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CardioVascular and Interventional Radiology

, Volume 41, Issue 11, pp 1654–1663 | Cite as

Ultrasound Evaluation of Puncture Sites After Deployment of Two Different Types of Vascular Closure Devices: A Prospective Comparative Study

  • Young Jin Heo
  • Hae Woong Jeong
  • Jin Wook Baek
  • Sun Joo Lee
  • Hye Jung Choo
  • Hyun Seok Jung
  • Gi Won Shin
  • Jung Hwa Seo
  • Sung Tae Kim
Clinical Investigation Arterial Interventions
Part of the following topical collections:
  1. Arterial Interventions

Abstract

Purpose

The aim of this study was to compare the ultrasonographic findings of femoral puncture sites and the complications of Perclose ProGlide® and FemoSeal™ after neurointerventional procedures.

Methods

In this prospective, single-center study, we randomly assigned 155 femoral puncture sites to treatment with Perclose ProGlide® or FemoSeal™. We hypothesized that the two different types of VCD cause different vascular changes. Ultrasonography of the femoral puncture sites was performed 24 h after the procedure and at an outpatient visit after 6 months. The intima–media thickness (IMT), vessel diameter, and minimal luminal diameter of the common femoral artery were measured; the perivascular soft tissue change and absorption of the hemostatic material were observed. The device failure rate and vascular complications associated with each device were also evaluated.

Results

Follow-up ultrasonography was performed at a median follow-up time of 187.0 days (range 147–240 days) after the initial ultrasonography. The IMT on follow-up ultrasonography was significantly higher in patients who received FemoSeal™ (P = 0.0000). Intimal hyperplasia and partial absorption of the hemostatic material were significantly more frequent in patients who received FemoSeal™. The vessel diameters on initial and follow-up ultrasonography were not significantly different, but the minimal diameter on follow-up ultrasonography was significantly lower in patients who received FemoSeal™. Device failure and pseudoaneurysms occurred at 9 and 3 puncture sites in patients who received Perclose ProGlide®, respectively.

Conclusions

Intimal hyperplasia was more frequently observed in patients who received FemoSeal™. However, more device failures and pseudoaneurysms occurred in patients who received Perclose ProGlide®.

Level of Evidence

Step 2 (level 2).

Keywords

Vascular closure device FemoSeal Perclose ProGlide Ultrasonography Intima–media thickness Intimal hyperplasia 

Notes

Funding

This study was funded by Abbott Vascular Korea.

Compliance with Ethical Standards

Conflict of interest

The authors do not have any conflicts of interest to declare.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in this study.

References

  1. 1.
    Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004;291:350–7.CrossRefGoogle Scholar
  2. 2.
    Biancari F, D’andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159:518–31.CrossRefGoogle Scholar
  3. 3.
    Sheth RA, Walker TG, Saad WE, Dariushnia SR, Ganguli S, Hogan MJ, Hohenwalter EJ, Kalva SP, Rajan DK, Stokes LS. Quality improvement guidelines for vascular access and closure device use. J Vasc Interv Radiol. 2014;25:73–84.CrossRefGoogle Scholar
  4. 4.
    Treitl KM, Ali A, Treitl M. Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study. Eur Radiol. 2016;26:2359–68.CrossRefGoogle Scholar
  5. 5.
    Ku YM, Kim YO, Kim JI, Choi YJ, Yoon SA, Kim YS, Song SW, Yang CW, Kim YS, Chang YS. Ultrasonographic measurement of intima-media thickness of radial artery in pre-dialysis uraemic patients: comparison with histological examination. Nephrol Dial Transplant. 2005;21:715–20.CrossRefGoogle Scholar
  6. 6.
    Michalis LK, Rees MR, Patsouras D, Katsouras CS, Goudevenos J, Pappas S, Sourla E, Kolettis T, Sioros L, Zotou P. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol. 2002;25:423–9.CrossRefGoogle Scholar
  7. 7.
    McTaggart R, Raghavan D, Haas R, Jayaraman M. StarClose vascular closure device: safety and efficacy of deployment and reaccess in a neurointerventional radiology service. Am J Neuroradiol. 2010;31:1148–50.CrossRefGoogle Scholar
  8. 8.
    Cox T, Blair L, Huntington C, Lincourt A, Sing R, Heniford B. Systematic review of randomized controlled trials comparing manual compression to vascular closure devices for diagnostic and therapeutic arterial procedures. Surg Technol Int. 2015;27:32–44.PubMedGoogle Scholar
  9. 9.
    Geyik S, Yavuz K, Akgoz A, Koc O, Peynircioglu B, Cil B, Cekirge S, Saatci I. The safety and efficacy of the Angio-Seal closure device in diagnostic and interventional neuroangiography setting: a single-center experience with 1,443 closures. Neuroradiology. 2007;49:739–46.CrossRefGoogle Scholar
  10. 10.
    Schulz-Schüpke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Böttiger C, Groha P, Bradaric C. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014;312:1981–7.CrossRefGoogle Scholar
  11. 11.
    Hirano Y, Ikuta S, Uehara H, Nakamura H, Taniguchi M, Kimura A, Hayashi T, Kotani A, Oku K, Tsuji Y, Matsumoto M, Ishikawa K. [Diagnosis of vascular complications at the puncture site after cardiac catheterization]. J Cardiol. 2004;43:259–65.PubMedGoogle Scholar
  12. 12.
    Banfić L, Vrkić Kirhmajer M, Vojković M, Strozzi M, Šmalcelj A, Lasić Z. Access site complications following cardiac catheterization assessed by duplex ultrasonography. Coll Antropol. 2008;32:385–90.PubMedGoogle Scholar
  13. 13.
    Applegate RJ, Grabarczyk MA, Little WC, Craven T, Walkup M, Kahl FR, Braden GA, Rankin KM, Kutcher MA. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol. 2002;40:78–83.CrossRefGoogle Scholar
  14. 14.
    Jaff M, Hadley G, Hermiller J, Simonton C, Hinohara T, Cannon L, Reisman M, Braden G, Fletcher D, Zapien M. The safety and efficacy of the StarClose® vascular closure system: the ultrasound substudy of the CLIP study. Catheter Cardiovasc Interv. 2006;68:684–9.CrossRefGoogle Scholar
  15. 15.
    Choo HJ, Jeong HW, Park JY, Jin S-C, Kim ST, Seo JH, Lee SJ, Park YM. Ultrasonographic features of vascular closure devices: initial and 6-month follow-up results. Ultrasonography. 2014;33:283.CrossRefGoogle Scholar
  16. 16.
    Ryu H, Jang JY, Kim TU, Lee JW, Park JH, Choo KS, Cho M, Yoon KT, Hong YM, Jeon UB. Morphologic features of puncture sites after ExoSeal vascular closure device implantation: changes on follow-up computed tomography. J Korean Soc Radiol. 2017;76:326–32.CrossRefGoogle Scholar
  17. 17.
    Gargiulo NJ III, Veith FJ, Ohki T, Scher LA, Berdejo GL, Lipsitz EC, Menegus M, Greenberg M. Histologic and duplex comparison of the perclose and angio-seal percutaneous closure devices. Vascular. 2007;15:24–9.CrossRefGoogle Scholar
  18. 18.
    Sanghi P, Virmani R, Do D, Erikson J, Elliott J, Cilingiroglu M, Matthews H, Kazi M, Ricker R, Bailey SR. A comparative evaluation of arterial blood flow and the healing response after femoral artery closure using angio-seal STS plus and StarClose in a porcine model. J Int Cardiol. 2008;21:329–36.CrossRefGoogle Scholar
  19. 19.
    Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003;14:865–85.CrossRefGoogle Scholar
  20. 20.
    Balzer JO, Scheinert D, Diebold T, Haufe M, Vogl TJ, Biamino G. Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: a study of 930 patients. Catheter Cardiovasc Interv. 2001;53:174–81.CrossRefGoogle Scholar
  21. 21.
    Nash JE, Evans DG. The Angio-Seal™ hemostatic puncture closure device. Herz. 1999;24:597–606.CrossRefGoogle Scholar
  22. 22.
    Chiu AHY, Wal RV, Tee K, Knight R, Coles SR, Nadkarni S. Comparison of arterial closure devices in antegrade and retrograde punctures. J Endovasc Ther. 2008;15:315–21.CrossRefGoogle Scholar
  23. 23.
    Fujihara M, Haramitsu Y, Ohshimo K, Yazu Y, Izumi E, Higashimori A, Yokoi Y. Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous revascularization. Cardiovasc Interv Ther. 2017;32:233–40.CrossRefGoogle Scholar
  24. 24.
    Vidi VD, Matheny ME, Govindarajulu US, Normand S-LT, Robbins SL, Agarwal VV, Bangalore S, Resnic FS. Vascular closure device failure in contemporary practice. JACC: Cardiovasc Interv. 2012;5:837–44.Google Scholar
  25. 25.
    Theodos G, Raymond C, Becker MC, Thornton J, Ellis SG, Bhatt DL, Raymond RE. Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: a comparative study. Catheter Cardiovasc Interv. 2013;81:294–300.CrossRefGoogle Scholar
  26. 26.
    Das R, Ahmed K, Athanasiou T, Morgan RA, Belli A-M. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol. 2011;34:723–38.CrossRefGoogle Scholar
  27. 27.
    Park Y, Roh HG, Choo SW, Lee SH, Shin SW, Do YS, Byun HS, Park KB, Jeon P. Prospective comparison of collagen plug (Angio-Seal™) and suture-mediated (the Closer S™) closure devices at femoral access sites. Korean J Radiol. 2005;6:248–55.CrossRefGoogle Scholar
  28. 28.
    Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A randomized trial comparing compression, perclose proglide™ and Angio-Seal VIP™ for arterial closure following percutaneous coronary intervention: the cap trial. Catheter Cardiovasc Interv. 2008;71:1–5.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018

Authors and Affiliations

  • Young Jin Heo
    • 1
  • Hae Woong Jeong
    • 1
  • Jin Wook Baek
    • 1
  • Sun Joo Lee
    • 1
  • Hye Jung Choo
    • 1
  • Hyun Seok Jung
    • 1
  • Gi Won Shin
    • 1
  • Jung Hwa Seo
    • 2
  • Sung Tae Kim
    • 3
  1. 1.Department of RadiologyInje University Busan Paik HospitalBusanKorea
  2. 2.Department of NeurologyInje University Busan Paik HospitalBusanKorea
  3. 3.Department of NeurosurgeryInje University Busan Paik HospitalBusanKorea

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