First Report of StarClose Vascular Closure System Dislodgement During Repeat Arterial Access
- Volume 19 - Issue 11 - November 2011
- Posted on: 10/31/11
- 1 Comments
- 6163 reads
Management of vascular access using closure devices has become increasingly common in the last decade. Use of these devices has allowed for earlier ambulation post-procedure and less patient discomfort. The Starclose device is a nitinol clip marketed by Abbott Vascular that closes the arteriotomy in a circumferential manner much like a purse-string suture. The safety profile for re-access through the clip has not been studied in a clinical trial. We present the case of arterial access for cardiac catheterization obtained through the center of a Starclose clip deployed three years earlier. Upon sheath removal, the Starclose clip was dislodged and was extracted with the sheath.
Manual compression of the femoral artery following diagnostic or interventional catheterization procedures requires prolonged periods of bed rest, associated with patient discomfort. Closure of the arteriotomy using various devices has become common in the last decade of catheter-based surgery, leading to improved patient comfort and earlier post-procedure ambulation.1 The Starclose Vascular Closure system employs a circular nitinol clip delivered via an exchange sheath. The clip approximates the edges of the arteriotomy in much the same fashion as a purse-string suture.
The safety of re-access through a Starclose device has not been well established using in vivo studies. According to the manufacturer, a porcine aorta model was used to assess the suitability of the Starclose for re-access. It is reported that access through the center of the clip using an 18-gauge needle and sheath advancement using an over-the-wire technique was possible with 5, 6 and 8 French (F) sheath sizes.
We report the case of a patient who underwent cardiac catheterization with re-puncture through a Starclose clip deployed three years earlier. This is the first case reported in the literature of a Starclose clip dislodgment upon sheath pull.
A 72-year-old male with prior coronary artery bypass presented to our facility with unstable angina. He was referred for cardiac catheterization, performed via right common femoral access. During sheath insertion, there was difficulty advancing the 6F sheath and successive dilations were performed, beginning with a 5F dilator up to a 6F dilator over a stiff Rosen 0.038-inch wire. The 6F sheath was advanced into the artery after sequential pre-dilation, and diagnostic coronary angiography and an intervention to a vein graft were performed using the same 6F sheath system. No significant calcification was seen in the right common femoral artery on fluoroscopy, but we elected to use manual compression closure due to concern over peripheral vascular disease contributing to the difficult access. Femoral angiography was not performed. Upon sheath removal, a metallic ring was found attached to the sheath. It was the Starclose clip that had been deployed in April 2006 (Figure 1). The patient had no complications from the arterial access and was discharged to home the following morning.
The safety of re-puncture through a previously placed Starclose clip has not been established by human clinical trials, and a risk of clip dislodgement and clip embolization is acknowledged by the manufacturer.2 The use of closure devices is becoming more commonplace, and the likelihood of repeat access after closure is increasing with expanding use. Recently, Varghese et al reported a case of an arterial line placed through the center of a Starclose clip which required surgical extraction due to tethering of the line to the clip.3 The original FDA approval of the Starclose clip was based on data from the Clip Closure In Percutaneous Procedures Trial (CLIP). This prospective, randomized, multi-center trial of patients undergoing diagnostic and interventional cardiac catheterization procedures compared Starclose with manual compression of the access site. Upon 30-day follow up, Starclose demonstrated non-inferiority to manual compression in terms of major and minor vascular complications.4,5 Re-access safety was determined based on experiments in a bench-top model of a pressurized porcine aorta conducted by the manufacturer. This model does not take into account the variables introduced by peri-vascular tissue and the angle of the subcutaneous needle track, vessel calcification, or manipulation of the sheath during catheter exchanges.
Although our patient had no short-term complications from the complicated access, it is conceivable that traversing the clip could have resulted in device embolization or laceration of the artery. Since this sentinel event, we have documented one additional case in our laboratory, demonstrating that this was not an isolated occurrence. We propose that proceduralists make special note of prior deployment of a Starclose clip in patients undergoing repeated femoral access, and that fluoroscopy be employed at the time of arterial puncture to avoid re-access through a previously placed device.
This article received a double-blind peer review from members of the Cath Lab Digest editorial board.
The authors can be contacted via Robert N. Piana, MD, [email protected].
Disclosure: The authors report no conflicts of interest regarding the content herein.
- Juergens CP, Leung DYC, Crozier JA. Patient tolerance and resource utilization associated with an arterial closure versus external compression device after percutaneous coronary intervention. Catheter Cardiovasc Interv 2004;63:166-170.
- Starclose Vascular Closure System. Instructions for Use. Available online at www.abbottvascular.com/ifu. Accessed October 13, 2011.
- Varghese R, Chess D, Lasorda D. Re-access complication with a Starclose device. Catheter Cardiovasc Interv 2009;73:899-901.
- Hermellier JB, Simonton C, Hinohara T. Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 2005; 17:504-551.
- Hermellier JB, Simonton C, Hinohara T. The Starclose vascular closure system: Interventional results from the CLIP study. Catheter Cardiovasc Interv 2006;68:677-683.