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Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous revascularization

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Abstract

To assess the safety and efficacy of routine use of ultrasound-guided puncture and the use of vascular closure device (VCD) in patients undergoing endovascular therapy (EVT) through femoral access. This was a single-center, non-randomized clinical study that enrolled 513 patients undergoing EVT via femoral artery access in which hemostasis was achieved using VCDs (406-patient EXOSEAL arm and 107-patient PROGLIDE arm). All cases were performed by routine use of ultrasound-guided access. The primary endpoint was the achievement of hemostasis without periprocedural and 30-day incidence of major or minor access site-related complications. The primary endpoint was achieved in 91.6 % of the cases (470/513) with a higher success rate in the EXOSEAL arm (93.6). Major complications were observed in 5 patients (0.9 %) in total cohort and 3 patients (0.7 %) treated with EXOSEAL arm vs. 2 patients (1.8 %) with PROGLIDE arm (p = 0.32). Combined treatment two VCDs with the routine ultrasound guidance access for patients who underwent the EVT procedure showed high efficacy and safety outcomes.

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References

  1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–67.

    Article  PubMed  Google Scholar 

  2. Organisation European Stroke, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–906.

    Article  Google Scholar 

  3. Ishihara T, Iida O, Awata M, Nanto K, Shiraki T, Okamoto S, et al. Extensive arterial repair 1 year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery. Cardiovasc Interv Ther. 2015;30(1):51–6.

    Article  CAS  PubMed  Google Scholar 

  4. Kalish J, Eslami M, Gillespie D, Schermerhorn M, Rybin D, Doros G, et al. Routine use of ultrasound guidance in femoral arterial access for peripheral vascular intervention decreases groin hematoma rates. J Vasc Surg. 2015;61:1231–8.

    Article  PubMed  Google Scholar 

  5. Gedikoglu M, Oguzkurt L, Gur S, Andic C, Sariturk C, Ozkan U. Comparison of ultrasound guidance with the traditional palpation and fluoroscopy method for the common femoral artery puncture. Catheter Cardiovasc Interv. 2013;82(7):1187–92.

    Article  PubMed  Google Scholar 

  6. Gardiner GA Jr, Meyerovitz MF, Stokes KR, Clouse ME, Harrington DP, et al. Complications of transluminal angioplasty. Radiology. 1986;159:201–8.

    Article  PubMed  Google Scholar 

  7. Sanborn TA, Ebrahimi R, Manoukian SV, McLaurin BT, Cox DA, et al. Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: the acute catheterization and urgent intervention triage strategy (ACUITY) trial. Circ Cardiovasc Interv. 2010;3:57–62.

    Article  CAS  PubMed  Google Scholar 

  8. 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.

    Article  PubMed  Google Scholar 

  9. Behan MW, Large JK, Patel NR, Lloyd GW, Sulke AN. A randomised controlled trial comparing the routine use of an Angio-Seal STS device strategy with conventional femoral haemostasis methods in a district general hospital. Int J Clin Pract. 2007;61:367–72.

    Article  CAS  PubMed  Google Scholar 

  10. Henry M, Amor M, Allaoui M, Tricoche O. A new access site management tool: the Angio-Seal hemostatic puncture closure device. J Endovasc Surg. 1995;2:289–96.

    Article  CAS  PubMed  Google Scholar 

  11. Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bøttcher M, et al. Randomized comparison of manual compression and FemoSeal™ vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. Eurointervention. 2014;10:183–90.

    Article  PubMed  Google Scholar 

  12. Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Rogers JH, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure’s Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009;2:785–93.

    Article  PubMed  Google Scholar 

  13. Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014;59:1181–93.

    Article  PubMed  Google Scholar 

  14. Rutherford RB, Becker GJ. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. J Vasc Interv Radiol. 1991;2:169–74.

    Article  CAS  PubMed  Google Scholar 

  15. Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014;1(83):E212–20.

    Article  Google Scholar 

  16. Tammam K, Ikari Y, Yoshimachi F, Saito F, Hassan W. Impact of transradial coronary intervention on bleeding complications in octogenarians. Cardiovasc Interv Ther. 2016 [Epub ahead of print].  

  17. Tarzamni MK, Eshraghi N, Fouladi RF, Afrasiabi A, Halimi M, Azarvan A. Atherosclerotic changes in common carotid artery, common femoral artery, and ascending aorta/aortic arch in candidates for coronary artery bypass graft surgery. Angiology. 2012;63:622–9.

    Article  PubMed  Google Scholar 

  18. Fargen KM, Hoh BL, Mocco J. A prospective randomized single-blind trial of patient comfort following vessel closure: extravascular synthetic sealant closure provides less pain than a self-tightening suture vascular compression device. J Neurointerv Surg. 2011;3:219–23.

    Article  PubMed  Google Scholar 

  19. Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, et al. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015;27:129–36.

    PubMed  Google Scholar 

  20. Katzenschlager R, Tischler R, Kalchhauser G, Panny M, Hirschl M. Angio-Seal use in patients with peripheral arterial disease (ASPIRE). Angiology. 2009;60:536–8.

    Article  PubMed  Google Scholar 

  21. Chu G, Yang W, Zhang G, Zhang Z, Liu S, Sun B, et al. Safety and efficacy of the StarClose vascular closure system following 8-Fr sheath placement for intra-aortic balloon pump: a single-center analysis of 42 consecutive patients. Med Princ Pract. 2014;23:313–7.

    Article  PubMed  Google Scholar 

  22. Sohail MR, Khan AH, Holmes DR Jr, Wilson WR, Steckelberg JM, Baddour LM. Infectious complications of percutaneous vascular closure devices. Mayo Clin Proc. 2005;80:1011–5.

    Article  PubMed  Google Scholar 

  23. Franco J, Motaganahalli R, Habeeb M, Wittgen C, Peterson G. Risk factors for infectious complications with angio-seal percutaneous vascular closure devices. Vascular. 2009;17:218–21.

    Article  PubMed  Google Scholar 

  24. Tiesenhausen K, Tomka M, Allmayer T, Baumann A, Hessinger M, Portugaller H, et al. Femoral artery infection associated with a percutaneous arterial suture device. Vasa. 2004;33:83–5.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

The authors thank Drs. Keita Odashiro, MD, and Koichi Akashi, MD, Department of Medicine and Biosystemic Science, Kyushu University hospital, who provided data management center; and Dr. Toru Maruyama, MD, Prof, Facility of Arts and Science, Kyushu University, who provided safety committee process.

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Authors and Affiliations

  1. Department of Cardiology, Kishiwada Tokushukai Hospital, 4-27-1 Kamori-cho, Kishiwada, Osaka, 596-8522, Japan

    Masahiko Fujihara, Akihiro Higashimori & Yoshiaki Yokoi

  2. Department of Medical Engineering, Kishiwada Tokushukai Hospital, Kishiwada, Osaka, Japan

    Yuichi Haramitsu, Kenji Ohshimo, Yuko Yazu & Eri Izumi

  3. Department of Medicine and Biosystemic Science, Faculty of Medicine, Kyushu University, Fukuoka, Japan

    Masahiko Fujihara

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  1. Masahiko Fujihara
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  2. Yuichi Haramitsu
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  3. Kenji Ohshimo
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  4. Yuko Yazu
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  5. Eri Izumi
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  6. Akihiro Higashimori
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  7. Yoshiaki Yokoi
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Correspondence to Masahiko Fujihara.

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The authors have no commercial, proprietary, or financial interest in any products or companies described in this article.

Human rights statement and informed consent

The study was performed in accordance with the Declaration of Helsinki, and written informed consent was obtained from all patients prior to their enrollment in this study.

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Fujihara, M., Haramitsu, Y., Ohshimo, K. et al. Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous revascularization. Cardiovasc Interv and Ther 32, 233–240 (2017). https://doi.org/10.1007/s12928-016-0409-x

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  • DOI: https://doi.org/10.1007/s12928-016-0409-x

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