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GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device.
Brinjikji, Waleed; Amar, Arun P; Delgado Almandoz, Josser E; Diaz, Orlando; Jabbour, Pascal; Hanel, Ricardo; Hui, Ferdinand; Kelly, Michael; Layton, Kennith D; Miller, Jeffrey W; Levy, Elad; Moran, Christopher; Suh, Dae C; Woo, Henry; Sellar, Robin; Ho, Brian; Evans, Avery; Kallmes, David F.
Affiliation
  • Brinjikji W; Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
  • Amar AP; Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota, USA.
  • Delgado Almandoz JE; Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
  • Diaz O; Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
  • Jabbour P; Department of Neurosurgery, Weil Cornel University, New York, New York, USA.
  • Hanel R; Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
  • Hui F; Department of Cerebrovascular and Stroke, Baptist Health System, Jacksonville, Florida, USA.
  • Kelly M; Department of Radiology, Johns Hopkins University, Baltimore, Maryland, USA.
  • Layton KD; Department of Neurosurgery, Univeristy of Saskatchewan, Saskatoon, Canada.
  • Miller JW; Department of Radiology, Baylor University, Dallas, Texas, USA.
  • Levy E; Department of Neurosurgery, Western Michigan University, Kalamazoo, Michigan, USA.
  • Moran C; Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
  • Suh DC; Department of Radiology, Washington University School of Medicine, Saint Louis, Missouri, USA.
  • Woo H; Department of Radiology, Asan Medical Center, Seoul, Korea, Republic of.
  • Sellar R; Departments of Radiology and Neurosurgery, Stony Brook University Medical Center, Stony Brook, New York, USA.
  • Ho B; Department of Minimally Invasive Surgery, Edinburgh University, Edinburgh, USA.
  • Evans A; Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
  • Kallmes DF; Department of Radiology, University of Virginia, Charlottesville, Virginia, USA.
J Neurointerv Surg ; 10(1): 83-87, 2018 Jan.
Article in En | MEDLINE | ID: mdl-28138062
ABSTRACT
BACKGROUND AND

PURPOSE:

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. MATERIALS AND

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 χ2 and 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%. TRIAL REGISTRATION NUMBER NCT01000675.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Postoperative Complications / Intracranial Aneurysm / Registries / Embolization, Therapeutic / Endovascular Procedures Type of study: Clinical_trials / Etiology_studies / Evaluation_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: J Neurointerv Surg Year: 2018 Document type: Article Affiliation country: United States
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Postoperative Complications / Intracranial Aneurysm / Registries / Embolization, Therapeutic / Endovascular Procedures Type of study: Clinical_trials / Etiology_studies / Evaluation_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: J Neurointerv Surg Year: 2018 Document type: Article Affiliation country: United States