The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil.

Autor:	Bendok BR; Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.; Department of Otolaryngology, Mayo Clinic, Phoenix, Arizona.; Department of Radiology, Mayo Clinic, Phoenix, Arizona.; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, Arizona.; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, Arizona., Abi-Aad KR; Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, Arizona.; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, Arizona., Ward JD; Department of Neurological Surgery, Northwestern University, Chicago, Illinois., Kniss JF; Department of Neurological Surgery, Northwestern University, Chicago, Illinois., Kwasny MJ; Department of Preventive Medicine, Feinberg School of Medicine, Chicago, Illinois., Rahme RJ; Department of Neurological Surgery, Northwestern University, Chicago, Illinois., Aoun SG; Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas., El Ahmadieh TY; Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas., El Tecle NE; Department of Neurological Surgery, Saint Louis University Hospital, St. Louis, Missouri., Zammar SG; Department of Neurological Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania., Aoun RJN; Department of General Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio., Patra DP; Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.; Precision Neuro-therapeutics Innovation Lab, Mayo Clinic, Phoenix, Arizona.; Neurosurgery Simulation and Innovation Lab, Mayo Clinic, Phoenix, Arizona., Ansari SA; Department of Radiology, Northwestern University, Chicago, Illinois., Raymond J; Laboratoire de Neuroradiologie Interventionnelle, Université de Montréal, Montreal, Canada., Woo HH; Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York., Fiorella D; Department of Radiology, Stony Brook University Hospital, Stony Brook, New York., Dabus G; Interventional Neuroradiology and Neuroendovascular Surgery, Miami Cardiac and Vascular Institute, Miami, Florida., Milot G; Département de Chirurgie, CHU de Quebec, Quebec City, Canada., Delgado Almandoz JE; Department of Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota., Scott JA; Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana., DeNardo AJ; Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana., Dashti SR; Department of Neurological Surgery Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky.
Jazyk:	angličtina
Zdroj:	Neurosurgery [Neurosurgery] 2020 May 01; Vol. 86 (5), pp. 615-624.
DOI:	10.1093/neuros/nyaa006
Abstrakt:	Background: Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. Objective: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). Methods: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. Results: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. Conclusion: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. (© Congress of Neurological Surgeons 2020.)
Databáze:	MEDLINE
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