Background and purpose GEL THE NEC (GTN) was a multicenter prospective registry developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We compared the angiographic and clinical outcomes of aneurysms treated with balloon assisted coil embolization (BACE) versus unassisted coil embolization (CE) in the ruptured aneurysm cohort.
Materials and methods GTN was performed at 27 centers in five countries. Patients aged 21–90 years with a ruptured aneurysm 3–15 mm in size were eligible for enrollment. We analyzed demographics/comorbidities, aneurysm location, and geometry, including maximum diameter, neck size, and dome to neck ratio, immediate and long term angiographic outcomes (graded by an independent core laboratory using the modified Raymond Scale), and procedure related adverse events. Angiographic and clinical outcomes were studied using χ2and t tests.
Results Of the 599 patients in the GTN, 194 met the inclusion criteria. 84 were treated with BACE and 110 with CE. There were more prior smokers in the BACE group (p=0.01). The BACE group also had more vertebrobasilar aneurysms (p=0.006) and a larger mean neck size (p=0.02). More aneurysms were immediately completely occluded in the BACE group (p=0.02) Procedure- related major morbidity and mortality were no different between the techniques (p=0.4 and p=1, respectively).
Conclusions In this prospective ruptured aneurysm cohort from the GTN, BACE resulted in greater occlusion rates compared with unassisted CE with similar morbi-mortality.
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Contributors GD, WB, APA, JEDA, OMD, PJ, RH, FH, MK, KFL, JWM, EIL, CJM, DCS, HW, RS, BH, AE, and DFK made (1) substantial contributions to conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; and (2) drafting of the work or revising it critically for important intellectual content; and (3) final approval of the version to be published; and (4) are in agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding The study was funded by MicroVention.
Competing interests GD is a consultant and speaker for MicroVention. CJM, HW, FH, PJ, and OMD received research funding from MicroVention.
Ethics approval The study was approved by the institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data could be made available by contacting the corresponding author following IRB approval.