J Korean Soc Radiol.  2016 Sep;75(3):171-176. 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

• Lee S
• Kim CW
• Jeon UB

• KMID: 2349321
• DOI: http://doi.org/10.3348/jksr.2016.75.3.171

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.

MeSH Terms

Angioplasty
Blood Vessel Prosthesis
Brachial Artery
Femoral Artery
Hemostasis*
Hemostatic Techniques
Humans
Off-Label Use
Punctures
Transplants
Vascular Closure Devices*

Figure

• 

  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.

• 

  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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