Each year in the U.S., over 250,000 patients undergo procedures where arteries or veins are surgically connected. Invariably, there is a risk of a clot (thrombosis) forming in the vessels postoperatively. Early detection of clot formation would allow removing the clot before vessels are irreversibly blocked and is key to preventing catastrophic surgical failures. Drawbacks of existing detection devices include high false positive rates, delays in detection that limit success of salvage interventions, and patient safety risks. A device that reliably detects clot formation before total occlusion has been greatly needed for years and can dramatically improve surgical success rates, decrease morbidity and length of stay, and cut hospital costs. The economic impact of eliminating unnecessary or failed procedures associated with reconstructive thrombosis alone is estimated at up to $180 million/year in the U.S. To have a successful clot monitoring device, it is necessary to register the surgical site and acquire bloo flow data over time accurately and precisely from this location. To solve this need, we have developed EchoSure, the first simple point-of-care system for direct visualization and flow quantification of post-surgical blood vessels. EchoSure will allow nurses to noninvasively monitor patients for clot formation without specialized sonographic training. Our system's first component is a novel bio-absorbable echogenic marker implant placed adjacent to the vessels intraoperatively. The second component is ultrasound image analysis software that locks onto the unique marker signature, determines the pose of the ultrasound probe vis-Ã -vis the marker, and guides the nurse to the correct location to monitor clot formation. Doppler data is then collected to analyze blood flow over time. In this Phase I proposal, we will: 1) perform cadaver testing to optimize our navigation algorithms; 2) use a 3D probe system for ground-truth validation of algorithm accuracy; and 3) obtain in vivo proof-of-concept for the system in a realistic surgical scenario. OVERALL IMPACT: By enabling routine detection of post-operative vascular thrombosis with high accuracy before complete blockage has occurred, EchoSure will solve a problem responsible for catastrophic patient morbidity and costs. Our work will have broad impact on numerous other clinical applications where clots lead to disastrous consequences, including organ transplantation and peripheral vascular surgery.
Public Health Relevance Statement: Public Health Relevance: Each year, over 250,000 patients in the U.S. alone undergo procedures where arteries or veins are surgically connected (anastomosis). These procedures are performed in reconstructive, transplant and vascular surgery. Invariably, there is a risk of a clot (thrombosis) forming in the vessels during the postoperative period. Detecting clot formation allows intervention to remove the clot before it irreversibly blocks the vessels and is key to preventing catastrophic surgical failures - time to detection directly correlates to the rate of salvage. Existing detection devices suffer from high false positive rates, delays in detection that limit success of salvage interventions, and patient safety risks. Because of these flaws, routine use of devices for postoperative monitoring now occurs only in reconstructive plastic surgery, where up to 15% of cases will require emergency salvage for clot formation, of which 50% fail with a $45,000 direct economic cost per failure. A device that reliably and noninvasively detects clot formation before it is too late to save the surgery is urgently needed to improve patient outcomes and cut salvage costs. Early non-invasive recognition of impending clot formation is also key to developing minimally invasive interventions to disrupt or dissolve small thromboses to reduce the morbidity of open thrombectomy. Here we propose to solve these public health needs using an ultrasound system that allows point-of-care quantitative measurement of the function and patency of post-operative blood vessels.
Project Terms: Address; Algorithms; Anastomosis - action; Animal Model; Animals; Arteries; Attitude; base; Blood flow; Blood Vessels; Cadaver; Catheters; clinical application; Coagulation Process; Color; Computer software; cost; Cues; Data; Data Set; design; Detection; Development; Devices; Doppler Ultrasound; Early Diagnosis; economic cost; economic impact; Emergency Situation; Failure (biologic function); Family suidae; Generations; Hospital Costs; Hour; Human; Image; Image Analysis; Imagery; Implant; implantation; improved; in vivo; interest; Intervention; laptop; Lead; Length of Stay; Location; Manuals; Measurement; Methods; minimally invasive; Modeling; Monitor; monitoring device; Morbidity - disease rate; motor control; novel; Nurses; Operative Surgical Procedures; Organ Transplantation; Outcome; Patient Monitoring; patient safety; Patients; Peripheral; Pharmaceutical Preparations; Phase; Plastic Surgical Procedures; point of care; Point-of-Care Systems; Positioning Attribute; Postoperative Period; prevent; Procedures; public health medicine (field); public health relevance; Recovery; Relative (related person); Risk; Running; Site; success; Surgical Flaps; System; Testing; Thrombectomy; Thrombosis; Time; Tissue Transplantation; Training; Transplantation; trend; Ultrasonography; Validation; Veins; visual feedback; Work
