Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal® Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study
- 466 Downloads
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.
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.
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].
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.
KeywordsVascular closure device ExoSeal® vascular closure device Femoral arterial access Angiography Access site management
Compliance with Ethical Standards
Conflicts of interest
All authors report that there are no disclosures relevant to this publication.
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.
- 5.Wong SC, Bachinsky W, Cambier P, 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(8):785–93.PubMedCrossRefGoogle Scholar
- 8.Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001;13(5):354–62.PubMedGoogle Scholar
- 16.Boschewitz JM, Andersson M, Naehle CP, et al. Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure and closure after repeat puncture in diagnostic and interventional radiology: single-center experience. J Vasc Interv Radiol. 2013;24(5):698–702.PubMedCrossRefGoogle Scholar