Background:
Bleeding complications related to endovascular procedures are frequent and associated with poor prognosis, including increased mortality, increased length of stay, and increased cost. These complications are often detected late, with significant blood loss occurring before signs and symptoms become clinically apparent. The Early Bird Bleed Monitoring System (EBBMS; Saranas, Inc., Houston, TX) is a novel technology composed of electrodes embedded into a standard endovascular sheath, designed to detect in real-time the onset and progression of an internal bleeding complication, with the ability to alert (visual and audible signals) health care professionals.
Methods:
The aim of this study was to evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related bleeding events. The EBBMS was used during and after endovascular procedures, either as a venous or arterial access sheath. EBBMS indicated the absence or presence of a bleeding complication and quantified bleeding severity at 3 levels (I, II, and III). The primary endpoint was the level of agreement in bleeding detection between the Saranas EBBMS and post-procedural computerized tomography.
Results:
From August 2018 and December 2018, a total of66 patients (mean age 76 years, 44% females) from 5 US sites were enrolled and underwent an endovascular procedure (TAVR 62%, PCI 17%, Impella 9%, balloon aortic valvuloplasty 6%, TMVR 3%, EVAR 1.5% and MitraClip 1.5%). EBBMS detected bleeding in 39 (59%) patients, with 20 (30%) at bleeding level I, 14 (21%) at bleeding level II, and 5 (8%) at bleeding level III. No device-related complications were reported.
Conclusions:
The Early Bird bleed Monitoring System was safe across a variety of endovascular procedures. Level of agreement in bleeding detection between the EBBMS and post-procedural CT, and complete study results, will be available and presented at the time of the meeting.