Case Study

Achieving Hemostasis with Angio-Seal Closure Device After Removal of Inadvertently Placed Triple Lumen Central Venous Catheter from Bifurcation of Innominate Artery

Lina Todorova, DO, Sumit Ringwala, MD, Kingston Okrah, MD
Affinity Medical Group, Mercy Medical Center, Oshkosh, Wisconsin

Lina Todorova, DO, Sumit Ringwala, MD, Kingston Okrah, MD
Affinity Medical Group, Mercy Medical Center, Oshkosh, Wisconsin

Abstract: The placement of a central venous catheter carries about a 15% risk of possible complications such as arterial puncture or erroneous placement in the arterial vasculature of the upper thorax.1 No guidelines have been developed for the removal of an erroneously placed central venous catheter in the bifurcation of the innominate artery. We present a successful case of achieving hemostasis with an Angio-Seal closure device (Terumo) after the removal of an accidentally placed central venous catheter from the innominate artery. In addition, other possible methods of managing this case (manual compression, the use of other vascular closure devices, endovascular and direct surgical repair) will be reviewed. 

History
 
An 88-year-old male presented to the emergency room with an episode of hemoptysis, hypoxemia, and respiratory failure. He was emergently intubated and a central venous line was blindly inserted in what was then thought to be the right internal jugular vein. Location was then confirmed by blood return and a chest x-ray. The patient was transferred to the intensive care unit (ICU) and placed on a mechanical ventilator. Two days later, a computed tomography (CT) scan was ordered to further evaluate the hemoptysis when it was discovered that the 7 French triple lumen central venous catheter was inadvertently placed in the bifurcation of the innominate artery with its tip extending into the aortic arch (Figure 1). All infusions through the line were stopped and vascular surgery and interventional cardiology were consulted.
 
A decision was made to remove the catheter in the cardiac catheterization lab. A 7 French Pinnacle Destination sheath (Terumo) was inserted in to the right femoral artery using the modified Seldinger technique. This alternative artery access was obtained to allow for contrast injections and visualization of the aortic arch and innominate artery. A headhunter catheter was used to engage the right innominate artery and exchanged over a wire for a Tennis Racquet catheter (Boston Scientific). Contrast angiography of the right innominate, subclavian, and carotid artery was obtained using the Tennis Racquet catheter. The triple lumen central venous catheter was then removed over a Newton J wire (Cook), leaving the wire in place.  A 6 French Angio-Seal closure device (Terumo) was deployed over the wire. A racquet catheter was used to inject contrast and no leakage was observed. The catheter and sheath were both removed, and the access site in the right groin area was closed via a 6 French Perclose closure device (Abbott Vascular). No immediate complications were noted. Two days later, the patient was discharged, free of complications such as bleeding or stroke. 
 
Discussion
 
The successful placement of a central venous catheter in the internal jugular vein is a challenging task. Physicians often use anatomical landmarks, ultrasound guidance, chest x-ray, the low pressure of the venous system, and the color of de-oxygenated blood to confirm correct placement. Despite these methods, erroneous central venous catheter placement is not a rare occurrence. Unfortunately, there are no current guidelines for the safe removal of a central venous catheter from an artery in which hemorrhage would be prevented or controlled. Also, there are no studies comparing the safety and/or complications of possible methods of management. Simple removal of the central venous catheter could lead to a myriad of complications, such as blood loss, stroke, thrombosis, neurological deficits, pneumothorax, hemothorax, and even death.2 Here, the primary focus will be on the different ways to achieve hemostasis after the removal of a central venous catheter from the innominate artery and why the Angio-Seal closure device was chosen for this case.
 
Ways to manage a punctured innominate artery after a central venous catheter removal include manual compression, the use of an off-label closure device, or open surgical or endovascular repair.2 According to Taylor et al, a puncture in the common carotid or subclavian artery can be very well tolerated if it is recognized early and enough pressure is applied to the site.1 However, other sources in the scientific literature rate manual compression as the worst way to manage a puncture of an artery and associate it with a higher risk of mortality as compared to endovascular closure.1 Upon further analysis, it seems logical that manual compression would not be very effective, because the chest wall and clavicle are anterior to the bifurcation of the innominate artery and will be a barrier to effective compression. Furthermore, the puncture site of the innominate artery is not directly under the skin access site, making it difficult to apply compression over the punctured site. Thus, manual compression does not seem very effective. It is also time consuming, prolongs patient bed rest,3 and carries a 5.6% stroke risk.4 Nevertheless, it remains as the “gold standard” for achieving hemostasis at any arterial puncture site. 
 
An alternative to manual compression is closure with an off-label vascular closure device (VCD). Many different VCDs exist and most are designed to close the femoral artery access site after a percutaneous coronary intervention (PCI). None of the devices discussed here are specifically designed to close a perforated innominate artery; therefore, their use is off label. The following devices could have been used in this case: Perclose, StarClose (Abbott Vascular), Angio-Seal, Exoseal (Cordis, A Cardinal Health company), and Mynx (Cardinal Health). Each device’s mechanism of vascular closure is vastly different. In short, the Perclose closure device delivers a single monofilament suture to the puncture site of the vessel.5 The Angio-Seal, on the other hand, creates a collagen plug that usually dissolves in 60 to 90 days.6 The StarClose delivers a nitinol (titanium, nickel, and alloy) clip to close the site7 and the Exoseal VCD delivers a plug made of polyglycolic acid (a synthetic substance, unlike the collagen plug used by the Angio-Seal)8. The Mynx works on the basis of a synthetic vascular seal made of polyglycolic acid.9 No studies have been done to determine the superiority of any single closure device. However, there seems to be an agreement in the medical community that vascular closure devices increase patient comfort and shorten the time to hemostasis and patient discharge as compared to manual compression.3 Unfortunately, the safety of these devices is still unclear.  VCDs could potentially increase the risk of infection and lower limb ischemia when used to close the femoral artery.3 
 
In this case, the Angio-Seal was used to close off the innominate artery puncture site. According to Schwarz et al, in a study of 4525 patients undergoing an interventional procedure, the Angio-Seal had a success rate of 97%.3 Meta-analyses show that Angio-Seal is superior to manual compression and is associated with fewer complications.3 Due to the location of the puncture site, the StarClose or Perclose could not be used. The brachial plexus is proximal to the bifurcation of the innominate artery, and could be severed by the nitinol clip of the StarClose or the monofilament suture of the Perclose. The Mynx could be potentially used in this case. However, the Angio-Seal was preferred due to its collagen plug, a naturally found substance in the human body, as opposed to the synthetic polyglycolic substance used by the Mynx. In addition, according to Schwarz et al, the Mynx has a 91-93% success rate, while the Angio-Seal had a 97% success rate, in separate studies.3 However, no prospective, controlled studies have been done to directly compare the Mynx and Angio-Seal side by side. Baker et al, in an analysis of PCI patients receiving either an Angio-Seal or Mynx device, found that safety and efficacy outcomes were similar between the two groups.10
 
The last two options that remain are open surgical repair and endovascular closure via the placement of a covered stent. Open surgical repair was avoided in this case due to the location of the perforation and the invasiveness of the procedure. As noted, the clavicle and the proximity of the brachial plexus make it a difficult surgical site on which to operate. Endovascular closure via the placement of a covered stent is another technique that is not as invasive. It was not used in this case, because the puncture site was at the bifurcation of the innominate artery and there is a possibility of occluding either the common carotid or the subclavian artery.
 
In our patient, the Angio-Seal closure device was used to achieve hemostasis because it was determined to be the safest, least invasive, and most effective choice. The patient had no complications and was discharged within 2 days. Although this case was successful, further studies are needed to determine if this method is the best course of management for all cases of a central venous catheter removal from an arterial vessel.
 
Conclusion
 
This case demonstrates one method of managing a central venous catheter removal from the innominate artery without complications. There are multiple options for achieving hemostasis after removal of the central venous catheter using different closure devices and variety of other methods, but there are no studies to determine which method is safest and most efficacious. Also, it should be noted that none of the vascular closure devices were specifically designed for the closure of a perforated innominate artery. Thus, their use is off label. There are no studies to determine which vascular closure device is superior. Thus, each patient should be assessed individually, and comorbid conditions such as high blood pressure, atherosclerosis, and stroke risk should be taken into consideration. Further investigation is needed to determine guidelines for safe central venous catheter removal from the bifurcation of the innominate artery. 
 
References
  1. Taylor RW, Palagiri AV. Central venous catheterization. Critical Care Medicine. 2016;35(5):1390-1396. doi:10.1097/01.CCM.0000260241.80346.1B.
  2. Yoon DY. Inadvertent arterial placement of central venous catheters: diagnostic and therapeutic strategies. Annals of Vascular Surgery. 2015; 29(8): 1567-1574. doi:10.1016/j.avsg.2015.05.030.
  3. Schwarz BG. Review of vascular closure devices. Cath Lab Digest. 2011; 19(7): 10-20. Available online at http://www.cathlabdigest.com/articles/Review-Vascular-Closure-Devices. Accessed December 12, 2017.
  4. Guilbert MC, Elkouri S, Bracco D, Corriveau MM, Beaudoin N, Dubois MJ, et al. Arterial trauma during central venous catheter insertion: Case series, review and proposed algorithm. J Vasc Surg. 2008 Oct; 48(4): 918-925; discussion 925. doi: 10.1016/j.jvs.2008.04.046.
  5. Perclose ProGlide Suture-Mediated Closure System (ProGlide SMC) – P960043/S080. Instructions for Use. Available online at https://www.accessdata.fda.gov/cdrh_docs/pdf/P960043S080C.pdf. Accessed December 12, 2017.
  6. Angio-Seal Vascular Closure Device. Available online at http://www.terumois.com/products/closure/angio-seal-vascular-closure-devices/angio-seal.html. Accessed December 12, 2017.
  7. StarClose SE Vascular Closure System. Available online at https://www.vascular.abbott/us/products/vessel-closure/starclose-se-vascular-closure-system.html. Accessed December 12, 2017.
  8. Exoseal Vascular Closure Device. Instructions for Use. Available online at  https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100013c.pdf. Accessed December 12, 2017.
  9. Mynx Vascular Closure Device. Available online at http://www.cardinalhealth.com/en/product-solutions/medical/cardiovascular/mynx-vascular-closure-devices.html. Accessed December 12, 2017.
  10. Baker NC, Escarcega RO, Lipinski MJ, Magalhaes MA, Koifman E, Kiramijyan S, et al. Active versus passive anchoring vascular closure devices following percutaneous coronary intervention: a safety and efficacy comparative analysis. J Interv Cardiol. 2016 Feb; 29(1): 108-112. doi: 10.1111/joic.12264.
Disclosures: The authors report no conflicts of interest regarding the content herein.
 
The authors can be contacted via Lina Todorova, DO, at lina.todd@dmu.edu.