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 |
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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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