Vascular closure devices are commonly employed to achieve rapid hemostasis and early patient mobilization following percutaneous procedures via the femoral artery.1 The AngioSeal® device (St. Jude Medical/Daig, Minnetonka, Minnesota) is a percutaneous, bioabsorbable, collagen-based hemostatic plug deployed to seal the arterial puncture. This case describes a complication following use of the AngioSeal device during routine angiography.
Case Report. A 69-year-old man with a history of balloon angioplasty to the left anterior descending (LAD) and circumflex 20 years before presented with worsening angina despite medical treatment. Diagnostic coronary angiography via the right femoral approach demonstrated tight circumflex disease and moderate LAD disease. An AngioSeal device was used for hemostasis and the patient was referred for consideration of coronary angioplasty. One week later, he presented to his general practitioner (GP) with right calf pain on walking. The GP diagnosed muscular pain, possibly statin-induced myositis. When he saw the interventional cardiologist, his exercise-induced right calf pain had not resolved despite cessation of statin therapy. The history was more suggestive of intermittent claudication and on examination the right femoral pulse was palpable but weaker than that on the left and his right dorsalis pedis was impalpable. It was noted that immediately following deployment of the AngioSeal, manual pressure had been required to achieve hemostasis. A vascular complication was suspected and a magnetic resonance angiogram was requested (Figure 1). This showed a well-defined focal filling defect at the division of the popliteal artery into the anterior tibial and tibio-peroneal trunk, suggestive of an embolus (Figure 2). He was referred to a vascular surgeon. The gentleman continued to have unstable angina and it was decided between surgeon, anesthetist and cardiologist that this required treatment prior to surgery. He underwent elective angioplasty to the tight circumflex lesion with a bare-metal stent via the radial approach. After 1 month of clopidogrel, he underwent surgical exploration of his popliteal artery. The AngioSeal collagen plug was found and removed (Figures 3 and 4) and he is now without angina or claudication.
Discussion. Despite the relatively low reported incidence of problems with vascular closure devices (VCD), this case is a reminder of their potentially serious complications.2–4 VCD failure is defined as unsuccessful deployment or failure to achieve hemostasis and increases the risk of vascular complications. Vascular complications requiring surgical repair have been described in approximately 1% of patients after coronary intervention.5
The AngioSeal closure device is very successful in achieving hemostasis and allowing early patient mobilization.5 However, closure devices are associated with several complications. Major complications include pseudoaneurysm, arterio-venous fistula formation, common femoral artery thrombosis, retroperitoneal hemorrhage, infection, limb ischemia due to dissection, arterial obstruction at site of puncture or embolization, and death. Minor complications include localized allergic reaction, continuous oozing at the puncture site and hematoma.6 One paper reported the rate of major complications ranged from 0–15.8% and minor complications ranged from 0–23%.7
Our case is most unusual, as the majority of vascular complications with AngioSeal devices are due to dissection and occlusion at the site of deployment in the femoral artery,8,9 not due to distal embolization. Manufacturer guidelines were followed in the placement of the device, with limited angiography performed immediately before deployment that showed no significant obstructive disease of the common femoral artery. In addition, the arterial puncture was seen to enter the common femoral vessel above the profundal femoralis and superficial femoral artery bifurcation, below the inguinal ligament and over the head of the femur. Presumably, the anchor fixed in atheroma within the vessel and the collagen plug was pulled though the vessel wall to lie intra-arterially and then migrated distally to the popliteal bifurcation to produce arterial obstruction and consequent claudication.
Hemostasis was not achieved immediately during the procedure and manual compression was required. It is possible that the compression itself contributed to the collagen plug migrating intra-arterially. The peripheral pulses were fine on discharge and it was over a week before he presented to his GP with calf pain.
Generally, most AngioSeal complications are manifested early. In one study, half of the adverse events were recognized soon after the initial procedure and half presented from 2–9 days later.10 Overall, the published data suggest that the use of VCD reduces the period of bed rest required following percutaneous vascular procedures, but does not reduce the incidence of vascular complications.11,12 This case illustrates that some vascular complications can have a delayed presentation and that the treating doctor should be aware of these.
VCD do not reduce vascular complications, but enable earlier patient mobilization than simple compression after femoral arterial puncture. Perhaps the best way to avoid vascular complications, at least for interventional procedures requiring 4–7 French catheters, is to employ a radial approach. This is associated with a significant decrease in bleeding complications due to the radial artery being smaller, easily compressible and distant from other major vascular structures.
One meta-analysis found a 73% reduction in major bleeding between radial and femoral access groups.13 Bleeding complications peri-procedure are associated with worse clinical outcomes and thus a radial approach (through reduced bleeding complications) probably offers a better long-term clinical outcome.14 Data from the National Cardiovascular Data Registry in the United States showed only a 0.19% vascular complication rate for the radial approach as opposed to 0.7% for the femoral approach.
Due to its small size, radial access can be difficult and there is a risk of spasm. Despite this, the frequency of switching to a femoral approach is very low in experienced hands (
This case illustrates an unusual complication of femoral access and AngioSeal deployment. This would have been entirely avoided with the radial approach.
- Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose Proglide and AngioSeal-VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv 2008;71:1–5.
- Kadner A, Schmidli J, Schwegler I, et al. Complications associated with the arterial puncture closure device AngioSeal. Vasc Endovascular Surg 2008;42:225–227.
- Kapoor B, Panu A, Berscheid B. AngioSeal in antegrade endovascular interventions: Technical success and complications in a 55 patient series. J Endovasc Ther 2007;14:382–386.
- Mukhopadhyay K, Puckett MA, Roobottom CA. Efficacy and complications of AngioSeal in antegrade puncture. Eur J Radiol 2005;56:409–412.
- Ferreira AC, Eton D, de Marchena E, et al. Late clinical presentation of femoral artery occlusion after deployment of the AngioSeal closure device. J Invasive Cardiol 2002;11:689–691.
- Koreny M, Riedmüller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. JAMA 2004;291:350–357.
- Gonze MD, Sternbergh WC 3rd, Salartash K, Money SR. Complications associated with percutaneous closure devices. Am J Surg 1999;11:178–209.
- Wille J, Vos JA, Overtoom TT, et al. Acute leg ischemia: The dark side of a percutaneous femoral artery closure device. Ann Vasc Surg 2006;20:278–281.
- Shaw JA, Gravereaux EC, Winters GL, Eisenhauer AC. An unusual cause of claudication. Catheter Cardiovasc Interv 2003;60:562–565.
- Gwechenberger M, Katzenschlager R, Heinz G, et al. The use of a collagen plug versus manual compression for sealing arterial puncture site after cardiac catheterization. Angiology 1997;48:121–126.
- Koreny M, Riedmueller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterisation: Systematic review and meta-analysis. JAMA 2004;291:350–357.
- Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. J Am Coll Cardiol 2004;44:1200–1209.
- Jolly SS, Amlani S, Hamon M, et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: A systematic review and meta-analysis of randomized trials. Am Heart J 2009;157:132–140.
- Vavalle J, Rao SV. The impact of radial access on PCI complications. Cardiac Interventions Today 2010;Mar/April:34–37.