artery / Q000473:pathology*; D002423:Cause of Death; D002533:Cerebral Angiography; D002543:Cerebral Hemorrhage / Q000209:etiology; D002561:Cerebrovascular Disorders / Q000209:etiology; D015331:Cohort Studies; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000503:physiopathology; D006801:Humans; D015994:Incidence; D002532:Intracranial Aneurysm / Q000503:physiopathology / Q000628:therapy*; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012449:Safety; D015996:Survival Rate; D014481:United States; D014486:United States Food and Drug Administration