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

Abstract

PurposeTo intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal{sup ®} vascular closure device (VCD) and manual compression (MC) in a prospective study design.MethodsPatients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal{sup ®}-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.Results48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal{sup ®}-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 generalmore » 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].ConclusionIntra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal{sup ®} use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.« less

Authors:
;  [1];  [2]; ; ;  [1]
  1. University of Bonn, Department of Radiology (Germany)
  2. University of Bonn, Institute for Medical Biometry, Informatics and Epidemiology (Germany)
Publication Date:
OSTI Identifier:
22469635
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 39; Journal Issue: 1; Conference: IROS 2015: Interventional Radiological Olbert Symposium, Berlin (Germany), 15-17 Jan 2015; Other Information: Copyright (c) 2016 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BIOMEDICAL RADIOGRAPHY; COMPARATIVE EVALUATIONS; MALES; MANUALS; PAIN; PATIENTS; SOLID WASTES

Citation Formats

Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de, Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de, Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de, Willinek, Winfried A., E-mail: w.willinek@bk-trier.de, Schild, Hans Heinz, E-mail: hans.schild@ukb.uni-bonn.de, and Meyer, Carsten, E-mail: carsten.meyer@ukb.uni-bonn.de. Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study. United States: N. p., 2016. Web. doi:10.1007/S00270-015-1204-2.
Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de, Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de, Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de, Willinek, Winfried A., E-mail: w.willinek@bk-trier.de, Schild, Hans Heinz, E-mail: hans.schild@ukb.uni-bonn.de, & Meyer, Carsten, E-mail: carsten.meyer@ukb.uni-bonn.de. Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study. United States. doi:10.1007/S00270-015-1204-2.
Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de, Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de, Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de, Willinek, Winfried A., E-mail: w.willinek@bk-trier.de, Schild, Hans Heinz, E-mail: hans.schild@ukb.uni-bonn.de, and Meyer, Carsten, E-mail: carsten.meyer@ukb.uni-bonn.de. Fri . "Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study". United States. doi:10.1007/S00270-015-1204-2.
@article{osti_22469635,
title = {Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study},
author = {Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de and Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de and Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de and Willinek, Winfried A., E-mail: w.willinek@bk-trier.de and Schild, Hans Heinz, E-mail: hans.schild@ukb.uni-bonn.de and Meyer, Carsten, E-mail: carsten.meyer@ukb.uni-bonn.de},
abstractNote = {PurposeTo intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal{sup ®} vascular closure device (VCD) and manual compression (MC) in a prospective study design.MethodsPatients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal{sup ®}-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.Results48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal{sup ®}-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].ConclusionIntra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal{sup ®} use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.},
doi = {10.1007/S00270-015-1204-2},
journal = {Cardiovascular and Interventional Radiology},
number = 1,
volume = 39,
place = {United States},
year = {Fri Jan 15 00:00:00 EST 2016},
month = {Fri Jan 15 00:00:00 EST 2016}
}
  • No abstract prepared.
  • We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deploymentmore » subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.« less
  • No abstract prepared.
  • No abstract prepared.
  • Purpose. To assess the efficacy and safety of the Exoseal vascular closure device for antegrade puncture of the femoral artery. Methods. In a prospective study from February 2011 to January 2012, a total of 93 consecutive patients received a total of 100 interventional procedures via an antegrade puncture of the femoral artery. An Exoseal vascular closure device (6F) was used for closure in all cases. Puncture technique, duration of manual compression, and use of compression bandages were documented. All patients were monitored by vascular ultrasound and color-coded duplex sonography of their respective femoral artery puncture site within 12 to 36more » h after angiography to check for vascular complications. Results. In 100 antegrade interventional procedures, the Exoseal vascular closure device was applied successfully for closure of the femoral artery puncture site in 96 cases (96 of 100, 96.0 %). The vascular closure device could not be deployed in one case as a result of kinking of the vascular sheath introducer and in three cases because the bioabsorbable plug was not properly delivered to the extravascular space adjacent to the arterial puncture site, but instead fully removed with the delivery system (4.0 %). Twelve to 36 h after the procedure, vascular ultrasound revealed no complications at the femoral artery puncture site in 93 cases (93.0 %). Minor vascular complications were found in seven cases (7.0 %), with four cases (4.0 %) of pseudoaneurysm and three cases (3.0 %) of significant late bleeding, none of which required surgery. Conclusion. The Exoseal vascular closure device was safely used for antegrade puncture of the femoral artery, with a high rate of procedural success (96.0 %), a low rate of minor vascular complications (7.0 %), and no major adverse events.« less