A 72-year-old woman with a history of type 2 diabetes, hypertension, hyperlipidemia, and peripheral vascular disease developed dry gangrene of the left great toe as well as rest pain over a 5-week period. She had a history of bilateral femoral stent placements and a 20 pack per year smoking history but quit 5 years ago. She did not have documented coronary artery disease or stroke and did not report chest pain, shortness of breath with exertion, or leg swelling. She had bilateral calf claudication at about one-half block.

Examination revealed a frail but alert woman brought in on a wheelchair. She had palpable femoral pulses on both sides but nonpalpable popliteal and pedal pulses. On the right side, she had 2-cm dry gangrene on the tip of her hallux. There was no drainage or surrounding erythema. She did have dependent rubor, which would resolve with leg elevation. Neurologic evaluation demonstrated decreased sensitivity to light touch in the feet bilaterally.

Ankle-brachial index was 0.55, with toe pressure of 17. Arterial duplex ultrasound confirmed right superficial femoral artery (SFA) stent occlusion with reconstitution of the popliteal artery above the knee. White blood cell count was 8.2, and creatinine was 1.1 mg/dL.

She underwent diagnostic peripheral angiography, which demonstrated an occluded right SFA stent with reconstitution of the above-knee popliteal artery. There was two-vessel runoff through the anterior tibial and peroneal artery (Figure 1).

We positioned a crossover sheath into the right SFA and administered therapeutic intravenous heparin. Initial attempts to cross the chronic total occlusion (CTO) with a Glidewire™ (Terumo Interventional Systems) and catheter were unsuccessful due to a calcified cap. Attempts at creating a subintimal plane only advanced our catheters outside the implanted femoral stent.

Our next maneuver involved using the Crosser® Catheter S6 (Bard Peripheral Vascular, Inc.) coupled with the Usher® Support Catheter (Bard Peripheral Vascular, Inc.). We positioned the Usher® Catheter at the center of the CTO cap. The Crosser® Catheter was able to successfully penetrate the calcified cap and continued intraluminally through the distal cap. The Usher® Catheter was advanced over the Crosser® Catheter into the reconstituted popliteal artery without difficulty (Figure 2).

We exchanged out for a 0.014-inch wire and performed mechanical atherectomy using a 2.4-mm Jetstream™ device (Bayer). Intravascular ultrasound revealed that the vessel size was 5.4 mm. We predilated the occlusion with a 5-mm Vascutrak® PTA Catheter (Bard Peripheral Vascular, Inc.) in preparation for stent placement using a Lifestent® Vascular Stent (Bard Peripheral Vascular, Inc.). Completion angiography and intravascular ultrasound demonstrated no residual stenoses, dissections, occlusions, or embolizations (Figure 3).

Two-vessel runoff was preserved. Routine mechanical compression was performed, and the patient tolerated the procedure without immediate complications.

DISCUSSION

Restenosis is a common clinical scenario resulting from endovascular treatment with balloon angioplasty and intra-arterial stenting, with complications of arterial occlusion, elastic recoil, dissection, or residual stenosis. Restenosis due to endothelial injury from PTA progresses through three phases: acute vessel recoil, negative remodeling, and neointimal hyperplasia.1 Although peripheral stenting can improve vessel recoil and negative remodeling, thrombus formation and neointimal hyperplasia are the primary causes of in-stent restenosis. Early reocclusions are usually the result of acute thrombosis, whereas late reocclusions are a result of neointimal hyperplasia.

Restenosis rates have been widely reported for balloon angioplasty of femoropopliteal lesions to be > 50% at 1 year, with the rate varying based on the type of lesion. One meta-analysis found that 3-year patency rates after PTA ranged from 61% in claudicants with stenosis to 30% for CLI patients with CTOs.2 While stenting can mitigate vessel recoil and negative remodeling, in-stent restenosis occurs at a rate of 19% to 37% at 1 year.3-6 Secondary interventions for nonocclusive restenosis include the use of repeat balloon angioplasty, cutting-balloon angioplasty, repeat stenting with either a bare-metal stent or covered stent, and atherectomy. Secondary interventions for CTOs can be more problematic. In our experience, restenotic occlusions tend to be quite fibrotic. In addition, the cap of the occluded lesion can sometimes be severely calcified, especially in patients with diabetes or end-stage renal disease.

In our experience, recanalization of a restenotic occlusion is usually more difficult than the treatment of a de novo TASC D lesion of an SFA that has not undergone previous intervention. Advancement of the wire and crossing catheter in the true lumen or the subintimal plane is usually difficult due to the fibrotic and sometimes calcified nature of the occlusion. Often, the wire and catheter enter the adventitial space outside the lumen and cannot be negotiated to remain inside the lumen.

In this particular patient, initial attempts at penetrating the calcified cap were unsuccessful; therefore, the Crosser® Catheter was used to treat this lesion. The Crosser® Catheter is a CTO recanalization system that uses a specialized catheter to transmit high-frequency vibrations at approximately 20,000 cycles/sec at an amplitude of 20 μm to penetrate the hard calcified cap. It works like a small jackhammer. The mechanism of action maximizes its ability to penetrate inelastic surfaces such as calcium and minimizes its impact on elastic structures such as the vessel wall. Thus, the catheter is more likely to stay in the true lumen while avoiding perforation of the vessel. The PATRIOT clinical study demonstrated that the Crosser® Recanalization Catheter was successful in traversing CTOs that were unable to be crossed with a conventional guidewire. 7,8 Moderate to severe calcium was noted in 75% of these patients (n = 85), and no clinical perforations related to the Crosser® Catheter were observed. In addition, 15.3% of the patients had restenotic occlusions, having previously received endovascular treatment at the target lesion site.8

In our case, an occluded stent was resistant to a conventional guidewire and catheter method to cross the lesion. In addition, guidewire manipulation frequently creates a channel outside the occluded stent, thereby making successful secondary intervention challenging. The Crosser® Recanalization Catheter offered an elegant percutaneous solution to this difficult secondary intervention vascular case.

Franklin S. Yau, MD, RPVI, is a vascular surgeon with Vanguard Vascular & Vein in Dallas, Texas. Dr. Yau has disclosed that he is a consultant for Bard Peripheral Vascular, Inc. Dr. Yau may be reached at yau@thevanguardway.com.

The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes. The physician has been compensated by Bard Peripheral Vascular, Inc. for the time and effort in preparing the above case study for Bard’s further use and distribution.

  1. Dieter RS, Laird JR. Overview of restenosis in peripheral arterial intervetions. Endovasc Today. 2004;10:36-38.
  2. Muradin, GSR, Bosch, JL, Stijnen, et al. Balloon dilatation and stent implantation for treatment of femoropopliteal arterial disease: Meta-analysis. Radiology. 2001;221:137-145.
  3. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879-1888.
  4. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267-276.
  5. Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745-2749.
  6. Laird JR, Katzen BT, Scheinert D, et al; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year followup from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1-9.
  7. PATRIOT evaluates FlowCardia’s Crosser to mediate CTO recanalization. Endovascular Today. October 22, 2009.
  8. Peripheral Approach to Recanalization in Occluded Totals" (PATRIOT) Clinical Trial. Clinical data on file.