title: GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device.
abstract: OBJECTIVE
  The HydroSoft coil was developed as a finishing coil, ideally to be placed along the aneurysm neck to enhance intracranial aneurysm healing. The GEL THE NEC (Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil) multicenter registry was developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We report angiographic and clinical results of this prospective registry.
  
  
  METHODS
  GEL THE NEC was performed at 27 centers in five countries. Patients aged 21-90 years with a ruptured or unruptured aneurysm 3-15 mm in size were eligible for enrollment. The following variables were obtained: demographics/comorbidities, aneurysm geometry, adjunctive devices used, proportion of patients in whom HydroSoft coils were successfully placed, and long-term angiographic outcomes (graded by an independent core laboratory using the Modified Raymond Scale), and procedure-related adverse events. Predictors of good angiographic outcome were studied using χ2and t-tests.
  
  
  RESULTS
  A total of 599 patients with 599 aneurysms were included in this study. HydroSoft coils were successfully deployed in 577 (96.4%) patients. Procedure-related major morbidity and mortality were 0.5% (3/599) and 1.3% (8/599), respectively. The most common perioperative complications were iatrogenic vasospasm (30/599, 5.0%), thromboemboli (27/599, 4.5%), and aneurysm perforation (16/599, 2.7%). At last angiographic follow-up (mean 9.0±6.3 months), the complete occlusion rate was 63.2% (280/442) and near complete occlusion rate was 25.2% (107/442). The core laboratory read recanalization rate was 10.8% (46/425) and the retreatment rate was 3.4% (20/599).
  
  
  CONCLUSIONS
  Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%.
  
  
  BACKGROUND
  NCT01000675.
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.|Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Waleed
authors.initials: W
authors.lastname: Brinjikji
authors.affiliation: Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
authors.forename: Arun P
authors.initials: AP
authors.lastname: Amar
authors.affiliation: Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
authors.forename: Josser E
authors.initials: JE
authors.lastname: Delgado Almandoz
authors.affiliation: Department of Neurosurgery, Weil Cornel University, New York, New York, USA.
authors.forename: Orlando
authors.initials: O
authors.lastname: Diaz
authors.affiliation: Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
authors.forename: Pascal
authors.initials: P
authors.lastname: Jabbour
authors.affiliation: Department of Cerebrovascular and Stroke, Baptist Health System, Jacksonville, Florida, USA.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Hanel
authors.affiliation: Department of Radiology, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Hui
authors.affiliation: Department of Neurosurgery, Univeristy of Saskatchewan, Saskatoon, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Kelly
authors.affiliation: Department of Radiology, Baylor University, Dallas, Texas, USA.
authors.forename: Kennith D
authors.initials: KD
authors.lastname: Layton
authors.affiliation: Department of Neurosurgery, Western Michigan University, Kalamazoo, Michigan, USA.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Miller
authors.affiliation: Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
authors.forename: Elad
authors.initials: E
authors.lastname: Levy
authors.affiliation: Department of Radiology, Washington University School of Medicine, Saint Louis, Missouri, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Moran
authors.affiliation: Department of Radiology, Asan Medical Center, Seoul, Korea, Republic of.
authors.forename: Dae C
authors.identifier: http://orcid.org/0000-0003-1561-5596
authors.initials: DC
authors.lastname: Suh
authors.affiliation: Departments of Radiology and Neurosurgery, Stony Brook University Medical Center, Stony Brook, New York, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Woo
authors.affiliation: Department of Minimally Invasive Surgery, Edinburgh University, Edinburgh, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Sellar
authors.affiliation: Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Ho
authors.affiliation: Department of Radiology, University of Virginia, Charlottesville, Virginia, USA.
authors.forename: Avery
authors.initials: A
authors.lastname: Evans
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.|Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Kallmes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002533:Cerebral Angiography / Q000379:methods; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods / Q000592:standards*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000000981:diagnostic imaging* / Q000209:etiology; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
keywords: Aneurysm; Coil; Hemorrhage; Technology