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ARFI ultrasound for in vivo hemostasis assessment postcardiac catheterization, part I: preclinical studies
Russell H Behler1, Mallory R Scola, Timothy C Nichols
1Joint Department of Biomedical Engineering, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
Insights
Acoustic Radiation Force Impulse (ARFI) ultrasound can un-blind the assessment of hemostasis at femoral artery puncture sites. This novel imaging technique shows promise for improving patient safety after cardiovascular procedures.
Area of Science:
- Cardiovascular Imaging
- Medical Ultrasound Technology
- Interventional Cardiology
Background:
- Percutaneous coronary catheterization frequently uses femoral artery access.
- Inadequate hemostasis at femoral puncture sites can lead to severe complications.
- Current hemostasis assessment is indirect and can be unreliable.
Purpose of the Study:
- To investigate Acoustic Radiation Force Impulse (ARFI) ultrasound for assessing hemostasis after femoral artery puncture.
- To establish proof of concept for ARFI ultrasound in a preclinical model.
Main Methods:
- In vivo ARFI ultrasound imaging was performed in canine models of femoral artery puncture.
- ARFI-induced displacements were measured above arteriotomies post-needle removal.
- Changes in displacement magnitude over time were analyzed.
Main Results:
- Large ARFI displacements (3.5 to >5.0 microm) were observed initially, indicative of extravasated blood.
- Displacements decreased significantly (to ~2 microm) over time, suggesting successful hemostasis.
- These findings provide preclinical validation for ARFI's utility in hemostasis assessment.
Conclusions:
- ARFI ultrasound can effectively visualize and quantify changes associated with hemostasis at femoral artery puncture sites.
- This imaging modality offers a potential method to "un-blind" hemostasis assessment, improving procedural safety.
- The study justifies further investigation in human clinical trials.
Abstract:
The world wide prevalence of cardiovascular disease leads to over seven million annual percutaneous coronary catheterization procedures, the majority of which exploit femoral artery access. Femoral puncture sites ('arteriotomies') can be associated with severe vessel complications after sheath removal if hemostasis is not properly achieved. Hemostasis onset is routinely determined by examination for bleeding at the skin puncture; however, clotting along the puncture path can obscure subcutaneous bleeding, and therefore hemostasis is blindly assessed. We hypothesize that hemostasis assessment can be un-blinded by Acoustic Radiation Force Impulse (ARFI) ultrasound. In this first of a two-part series, we present in vivo ARFI hemostasis imaging data obtained in relevant canine models of femoral artery puncture. Above arteriotomies, ARFI-induced displacements were large (3.5 to >5.0 microm) relative to surrounding soft tissue soon after needle removal, which was consistent with our expectation for pooled extravasated blood. ARFI-induced displacements above arteriotomies decreased in magnitude (to approximately 2 microm) some time after needle removal and suggested the onset of hemostasis. This preclinical investigation served as proof of concept and justification for a pilot human study, which is presented in part two of this series.
