دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil.
المؤلفون: 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.
مؤلفون مشاركون: HEAT Study Investigators
المصدر: Neurosurgery [Neurosurgery] 2020 May 01; Vol. 86 (5), pp. 615-624.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins, Inc Country of Publication: United States NLM ID: 7802914 Publication Model: Print Cited Medium: Internet ISSN: 1524-4040 (Electronic) Linking ISSN: 0148396X NLM ISO Abbreviation: Neurosurgery Subsets: MEDLINE
أسماء مطبوعة: Publication: 2022- : [Philadelphia] : Lippincott Williams & Wilkins, Inc.
Original Publication: Baltimore, Williams & Wilkins.
مواضيع طبية MeSH: Blood Vessel Prosthesis* , Hydrogels*, Embolization, Therapeutic/*instrumentation , Endovascular Procedures/*instrumentation , Intracranial Aneurysm/*therapy, Adult ; Aged ; Aneurysm, Ruptured/epidemiology ; Female ; Humans ; Male ; Middle Aged ; Platinum ; Postoperative Complications/epidemiology ; Recurrence ; Retreatment ; Treatment Outcome
مستخلص: 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.)
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معلومات مُعتمدة: UL1 TR001422 United States TR NCATS NIH HHS
فهرسة مساهمة: Investigator: S Ansari; E Deshaies; S Lavine; H Bozorgchami; J Delgado; E Veznedaroglu; F Albuquerque; D Fiorella; A Boulos; M Cortes; H Kanaan; G Jindal; R Klucznik; G Dabus; D Kalmes; R Tawk; J Raymond; C Romero; A Xavier; M Hussain; M Kelly; C Moran; I Chaudry; A Pandey; D Wang; B van Adel; G Milot; J Hirsch; J Carpenter; C Powers; P Jabbour; G Luh; J Shankar; R Tummala; A Patsalides; A Evans; A Garg; S Dashti; S Lee; R James; M Jayaraman; S Satti; E Sauvageau; J Fields; T Grobelny; J Hartman
Keywords: Bare platinum coil; Coil embolization; Endovascular; HydroCoil Embolic System; Intracranial aneurysm; Randomized controlled trial
سلسلة جزيئية: ClinicalTrials.gov NCT01407952
المشرفين على المادة: 0 (Hydrogels)
49DFR088MY (Platinum)
تواريخ الأحداث: Date Created: 20200221 Date Completed: 20201118 Latest Revision: 20210407
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC7534546
DOI: 10.1093/neuros/nyaa006
PMID: 32078692
قاعدة البيانات: MEDLINE
الوصف
تدمد:1524-4040
DOI:10.1093/neuros/nyaa006