Real-Time Bleed Detection and Monitoring: Initial Clinical Experience with the Early Bird™ Bleed Monitoring System

Background: Access site-related bleeding complications are associated with worse outcomes and increased costs. The Early Bird Bleed Monitoring System (EBBMS; Saranas™, Inc, Houston, TX), has been designed to detect the occurrence of internal bleed complication (IBC) and monitor its progression by analyzing the change in bioimpedance response at and around the access site. Once IBC is detected, the EBBMS notifies the operator via visual and auditory indicators. The purpose of this study is to evaluate the accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during endovascular procedures. Methods: Up to 60 subjects undergo a CT scan prior to the endovascular procedure to assess for the presence of prior recent bleeding events or vascular complications. Patients undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. Following completion of the endovascular procedure, subjects undergo non-contrast CT to detect or confirm internal bleeding, if medically possible. Subjects continue Saranas EBBMS monitoring for up to 12 hours after completion of the endovascular procedure. Results: To date, 25 patients have been enrolled into the study including TAVR and high-risk percutaneous coronary intervention requiring a hemodynamic support device. Conclusion: The EBBMS appears to be effective in accurately detecting the onset of an IBC and its progression by analyzing the change in bioimpedance response of surrounding tissue. Early notification of access-related bleeding complication, before becoming clinically significant, could potentially mitigate downstream consequences of bleeding events and its associated healthcare costs.