Cutaneous migration of the StarClose® device

Abstract

We report the first case of a transcutaneous migration of a vascular clip closure device 10 weeks after placement during femoral artery puncture for percutaneous transluminal angioplasty. We postulate focal inflammatory vascular wall changes as the predisposing factor in this patient with giant cell arteritis.

The road to perfect closure—Still unpaved

“…Although the authors express concern about utilizing VCDs in vessels <6 mm, they should be aware that the instructions for use and the pivotal trial on which they are based excluded vessels <5, not 6 mm in size. In contrast, the article by Aschwanden et al [7] does not mention an angiogram of the sheath inser-tion site (though perhaps one was done), and although they claim that ''the standard deployment steps were followed as recommended by the company,'' in fact closure of an antegrade stick is off-label, and without an angiogram of the puncture site, it is impossible to know the extent of local vascular disease, exact location of the puncture, or size of the vessel at the puncture site. For reasons that I cannot fathom, sheath angiography of the puncture site remains uncommon outside the United States.…”

“…For reasons that I cannot fathom, sheath angiography of the puncture site remains uncommon outside the United States. In some respects, both of the studies in this issue are incomplete, and I believe that insufficient information is presented in either article to make broad conclusions, though the suggestion by Aschwanden et al [7] that patients with active inflammatory vasculitis may be better served with manual compression is a very interesting one for hypothesis testing. With regard to the case by Osborn et al, most of us who routinely use StarClose make a point of not pushing significantly and primarily stabilizing the device prior to firing the clip (the IFU states ''allow the weight of the device to rest on the artery or gently push down''), and in general, rather than shying away from vessels like the one described, we are happiest using the device in healthy, compliant arteries.…”

The utility of duplex ultrasound scanning in reporting the vascular complications after heart catheterization performed from new arterial approaches – radial or femoral artery access with StarClose usage – a substudy of the RADIAMI II trial

“…1). The sheath is a 6 F sheath with a sidearm that is introduced into the target vessel and then used as a passageway for the insertion of diagnostic, guide, or other interventional catheters [9][10][11]. The angiography of femoral arteries was not executed before the implantation of the StarClose clip.…”

In search of perfect closure

“…Aschwanden et al [1] report the case of transcutaneous migration of the star close vascular clip 10 weeks after placement for femoral artery closure. Initial hemostasis and device placement was entirely successful.…”