Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Jun;21(3):401-6.
doi: 10.1177/1591019915581776. Epub 2015 May 26.

Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

Ramesh Grandhi  1 , Xiaoran Zhang  2 , David Panczykowski  1 , Phillip Choi  2 , Christopher T Hunnicutt  3 , Ashutosh P Jadhav  4 , Andrew F Ducruet  1 , Tudor Jovin  5 , Brian Jankowitz  6
Affiliations

Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

Ramesh Grandhi et al. Interv Neuroradiol. 2015 Jun.

Abstract

Background and purpose: Femoral artery injuries are known complications of percutaneous vascular closure devices (VCDs). We studied the incidence of delayed femoral artery angiographic irregularities after neurointerventional procedures in which the EXOSEAL extravascular closure device was used for femoral arterial puncture closure.

Methods: Adult patients who underwent femoral arterial puncture closures with an EXOSEAL VCD and had a follow-up femoral artery angiogram from June 2012 through August 2013 were reviewed. A blinded radiologist compared pre-deployment and follow-up femoral arteriograms for the presence of femoral artery stenosis, dissection, pseudoaneurysm, or development of an arteriovenous fistula. Hospital records were reviewed for major or minor complications of the groin site or femoral artery.

Results: The EXOSEAL VCD achieved hemostasis, without evidence of a groin hematoma or requiring subsequent prolonged manual compression, in 400 of 441 closures following transfemoral arterial access, representing a device success rate of 90.7%. A total of 98 patients underwent 102 repeat angiograms following closure with the EXOSEAL VCD. The average time to the repeat angiogram was 73.5 days (range 0-488, median 28). Follow-up femoral arteriography demonstrated an irregularity in seven cases, all of which were vessel stenoses of <50%. There were no dissections, pseudoaneurysms, infections, or ischemic events in the study population.

Conclusions: Angiographic irregularities were seen in 6.86% of cases after closure with the EXOSEAL VCD. There were no clinically significant vascular complications. Thus, femoral artery closure with EXOSEAL carries a low risk of clinically significant delayed angiographic findings.

Keywords: EXOSEAL vascular closure device; endovascular intervention; percutaneous femoral arterial puncture; vascular complications.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
EXOSEAL device deployment, using a dissolvable polyglycolic acid (PGA) plug, involves first inserting the device into the femoral sheath (a) and securing it to the sheath to allow for intraluminal deployment of an indicator wire (b). The sheath and device are pulled back until the indicator wire is at the arteriotomy (c), and the PGA sealant is then delivered to produce permanent hemostasis and the device is removed (d). Images courtesy of Cordis Corporation, http://www.exoseal.com.
Figure 2.
Figure 2.
Femoral angiogram of vessel stenosis observed after EXOSEAL vascular closure device (VCD) closure. Figure (a) shows the femoral artery prior to EXOSEAL VCD-mediated closure, with mild stenosis of the artery (red arrow) on follow-up angiography performed 19 days after the initial angiogram (b).
See this image and copyright information in PMC

References

    1. Chevalier B, Lancelin B, Koning R, et al. Effect of a closure device on complication rates in high-local-risk patients: Results of a randomized multicenter trial. Catheter Cardiovasc Interv 2003; 58: 285–291. - PubMed
    1. Juergens CP, Leung DY, Crozier JA, et al. Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention. Catheter Cardiovasc Interv 2004; 63: 166–170. - PubMed
    1. Mlekusch W, Minar E, Dick P, et al. Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression. Radiology 2008; 249: 1058–1063. - PubMed
    1. Nasu K, Tsuchikane E, Sumitsuji S, et al. The safety and efficacy of “pre-closure” utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: Results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) trial. J Invasive Cardiol 2005; 17: 30–33. - PubMed
    1. Noguchi T, Miyazaki S, Yasuda S, et al. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg 2000; 19: 451–455. - PubMed

LinkOut - more resources