✓From December 1990 to July 1995, the investigators participated in a prospective clinical study to evaluate the safety of the Guglielmi detachable coil (GDC) system for the treatment of aneurysms. This report summarizes the perioperative results from eight initial interventional neuroradiology centers in the United States. The report focuses on 403 patients who presented with acute subarachnoid hemorrhage from a ruptured intracranial aneurysm. These patients were treated within 15 days of the primary intracranial hemorrhage and were followed until they were discharged from the hospital or died.
Seventy percent of the patients were female and 30% were male. The patients' mean age was 58 years old. Aneurysm size was categorized as small (60.8%), large (34.7%), and giant (4.5%); and neck size was categorized as small (53.6%), wide (36.2%), fusiform (6%), and undetermined (4.2%). Fifty-seven percent of the aueurysms were located in the posterior circulation and 43% in the anterior circulation.
Eighty-two patients were classified as Hunt and Hess Grade I (20.3%), 105 Grade II (26.1%), 121 Grade III (30%), 69 Grade IV (17.1%), and 26 Grade V (6.5%). All patients in this study were excluded from surgical treatment either because of anticipated surgical difficulty (69.2%), attempted and failed surgery (12.7%), the patient's poor neurological (12.2%) or medical (4.7%) status, and/or refusal of surgery (1.2%).
The GDC embolization was performed within 48 hours of primary hemorrhage in 147 patients (36.5%), within 3 to 6 days in 156 patients (38.7%), 7 to 10 days in 71 patients (17.6%), and 11 to 15 days in 29 patients (7.2%). Complete aneurysm occlusion was observed in 70.8% of small aneurysms with a small neck, 35% of large aneurysms, and 50% of giant aneurysms. A small neck remnant was observed in 21.4% of small aneurysms with a small neck, 57.1% of large aneurysms, and 50% of giant aneurysms. Technical complications included aneurysm perforation (2.7%), unintentional parent artery occlusion (3%), and untoward cerebral embolization (2.48%). There was a 8.9% immediate morbidity rate related to the GDC technique. Seven deaths were related lo technical complications (1.74%) and 18 (4.47%) to the severity of the primary hemorrhage.
The findings of this study demonstrate the safety of the GDC system for the treatment of ruptured intracranial aneurysms in anterior and posterior circulations. The authors believe additional randomized studies will further identify the role of this technique in the management of acutely ruptured incranial aneurysms.