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Lee, Kim, and Jeon: Safety and Effectiveness of a Circumferential Clip-Based Vascular Closure Device for Hemostasis in Off-Label Applications: Comparison with Standard Applications
Interventional Radiology
Original Article

Journal of the Korean Society of Radiology 2016; 75(3): 171-176.

Published online: 18 August 2016

DOI: https://doi.org/10.3348/jksr.2016.75.3.171

Safety and Effectiveness of a Circumferential Clip-Based Vascular Closure Device for Hemostasis in Off-Label Applications: Comparison with Standard Applications

Seungchan Lee, MD1, Chang Won Kim, MD1, Ung Bae Jeon, MD2

1Department of Radiology, Pusan National University School of Medicine, Pusan National University Hospital, Busan, Korea.

2Department of Radiology, Pusan National University School of Medicine, Yangsan Pusan National University Hospital, Yangsan, Korea.

Corresponding author: Chang Won Kim, MD. Department of Radiology, Pusan National University School of Medicine, Pusan National University Hospital, 179 Gudeok-ro, Seo-gu, Busan 49241, Korea. Tel. 82-51-240-7654, Fax. 82-51-244-7534, radkim@nate.com

Received 10 April 2016       Revised 25 May 2016       Accepted 2 June 2016

Copyright © 2016 The Korean Society of Radiology

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

We investigated the efficacy and safety of a circumferential nitinol clip based arterial closure device following arteriotomy, especially in off-label applications.

Materials and Methods

Consecutive patients who underwent the procedure with arteriotomy from January 2011 to February 2014 were included in this study. We defined standard use as the use of StarClose for retrograde puncture of the common femoral artery (CFA) and off-label use as the use of StarClose for retrograde puncture of the superficial femoral artery (SFA), antegrade puncture of the CFA or SFA, puncture of the brachial artery or puncture of the vascular graft. The procedures performed included percutaneous transluminal angioplasty and thrombolysis. Technical success was defined as complete hemostasis achieved within 3 minute after the closure. Complications, and laboratory findings associated with coagulation function, were also investigated.

Results

There were 146 cases of standard applications and 111 cases of off-label applications. Technical success was achieved in all cases. The off-label group comprised the use of StarClose for retrograde puncture of the SFA (n = 19), antegrade puncture of the CFA or SFA (n = 74), brachial artery puncture (n = 5), larger sheath than 6 Fr (n = 7) and vascular graft puncture (n = 6). Minor complications were noted in both groups (standard group: 7.5%, off-label group: 2.7%).

Conclusion

Off-label use of StarClose is safe and feasible.

Keywords: Vascular Closure Devices, Femoral Artery, Brachial Artery, Blood Vessel Prosthesis, Hemostatic Techniques

Figures and Tables

Fig. 1

Picture of StarClose.

A. Main body (from Abbott).
B. Exchange sheath and dilator and wire (from Abbott).
C. Engage the main body to the main body to lock the hub and verify by audible "Click" (from Abbott).
D. Retract the device 3 to 4 cm and depress the plunger (from Abbott).
E. Picture of the open locator wing of the main body (from Abbott). The whole diameter of the locator wing is 5 mm.
F. Retract the device until slight resistance is felt and advance the thumb advancer.
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Fig. 2

A 64-year-old man with transplantation of femorofemoral bypass graft and transplantation of both femoropopliteal bypass grafts.

A. DSA after graft puncture on both sides of the femorofemoral bypass graft shows thrombosis in both femoropopliteal bypass grafts.
B. DSA after overnight thrombolysis shows complete thrombolysis. Also, hemostasis at the puncture site was achieved by using StarClose.
DSA = digital subtraction angiography
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Table 1

Demographics and Complication of Standard Use and Off Label Use of StarClose

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Standard Use (n = 146) Off Label Use (n = 111) p-Value
Age 68.93 ± 10.23 70.9 ± 9.22 0.1
Sex (M:F) 6.3:1 5.2:1 0.7
PT (INR) 1.24 ± 0.85 1.22 ± 0.38 0.76
aPTT 81.76 ± 52.67 74.42 ± 53.24 0.3
Platelet count 227.7 ± 84.57 218.4 ± 78.73 0.37
Platelet count < 50000 1.4% (2) 0.9% (1) 1
Heparin use in procedure 74% (108) 63% (70) 0.08
Pre-procedure UK 3.4% (5) 6.3% (7) 0.43
UK use in procedure 6.8% (10) 6.3% (7) 1
Minor complication 7.5% (11) 2.7% (3) 0.16

aPTT = activated partial thromboplastin time, INR = international normalized ratio, PT = prothrombin time, UK = urokinase

Table 2

Cause of Off-Label Sue and Number, Complication Number and Puncture Direction of Each Cause

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Cause of Off Label Use n Complication Antegrade Puncture
Brachial artery puncture 5 0 0
Bypass graft puncture 6 0 0
Superficial femoral artery puncture 19 0 3
Antegrade puncture of common femoral artery 74 3
Puncture with 7, 8, 9 Fr sheath 7 0 2

Acknowledgments

This work was supported by clinical research grant from Pusan National University Hospital in 2015.

References

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