Safety and effectiveness of a circumferential clip-based vascular closure device for hemostasis in off-label applications: Comparison with standard applications

We investigated the efficacy and safety of a circumferential nitinol clip based arterial closure device following arteriotomy, especially in off-label applications. 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. 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%). Off-label use of StarClose is safe and feasible