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).
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References
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003;14:865–85.
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.
Nash JE, Evans DG. The Angio-Seal™ hemostatic puncture closure device. Herz. 1999;24:597–606.
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.
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.
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.
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.
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.
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.
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.
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This study was funded by Abbott Vascular Korea.
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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.
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Informed consent was obtained from all individual participants included in this study.
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Heo, Y.J., Jeong, H.W., Baek, J.W. et al. Ultrasound Evaluation of Puncture Sites After Deployment of Two Different Types of Vascular Closure Devices: A Prospective Comparative Study. Cardiovasc Intervent Radiol 41, 1654–1663 (2018). https://doi.org/10.1007/s00270-018-2056-3
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DOI: https://doi.org/10.1007/s00270-018-2056-3