Late Clinical Presentation of Femoral Artery Occlusion After Deployment of the Angio-Seal Closure Device

Vascular complications requiring surgical repair have been described in approximately 1% of patients after coronary intervention. Despite availability of multiple closure devices, this vexing problem is yet to be resolved. Approximately 75,000 surgical vascular procedures are performed every year to repair vascular entry site complications after cardiac procedures.1 Although safety has been established for many of the commercially available closure devices, they are not without complications, and some groups have actually reported an increase in complication rate since their inception. We report a case of late femoral artery thrombosis four weeks after deployment of the Angio-Seal device. Successful surgical retrieval, endarterectomy and patch angioplasty successfully relieved obstruction and patient symptoms. Case Report. Our patient was a 58-year-old diabetic female with an extensive history of coronary artery disease, but no history of symptomatic peripheral vascular disease. She presented one month prior for elective cardiac catheterization performed for evaluation of medically refractory angina pectoris. Cardiac catheterization was performed using a modified Seldinger technique through a 5 French (Fr) sheath introduced into the right common femoral artery. After coronary angiography, we proceeded with an ad hoc 2-vessel angioplasty and stent placement through a 7 Fr sheath. The patient was pre-medicated with a IIb/IIIa inhibitor (eptifibatide), unfractionated heparin at 60 mg/kg bolus and 300 mg of oral clopidogrel. An ACT of 233 seconds was documented upon completion of the procedure. Immediately after the angioplasty, an 8 Fr Angio-Seal device was deployed using recommended techniques. Entry site at the common femoral artery and absence of atherosclerosis were documented by limited femoral angiography prior to deployment of the seal. A mild calcification of the iliac vessels was noted. After deployment there was no evidence of an expanding hematoma or oozing. Examination of distal pulses revealed diminished dorsalis and malleolar pulses. Ankle Brachial Index (ABI) was 0.7 on the affected limb. There was evidence of a new bruit over the groin area. The patient had no pain and there was no evidence of pallor or coolness of the affected extremity. A duplex ultrasonography revealed loss of triphasic flow and increased velocities at the common femoral artery. Velocities were increased from 43 cm/second to 305 cm/second. There was a filling defect, presumably due to the Angio-Seal device, and a lumen narrowing of approximately 80%. Considering that the patient was asymptomatic and the stenosis was non-occlusive, conservative management was recommended. Four weeks after deployment of the Angio-Seal, the patient developed rapidly progressive claudication and rest pain. Physical examination revealed dependency rubor and elevation pallor. Angiography revealed a subtotal occlusion of the right common femoral artery (Figure 1). Endarterectomy and surgical removal of the Angio-Seal were recommended. During surgical dissection, the artery was noted to be calcific and atherosclerotic. Endarterectomy was performed from the external iliac artery to the superficial femoral artery. The entire plaque and the Angio-Seal were removed (Figures 2 and 3). A hemashield graft was used for reconstruction. The patient did well and remains asymptomatic to date. Discussion. We describe a case of late vascular thrombosis associated with deployment of an Angio-Seal device. Our patient had disabling claudication with severe rest pain, dependency rubor and elevation pallor rapidly progressive over a period of weeks. As recommended by the manufacturer, limited angiography was performed immediately before deployment and showed no significant obstructive disease of the common femoral artery. Furthermore, the artery was entered at the common femoral vessel above the take-off of the profundal femoralis, below the inguinal ligament and over the head of the femur. Diagnostic angiography via the contralateral limb 4 weeks later revealed a critical stenosis of the common femoral artery, presumably where the anchor was deployed. It appeared that the anchor had not been securely seated against the arterial wall and was enmeshed in a large intraluminal thrombus. On exploration, the patient was found to have a significant amount of focal intimal hyperplasia and thrombosis in the common femoral artery. Endarterectomy and patch angioplasty successfully cleared the obstruction and relieved the patient’s symptoms. To the best of our knowledge, late vascular thrombosis after Angio-Seal deployment has not been described. The Angio-Seal closure device is composed of a collagen sponge and an absorbable polymer anchor that compresses the hole in the arteriotomy site. This was the first device approved by the FDA in September 1996 and has been extensively used in the U.S. This device has been very successful in achieving hemostasis and allowing early ambulation. A large multicenter trial reported an incidence of Angio-Seal related groin complications, requiring surgical repair of 0.5%.2 Mechanical failure of the device is rare and infection is exceedingly uncommon. Acute vascular closure and distal embolization have been described. The most frequently encountered surgical complication following Angio-Seal placement is arterial obstruction. Improper deployment of the Angio-Seal device may result in complete occlusion of the femoral artery at the site of arterial puncture. Rarely, the anchor may impale a large posterior wall atherosclerotic plaque and occlude the lumen.3 Physical examination appears to identify most groin complications associated with manual compression. Hematomas, pseudoaneurysms and oozing are not uncommonly detected by bedside physical examination. In one study, there was a poor correlation between the physical examination finding and the ultrasound pathology detected. Discrepancies between physical examination alone and the ultrasound diagnosis challenge the utility of clinical assessment alone mainly when closure devices, which may include intravascular components, are used.4 In our patient, the Angio-Seal failure was detected clinically after the patient was noted to have asymptomatic absence of distal pulses and development of a new femoral bruit. This underscores the need for diligent examination of pulses and auscultation of the femoral area prior to catheterization and immediately after the use of closure devices. Furthermore, the failure of the device was demonstrated with the help of the ultrasound. Ultrasound imaging demonstrated in our patient a significant non-occlusive stenosis that was immediately detected after deployment. Most Angio-Seal 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.5 Our patient represents an unusual case. Albeit diagnosed early, the patient did not become symptomatic until 4 weeks after the procedure. We postulate that a progressive obstructive process due to slow propagation of thrombus was likely delayed due to aggressive anticoagulation post-stenting using IIb/IIIa inhibitor and ASA-clopidogrel combination. Alternatively, an intimal hyperplasia process secondary to vessel injury, a process similar to myointimal proliferation post-angioplasty injury associated with some thrombosis at the site of the anchor, could explain the delayed presentation in our patient. The FDA has approved three other devices since the Angio-Seal: the Vaso-Seal, Perclose and Duett systems. Vaso-Seal uses a collagen plug deployed outside the vessel to achieve hemostasis. The most common complication associated with this device is infection, likely due to the presence of a foreign body.6 The Perclose sealing device consists of a rotating barrel that deploys 4 needles through the arteriotomy, after which individual knots are extracorporally tied. The needles may become trapped in the arterial wall necessitating surgical removal of the device. If the device is forcefully removed from the artery, surgery may be needed to close the enlarged arteriotomy.7 The Duett device, the most recently approved closure device, consists of a balloon occluding catheter and injectable collagen and thrombin; a 5.8% device failure requiring manual compression was reported. Surgical repair for bleeding or pseudoaneurysm formation was required in 2.3% of the patients.8 Although studies using sealant devices have shown that the times to hemostasis and patient ambulation are improved, no conclusive data are available to translate this earlier ambulation into earlier discharge and therefore cost savings. Currently, the cost of the Angio-Seal device is approximately $205, and the cost of the Perclose device is around $365.9 This case illustrates that vascular complications may have a delayed presentation and physicians using those devices must be alert for possible complications arising late after utilization of closure seals. Vascular surgeons need to be familiar with the design of these devices since they may be required to repair a variety of arterial injuries associated with its use. Furthermore, institutions should track all complications related to these devices to as many studies that have recently reported an increase in vascular complications since their inception. It is also possible that many serious complications may not have been apparent in strictly controlled pre-marketing investigational trials. In any case, manual compression, although uncomfortable for the patient and fatiguing and time-consuming for the staff, is cheap and still associated with a very low complication rate.

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