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Vascular Disease
First Clinical Experience with a Rapid Exchange Nitinol
Self-expanding Stent in Combination with Balloon-expandable Coronary S
January 2005
Case report. An 86-year-old male with coronary artery disease, congestive heart failure and peripheral arterial occlusive disease presented with claudication, weakness and cramping of his left lower extremity. In March 2003, he had undergone a left-sided femoral-popliteal bypass graft following thrombosis of a popliteal artery aneurysm. The patient was without symptoms until six months post-surgery when he presented with rest ischemia involving the same lower extremity. Baseline angiogram performed at that time revealed an occluded graft with distal vessel runoff. The bypass graft was recanalized via a 24-hour thrombolytic infusion, followed by percutaneous transluminal angioplasty (PTA) of the distal anastomotic stenosis and peroneal tibial trunk. In October 2003, the patient had his dual chamber pacemaker upgraded to a biventricular pacemaker for class IV congestive heart failure. His clopidogrel was held prior to this procedure and for a short period following the pocedure.
The patient again reported an improvement in his claudication following the successful thrombolysis and PTA until December 2003, when he again noted symptoms consistent with rest ischemia of the left lower extremity. The patient had been on clopidogrel and was complaining of frequent nosebleeds which necessitated the discontinuation of the drug one week prior to exacerbation of the lower extremity symptoms.
Following successful surgical therapy for the epistaxis, a left lower extremity runoff arteriogram was performed which revealed diffuse, moderately severe left superficial femoral artery atherosclerotic plaquing with segmental stenoses up to 40% and occluded left femoral-popliteal artery bypass graft with delayed filling of the peroneal artery (Figures 1 and 2).
Access to the left common femoral artery was obtained via antegrade approach and 3,000 units of intravenous heparin were administered. A 5 Fr Kumpe catheter was advanced over a 0.035 inch Glidewire into the superficial femoral artery and across the thrombosed left popliteal artery bypass graft, and placed distal to the tibial peroneal trunk. A 0.018 inch wire was exchanged after placement of the Kumpe catheter. An AngioJet (Possis Medical, Inc., Minneapolis, Minnesota) graft thrombolysis catheter was advanced into the graft and placed at the level of the occlusion distally. Using the pulse spray technique, approximately 6 mg of tenecteplase was delivered into the thrombosed graft. After a 20-minute thrombolytic time, the AngioJet catheter was then advanced distal to the site of occlusion and multiple passes were made for thrombus extraction. Repeat arteriography was performed to assess the results (Figure 3).
Following the placement of a 0.014 Glidewire (BMW-Guidant) into the distal tibial bed, a 3 x 15 mm coronary balloon expandable stent was advanced and deployed across the left tibioperoneal trunk stenosis. Subsequently, a second coronary stent was deployed proximally via an overlapping technique. Following this, a 6 x 20 mm rapid exchange nitinol stent was deployed in overlapping fashion across the distal graft anastomotic site (Figure 3). Post-stent expansion was performed using a 5 mm balloon across the distal graft anastomosis and using a 4 mm balloon across the residual distal popliteal and tibioperoneal trunk stenosis (Figure 4).
The patient was observed overnight and was commenced on clopidogrel. He tolerated the procedure well with no bleeding complications and no residual neuropathy or rest pain.
Discussion. The present case describes the successful treatment of subacute thrombotic occlusion of a femoral-popliteal graft using a pulse spray AngioJet followed by stenting with a combination of self-expanding nitinol and balloon-expandable coronary stents.
The AngioJet rheolytic thrombectomy (RT) system (Possis Medical, Inc.) comprises a drive unit console, pulsatile jets and a variety of specifically designed RT catheters. The effectiveness of the device is due to a combination of rapid streaming of fluid and hydrodynamic forces. This allows extraction of thrombotic material at the distal catheter tip by means of negative pressure created due to the Bernoulli/Venturi effect,1,2 thereby decreasing distal embolization. The Bernoulli/Venturi effect from the RT system can be removed by occluding the Angiojet outflow with a stopcock. This converts the system into a high-pressure lytic delivery system.3
There are several advantages to using this approach. Hemorrhagic complications are potentially reduced due to the delivery of the lytic agent directly into the thrombus with fewer systemic effects. In addition, delivering the lytic agent under high pressure directly into the thrombus further increases thrombus removal. Distal embolic complications have been reported in up to 20% of RT cases.2,4 The high occurrence rate of this complication is thought to be due to the use of multiple passes of the RT catheter through the thrombus, and the washout of emboli downstream following successful thrombolysis.3 The technique described here may minimize this complication by avoiding the potential mechanisms described above.
It has been estimated that critical limb ischemia has an annual incidence of 400 to 1,000 per million among the general population.5 The role of PTA in the management of lower limb peripheral arterial disease is increasing because it is a less invasive alternative to surgical revascularization procedures.6 Evidence suggests that PTA is highly effective in treating patients with peripheral arterial disease involving the aorto-iliac system.5 In comparison, the effectiveness of PTA remains controversial when arterial segments below the inguinal ligament are involved. Various reports document one-year patency ranging from 12% to 88%.5,7,8
In a retrospective study by Blair et al,9 the results of percutaneous transluminal angioplasty (PTA) were compared with those of infrainguinal bypass procedures in patients with critical arterial ischemia to determine which procedure had superior patency, limb salvage and durability. The records of 54 patients who underwent 54 PTAs and 56 patients who underwent 63 infrainguinal bypasses (29 femoropopliteal and 34 femorodistal) from 1981 to 1987 were reviewed. Femorodistal bypasses had a two-year patency of 47% and a limb salvage rate of 74%. In patients treated for limb-threatening ischemia, the two-year patency after femorodistal bypass (47%) was significantly better than that from PTA (18%). Whereas limb salvage after PTA (78%) was not significantly different from that after femorodistal bypass (74%), the PTA group required a significantly greater number of subsequent procedures compared to the surgery group (59% versus 33%). The authors thus concluded that due to the low patency rate and the greater need for subsequent procedures after PTA, bypass procedures were more durable than PTA procedures.
In contrast to the study quoted above, Matsagas et al10 documented a total of 67 infrainguinal endovascular procedures of which 88.1% were considered to be technically successful. The median follow-up period in this study was 12 months. The 30-day mortality was 4%. The cumulative primary patency rates at 12 and 24 months were 63% and 52%, respectively, and remained unchanged thereafter. The estimated secondary patency rate was 72% at 36 months. There was only one below-knee amputation in the patients who were treated exclusively with infrainguinal PTA. This would suggest that the results of PTA are comparable to those of surgical revascularization in the treatment of chronic limb ischemia.
Conclusion. Successful treatment of thrombosis of a femoral-popliteal bypass graft can be achieved by using local delivery of a thrombolytic agent by means of the “pulse spray” technique. We report the use of coronary stent with rapid exchange nitinol stent to reduce residual stenosis.
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2. Ansel GM, George BS, Botti CF, et al. Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry. J Endovasc Ther 2002;9:395–402.
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