According to the Centers for Disease Control and Prevention, peripheral arterial disease (PAD) affects approximately 8.5 million Americans over 40 years of age. PAD is associated with significant morbidity and mortality, potential limb loss, and negative impact on quality of life. The manifestations of PAD are broad in range, from asymptomatic to intermittent claudication, to critical limb ischemia (CLI) with tissue loss. CLI is a disabling disease that can lead to amputation and reduce lifespan. American Heart Association/American College of Cardiology guidelines on the management of patients with CLI state, “critical limb ischemia is characterized by chronic ischemic rest pain, nonhealing wound or ulcers, gangrene on at least 1 leg attributable to objectively proven arterial disease.”1 We present three cases of patients who presented with CLI and after failing an endovascular approach and failed surgical fem-pop bypass, were treated with help of a centering device during peripheral intervention. Femoral-popliteal (fem-pop) artery grafts in two patients were successfully recanalized, and in a third case, the patient’s native superficial femoral artery (SFA) was reopened.
Case No. 1
A 63-year-old male smoker presented with critical limb ischemia of his left foot. Four years prior, the patient underwent right fem-pop bypass after failed intervention on his right leg. He ended up losing the fifth digit on his right foot. Three years prior to his visit, he underwent a fem-pop bypass procedure on his left leg for severe claudication after failed intervention. One year later, he underwent a redo fem-pop on his left leg with a cadaveric vein. Twelve months prior to the visit, a self-expanding stent was placed in that fem-pop graft because of continued foot ischemia. Seven months prior to his visit, his symptoms re-occurred, and the patient was told nothing could be done after an angiogram showed the vessel was occluded. The patient suffered from polyneuropathy and was unable to walk, but did not want amputation. The patient was on cilastazol and coumadin, and had type II diabetes mellitus. His exam revealed a cool and red left foot, but no ulcers. Capillary filling was adequate. The right dorsalis pedis was normal, and there was no popliteal pulse on either side and no left pedal pulses. A contralateral approach was utilized and revealed the graft was occluded on the left side (Figure 1). The patient likely had thrombus in the graft, and we felt that a laser would be appropriate, used either in the traditional manner or with the step-by-step method. Whenever the step-by-step method is utilized, we use the CrossLock LP device (Radius Medical) for centering (Figure 2). The CrossLock LP is usually utilized for infrapopliteal lesions, but in this case, the 3 mm elastomeric balloon would fit well into the nub of the bypass graft. We immediately subtended the bypass graft all the way down and then were able to access the infrapopliteal vessels (Figures 3-4). We performed .9 mm laser (Spectranetics) in the graft and balloon angioplasty (Figure 5). Two Xience stents (Abbott Vascular) were placed, a 4.0 cm and 3.5 cm, at the anastomosis site, and because of residual stenosis at the popliteal, we placed a 5.5 cm Supera stent (Abbott Vascular). Due to multiple failures of the graft, the graft was covered with a 6.0 mm x 250 mm Gore Viabahn stent graft (W.L. Gore & Associates). At the end of the procedure, we were able to achieve brisk 2-vessel runoff (Figures 6-7). Fluoroscopic time was long at 73 minutes and the contrast utilization was 236 mL.
Case No. 2
A 90-year-old woman presented with CLI of her left foot. She suffered from claudication beginning 12 years ago. Six months prior, she developed an ulcer on her foot and shortly thereafter, underwent femoral popliteal bypass. Her symptoms recurred and repeat fem-pop surgery was performed at that time. It immediately failed and she had a cadaveric vein placed as a fem-pop conduit, which again occluded and after two revisions of the fem-pop bypass, she was told five months prior to her current presentation that she would not be able to have any further intervention on her leg. At that time, it was suggested she go to hospice. A medial 1 cm x 6 cm foot ulcer was noted on examination, but the patient refused any intervention. Six weeks later, with insistence from the wound care center, and with the patient’s second and third digit now black on that foot, the patient permitted an evaluation for possible limb salvage. The examination showed that the foot was now cool and the second, third, and fourth digits were bluish-black. No pedal pulses were present. The patient was approached via the contralateral groin, and the angiogram revealed her native SFA and graft to be occluded at the origin (Figure 8). With the thought that there was a likelihood of thrombus in the vessel, we utilized the CrossLock LP and crossed the occlusion down to the tibial vessels with a Command wire (Abbott Vascular) wire (Figures 9-10). With some suggestion of thrombus in the digital arteries, 3 mg of tPA was administered locally. A .9 laser was used and subsequent balloon angioplasty was performed using embolic protection (Figures 11-12). The fluoroscopic time was 25.2 minutes and contrast was 273 cc. At the end of the procedure, the patient had 2-vessel infrapopliteal flow and several hours later, was seen by the orthopedic surgeon for metatarsal surgery. The surgeon stated that all the toes were now pink, the patient had palpable pedal pulses, and although it was very likely that some amount of amputation may be necessary in the second and third toe, nothing was removed, and the patient was discharged the next day.
Case No. 3
A 73-year-old former smoker presented with severe and progressive claudication of her left leg with resting foot pain. Her symptoms first began 35 years ago and approximately 10 years ago, she had a left iliac artery occlusion that was treated with recanalization and stenting. At the same time, her SFA was treated, but after multiple interventions had failed, she underwent fem-pop bypass grafting. Unfortunately, she suffered a graft infection and had to have the fem-pop graft removed. She was told by her vascular surgeon nothing could be done. She now presented with calf claudication and resting pain. A 6 French Ansel (Cook Medical) also confirmed the left SFA was occluded at the origin, with an extensive network of collaterals from the deep femoral artery (Figure 13). We passed a Frontrunner catheter (Cordis) through the CrossLock with the CrossLock inflated for super support (Figure 15). We also passed the CrossLock over the Frontrunner with the CrossLock balloon deflated. The balloon support catheter and Frontrunner were removed. Focused balloon dilation and multiple drug-eluting balloon dilations (Lutonix, Bard Peripheral Vascular) were performed. Excellent 3-vessel runoff was visualized on angiography (Figure 16).
In patients presenting with deteriorating or unsuccessful fem-pop grafts, it is imperative to remove the thrombus likely present in the occluded vessels. Use of the CrossLock LP with the laser permitted us to ablate and achieve successful recanalization without the necessity of using intragraft, prolonged tPA infusion. In the second case, the patient likely had thrombus present. We were hesitant to subject a 90-year-old woman to a prolonged tPA infusion. Centering was essential, as was use of the laser and an embolic protection filter. Patients who have been told nothing can be done still may have options to not only revascularize, but salvage previously unsuccessful fem-pop grafts.
Notable studies in the treatment of critical limb ischemia include the BEST-CLI trial, which is looking at best available surgical treatment versus best available endovascular treatment in up to 2100 patients with critical limb ischemia eligible for either option.2 BEST-CLI, sponsored by the National Institutes of Health, is a highly anticipated and pragmatic real-world trial. Investigators are allowed to use any bypass or endovascular device that will address the patient’s clinical syndrome. The Prodigy (Radius Medical), an over-the-wire supporting balloon,3 and CrossLock device allow not only centering of the catheter, but balloon inflation in order to provide strong support for other devices such as balloons, the 0.9 laser, Frontrunner, Crosser (Bard Peripheral Vascular), Viance (Medtronic), and CrossBoss (Boston Scientific).
The interventionalist’s goal is to perform procedures quickly with less contrast, less fluoroscopy, and higher safety margins. Even though many cases of critical limb ischemia can be treated with either an endovascular or surgical approach, this small series discusses three cases that underwent a surgical approach that subsequently failed. In each case, the surgeon did not feel it was appropriate to re-operate on the patient. An endovascular approach was then utilized and provided a positive outcome for these three patients.
- Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21; 69(11): e71-e126. doi: 10.1016/j.jacc.2016.11.007.
- The BEST-CLI trial. Available online at https://clinicaltrials.gov/ct2/show/NCT02060630. Accessed January 22, 2018.
- Moualla SK, Khan S, Heuser RR. Anchoring improved: Introduction of a new over-the-wire support balloon. J Invasive Cardiol: 2014; 26(9): E130-E132.
Note: A version of this article containing the first two cases was first posted at www.cathlabdigest.com/blog/Fem-Pop-Graft-Failure-Resurrection-CrossLock-LP
Disclosure: Dr. Heuser reports equity in Radius Medical.
The authors can be contacted at email@example.com.