Retrospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Radiol. Sep 28, 2018; 10(9): 108-115
Published online Sep 28, 2018. doi: 10.4329/wjr.v10.i9.108
Korean single-center experience with femoral access closure using the ExoSeal device
Yoonhee Han, Jae Hyun Kwon, Surin Park
Yoonhee Han, Jae Hyun Kwon, Surin Park, Department of Radiology, Dongguk University Ilsan Hospital, Goyang-si 10326, Gyeonggi-do, South Korea
Author contributions: Han Y performed the clinical procedures, data analysis and manuscript writing; Kwon JH performed the clinical procedures and data analysis; Park S performed the data analysis and manuscript writing.
Institutional review board statement: This study was reviewed and approved by the Dongguk University Ilsan Hospital Institutional Review Board (approval No. DUIH 2017-10-003-001).
Informed consent statement: The study investigators obtained informed consent from all included patients, and the study was conducted in accordance with the principles of the Helsinki Declaration.
Conflict-of-interest statement: All authors declare no conflicts-of-interest related to this article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Yoonhee Han, MD, PhD, Associate Professor, Department of Radiology, Dongguk University Ilsan Hospital, 27 Dongguk-ro, Siksa-dong, Ilsandong-gu, Goyang-si 10326, Gyeonggi-do, South Korea. hanyoonhee@naver.com
Telephone: +82-10-52729747 Fax: +82-31-9618281
Received: April 27, 2018
Peer-review started: April 27, 2018
First decision: June 14, 2018
Revised: August 6, 2018
Accepted: August 23, 2018
Article in press: August 24, 2018
Published online: September 28, 2018
Processing time: 154 Days and 6.6 Hours
ARTICLE HIGHLIGHTS
Research background

The gold standard method for achieving hemostasis at the femoral arterial puncture site has been manual compression (MC). However, MC has limitations, such as prolonged hemostasis time, patient pain and discomfort, and a requirement for prolonged bed rest. Therefore, various hemostatic devices have been developed to improve the efficacy and safety of percutaneous intravascular treatment and one of those hemostasis devices is ExoSeal.

Research motivation

We have used MC or other compressive devices (such as sand bags or balloon compressive devices) before introducing ExoSeal into our clinical practice. When we first started to use ExoSeal, we began studying the cases in which it was applied.

Research objectives

To report the experience of closure of the femoral artery using ExoSeal vascular closure devices (VCDs) over a 17-mo period.

Research methods

We evaluated the technical and procedural success rates, complications, and factors affecting the hemostasis time of the ExoSeal VCDs.

Research results

Technical and procedural successes were achieved in 176 cases (98.0%) and 128 cases (71.5%), respectively. In one case (0.6%), a small hematoma developed, but there were no major complications. A history of drinking alcohol, low platelet (PLT) count, and high prothrombin time-international normalized ratio (PT-INR) values were the statistically significant predictors of the need for longer MC.

Research conclusions

The ExoSeal VCD is a simple, safe and effective device for hemostasis of femoral punctures. In addition, the ExoSeal VCD is an instrument that effectively achieves hemostasis with few complications, even when used repeatedly in the same patient. However, longer light MC may be needed in patients with a history of drinking alcohol, low PLT count, and high PT-INR values.

Research perspectives

Based on this and other studies, ExoSeal is expected to improve further and other similar VCDs will be developed.