Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model.

OBJECTIVES

The aim of this study was to determine the safety and accuracy of a novel bleed detection system, the Early Bird Bleed Monitoring System (EBBMS; Saranas) for the detection of simulated internal bleeding and the monitoring of bleed progression associated with endovascular procedures.

BACKGROUND

Periprocedural bleeding events during endovascular procedures are frequent and are associated with increased morbidity, mortality, and healthcare costs.

METHODS

This study was a prospective, self-controlled, acute animal study including 20 Yorkshire cross swine undergoing endovascular procedures involving cannulation of both femoral artery and vein. Extravascular bleeding was simulated by a continuous and controlled subcutaneous injection of a blood solution proximal to the access site. The capacity of the EBBMS to detect bleed occurrence and to characterize its progression in three levels of severity (level 1, level 2, level 3) was assessed. Sensitivity and specificity in bleed detection were determined.

RESULTS

Forty EBBMS devices were inserted in 20 animals. During these 40 procedures, bleeding was appropriately detected in all of them. The EBBMS achieved a sensitivity of 100% and specificity of 100% in detection of bleeding. Detection of bleeding progression at level 1 severity occurred at 31.5 ± 12.7 mL, level 2 severity at 77.8 ± 53.5 mL, and level 3 severity at 145.5 ± 100.5 mL, with a significant difference in blood volume (P<.001). No significant difference in bleed detection was seen when the EBBMS was inserted in the femoral vein or artery. CONCLUSION The EBBMS accurately detected access-related bleeding onset and progression during a simulated endovascular procedure.