Treatment of Complex Thrombotic Popliteal Chronic Total Occlusion

Using Pathway PV Jetstream or Laser Atherectomy, and Localized Delivery of Abciximab via ClearWay Rx Catheter

Part 4 in a 5-part series In recent years, peripheral vascular intervention has seen significant growth with the advent of innovative devices, patient preferences for less invasive procedures and low morbidity associated with these procedures. Despite multiple new devices and approaches, thrombotic lesions and distal embolization remain a significant challenge for interventionalists. Thrombolysis has been utilized for many years as a primary modality for treatment of thrombotic occlusions; however, poor patient candidates and life-threatening bleeding remains a significant problem utilizing this approach.6 Moreover, it has limited success in patients with chronic total occlusions. Herein, we present an innovative approach to reduce thrombus burden using a localized glycoprotein (GP) IIb/IIIa inhibitor in conjunction with Jetstream™ atherectomy (Pathway Medical Technologies, Inc., Kirkland, WA), which allows aspiration of thrombotic atherosclerotic debris, or pulverization of thrombus with laser atherectomy. Case 1 Patient 1 is a 57-year-old female with a history of hypertension. She was initially evaluated for severe, lifestyle-limiting claudication of right lower extremity in May 2008. She underwent a noninvasive vascular Doppler study which demonstrated right popliteal artery occlusion with an ankle-brachial index (ABI) of 0.51. Patient was started on aspirin, cilastazol therapy and a walking program. However, she did not tolerate cilastazol and had continued symptoms of claudication. She then underwent angiography and attempted endovascular intervention which failed. At this point, the patient was referred to us for further consultation. Despite an aggressive walking program, her symptoms continued, hence the decision was made for a second attempt at endovascular intervention after discussing alternatives with her such as surgical bypass. An 8F/55cm Raabe sheath (Cook Medical, Bloomington, IN) was inserted into the right common femoral artery via a contralateral approach from a left femoral access site. Intravenous (IV) heparin was chosen as a foundation anticoagulant. Angiography of right lower extremity again demonstrated complex occlusion of right popliteal artery with reconstitution at the level of tibioperoneal trunk via collaterals (Figure 1). It was very easy to cross this occlusion with an assembly of 0.035-inch Glidewire (Terumo Medical Corp., Somerset, NJ) and Quick-Cross support catheter (Spectranetics Corp., Colorado Springs, CO). In our clinical experience, when the Glidewire easily crosses a total occlusion, it is almost always associated with thrombus and soft plaque. Next, a ClearWay Rx 2.0mm x 50mm therapeutic infusion catheter (Atrium Medical Corp., Hudson, NH) was inserted inside the occlusion, and a weight-based abciximab bolus was administered (Figure 2). Repeat angiography demonstrated restoration of flow into the popliteal artery (Figure 3). At this point, Jetstream atherectomy was chosen to debulk the lesion further (Figure 4). Subsequent to atherectomy, we performed balloon angioplasty of the entire segment of popliteal artery using 4.0 x 120mm and 5.0 x 120mm VascuTrak II balloon catheters (Invatec, Inc., Bethlehem, PA) (Figure 5). In addition, disease was identified in origin of anterior tibial and tibioperoneal arteries. Kissing balloon angioplasty of these lesions were performed by utilizing two 3mm x 40mm Amphirion Deep (Invatec, Inc.) balloons (Figure 6). Post angiography still demonstrated suboptimal result in the popliteal segment. Given the location of the vessel, helical, high radial strength Supera 5 x 100mm and 5 x 60mm (Idev Technologies, Inc., Houston, TX) were chosen. In addition, a 6 x 20mm Exceed self-expanding stent (Abbott Vascular, Redwood City, CA) was placed in the distal popliteal artery (Figure 7). Repeat angiography demonstrated a superb angiography result with brisk three-vessel runoff (Figure 8). Case 2 Patient 2 is a 51-year-old female with prior history of smoking and hyperlipidemia. She previously had a vascular evaluation at an outlying facility in July 2008. She was found to have right common iliac artery stenosis (70%), as well as right popliteal artery occlusion. A right common iliac artery balloon angioplasty and placement of a balloon-expandable stent was performed. She was also given cilastazol therapy and a walking program. Despite these treatments, she had minimal improvement in her claudication symptoms. The patient was then referred to us for further treatment of the right popliteal artery intervention. Left femoral access was obtained and a 5F catheter was placed in the right common femoral artery via a contralateral approach for right lower extremity angiography (Figure 9). A 7F/55cm Raabe sheath was placed in the right common femoral artery without any difficulty via contralateral approach. Surprisingly, a significant pressure dampening was observed and an iliac lesion was suspected. We opted to treat the iliac artery after completion of the popliteal intervention on the ipsilateral side. A 0.035-inch Quick-Cross Catheter and Miracle Bros 6 gm wire (Abbott Vascular) as well as a 0.035-inch stiff Glidewire were utilized to cross the chronic occlusion of the popliteal artery. The wire crossed the total occlusion very easily and a thrombotic component in the occlusion was suspected. At that point, a ClearWay Rx 2.0 x 50mm catheter was placed inside the occlusion and an abciximab weight-based bolus administered (Figure 10). Post-abciximab angiography demonstrated restoration of flow through the occlusion (Figure 11). Further debulking was performed with Laser 1.7 and 2.0 mm Turbo Elite catheters (Spectranetics) (Figure 12). The right popliteal artery was then treated using 4.0mm x 120mm Vascutrak II and 5.0mm x 120mm Submarine Plus balloon (Invatec, Inc.) (Figure 13). Post angiography demonstrated excellent angiographic result with brisk runoff of all three vessels. (Figure 14). At this time, the contralateral sheath was pulled back into the left common iliac artery and iliac angiography was performed. It demonstrated under-expansion of a previously placed stent with aneurysm formation and stenosis in the right common iliac artery distal to the stent (Figure 15). Next, a second ipsilateral access was obtained and the right common iliac artery was examined with intravascular ultrasound (IVUS). IVUS confirmed our angiographic findings, and appropriate vessel-size measurement was performed. We then placed a 6mm x 38mm iCast balloon-expandable covered stent graft (Atrium Medical) in the right common iliac artery with resolution of the stenosis and aneurysm (Figure 16). Discussion These cases address several difficult challenges encountered by the endovascular specialist: location of the disease, potential for stent failures due to adverse anatomical location, distal embolization from atherothrombotic material and long-term durability of treatment. First, let us address the thrombotic component of this lesion. Peripheral interventional procedures produce injury to the vessel wall endothelium, triggering a reaction of thrombosis, inflammation and neointimal proliferation. The exposed endothelium is highly thrombogenic, and contributes to procedural complications such as distal embolization, early re-occlusion and longer procedural times.1 Conventional anti-platelet strategies are often insufficient to prevent re-occlusion, since platelets can be activated by means of multiple pathways.2,6 Furthermore, heparin, the most widely used anti-coagulant in peripheral procedures, is unable to inhibit clot-bound thrombin, and stimulates platelet activation and aggregation, which increases the likelihood of a thrombotic event.3 GP IIb/IIIa inhibitors have shown clinical outcome benefit in the primary percutaneous intervention setting.4,6 In a recent trial of 149 patients, Allie et al showed improved distal embolization (1.3% versus 5.4%) and statistically significant lower re-intervention rates (10.7% versus 18.8%) in the bivilrudin/tirofiban group versus the heparin control group.4 Inflammation and thrombosis are strongly linked. Unfortunately, angiography is a poor tool to detect thrombus, underestimating the presence of thrombus in patients with critical limb ischemia. One strategy that shows promise is delivery of GP IIb/IIIa inhibitors in these patients, to prevent thrombus from forming, thus reducing the likelihood of resulting complications. INFLAME trial investigators noted that peripheral patients had a heightened inflammatory state after angioplasty of the renal, femoro-popliteal, iliac, carotid and tibial arteries.5 They noted that a rise in fibrinogen was present 7 days post-intervention. The ClearWay Rx Therapeutic infusion catheter allows 500 times the systemic concentration of abciximab locally with its unique property of occlusion, containment and selective local infusion. In high concentrations, abciximab is capable of the dissolution of thrombus, taking on “lytic properties”6 allowing significant reduction in thrombus burden, as seen in the procedures we describe. Similar results have also been shown in coronary circulation during ST-elevation myocardial infarction procedures as described in this publication last year. The Pathway PV Jetstream is a novel atherectomy device which combines the cutting power of atherectomy while at the same time allowing for the aspiration of this material. The photoablative energy of laser atherectomy is another excellent tool for thrombus-containing lesions. As shown, both tools worked extremely well in each case. Our usual goal is to not place a stent in this difficult anatomical location, but at times, stent placement is necessary. Supera, a newer, flexible, high radial strength stent with a helical design, is well-suited for this adverse anatomical location. The iCast balloon-expandable covered stent graft is an excellent choice for complex iliac lesions with calcification, ectasia and aneurismal disease. In our clinical practice, we find excellent long-term durability (>4 to 5 years) for iCast covered stents in iliac disease. In summary, a complex popliteal artery occlusion, as described in these cases, requires a comprehensive, multi-device approach to lead to a successful outcome. Rajesh M. Dave, MD, can be contacted at rdintervention@yahoo.com

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