Successful Endovascular Treatment of Common Femoral Artery Thrombosis Occurring 2 Months After Catheterization and Angioseal Closure

Abstract

A patient presented for coronary angiography that was followed by ad hoc percutaneous coronary intervention. Upon completion of the procedure, angiogram of the left common femoral artery revealed minimal disease, and an Angioseal vascular closure device was successfully deployed for hemostasis. Two months later, the patient presented with acute thrombosis of the femoral artery at the site of Angioseal deployment requiring successful percutaneous revascularization using rheolytic thrombectomy, laser atherectomy, and balloon angioplasty.

VASCULAR DISEASE MANAGEMENT 2012;9(2):E27–E29

_____________________________________

Case Report

A 57-year-old male with history of hypertension, dyslipidemia, and prior coronary artery bypass grafting underwent successful percutaneous coronary intervention (PCI) via access from the left femoral artery. Upon completion of the procedure, a limited angiogram of the left common femoral artery revealed minimal disease (Figure 1) and a 6 Fr Angioseal vascular closure device (St. Jude Medical) was deployed successfully with adequate hemostasis. Vascular examination post-intervention was unchanged from baseline with resting left ankle-brachial index of 1.23. The patient was discharged on dual antiplatelet therapy including 325 mg aspirin and 75 mg clopidogrel without complications. Two months later, the patient presented with vague symptoms of burning and tingling involving his left thigh as well as typical symptoms of claudication.

Repeat vascular testing confirmed a significantly diminished left ankle-brachial index of 0.38. A CT angiogram with runoff of the left lower extremity demonstrated complete occlusion of the left common femoral artery with collateral filling of the superficial femoral artery. He was then referred for left lower extremity angiogram and percutaneous intervention.

Access was obtained in the right common femoral artery and selective left external iliac artery angiogram was performed, which confirmed hazy thrombotic occlusion of the left common femoral artery at the site of AngioSeal (St. Jude) deployment with reconstitution at the bifurcation of the left superficial femoral and profunda femoris arteries (Figure 2). With the support of a 4 Fr glide catheter, an angled Glidewire (Terumo Medical) was used to cross the occlusion into the distal superficial femoral artery (SFA) with a gradient of 50 mmHg across the occlusion. Rheolytic thrombectomy was then performed using an AngioJet catheter (Medrad Interventional) with multiple runs into the SFA (Figure 3) and profunda femoris artery with improvement in flow across the lesion but persistence of residual thrombus. The glidewire was then exchanged for a Confianza Pro 0.014 mm wire (Asahi Intecc) and laser atherectomy was performed using a 1.7 mm Turbo Elite laser catheter (Spectranetics) utilizing fluence/rate settings of 40/40, 60/60, and 60/80 serially (Figure 4) with further improvement of flow across the left common femoral artery.

Balloon angioplasty was then performed with a Savvy 4.0 x 20 mm (Cordis Corporation) followed by EverCross 5.0 x 20 mm (ev3 Endovascular) balloons at 20 and 18 atm, respectively. Final angiogram confirmed an excellent angiographic result and absence of a gradient across the common femoral artery (Figure 5). The patient was discharged on dual antiplatelet therapy the following day with no additional hypercoagulable workup.

Discussion

The emergence of arteriotomy closure devices as an alternative to mechanical compression after PCI has introduced numerous benefits, including reducing time to hemostasis, facilitating earlier patient mobilization, decreasing hospital length of stay, and improving patient satisfaction.^1-13 However, safety and vascular complications remain an ongoing detriment to this new technology.^14-15 Outcomes related to access site complications with arterial closure devices in the setting of percutaneous intervention and antiplatelet agents have demonstrated a 4.2% incidence of vascular complications.^15-16

The AngioSeal device (St. Jude) consists of a polymer anchor, composed of a mixture including polyglycolide and polylactide, that is deployed in the endoluminal surface of the artery with external compression achieved through the connection of an absorbable suture to a bovine collagen plug.^17-18 Over time, the AngioSeal anchor softens and is reabsorbed with complete dissipation in approximately 30 days by microscopy and in nearly 90 days by chemical analysis.¹⁷ Several device-related complications have been described including pseudoaneurysms, arteriovenous fistulas, thrombosis, infection, localized allergic reactions, bleeding, and hematomas at the puncture site.^14,15,18-20 The overall rate of ischemia of the extremity has been low, ranging from 0% to 2.9%.¹⁷ A meta-analysis by Nikolsky et al reviewed 12 studies that evaluated AngioSeal and Perclose versus mechanical compression without significant risk with respect to vascular complications during PCI.¹⁵ Another study by Castelli et al presented a similar case of acute limb thrombosis after AngioSeal deployment.²¹ In their investigation, a surgical approach was performed that confirmed the etiology of arterial thrombosis. Firstly, there was an extensive posterior intimal dissection along the previous sheath entry site with the anchor of the AngioSeal entrapping the posterior wall plaque against the anterior wall, which was obstructing the arterial lumen and causing a high grade stenosis. Secondly, histologic analysis of the device anchoring system demonstrated an inflammatory clot.²¹

The report by Castelli et al and our current case demonstrate a rare complication of the AngioSeal device leading to acute thrombosis of the lower extremity. Although the etiology was not determined in this case, it presented a few unique aspects including a late presentation of the thrombosis and successful percutaneous management using rheolytic thrombectomy, laser atherectomy, and balloon angioplasty.

References

1. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992 Jan;69(1):63-68.
2. Chandrasekar B, Doucet S, Bilodeau L, et al. Complications of cardiac catheterization in the current era: a single-center experience. Catheter Cardiovasc Interv. 2001 Mar;52(3):289-295.
3. Kussmaul WG 3rd, Buchbinder M, Whitlow PL, et al. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995 Jun;25(7):1685-1692.
4. Slaughter PM, Chetty R, Flintoft VF, et al. A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings? Cathet Cardiovasc Diagn. 1995 Mar;34(3):210-214.
5. Gwechenberger M, Katzenschlager R, Heinz G, Gottsauner-Wolf M, Probst P. Use of a collagen plug versus manual compression for sealing arterial puncture site after cardiac catheterization. Angiology. 1997 Feb;48(2):121-126.
6. Ward SR, Casale P, Raymond R, Kussmaul WG 3rd, Simpfendorfer C; for the Angio-Seal Investigators. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998 Mar;81(5):569-572.
7. Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol. 1999 Jun;83(12):1658-1663.
8. Noguchi T, Miyazaki S, Yasuda S, et al. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000 May;19(5):451–455.
9. Chevalier B, Lancelin B, Koning R, et al; for the HEMOSTASE Trial Investigators. Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv. 2003 Mar;58(3):285-291.
10. Nasu K, Tsuchikane E, Sumitsuji S; for the PARADISE Investigators. Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial. J Invasive Cardiol. 2003 May;15(5):251-256.
11. Amin FR, Yousufuddin M, Stables R, et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device. Int J Cardiol. 2000 Nov-Dec;76(2-3):235-240.
12. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001 May;13(5):354-362.
13. Rickli H, Unterweger M, Sütsch G, et al. Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions. Catheter Cardiovasc Interv. 2002 Nov;57(3):297-302.
14. Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004 Jan;291(3):350-357.
15. 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 Sep;44(6):1200-1209. 
16. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol. 2001 Sep;88(5):493-496.
17. Applegate RJ, Rankin KM, Little WC, Kahl FR, Kutcher MA. Restick following initial Angioseal use. Catheter Cardiovasc Interv. 2003 Feb;58(2):181-184.
18. Mukhopadhyay K, Puckett MA, Roobottom CA. Efficacy and complications of Angioseal in antegrade puncture. Eur J Radiol. 2005 Dec;56(3):409-412.
19. Applegate RJ, Grabarczyk MA, Little WC, et al. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol. 2002 Jul;40(1):78-83.
20. Chevalier B, Lancelin B, Koning R, et al; for the HEMOSTASE Trial Investigators. Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv. 2003 Mar;58(3):285-291.
21. Castelli P, Caronno R, Piffaretti G, Tozzi M, Lomazzi C. Incidence of vascular injuries after use of the Angio-Seal closure device following endovascular procedure in a single center. World J Surg. 2006 Mar;30(3):280-284.

_____________________________________

From the Deborah Heart and Lung Center, Browns Mills, New Jersey.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted December 7, 2011, provisional acceptance given December 12, 2011, final version accepted December 27, 2011.
Address for correspondence: Jon C. George, MD, Deborah Heart and Lung Center, Interventional Cardiology and Endovascular Medicine, 200 Trenton Road, Browns Mills, NJ 08015. E-mail: jcgeorgemd@hotmail.com