Balloon Angioplasty for Treatment of Femoral Artery Occlusion following the Use of a Suture- Mediated Closure Device
pg. E31 - E33
Arterial occlusion from the use of suture-mediated closure devices following a percutaneous procedure is a very rare but clinically significant complication for which surgical intervention is thought to be the gold standard for treatment. We present a case of acute femoral artery occlusion following Perclose deployment that was successfully treated with percutaneous balloon angioplasty. Additionally, this report also reviews the current published data on the use of percutaneous intervention following arterial compromise from suture-mediated closure devices.
Key words: Perclose, interventional cardiology; angioplasty, arterial closure device, vascular complications
It is estimated that arterial puncture closure devices are utilized in approximately 50% of patients undergoing a percutaneous coronary procedure.1 The most well described vascular complications of arteriotomy closure devices are pseudoaneurysm, arteriovenous fistula, hematoma, thrombosis, and infection.1,2 One rare, but reported complication has been occlusion of the femoral artery by a suture-mediated closure devices.3–5 In the majority of the reported cases, suture mediated arterial occlusion has been treated with open visualization and surgical correction of the sutured artery. In this report we present a case of acute femoral artery occlusion following deployment of a suture mediated arteriotomy closure device that was treated successfully with balloon angioplasty without the need for surgical exploration and intervention. In addition, we also present a brief review of the current literature on suture mediated complications treated with percutaneous angioplasty. We believe percutaneous treatment performed by skilled operators represents a safe and effective treatment strategy in the acute setting of suture mediated femoral artery occlusion should it occur.
A 64 year-old white male presented to our institution with a diagnosis of left internal carotid artery stenosis. Right femoral artery access was obtained using traditional fluoroscopic guidance and a 6 French (Fr) sheath was used for the procedure. Carotid angiography disclosed a 95% left internal carotid lesion that was successfully stented using an anticoagulation regimen of bivalirudin standard weight0based bolus and a drip. Hemostasis of the right femoral arteriotomy sight was obtained via a Perclose® closure device (Abbott Vascular, Abbott Park, Illlinois). Within 15–20 minutes of completing the procedure, the patient began to complain of right foot numbness. He was then noted on examination to have a mottled right lower extremity with absent peripheral pulses. Bedside ultrasound Doppler examination revealed severe stenosis of the right common femoral artery necessitating emergent transfer back to the catheterization laboratory. Left femoral access was obtained initially with a 7 Fr short-sheath system and a pigtail catheter was placed over the aortic bifurcation in the right external iliac artery. Angiography proved a 95% focal stenosis of the right common femoral artery at the sight of previous arterial access, with very slow flow distal to the occlusion. A 7 Fr Destination sheath (Terumo Medical, Somerset New Jersey) was exchanged to approach the lesion and guide the intervention. The lesion was then successfully crossed with a 0.014 inch coronary wire. A 0.035 inch Quick-Cross catheter (Spectranetics, Inc., Colorado Springs, Colorado) was used to cross the lesion over the 0.014 inch wire. The wire was then exchanged for a long Rosen wire (Infinity Medical, Malibu, California) that was placed in the distal superficial femoral artery (SFA). A 3.0 x 20 mm Fox balloon (Abbott Vascular, Abbott Park, Illinois) was inflated across the lesion to 10 atm. This balloon failed to rupture the suture, thus a 5.0 x 20 mm Fox balloon (Abbott Vascular) was then exchanged and placed across the lesion. Inflation resulted in apparent rupture of the previously placed suture with restoration of femoral blood flow. Final angiography demonstrated no extravasation of contrast outside the common femoral artery and no residual dissection or stenosis within the artery. Clinical follow-up before discharge the next day showed normal peripheral pulses bilaterally and an absence of tenderness, hematomas, or bruits at both the right or left common femoral artery locations.
Based on our literature search at the time of this report, there have been 6 cases of successful percutaneous treatment of suture-mediated common femoral artery ligation. It is likely that the first report of successful percutaneous repair took place in 2003 by Gemmete et al, in which they described the successful use of percutanous balloon angioplasty to dilate a focal suture-related arterial stenosis. In this report, the patient presented back to his institution 1 week after initial arteriotomy closure with right calf claudication. Following balloon angioplasty, a 6-month clinical follow-up revealed no recurrent symptoms.4 In 2006 a single case report by Kalsch et al documented arterial closure using the Perclose system in a middle-aged male following diagnostic left-heart catheterization that developed acute right-limb ischemia on the same day of the procedure. Angiography confirmed the stenosis and successful treatment followed with balloon angioplasty and stenting.5 The most significant report came in a 2006 case series by Jang et al describing 9 individual cases of arterial stenoses resulting from suture-mediated closure devices. Four of the cases in this series were treated successfully with percutaneous balloon angioplasty or stenting to dilate the suture-mediated lesion. Of the 4 cases treated with percutaneous intervention, 2 were treated with balloon angioplasty alone, 1 with balloon angioplasty followed by stent placement, and the last with aspiration thrombectomy, balloon angioplasty, and stent placement.3
The occurrence of claudication and arterial stenosis from suture-mediated closure devices is unknown, but the reported incidence of complications requiring surgical access repair from Perclose closure device ranges from 0.3% to 2.5%.6 In a large study of 2,177 patients who received a Perclose closure device after percutaneous coronary intervention, there was a reported post-procedural arterial occlusion or loss of pulse rate in only 0.1% of patients.7 CT angiographic follow-up of 100 patients who received a Perclose device showed no evidence of stenosis an average of 7.5 months after their initial procedure.8 Overall, suture-mediated arterial occlusion represents a rare, but clinically significant, complication. In most reported cases of femoral artery occlusion, the exact mechanism is not elucidated. Surgical pathology from studies reported with delayed onset of limb ischemia (weeks to months) have shown severe inflammatory reaction and fibrosis at the occlusion site.1 This likely represents a different etiology than that of acute arterial compromise, as in the case we describe. This was displayed in the case by Park et al, where surgical exploration following acute arterial occlusion after a Perclose device revealed suture-mediated intussusception of the proximal arterial wall within the arterial lumen.9 They hypothesize that the device was inserted at an angle 2
Acute or subacute limb ischemia after suture-mediated closure as has been described in the literature necessitates the need for efficient diagnosis and repair. The patient we describe had clinical evidence of acute limb ischemia and prompt vascular ultrasound confirmed critical luminal stenosis. In cases reported prior to ours, the time from initial suture closure device deployment to percutaneous intervention varied between less than 24 hours to 2 weeks.1,3,4 It should be mentioned that potential complications related to balloon rupturing of a ligated common femoral artery would include the development of arterial rupture, dissection, or perforation, with the possible development of hematoma, pseudoaneurysm, or even life-threatening retroperitoneal hematoma. Although surgery remains the gold standard, we believe that from the evidence now published in the literature, the acute luminal occlusion of the arteriotomy sight via suture-mediated closure devices may be approached percutaneously, as described in this report in the appropriate clinical setting.
From the University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Address for correspondence: Mazen Abu-Fadel, MD, FACC, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Blvd., Room WP3010, Oklahoma City, OK 73104. E-mail: [email protected]