AngioSeal Closure Device Related Dissection: Anchor-Related Trauma in a Normal Vessel

Case Report

The use of vascular closure devices has dramatically increased in recent years in an attempt to reduce access site complications, patient discomfort and duration of immobilization.¹ Three Food and Drug Administration (FDA)-approved devices are currently available- AngioSeal (St. Jude Medical, Minnetonka, Minn.), Perclose (Abbott, Redwood City, Cal.) and Vasoseal (Datascope, Montvale, New Jersey). The AngioSeal device consists of an absorbable polymer anchor within the arterial lumen and a thrombin plug that is delivered to the surface of the artery with a stitch. Significant AngioSeal device-related complications occur in approximately 2% of implants, and include groin infections, complete occlusion of the femoral artery, failure to deploy resulting in hematoma and pseudoaneurysm.^2-4 While dissection of the arterial intima at the time of AngioSeal placement has been reported, the mechanism of injury remains unclear.^5,6

We recently encountered a patient that developed loss of distal pulses following the placement of an AngioSeal closure device, with subsequent surgical exploration showing probable anchor-mediated vascular injury and dissection. A 37-year-old female with a history of a dilated cardiomyopathy and atypical chest pain was referred for coronary angiography following an abnormal exercise echocardiogram. Coronary angiography, left heart catheterization and ventriculography were performed without issue. Femoral angiography showed no evidence of atherosclerosis, placement of the sheath above the origin of the superficial femoral artery and a normal appearance of the common femoral artery.

A 6 Fr AngioSeal STS-Plus closure device was placed with excellent hemostasis. One hour following the procedure during initial ambulation, she complained of right foot pain and paresthesias. Physical examination showed decreased temperature over the right foot and non-palpable right popliteal, dorsal pedis and posterior tibial pulses. Doppler examination showed a weak, mono-phasic signal at these levels. She was returned to the cardiac catheterization laboratory, contralateral access was obtained and selective right iliac angiography performed. Right iliac angiography showed a mobile, linear filling defect within the proximal common femoral artery, followed by a small filling defect in the distal common femoral artery consistent with the AngioSeal anchor and diminished distal flow.

The mobile, linear filling defect was thought to represent possible dissection with associated thrombus. Percutaneous treatment options were considered but not pursued, given a concern about possible AngioSeal device embolization with balloon angioplasty and/or thrombectomy. In an attempt to treat any superimposed thrombus, an infusion catheter was placed just proximal to the filling defect and tissue plasminogen activator (tPA) was initiated at 2 mg/hour. Three hours following the initiation of tPA, there was no significant improvement with continued pain and loss of distal pulses, and she was taken for surgical exploration. The anchor device was present within the common femoral artery lumen adjacent to a large intimal dissection flap that was occluding distal flow. The dissection began distal to the arterial puncture site and was not in continuity with it, suggesting that it did not occur on initial entry into the vessel, but rather during deployment of the AngioSeal device. On direct visual examination, there was no apparent atherosclerosis of the vessel. The anchor device was removed, the intimal flap was resected and the vessel was reconstructed with a portion of a venous patch. She was discharged the following day.

Discussion

The most-feared complication of vascular closure devices is acute limb ischemia requiring emergent surgical or endovascular intervention. This can occur secondary to embolization, thrombosis or occlusion from the intravascular component of the device.⁷ In a prospective study evaluating different closure devices, acute occlusion of the femoral artery was seen in 0.7% and occurred only in patients treated with the AngioSeal device.⁵ Additional studies found that acute occlusion occurred secondary to placement of the device within an area of the common femoral artery that contained significant atherosclerosis.^6,8

However, there have been no previous descriptions of acute occlusion occurring in the setting of an angiographically normal appearing common femoral artery. Based on the operative findings, we suspect that during anchor deployment, a portion of the anchor caused trauma to the common femoral artery with subsequent intimal dissection, associated thrombus and compromised distal flow. While vascular closure devices clearly reduce time of immobilization following invasive procedures, they expose patients to additional risks that must be anticipated and treated expeditiously.