Don't Forget Fogarty

Abstract

Acute thromboembolic events can occur in percutaneous peripheral interventions. We present a case of periprocedural acute limb ischemia due to embolic thrombosis of the right tibioperoneal trunk during percutaneous transluminal angioplasty and stenting of the external iliac artery, with final resolution using an over-the-wire balloon in a Fogarty-type manner.

Introduction

Thromboembolic complications of periprocedural peripheral percutaneous transluminal angioplasty (PTA) and/or stenting can occur and lead to acute limb ischemia (ALI) that requires prompt intervention. Treatment can include thrombolytic infusion, surgical bypass or endovascular treatment. We present a case of periprocedural thromboembolic ALI to the tibioperoneal trunk after PTA and stenting of the right common and external iliac artery, successfully treated with a percutaneous Fogarty-type method using an over-the-wire (OTW) balloon.

Case Report

A 64-year-old male with a history of hypertension, hyperlipidemia, chronic obstructive pulmonary disease, and known prior peripheral arterial disease (PAD) requiring bilateral common iliac arterial stents presented with worsening right leg claudication at less than one-block distance with ambulation, despite smoking cessation, antiplatelet therapy and a trial exercise regimen. His right lower-extremity ankle-brachial index (ABI) was 0.47 with nonpalpable distal foot pulses. Peripheral angiography of his right leg was performed via a contralateral approach. We placed a Contra-2 catheter (Boston Scientific Corp., Natick, Massachusetts) through a 6 Fr sheath catheter, gaining entrance from the left iliac artery to the right iliac artery. The peripheral angiogram of his right lower extremity showed 100% in-stent restenosis of the right common and external iliac artery distal to the common iliac stent with collateral reconstitution in the proximal right superficial femoral artery (SFA). Next, the Contra-2 catheter was exchanged using a Glidewire (Terumo Medical Corp., Somerset, New Jersey) in order to cross the lesion, then exchanged for an Ansel sheath (Cook, Inc., Bloomington, Indiana) in preparation for PTA and stenting. A 6.0 x 60 mm Vascular Fox balloon (Abbott Vascular, Redwood City, California) was used to dilate the lesion, followed by stenting with a 7.0 x 120 mm, overlapping proximally with an 8.0 x 60 mm Xceed Biliary self-expanding stent (Abbott Vascular), and finally, post-stent balloon dilation was performed using an 8.0 x 80 mm Vascular Fox balloon. Angiography at this time showed no flow beyond the tibioperoneal trunk, suggestive of distal embolization of atherosclerotic debris, although no visible thrombus could be visualized. During this period, the patient had already been on aspirin and clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals, Bridgewater, New Jersey), given intravenous heparin sodium (Baxter Healthcare Corp., Deerfield, Illinois) prior to the start of peripheral intervention. Eptifibatide (Integrilin, Millennium Pharmaceuticals, Schering Corp., Kenilworth, New Jersey) bolus and infusion was added at this time. Several passes with the Pronto extraction catheter (Vascular Solutions, Inc., Minneapolis, Minnesota) were completed, but unsuccessful. Following this, we placed a 5.0 mm EPI filter (Boston Scientific) device just distal to the right tibioperoneal trunk to attempt to capture any debris. This was also unsuccessful. Then several passes with the AngioJet Rheolytic Thrombectomy System (Possis Medical, Inc., Minneapolis, Minnesota) were completed. Again, this was unsuccessful, with continued no-flow distal to the tibioperoneal trunk. Several 300 µg doses of intravascular nitroglycerin given through a Glidecatheter (Terumo) also failed to restore blood flow distal to the tibioperoneal trunk. As a last resort, a 2.0 x 12 mm over-the-wire Voyager balloon (Abbott Vascular) was used in a Fogarty-type manner by placing it just distal to the tibioperoneal trunk. We used a low balloon inflation to 8 atm and pulled proximally into the right SFA and finally into the right common femoral artery. Used in a Fogarty-type thrombectomy manner, it resulted in immediate two-vessel runoff below the knee. The patient’s symptoms of right leg pain resolved and eptifibatide infusion was continued for 18 hours post procedure. We repeated the peripheral angiogram 24 hours later and confirmed two-vessel runoff below the right knee.

Discussion

Acute limb ischemia is defined as a sudden decrease in limb perfusion that causes a potential threat to limb viability (manifested by ischemic rest pain, ischemic ulcers and/or gangrene) in patients who present in less than 24 hours to within 2 weeks of the acute event.¹ ALI can occur as a result of an embolic or local thrombosis in a previously asymptomatic patient.¹ Although little information is available on the incidence of ALI, several registries and surveys suggest an incidence of ~140/million/year.¹ Ouriel reports an incidence of 1.7 cases/10,000/year, with a mortality rate of 26% and an amputation rate of 37%.² Even with newer endovascular techniques that include thrombolysis, published data report a 10–30% 30-day amputation rate.¹ The TASC II recommendations for treatment of ALI during endovascular procedures include pharmacologic thrombolysis, percutaneous aspiration thrombectomy (PAT), percutaneous mechanical thrombectomy (PMT), surgery, or a combination thereof.¹ Thomas Fogarty’s balloon embolectomy catheter was first described in 1961.³ Open surgical thrombectomy was introduced in 1963 by Fogarty et al.⁴ The embolectomy catheter patent was issued April 1, 1969.³ It is used by placing a balloon-tip catheter past a thrombus, inflating the balloon distal to the thrombus, continuing inflation while dragging the catheter with the presumed thrombus proximal and maintaining continual traction against the arterial wall. Fogarty catheter thromboembolectomy is generally considered a safe procedure. Complications of Fogarty balloon catheter thromboembolectomy can include arterial perforation, arterial rupture, intimal injury, arteriovenous fistula and pseudoaneurysms.⁵ It can also lead to myointimal hyperplasia.⁵

In our patient, no-flow at the right peritoneal trunk occurred after PTA and stenting of the right common and right external iliac artery, with symptomatic right leg pain suggesting an acute thromboembolic event. Multiple pharmacologic and clot removal techniques were used during the procedure. Arterial flow returned to normal only after a 2 x 12 mm OTW Voyager balloon was used in a Fogarty-type manner. Although choosing the correct balloon diameter can be challenging, we specifically chose a 2.0 balloon diameter, small enough to not be occlusive, but large enough to be able to manipulate and remove a thrombus. To truly perform a Fogarty-type procedure would require an elastomeric balloon that was actually larger than the vessel. Since no balloon of that type is currently available, we used what was available. Using the larger size in the vessel runs the risk of dissection or possible barotraumas, which could result in future restenosis. Although clear visualization of the thrombus was not possible, it was safely presumed that the thromboembolic material was large enough to have occluded the tibioperoneal trunk, but small enough to have been absorbed or not be of consequence in a more proximal, larger femoral arterial vessel or branch vessel after mechanical removal or relocation of the thromboembolic material. It is also very possible that material broke up with the movement of our 2 mm balloon, resulting in dissolution of the thrombus or embolic material. Since with this technique it is not possible to extract the clot, we can never be sure of what the material was, its size and where it actually went. In our case, a simple OTW balloon used in a Fogarty-type manner made all the difference. We cannot be sure that the balloon catheter did not just create a channel, because we did not actually visualize the embolic plaque or thrombus. However, the flow was completely restored following its use, which we felt supported evidence of removal of clot.

What were our other options? We considered catheter-directed thrombolysis (CDT), but time was of the essence. Treating with thrombolysis as a first-line therapy would have taken more time than could be afforded. In addition, we thought our patient, particularly with his history of smoking, may have been resistant to thrombolysis therapy. Thrombosis generated by atherosclerosis relates to vessel injury, platelet adhesion, activation and aggregation, forming the arterial thrombus caused by the disrupted plaque.⁶ We thought the obstructive nature of the disrupted plaque meant it would be best treated by mechanical removal. Furthermore, open surgical techniques and revascularization still have high mortality rates in the range of 6–18%.^7–9 If our efforts with PAT and PMT had failed, our next step would have been thrombolysis and/or open surgical thrombectomy as a last resort.

Limitations and Cautions

This is a single case report of a technique that is similar to, but not the same as, a Fogarty embolectomy procedure. First of all, the balloon was much smaller than the vessel size and there was no material removed. Although we feel the material probably was broken down to a smaller size and then metabolized by the reticular endothelial system, we can only speculate that this is what occurred. More research needs to be done before this technique can be applied universally. An issue that needs to be raised is whether embolization could be more dangerous when the particles are dispersed profusely throughout the peripheral vascular system.

Conclusion

We present the case of a periprocedural thromboembolic event during PTA and stenting of the right external iliac artery which was unsuccessfully treated with multiple pharmacologic agents and sophisticated clot-removing devices. It was only after a small OTW balloon was used in a Fogarty-type manner that flow was restored.

From the Department of Cardiology, St. Luke’s Medical Center, and the University of Arizona College of Medicine, Phoenix, Arizona.

The author reports no conflicts of interest regarding the content herein.

Manuscript submitted February 10, 2009, provisional acceptance given February 19, 2009, and final version accepted February 23, 2009.

Address for correspondence: Richard R. Heuser, MD, FACC, FACP, FESC, FASCI, Director of Cardiology, St. Luke’s Medical Center, Clinical Professor of Medicine, University of Arizona College of Medicine, 1331 N. 7th Street, Suite 400, Phoenix, AZ 85006. E-mail: rheuser@affcard.com