Jensen, Mary E.

Background and Purpose: The HydroSoft coil was developed to be placed along the aneurysm neck to enhance intracranial aneurysm healing. In order to better understand the safety and efficacy of Hydrosoft coils in treating the aneurysm neck, the GEL THE NEC multicenter registry was developed. We report immediate angiographic and clinical results of this prospective registry. Methods: The GEL THE NEC study was undertaken at 30 centers in 5 countries. Patients aged 21-90 years with a ruptured or unruptured aneurysm 3-15 mm in size were eligible for enrollment. For each patient the following data were obtained: demographics and comorbidities, aneurysm geometry, use of adjunctive devices, immediate angiographic outcomes, and early (<30 days) adverse events. Postoperative anatomic results were graded by on-site neuroradiologists using the Modified Raymond Scale (Raymond 1=complete obliteration of aneurysm including the neck, Raymond 2=contrast filling the neck of the aneurysm without opacification of the aneurysm sac, Raymond 3=contrast filling the sac of the aneurysm). Predictors of good angiographic outcome were studied using chi-squared and t-tests. Results: A total of 571 patients with 571 aneurysms have been treated thus far in the study (196 ruptured, 375 unruptured). HydroSoft coils were successfully deployed in 549 (96.3%) of these patients. Adjunctive devices were used in 307 cases (53.8%) (212 balloon assistance, 89 stent). Aneurysmal occlusion rates were the following: 261 patients (47.3%) exhibited Raymond 1 occlusion, 257 patients (47.0%) had Raymond 2, and 29 patients (5.3%) had Raymond 3. Early post-operative stroke occurred in 10 patients (1.8%). Aneurysm perforation occurred in 11 patients (1.9%). Coil prolapse/migration occurred in 8 patients (1.4%). Early post-operative death occurred in 3 patients, all of whom presented with SAH (0.5%). Small aneurysm neck size was a significant predictor of good angiographic outcome (P=0.0003). Conclusions: Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in high rates of satisfactory occlusion (94.3%) and low rates of major clinical complications. Aneurysm neck size was a significant predictor of angiographic outcomes.