A novel inflatable device for perihepatic packing and hepatic hemorrhage control: A proof-of-concept study.

Introduction: Uncontrolled bleeding is the primary cause of death in complex liver trauma and perihepatic packing is regularly utilized for hemorrhage control. The purpose of this study was to investigate the effectiveness of a novel inflatable device (the airbag) for perihepatic packing using a validated liver injury damage control model in swine.
Material and Methods: The image of the human liver was digitally isolated within an abdominal computerized tomography scan to produce a silicone model of the liver to mold the airbag. Two medical grade polyurethane sheets were thermal bonded to the configuration of the liver avoiding compression of the hepatic pedicle, hepatic veins, and the suprahepatic vena cava after inflation. Yorkshire pigs (n = 22) underwent controlled hemorrhagic shock (35% of the total blood volume), hypothermia, and fluid resuscitation to reproduce the indications for damage control surgery (coagulopathy, hypothermia, and acidosis) prior to a liver injury. A 3 × 10 cm rectangular segment of the left middle lobe of the liver was removed to create the injury. Subsequently, the animals were randomized into 4 groups for liver damage control (240 min), Sponge Pack (n = 6), Pressurized Airbag (n = 6), Vacuum Airbag (n = 6), and Uncontrolled (n = 4). Animals were monitored throughout the experiment and blood samples obtained.
Results: Perihepatic packing with the pressurized airbag led to significantly higher mean arterial pressure during the liver damage control phase compared to sponge pack and vacuum airbag 52 mmHg (SD 2.3), 44.9 mmHg (SD 2.1), and 32 mmHg (SD 2.3), respectively (p < 0.0001), ejection fraction was also higher in that group. Hepatic hemorrhage was significantly lower in the pressurized airbag group compared to sponge pack, vacuum airbag, and uncontrolled groups; respectively 225 ml (SD 160), 611 ml (SD 123), 991 ml (SD 385), 1162 ml (SD 137) (p < 0001). Rebleeding after perihepatic packing removal was also significantly lower in the pressurized airbag group; respectively 32 ml (SD 47), 630 ml (SD 185), 513 ml (SD 303), (p = 0.0004). Intra-abdominal pressure remained similar to baseline, 1.9 mmHg (SD 1), (p = 0.297). Histopathology showed less necrosis at the border of the liver injury site with the pressurized airbag.
Conclusion: The pressurized airbag was significantly more effective at controlling hepatic hemorrhage and improving hemodynamics than the traditional sponge pack technique. Rebleeding after perihepatic packing removal was negligible with the pressurized airbag and it did not provoke hepatic injury.
Competing Interests: Declaration of Competing Interest Dr. Joao Rezende-Neto MD, PhD, was the inventor of the Liver Airbag Device and has filed a patent. Patent Cooperation Treaty (PCT/CA/2019/050345). Sachin Doshi MD, M.Eng, David Gomez MD, PhD, Bruna Camilotti MD, Dan Marcuzzi BSc, MD, Andrew Beckett CD, MD. Have no conflicts to declare.
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