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CardioVascular and Interventional Radiology

, Volume 39, Issue 1, pp 21–27 | Cite as

Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal® Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study

  • Claus Christian Pieper
  • Daniel Thomas
  • Jennifer Nadal
  • Winfried A. Willinek
  • Hans Heinz Schild
  • Carsten MeyerEmail author
Clinical Investigation

Abstract

Purpose

To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal® vascular closure device (VCD) and manual compression (MC) in a prospective study design.

Methods

Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal®-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design.

Results

48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal®-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1–7) vs. 6 (2–10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1–3) vs. 5 (2–10) and 1 (1–2) vs. 2 (1–4), respectively; p < 0.0001].

Conclusion

Intra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal® use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.

Keywords

Vascular closure device ExoSeal® vascular closure device Femoral arterial access Angiography Access site management 

Notes

Compliance with Ethical Standards

Conflicts of interest

None.

Disclosure

All authors report that there are no disclosures relevant to this publication.

Ethical standards

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

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Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015

Authors and Affiliations

  • Claus Christian Pieper
    • 1
  • Daniel Thomas
    • 1
  • Jennifer Nadal
    • 2
  • Winfried A. Willinek
    • 1
  • Hans Heinz Schild
    • 1
  • Carsten Meyer
    • 1
    Email author
  1. 1.Department of RadiologyUniversity of BonnBonnGermany
  2. 2.Institute for Medical Biometry, Informatics and EpidemiologyUniversity of BonnBonnGermany

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