The majority of interventional procedures require access via the femoral artery. A variety of closure devices have been developed to facilitate access site management and early ambulation. The StarClose™ Vascular Closure System (Abbott Vascular, Abbott Park, Illinois), which features a nitinol clip, has received approval for repuncture and reclosure in patients undergoing percutaneous catheterization procedures. We report a case of entrapment of a micropuncture vascular sheath into a previously placed StarClose™ device and its successful retrieval.
VASCULAR DISEASE MANAGEMENT 2011;8:E132–E133
A 46-year-old white female with known coronary artery disease was admitted to a community hospital with a 6-week history of recurrent chest pain on exertion associated with left arm numbness and recurrent episodes of syncope and dyspnea on exertion. Laboratory workup revealed troponin of 0.4 ng/ml. She underwent a left heart catheterization, which revealed an 80% stenosis of the right coronary artery (RCA). Arterial puncture site was sealed using StarClose™ Vascular Closing System (Abbott Vascular). Subsequently, she was transferred to our facility for percutaneous intervention of the right coronary artery. On arrival, her vitals revealed a blood pressure of 154/85 mmHg and a heart rate of 82 bpm with regular rate and rhythm. She denied any chest pain or shortness of breath. The patient was taken for percutaneous coronary intervention of RCA.
During the procedure, we encountered difficulty in obtaining access to the right femoral artery secondary to preexisting ecchymosis, tenderness and a previously placed closure device. Access was attempted with a micropuncture needle after unsuccessful attempts with a standard needle were made. The micropuncture wire and sheath were passed easily; however, sheath could not be withdrawn easily from the artery and a part of the micropuncture sheath was sheared and caught in the previously placed StarClose™ closure device while trying to exchange for a 6 Fr sheath. Close fluoroscopic inspection of the femoral artery area revealed part of a sheath (Figure 1). In order to retrieve the micropuncture sheath from the StarClose™ clip, the left femoral artery was cannulated and a snare was passed from this access site into the proximal right femoral artery. The micropuncture sheath was snared off the StarClose™ device and was safely retrieved through the left femoral artery (Figure 2). An aortogram and runoff images showed good distal leg blood flow without evidence of distal embolization or ischemia. Following this, RCA was successfully stented through the left femoral artery access site (Figures 3 and 4).
The StarClose™ Vascular Closure System (Abbott Vascular) is designed to deliver a nitinol clip to close femoral artery access sites following percutaneous catheterization procedures and it is reported to be safe even in patients with high-risk femoral artery anatomy and recurrent femoral punctures.1–4 According to the manufacturer, repuncture through the StarClose™ system was demonstrated in the porcine aorta with 512 repunctures and reclosures using 5 Fr and 6 Fr sheaths.5 However, such a demonstration has not been made in human settings. Despite these advantages, a number of uncommon complications have been reported with this device. Osborn and his colleagues reported a case of femoral artery stenosis requiring removal of the closure device and subsequent surgical intervention.6 Intravascular misplacement of the nitinol clip at the time of vascular closure is also a known complication, which can cause femoral artery laceration and stenosis.7 Also reported was a delayed transcutaneous migration or a trapping of the vascular clip closure device.8,9 A similar case report of entrapment of an arterial line in StarClose™ requiring surgical removal has been reported.10
Our case is the first reported incident of percutaneous retrieval of entrapped micropuncture sheath in the StarClose™ device. Based on our experience we recommend that operators exercise caution in patients undergoing repuncture when their previous arteriotomy was closed with a StarClose™ device.
- Hermiller JB, Simonton C, Hinohara T, et al. Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 2005;17:504–510.
- Hermiller JB, Simonton C, Hinohara T, et al. The StarClose Vascular Closure System: Interventional results from the CLIP study. Catheter Cardiovasc Interv 2006;68(5):677–683.
- Rashid MN, Ahmed B, Straight F, et al. Extravascular closure for patients with high-risk femoral anatomy. J Invasive Cardiol 2008;20(7):328–332.
- Tay EL, Melissa CO, Tai BC, et al. Clinical experience of StarClose vascular device in patients with first and recurrent femoral punctures. J Interv Cardiol 2008;21:67–73.
- Available at http://www.fda.gov/cdrh/pdf5/p050007c.pdf.
- Osborn LA, Sunderman H, Langsfeld M. Common femoral artery stenosis after deployment of vascular clip closure device. Catheter Cardiovasc Interv 2008;71(6):736–737.
- Stock U, Flach P, Gross M, Meyhöfer J, Albes J, Butter C. Intravascular misplacement of an extravascular closure system: StarClose. J Interv Cardiol 2006;19(2):170–172.
- Aschwanden M, Bilecen D, Thalhammer C. Cutaneous migration of the StarClose device. Catheter Cardiovasc Interv 2008;71(6):744–746.
- Fowler SJ, Nguyen A, Kern M. Trapping of vascular clip closure device in previously accessed femoral puncture site. Catheter Cardiovasc Interv 2007;70:62–64.
- Varghese R, Chess D, Lasorda D. Re-access complication with a StarClose device. Catheter Cardiovasc Interv 2009;73:899–901.
From the Health Sciences Center, Louisiana State University, Shreveport, Louisiana.
The authors report no financial relationships or conflicts of interest regarding the content herein.
Manuscript submitted November 30, 2010, provisional acceptance given December 30, 2010, final version accepted May 12, 2011.
Address for correspondence: Kalgi A. Modi, MD, FACC, LSUHSC, Cardiology, 1501 Kings Highway, Shreveport, LA 71130. Email: firstname.lastname@example.org