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

Autor: Guilherme Dabus, Shervin R. Dashti, Maria Cortes, Thomas Grobelny, Josser E Delgado Almandoz, Sudhakar R Satti, Erol Veznedaroglu, Mahesh V Jayaraman, Ankur Garg, Alan S. Boulos, Joshua A Hirsch, John A. Scott, Samer G. Zammar, Sean D. Lavine, Athos Patsalides, Johnathan Hartman, Richard P. Klucznik, Jeffrey S Carpenter, Jean Raymond, Devi P. Patra, Imran Chaudry, Roberts James, Charles E. Romero, Brian van Adel, Andrew J. Denardo, Tarek Y. El Ahmadieh, Ramanchandra Tummala, David Fiorella, Josser Delgado, Muhammad S Hussain, Gaurav Jindal, Michael Kelly, Geneviève Milot, Bernard R. Bendok, Felipe C. Albuquerque, Eric Sauvageau, Sung Lee, Mary J. Kwasny, Pascal Jabbour, Henry H. Woo, Hormozd Bozorgchami, Rudy J. Rahme, Ciaran J. Powers, Andrew R. Xavier, Hilal A Kanaan, Dennis Wang, George Luh, Sameer Ansari, Salah G. Aoun, David Kalmes, Jennifer D. Ward, Christopher J. Moran, Najib E. El Tecle, Rabih G. Tawk, Jai Jai Shiva Shankar, Sameer A. Ansari, Aditya S. Pandey, Rami James N. Aoun, Karl R. Abi-Aad, Shervin Dashti, Eric M. Deshaies, Jason F. Kniss, Avery J. Evans, Jeremy D. Fields
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
medicine.medical_treatment
HydroCoil Embolic System
Neuros/2
Aneurysm
Ruptured
030218 nuclear medicine & medical imaging
law.invention
0302 clinical medicine
Postoperative Complications
Randomized controlled trial
law
Recurrence
Occlusion
Clinical endpoint
Embolization
Bare platinum coil
Endovascular
Endovascular Procedures
Hydrogels
Middle Aged
Embolization
Therapeutic
Treatment Outcome
Retreatment
cardiovascular system
Female
Adult
medicine.medical_specialty
AcademicSubjects/MED00930
03 medical and health sciences
Aneurysm
medicine
Humans
cardiovascular diseases
Adverse effect
Research—Human—Clinical Trials
Aged
Platinum
business.industry
Surrogate endpoint
Coil embolization
Intracranial Aneurysm
medicine.disease
Surgery
Blood Vessel Prosthesis
Editor's Choice
Embolism
Neurology (clinical)
business
030217 neurology & neurosurgery
Zdroj: Neurosurgery
ISSN: 1524-4040
0148-396X
Popis: 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. VIDEO ABSTRACT
Databáze: OpenAIRE
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