ARFI Ultrasound for In Vivo Hemostasis Assessment Postcardiac Catheterization,Part II: Pilot Clinical Results

Abstract

In this second of a two part series, we present pilot clinical data demonstrating Acoustic Radiation Force Impulse (ARFI) ultrasound for monitoring the onset of subcutaneous hemostasis at femoral artery puncture sites (arteriotomies), in vivo. We conducted a randomized, reader-blinded investigation of 20 patient volunteers who underwent diagnostic percutaneous coronary catheterization. After sheath removal (6 French), patients were randomized to treatment with either standard of care manual compression alone or, to expedite hemostasis, manual compression augmented with a p-GlcNAc fiber-based hemostatic dressing (Marine Polymer Technologies, Danvers MA). Concurrent with manual compression, serial ARFI imaging began at the time of sheath removal and continued every minute for 15 min. Serial data sets were processed with custom software to (1) estimate the time of hemostasis onset, and (2) render hybrid ARFI/B-Mode images to highlight displacements considered to correspond to extravasted blood. Images were read by an observer blinded to the treatment groups. Average estimated times to hemostasis in patient volunteers treated with manual compression alone (n = 10) and manual compression augmented by hemostatic dressing (n = 9) were, respectively, 13.00 ± 1.56 and 9.44 ± 3.09 min, which are statistically significantly different (p = 0.0065, Wilcoxon two-sample test). Example images are shown for three selected patient volunteers. These pilot data suggest that ARFI ultrasound is relevant to monitoring subcutaneous bleeding from femoral arteriotomies clinically and that time to hemostasis was significantly reduced by use of the hemostatic dressing.

Keywords

Acoustic radiation force impulse (ARFI) ultrasound arterial puncture closure device cardiac catheterization femoral artery hemostasis human p-GlcNAc fiber-based dressing

Get full access to this article

View all access options for this article.

References

Behler

Nichols

Bellinger

. ARFI ultrasound for in vivo hemostasis assessment post cardiac catheterization, part I: preclinical studies, Ultrasonic Imaging 31, 151–158 (2009).

Koreny

Riedmuller

Nikfardjam

. Arterial puncture closure devices compare with standard manual compression after cardiac catheterization: systematic review and meta-analysis, J Amer Med Ass 291 (3), 350–357 (2004).

Dauerman

Applegate

Cohen

. Vascular closure devices, J Amer Coll Cardiol 50, 1617–26 (2007).

Doyle

Konz

Lennon

. Ambulation 1 hour after diagnostic cardiac catheterization: a prospective study of 1009 procedures, Mayo Clinic Proc 81, 1537–1540 (2006).

Nikolsky

Mehran

Halkin

. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis, J Am Coll Cardiol 44, 1200–1209 (2004).

Carey

Martin

Moore

. Complications of femoral artery closure devices, Catheter Cardiovasc Interv 52, 3–7 (2001).

Dangas

Mehran

Kokolis

. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices, J Am Coll Cardiol 38, 638–641 (2001).

Nehler

Lawrence

Whitehill

. Iatrogenic vascular injuries from percutaneous vascular suturing devices, J Vase Surg 33, 943–947 (2001).

Sohail

Khan

Holmes

Jr. . Infectious complications of percutaneous vascular closure devices, Mayo Clin Proc 80, 1011–1015 (2005).

10.

Wille

Vos

Overtoom

. Acute leg ischemia: the dark side of a percutaneous femoral artery closure device, Ann Vase Surg 20, 278–281 (2006).

11.

Najjar

Healey

. Evalulation of poly-n-acetyl glucosamine as a hemostatic agent in patients undergoing cardiac catheterization: A double-blind, randomized study, J Trauma 57, S38-S41 (2004).

12.

Palmer

Gantt

Lawrence

. Effectiveness and safety of manual hemostasis facilitated by the SyvekPatch with one hour of bedrest after coronary angiography using six-French catheters, Am J Cardiol 93, 96–97 (2004).

13.

Nader

Garcia

Drushal

Pesek

. Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures, J Invasive Cardiol 14, 305–307 (2002).

14.

Palmeri

Nightingale

. On the thermal effects associated with radiation force imaging in soft tissue, Ultrasound in Medicine and Biology 26, 29–40 (2004).

15.

Behler

Merricks

Nichols

Gallippi

. A rigid wall approach to physiological motion rejection in arterial ARFI imaging: Simulation and in vivo demonstration, in Proc IEEE Ultrasonics Symp, pp. 359–364 (2007).

16.

Booi

Carson

O'Donnell

. Diagnosing cysts with correlation coefficient images from 2-dimensional freehand elastography, J Ultrasound Med 26, 201–207 (2007).

17.

Pan

Chiang

. Ultrasound low-velocity flow estimation using cross-correlation and decorrelation: a thread phantom study, Med Engineer Phys 19, 602–614 (2007).

18.

vanderSteen

AFW

Lancee

. Temproal correlation of blood scattering signals in vivo from radiofrequency intravascular ultrasound, Ultrasound Med Biol 22, 583–590 (1996).

19.

Ledoux

Willigers

Brands

. Experimental verification of the correlation behavior of analytic ultrasound radiofrequency signals received from moving structures, Ultrasound Med Biol 24, 1381–1396 (1998).