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Title: Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures

Abstract

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 deployment 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 amore » significant increased risk of major puncture-site complications in women with peripheral vascular disease.« less

Authors:
; ; ; ;  [1]
  1. St. George's Hospital, Department of Radiology (United Kingdom), E-mail: Anna.Belli@stgeorges.nhs.uk
Publication Date:
OSTI Identifier:
21091014
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 30; Journal Issue: 2; Other Information: DOI: 10.1007/s00270-006-0226-1; Copyright (c) 2007 Springer Science+Business Media, Inc.; 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; ARTERIES; COMPRESSION; EQUIPMENT; FAILURES; PATIENTS; VASCULAR DISEASES

Citation Formats

Ratnam, Lakshmi A., Raja, Jowad, Munneke, Graham J., Morgan, Robert A., and Belli, Anna-Maria. Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures. United States: N. p., 2007. Web. doi:10.1007/S00270-006-0226-1.
Ratnam, Lakshmi A., Raja, Jowad, Munneke, Graham J., Morgan, Robert A., & Belli, Anna-Maria. Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures. United States. doi:10.1007/S00270-006-0226-1.
Ratnam, Lakshmi A., Raja, Jowad, Munneke, Graham J., Morgan, Robert A., and Belli, Anna-Maria. Sun . "Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures". United States. doi:10.1007/S00270-006-0226-1.
@article{osti_21091014,
title = {Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures},
author = {Ratnam, Lakshmi A. and Raja, Jowad and Munneke, Graham J. and Morgan, Robert A. and Belli, Anna-Maria},
abstractNote = {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 deployment 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.},
doi = {10.1007/S00270-006-0226-1},
journal = {Cardiovascular and Interventional Radiology},
number = 2,
volume = 30,
place = {United States},
year = {Sun Apr 15 00:00:00 EDT 2007},
month = {Sun Apr 15 00:00:00 EDT 2007}
}
  • No abstract prepared.
  • 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)].more » 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.« less
  • StarClose is a novel arterial closure device which achieves hemostasis, following arteriotomy, via a nitinol clip deployed on the outer arterial wall. Since its introduction to the market, several studies have shown StarClose to be both safe and effective, with few major complications encountered. We report a case of common femoral artery laceration following deployment of the StarClose vascular closure system. We conclude that the injury occurred secondary to intravascular misplacement of the nitinol clip.
  • A complication of the StarClose Vascular Closure System (Abbott, Des Plaines, IL) after a transarterial hepatic chemoembolization is described. After attempted clip deployment, the entire device became lodged in the tissues overlying the common femoral artery and could not be removed percutaneously. Successful removal of the device required surgical cutdown for removal and arterial repair. Entrapment of the StarClose vascular closure deployment system is a potentially serious complication that has been reported in the Manufacturer and User Facility Device Experience database, but has not been recognized in the literature.
  • Introduction: The purpose of the present study was to analyze complications following antegrade puncture of the common femoral artery (CFA) and the superficial femoral artery (SFA) using vascular closure systems (VCS). Methods: A single-center, retrospective study was performed after obtaining approval from the institutional review board and informed consent from all patients. At our center, the CFA or SFA are used for arterial access. All patients were evaluated clinically on the same day. If there was any suspicion of an access site problem, Duplex ultrasound was performed. Results: Access location was the CFA in 50 patients and the SFA inmore » 130 patients. The sheath size ranged from 4F to 10F. Two patients had to be excluded because of lack of follow-up. Successful hemostasis was achieved in 162 of 178 cases (91 %). The following complications were observed in 16 patients (8.9 %): 4 pseudoaneurysms (2.2 %), 11 hematomas (6.2 %), and 1 vascular occlusion (0.5 %). The two pseudoaneurysms healed spontaneously, in one case an ultrasound-guided thrombin injection was performed, and one aneurysm was compressed manually. No further medical therapy was needed for the hematomas. The one vascular occlusion was treated immediately with angioplasty using a contralateral approach. No significant difference was noted between the CFA and the SFA group with respect to complications (p = 1.000). Conclusions: The use of closure devices for an antegrade approach up to 10F is feasible and safe. No differences in low complication rates were observed between CFA and SFA.« less