title: Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal(®) Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study.
abstract: OBJECTIVE
  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].
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. claus.christian.pieper@ukb.uni-bonn.de.
authors.forename: Claus Christian
authors.initials: CC
authors.lastname: Pieper
authors.affiliation: Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. daniel.thomas@ukb.uni-bonn.de.
authors.forename: Daniel
authors.initials: D
authors.lastname: Thomas
authors.affiliation: Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. jennifer.nadal@ukb.uni-bonn.de.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Nadal
authors.affiliation: Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. w.willinek@bk-trier.de.
authors.forename: Winfried A
authors.initials: WA
authors.lastname: Willinek
authors.affiliation: Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. hans.schild@ukb.uni-bonn.de.
authors.forename: Hans Heinz
authors.initials: HH
authors.lastname: Schild
authors.affiliation: Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. carsten.meyer@ukb.uni-bonn.de.
authors.forename: Carsten
authors.initials: C
authors.lastname: Meyer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D005260:Female; D005263:Femoral Artery; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D065506:Vascular Closure Devices / Q000706:statistics & numerical data*
keywords: Access site management; Angiography; ExoSeal® vascular closure device; Femoral arterial access; Vascular closure device