Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy

Introduction: Current agents for the intravascular embolization of traumatic hemorrhage are used off-label and have been minimally studied with respect to their performance under differing coagulation conditions. We studied the hemorrhage control efficacy of a novel, liquid, polyethylene glycol-base...

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Main Authors: David S. Kauvar, MD, MPH, FSVS, FACS, I. Amy Polykratis, BS, Rodolfo De Guzman, BS, M. Dale Prince, BS, Amber Voelker, BS, Bijan S. Kheirabadi, PhD, Michael A. Dubick, PhD (deceased)
Format: Article
Language:English
Published: Elsevier 2021-01-01
Series:JVS - Vascular Science
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666350321000043
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author David S. Kauvar, MD, MPH, FSVS, FACS
I. Amy Polykratis, BS
Rodolfo De Guzman, BS
M. Dale Prince, BS
Amber Voelker, BS
Bijan S. Kheirabadi, PhD
Michael A. Dubick, PhD (deceased)
author_facet David S. Kauvar, MD, MPH, FSVS, FACS
I. Amy Polykratis, BS
Rodolfo De Guzman, BS
M. Dale Prince, BS
Amber Voelker, BS
Bijan S. Kheirabadi, PhD
Michael A. Dubick, PhD (deceased)
author_sort David S. Kauvar, MD, MPH, FSVS, FACS
collection DOAJ
description Introduction: Current agents for the intravascular embolization of traumatic hemorrhage are used off-label and have been minimally studied with respect to their performance under differing coagulation conditions. We studied the hemorrhage control efficacy of a novel, liquid, polyethylene glycol-based hydrogel delivered as two liquid precursors that polymerize within the target vessel in a unique animal model of severe solid organ injury with and without dilutional coagulopathy. Methods: Anesthetized swine (n = 36, 45 ± 3 kg) had laparotomy and splenic externalization. Half underwent 50% isovolemic hemodilution with 6% hetastarch and cooling to 33°C-35°C (coagulopathic group). All animals had controlled 20 mL/kg hemorrhage and endovascular proximal splenic artery access with a 4F catheter via a right femoral sheath. Splenic transection and 5-minute free bleeding were followed by treatment (n = 5/group) with 5 mL of gelfoam slurry, three 6-mm coils, up to 6 mL of hydrogel, or no treatment (n = 3, control). Animals received 15 mL/kg plasma and were monitored for 6 hours with continuous blood loss measurement. Results: Coagulopathy was successfully established, with coagulopathic animals having greater pretreatment blood loss and earlier mean time to death regardless of the treatment group. All control animals died within 100 minutes. Overall survival without coagulopathy was 5/5 for hydrogel, 4/5 for coil, and 3/5 for gelfoam. With coagulopathy, one hydrogel animal survived to the end of the experiment, with 2/4 hydrogel deaths occurring in the final hour of observation. In noncoagulopathic animals, hydrogel demonstrated improved survival time (P < .01) and post-treatment blood loss (1.46 ± 0.8 mL/kg) over controls (18.8 ± 0.7, P = .001), gelfoam (4.7 ± 1.3, P > .05), and coils (4.6 ± 1.5, P > .05). In coagulopathic animals, hydrogel had improved survival time (P = .003) and decreased blood loss (4.2 ± 0.8 mL/kg) compared with control (20.4 ± 4.2, P = .003). Conclusions: The hydrogel demonstrated equivalent hemorrhage control performance to standard treatments under noncoagulopathic conditions and improved performance in the face of dilutional coagulopathy. This agent should be explored as a potential preferable treatment for the embolization of traumatic solid organ and other injuries. (JVS–Vascular Science 2021;2:43-51.) Clinical Relevance: In a translational model of severe solid organ injury hemorrhage with and without coagulopathy, a novel hydrogel transarterial embolization agent demonstrated equivalent hemorrhage control performance to standard agents under noncoagulopathic conditions and improved performance in the face of dilutional coagulopathy. This agent represents a promising future treatment for the embolization of traumatic solid organ and other injuries.
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spelling doaj.art-3616ba14d1924d6287637a8457fbb90e2022-12-21T18:12:57ZengElsevierJVS - Vascular Science2666-35032021-01-0124351Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathyDavid S. Kauvar, MD, MPH, FSVS, FACS0I. Amy Polykratis, BS1Rodolfo De Guzman, BS2M. Dale Prince, BS3Amber Voelker, BS4Bijan S. Kheirabadi, PhD5Michael A. Dubick, PhD (deceased)6Vascular Surgery Service, Brooke Army Medical Center, JBSA Fort Sam Houston, Tex; Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Md; Correspondence: David S. Kauvar, MD, MPH, FSVS, FACS, Brooke Army Medical Center, 3551 Roger Brooke Dr, JBSA Fort Sam Houston, TX 78234Combat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexCombat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexCombat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexCombat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexCombat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexCombat Casualty Care, United States Army Institute of Surgical Research, JBSA Fort Sam Houston, TexIntroduction: Current agents for the intravascular embolization of traumatic hemorrhage are used off-label and have been minimally studied with respect to their performance under differing coagulation conditions. We studied the hemorrhage control efficacy of a novel, liquid, polyethylene glycol-based hydrogel delivered as two liquid precursors that polymerize within the target vessel in a unique animal model of severe solid organ injury with and without dilutional coagulopathy. Methods: Anesthetized swine (n = 36, 45 ± 3 kg) had laparotomy and splenic externalization. Half underwent 50% isovolemic hemodilution with 6% hetastarch and cooling to 33°C-35°C (coagulopathic group). All animals had controlled 20 mL/kg hemorrhage and endovascular proximal splenic artery access with a 4F catheter via a right femoral sheath. Splenic transection and 5-minute free bleeding were followed by treatment (n = 5/group) with 5 mL of gelfoam slurry, three 6-mm coils, up to 6 mL of hydrogel, or no treatment (n = 3, control). Animals received 15 mL/kg plasma and were monitored for 6 hours with continuous blood loss measurement. Results: Coagulopathy was successfully established, with coagulopathic animals having greater pretreatment blood loss and earlier mean time to death regardless of the treatment group. All control animals died within 100 minutes. Overall survival without coagulopathy was 5/5 for hydrogel, 4/5 for coil, and 3/5 for gelfoam. With coagulopathy, one hydrogel animal survived to the end of the experiment, with 2/4 hydrogel deaths occurring in the final hour of observation. In noncoagulopathic animals, hydrogel demonstrated improved survival time (P < .01) and post-treatment blood loss (1.46 ± 0.8 mL/kg) over controls (18.8 ± 0.7, P = .001), gelfoam (4.7 ± 1.3, P > .05), and coils (4.6 ± 1.5, P > .05). In coagulopathic animals, hydrogel had improved survival time (P = .003) and decreased blood loss (4.2 ± 0.8 mL/kg) compared with control (20.4 ± 4.2, P = .003). Conclusions: The hydrogel demonstrated equivalent hemorrhage control performance to standard treatments under noncoagulopathic conditions and improved performance in the face of dilutional coagulopathy. This agent should be explored as a potential preferable treatment for the embolization of traumatic solid organ and other injuries. (JVS–Vascular Science 2021;2:43-51.) Clinical Relevance: In a translational model of severe solid organ injury hemorrhage with and without coagulopathy, a novel hydrogel transarterial embolization agent demonstrated equivalent hemorrhage control performance to standard agents under noncoagulopathic conditions and improved performance in the face of dilutional coagulopathy. This agent represents a promising future treatment for the embolization of traumatic solid organ and other injuries.http://www.sciencedirect.com/science/article/pii/S2666350321000043AngioembolizationSolid organ injuryHydrogelGelfoamEmbolization coilsEndovascular
spellingShingle David S. Kauvar, MD, MPH, FSVS, FACS
I. Amy Polykratis, BS
Rodolfo De Guzman, BS
M. Dale Prince, BS
Amber Voelker, BS
Bijan S. Kheirabadi, PhD
Michael A. Dubick, PhD (deceased)
Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
JVS - Vascular Science
Angioembolization
Solid organ injury
Hydrogel
Gelfoam
Embolization coils
Endovascular
title Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
title_full Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
title_fullStr Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
title_full_unstemmed Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
title_short Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
title_sort evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy
topic Angioembolization
Solid organ injury
Hydrogel
Gelfoam
Embolization coils
Endovascular
url http://www.sciencedirect.com/science/article/pii/S2666350321000043
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