Safety and Efficacy of the StarClose Vascular Closure Device in More Than 1000 Consecutive Peripheral Angioplasty Procedures

Abstract

The StarClose vascular closure device is safe and effective in achieving hemostasis during antegrade and retrograde peripheral angioplasty procedures.

Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients

“…Although according to the manufacturing company, Starclose SE® VCD deployment in calcified arteries is contraindicated, calcifications did not influence the hemostasis or complication rates. Notably, its successful antegrade use in calcified vessels has been previously reported (11). Consequently, we believe that hemostasis can be achieved with this VCD in antegrade punctures of calcified below the femoral head SFA segments; however, it should be cautioned that technical failure is more possible because the device's hemostatic mechanism is based on constricting the outer arterial wall.…”

“…Usually bleeding complications occur due to suboptimal clip sealing or early patient mobilization, which are amenable to manual compression. The main disadvantages of this specific VCD include the possibility of delayed oozing or bleeding mainly in cases of hypertension and increased technical difficulty in clip deployment in obese patients, attributed to nonadequate aligning of the device as to successfully deliver the nitinol clip to the adventitia (11). Perhaps this technical detail is one of the main reasons for 100% of hemostasis achieved in this series, since in low SFA access there is no steep angulation between the artery and the device created by large abdomen, leading to easier clip deployment.…”

“…Following sheath positioning a bolus dose of 50 IU/kg of unfractioned heparin was administrated according to international guidelines (14,15). Following completion of endovascular revascularization, hemostasis was achieved with the nitinol clipbased, StarClose SE® extraluminal VCD, as previously described for antegrade access, after meticulously creating a subcutaneous canal for clip deployment using mosquito forceps for bland dissection and exchanging the arterial sheath with the sheath of the VCD over a nonhydrophilic stiff guidewire (Amplatz Super stiff ™ guidewire, Boston Scientific) (11)…”

“…The safety and efficacy of Starclose SE ® extraluminal VCD in obtaining hemostasis following antegrade CFA access for peripheral arterial interventions has been widely reported (11,12). However, data regarding its use in antegrade direct SFA access remain limited (8).…”

Thermic sealing in femoral catheterization: First experience with the Secure Device

“…The StarClose system, a clip based device, has a malfunction rate around 1.1%. AngioSeal, a well-established collagen plug induced vascular closure device, has been found to have malfunction rates up to 10% [13,14]. The majority of the device malfunctions occurred at the beginning of the Secure Device activation, so the device was able to be changed and did not influence the study procedure.…”