GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

Waleed Brinjikji; Arun P Amar; Josser E Delgado Almandoz; Orlando Diaz; Pascal Jabbour; Ricardo Hanel; Ferdinand Hui; Michael Kelly; Kennith D Layton; Jeffrey W Miller; Elad Levy; Christopher Moran; Dae C Suh; Henry Woo; Robin Sellar; Brian Ho; Avery Evans; David F Kallmes

doi:10.1136/neurintsurg-2016-012915

GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30.

Authors

Waleed Brinjikji^{1

2}, Arun P Amar³, Josser E Delgado Almandoz⁴, Orlando Diaz⁵, Pascal Jabbour⁶, Ricardo Hanel⁷, Ferdinand Hui⁸, Michael Kelly⁹, Kennith D Layton¹⁰, Jeffrey W Miller¹¹, Elad Levy¹², Christopher Moran¹³, Dae C Suh¹⁴, Henry Woo¹⁵, Robin Sellar¹⁶, Brian Ho¹⁷, Avery Evans¹⁸, David F Kallmes^{1

2}

Affiliations

¹ Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
² Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota, USA.
³ Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
⁴ Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
⁵ Department of Neurosurgery, Weil Cornel University, New York, New York, USA.
⁶ Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
⁷ Department of Cerebrovascular and Stroke, Baptist Health System, Jacksonville, Florida, USA.
⁸ Department of Radiology, Johns Hopkins University, Baltimore, Maryland, USA.
⁹ Department of Neurosurgery, Univeristy of Saskatchewan, Saskatoon, Canada.
¹⁰ Department of Radiology, Baylor University, Dallas, Texas, USA.
¹¹ Department of Neurosurgery, Western Michigan University, Kalamazoo, Michigan, USA.
¹² Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
¹³ Department of Radiology, Washington University School of Medicine, Saint Louis, Missouri, USA.
¹⁴ Department of Radiology, Asan Medical Center, Seoul, Korea, Republic of.
¹⁵ Departments of Radiology and Neurosurgery, Stony Brook University Medical Center, Stony Brook, New York, USA.
¹⁶ Department of Minimally Invasive Surgery, Edinburgh University, Edinburgh, USA.
¹⁷ Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
¹⁸ Department of Radiology, University of Virginia, Charlottesville, Virginia, USA.

PMID: 28138062
DOI: 10.1136/neurintsurg-2016-012915

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.

Keywords: Aneurysm; Coil; Hemorrhage; Technology.

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Publication types

Evaluation Study
Multicenter Study

MeSH terms

Adult
Aged
Aged, 80 and over
Cerebral Angiography / methods
Embolization, Therapeutic / adverse effects
Embolization, Therapeutic / methods
Embolization, Therapeutic / standards*
Endovascular Procedures / adverse effects
Endovascular Procedures / methods
Endovascular Procedures / standards*
Female
Follow-Up Studies
Humans
Intracranial Aneurysm / diagnostic imaging*
Intracranial Aneurysm / therapy*
Male
Middle Aged
Postoperative Complications / diagnostic imaging*
Postoperative Complications / etiology
Prospective Studies
Registries*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01000675