New device for temporary hemorrhage control in penetrating injuries to the ventricles

BACKGROUND: The best way to control hemorrhage from cardiac injuries is through digital occlusion followed by suture. However, this is difficult to accomplish in the emergency department (ED) setting. Generally, temporary control is obtained in advance of definitive treatment in the operating room. Despite safety and efficacy concerns, balloon Foley catheter insertion through the injury is still an option following ED thoracotomies. We developed a new device for temporary hemorrhage control in cardiac injuries and compared it to the Foley. METHODS: 6 adult swine (n=6) underwent full-thickness (1.5 cm) injury along the longitudinal axis of the right ventricle (RV). After 5 s of bleeding, hemorrhage control was attempted with either the device or the Foley, and blood loss quantified. Subsequently, the wound was sutured and mean arterial pressure was restored to baseline with lactated Ringer's infusion. Subsequently, another injury 2 cm apart in the same ventricle was managed with apparatus not employed in the first injury. The same followed in the LV totaling 4 injuries per animal, 2 in each ventricle. Intraoperative echocardiogram, laboratory test and final wound sizes assessed. RESULTS: The device resulted in less bleeding than the Foley; RV 58.7±11.3 vs 147.7±30.9 mL, LV 81.7±11.9 vs 187.5±40.3 mL (p<0.05). Percent change in tricuspid regurgitation was less with the device than FO, 66.6% vs 400%. Mitral regurgitation increased 16% with Foley, but remained unchanged with the device. Changes in stroke volume and LV ejection fraction were less with the device than with Foley; SV 2.09% vs 12.48%, left ventricular ejection fraction 0.46% vs 5.45%. Foley insertion enlarged the wounds. Platelet count, complete blood count, prothrombin time, activated prothrombin time and fibrinogen decreased, whereas troponin and lactate increased compared with baseline, underscoring the magnitude of shock. CONCLUSIONS: Cardiac hemorrhage was effectively controlled with the new device. The low-profile collapsible blocking membrane interfered less with cardiac function than did the balloon of the Foley, an important asset in the context of shock.