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

Bernard R. Bendok; Karl R. Abi-Aad; Jennifer D. Ward; Jason F. Kniss; Mary J. Kwasny; Rudy J. Rahme; Salah G. Aoun; Tarek Y. El Ahmadieh; Najib E. El Tecle; Samer G. Zammar; Rami James N. Aoun; Devi P. Patra; Sameer A. Ansari; Jean Raymond; Henry H. Woo; David Fiorella; Guilherme Dabus; Genevieve Milot; Josser E. Delgado Almandoz; John A. Scott; Andrew J. Denardo; Shervin R. Dashti; Sameer Ansari; Eric Deshaies; Sean Lavine; Hormozd Bozorgchami; Josser Delgado; Erol Veznedaroglu; Felipe Albuquerque; David Fiorella; Alan Boulos; Maria Cortes; Hilal Kanaan; Gaurav Jindal; Richard Klucznik; Guilherme Dabus; David Kalmes; Rabih Tawk; Jean Raymond; Charles Romero; Andrew Xavier; Muhammad Hussain; Michael Kelly; Christopher Moran; Imran Chaudry; Aditya Pandey; Dennis Wang; Brian Van Adel; Genevieve Milot; Joshua Hirsch; Jeffrey Carpenter; Ciaran Powers; Pascal Jabbour; George Luh; Jai Shankar; Ramanchandra Tummala; Athos Patsalides; Avery Evans; Ankur Garg; Shervin Dashti; Sung Lee; Roberts James; Mahesh Jayaraman; Sudhakar Satti; Eric Sauvageau; Jeremy Fields; Thomas Grobelny; Johnathan Hartman

doi:10.1093/neuros/nyaa006

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

Bernard R. Bendok, Karl R. Abi-Aad, Jennifer D. Ward, Jason F. Kniss, Mary J. Kwasny, Rudy J. Rahme, Salah G. Aoun, Tarek Y. El Ahmadieh, Najib E. El Tecle, Samer G. Zammar, Rami James N. Aoun, Devi P. Patra, Sameer A. Ansari, Jean Raymond, Henry H. Woo, David Fiorella, Guilherme Dabus, Genevieve Milot, Josser E. Delgado Almandoz, John A. ScottAndrew J. Denardo, Shervin R. Dashti, Sameer Ansari, Eric Deshaies, Sean Lavine, Hormozd Bozorgchami, Josser Delgado, Erol Veznedaroglu, Felipe Albuquerque, David Fiorella, Alan Boulos, Maria Cortes, Hilal Kanaan, Gaurav Jindal, Richard Klucznik, Guilherme Dabus, David Kalmes, Rabih Tawk, Jean Raymond, Charles Romero, Andrew Xavier, Muhammad Hussain, Michael Kelly, Christopher Moran, Imran Chaudry, Aditya Pandey, Dennis Wang, Brian Van Adel, Genevieve Milot, Joshua Hirsch, Jeffrey Carpenter, Ciaran Powers, Pascal Jabbour, George Luh, Jai Shankar, Ramanchandra Tummala, Athos Patsalides, Avery Evans, Ankur Garg, Shervin Dashti, Sung Lee, Roberts James, Mahesh Jayaraman, Sudhakar Satti, Eric Sauvageau, Jeremy Fields, Thomas Grobelny, Johnathan Hartman

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

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: 10.1093/neuros/nyaa006

Original language	English (US)
Pages (from-to)	615-624
Number of pages	10
Journal	Neurosurgery
Volume	86
Issue number	5
DOIs	https://doi.org/10.1093/neuros/nyaa006
State	Published - May 1 2020

Keywords

Bare platinum coil
Coil embolization
Endovascular
HydroCoil Embolic System
Intracranial aneurysm
Randomized controlled trial

ASJC Scopus subject areas

Clinical Neurology
Surgery

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10.1093/neuros/nyaa006

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Bendok, B. R., Abi-Aad, K. R., Ward, J. D., Kniss, J. F., Kwasny, M. J., Rahme, R. J., Aoun, S. G., El Ahmadieh, T. Y., El Tecle, N. E., Zammar, S. G., Aoun, R. J. N., Patra, D. P., Ansari, S. A., Raymond, J., Woo, H. H., Fiorella, D., Dabus, G., Milot, G., Delgado Almandoz, J. E., ... Hartman, J. (2020). The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil. Neurosurgery, 86(5), 615-624. https://doi.org/10.1093/neuros/nyaa006

Bendok, BR, Abi-Aad, KR, Ward, JD, Kniss, JF, Kwasny, MJ, Rahme, RJ, Aoun, SG, El Ahmadieh, TY, El Tecle, NE, Zammar, SG, Aoun, RJN, Patra, DP, Ansari, SA, Raymond, J, Woo, HH, Fiorella, D, Dabus, G, Milot, G, Delgado Almandoz, JE, Scott, JA, Denardo, AJ, Dashti, SR, Ansari, S, Deshaies, E, Lavine, S, Bozorgchami, H, Delgado, J, Veznedaroglu, E, Albuquerque, F, Fiorella, D, Boulos, A, Cortes, M, Kanaan, H, Jindal, G, Klucznik, R, Dabus, G, Kalmes, D, Tawk, R, Raymond, J, Romero, C, Xavier, A, Hussain, M, Kelly, M, Moran, C, Chaudry, I, Pandey, A, Wang, D, Van Adel, B, Milot, G, Hirsch, J, Carpenter, J, Powers, C, Jabbour, P, Luh, G, Shankar, J, Tummala, R, Patsalides, A, Evans, A, Garg, A, Dashti, S, Lee, S, James, R, Jayaraman, M, Satti, S, Sauvageau, E, Fields, J, Grobelny, T & Hartman, J 2020, 'The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil', Neurosurgery, vol. 86, no. 5, pp. 615-624. https://doi.org/10.1093/neuros/nyaa006

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

abstract = "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: 10.1093/neuros/nyaa006",

keywords = "Bare platinum coil, Coil embolization, Endovascular, HydroCoil Embolic System, Intracranial aneurysm, Randomized controlled trial",

author = "Bendok, {Bernard R.} and Abi-Aad, {Karl R.} and Ward, {Jennifer D.} and Kniss, {Jason F.} and Kwasny, {Mary J.} and Rahme, {Rudy J.} and Aoun, {Salah G.} and {El Ahmadieh}, {Tarek Y.} and {El Tecle}, {Najib E.} and Zammar, {Samer G.} and Aoun, {Rami James N.} and Patra, {Devi P.} and Ansari, {Sameer A.} and Jean Raymond and Woo, {Henry H.} and David Fiorella and Guilherme Dabus and Genevieve Milot and {Delgado Almandoz}, {Josser E.} and Scott, {John A.} and Denardo, {Andrew J.} and Dashti, {Shervin R.} and Sameer Ansari and Eric Deshaies and Sean Lavine and Hormozd Bozorgchami and Josser Delgado and Erol Veznedaroglu and Felipe Albuquerque and David Fiorella and Alan Boulos and Maria Cortes and Hilal Kanaan and Gaurav Jindal and Richard Klucznik and Guilherme Dabus and David Kalmes and Rabih Tawk and Jean Raymond and Charles Romero and Andrew Xavier and Muhammad Hussain and Michael Kelly and Christopher Moran and Imran Chaudry and Aditya Pandey and Dennis Wang and {Van Adel}, Brian and Genevieve Milot and Joshua Hirsch and Jeffrey Carpenter and Ciaran Powers and Pascal Jabbour and George Luh and Jai Shankar and Ramanchandra Tummala and Athos Patsalides and Avery Evans and Ankur Garg and Shervin Dashti and Sung Lee and Roberts James and Mahesh Jayaraman and Sudhakar Satti and Eric Sauvageau and Jeremy Fields and Thomas Grobelny and Johnathan Hartman",

note = "Publisher Copyright: {\textcopyright} 2020 Congress of Neurological Surgeons 2020.",

year = "2020",

month = may,

day = "1",

doi = "10.1093/neuros/nyaa006",

language = "English (US)",

volume = "86",

pages = "615--624",

journal = "Neurosurgery",

issn = "0148-396X",

publisher = "Lippincott Williams and Wilkins",

number = "5",

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TY - JOUR

T1 - The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

T2 - A Randomized Controlled Trial of the Second-Generation Hydrogel Coil

AU - Bendok, Bernard R.

AU - Abi-Aad, Karl R.

AU - Ward, Jennifer D.

AU - Kniss, Jason F.

AU - Kwasny, Mary J.

AU - Rahme, Rudy J.

AU - Aoun, Salah G.

AU - El Ahmadieh, Tarek Y.

AU - El Tecle, Najib E.

AU - Zammar, Samer G.

AU - Aoun, Rami James N.

AU - Patra, Devi P.

AU - Ansari, Sameer A.

AU - Raymond, Jean

AU - Woo, Henry H.

AU - Fiorella, David

AU - Dabus, Guilherme

AU - Milot, Genevieve

AU - Delgado Almandoz, Josser E.

AU - Scott, John A.

AU - Denardo, Andrew J.

AU - Dashti, Shervin R.

AU - Ansari, Sameer

AU - Deshaies, Eric

AU - Lavine, Sean

AU - Bozorgchami, Hormozd

AU - Delgado, Josser

AU - Veznedaroglu, Erol

AU - Albuquerque, Felipe

AU - Fiorella, David

AU - Boulos, Alan

AU - Cortes, Maria

AU - Kanaan, Hilal

AU - Jindal, Gaurav

AU - Klucznik, Richard

AU - Dabus, Guilherme

AU - Kalmes, David

AU - Tawk, Rabih

AU - Raymond, Jean

AU - Romero, Charles

AU - Xavier, Andrew

AU - Hussain, Muhammad

AU - Kelly, Michael

AU - Moran, Christopher

AU - Chaudry, Imran

AU - Pandey, Aditya

AU - Wang, Dennis

AU - Van Adel, Brian

AU - Milot, Genevieve

AU - Hirsch, Joshua

AU - Carpenter, Jeffrey

AU - Powers, Ciaran

AU - Jabbour, Pascal

AU - Luh, George

AU - Shankar, Jai

AU - Tummala, Ramanchandra

AU - Patsalides, Athos

AU - Evans, Avery

AU - Garg, Ankur

AU - Dashti, Shervin

AU - Lee, Sung

AU - James, Roberts

AU - Jayaraman, Mahesh

AU - Satti, Sudhakar

AU - Sauvageau, Eric

AU - Fields, Jeremy

AU - Grobelny, Thomas

AU - Hartman, Johnathan

PY - 2020/5/1

Y1 - 2020/5/1

N2 - 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: 10.1093/neuros/nyaa006

AB - 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: 10.1093/neuros/nyaa006

KW - Bare platinum coil

KW - Coil embolization

KW - Endovascular

KW - HydroCoil Embolic System

KW - Intracranial aneurysm

KW - Randomized controlled trial

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U2 - 10.1093/neuros/nyaa006

DO - 10.1093/neuros/nyaa006

M3 - Article

C2 - 32078692

AN - SCOPUS:85083546305

SN - 0148-396X

VL - 86

SP - 615

EP - 624

JO - Neurosurgery

JF - Neurosurgery

IS - 5

ER -

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

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