A Step Forward: The Use of the CrossLock Catheter in a Patient With Critical Limb Ischemia and a Popliteal Occlusion

Abstract: A 75-year-old diabetic female presented with resting pain in her left foot. Her resting ankle-brachial indexes were 1.25 on the left and 1.22 on the right. We accessed the right groin and passed an Omni catheter (AngioDynamics) to access the contralateral common femoral artery. An angiogram revealed that the common femoral, deep femoral, and superficial femoral were patent, but the popliteal was 100% occluded. We utilized the 0.014˝ Command wire (Abbott Vascular), and after the extension was passed, inflated the CrossLock balloon. With the balloon inflated, we crossed the total occlusion and passed the wire into the peroneal vessel. Through the CrossLock, we then performed a kissing-balloon technique with a 3.5 mm Chocolate balloon (Cordis Corporation) and a 4.0 mm Chocolate balloon in the peroneal. We individually stented the anterior tibial artery with a 3.5 x 28 mm Alpine stent (Abbott Vascular) and a 4.0 x 23 mm Alpine stent in the peroneal artery. Angiography confirmed excellent patency of the popliteal, peroneal, and anterior tibial with two-vessel run-off. The CrossLock has a distinct advantage of keeping one central in the lumen and also has very firm support to allow passage of a balloon catheter or other device.

J INVASIVE CARDIOL 2016;28(1):E13-E16

Key words: critical limb ischemia, popliteal occlusion

__________________________________________

Lower-extremity peripheral arterial disease (PAD) occurs in 4.3%-29% of patients worldwide. In patients with critical limb ischemia (CLI), the most severe form of PAD, the resting metabolic need of tissue is not being met by the arterial supply. CLI exists in 1%-2% of the PAD population and is defined as ischemic rest pain, non-healing wounds, or gangrene.^1-5 The ischemic rest pain associated with CLI typically occurs at night. In some cases, with dependency of the limb there is some pain relief. 

Many patients with PAD present with infrainguinal lesions, with 50% of patients presenting with chronic total occlusion (CTO).^5,6 In CLI, the urgency to restore the patency of the affected vessels is paramount. This may include in-flow therapy at the first stage and out-flow intervention in a second setting if the first attempt is not effective. Staged procedures require not only additional risk, but additional inconvenience to patients. Most operators attempt to perform the revascularization as completely as possible, with a minimum of single-vessel run-off after intervention. 

In the case of a CTO in the popliteal vessel or below, many approaches are possible. The first principle is effective access. From a practical standpoint, if the diagnostic procedure is done and the interventional procedure follows, this will determine the access location. The majority of interventions from the popliteal on down are still performed either with a contralateral approach or with antegrade common femoral or superficial femoral artery access. If the contralateral approach has been utilized, guiding catheter support is paramount. A cross-over catheter, such as the Ansel (Cook Corporation) or Shuttle sheath (Cook Corporation), or other catheters are usually effective. Depending on the anatomy, usually a microcatheter is passed through this support catheter to allow the operator to utilize a wire to direct it to the total occlusion or tight stenosis. Over the years, industry has supplied alternatives for treatment of CTOs when the wire itself cannot cross. Those devices include the Viance (Covidien), the Wildcat/Ocelot (Avinger), the Crosser (Bard), and the Enabler (EndoCross). Although the Enabler theoretically is thought to allow the operator to be positioned in the middle of the lumen, published experience of this device is limited. We recently described the use of the Prodigy balloon support catheter (Radius Medical) (Figure 1A) in a case report.⁷ Although initially this support device was primarily designed for coronary artery CTOs, we have utilized it effectively in peripheral CTOs.⁸ As a variant of the Prodigy support balloon (Figure 1), we recently introduced the CrossLock catheter (Radius Medical) (Figures 1B, 1C, 1D).⁹ The device consists of an extension support catheter that can be utilized for both coronary and peripheral applications. With inflation of the elastomeric balloon size ranging from 1-8 mm in diameter, the wire lumen is placed in a central position, theoretically resulting in maintaining the wire in the intraluminal position. What is unique about the CrossLock catheter is that we can inflate the elastomeric balloon and pass a balloon catheter, laser, or stent with the balloon inflated. This allows these treatment catheters to be passed with excellent and firm support. 

We present the case of an elderly lady with resting leg pain and a complex total occlusion of the popliteal artery that we approached with the CrossLock catheter. The CrossLock’s ability to center the wire was useful to recanalize this CTO first with the wire, and with the balloon support of the CrossLock, we were able to immediately and with little effort cross the resistant occlusive lesion with a balloon catheter.

Case Report

A 75-year-old woman presented with resting pain of her left foot. She suffered from diabetes and hypertension, had known cardiomyopathy, and was status post implantable cardioverter-defibrillator placement. She was a non-smoker. A magnetic resonance angiogram performed 6 months prior to treatment revealed a severe stenosis of the popliteal artery. Her resting ankle-brachial indexes (ABIs) were 1.25 on the left and 1.22 on the right. With the knowledge of the non-invasive tests, we approached via the right groin and passed an Omni catheter (AngioDynamics) to access the contralateral common femoral artery. An angiogram revealed that the common femoral, deep femoral, and superficial femoral were patent, but the popliteal was 100% occluded (Figure 1E). We utilized the .014˝ Command wire (Abbott Vascular), and after the extension was passed, inflated the CrossLock balloon. With the balloon inflated, we crossed the total occlusion and passed the wire into the peroneal vessel (Figure 1F). Following balloon inflation, we easily passed a 4 cm-long balloon. We could see filling of the anterior tibial artery; however, the posterior tibial artery was 100% occluded (Figure 1G). Utilizing an .014˝ QuickCross (Spectranetics) through the CrossLock, we recanalized the anterior tibial artery to the digital arteries using a Runthrough .014˝ wire (Terumo Medical). Through the CrossLock, we then performed a kissing-balloon technique with a 3.5 mm Chocolate balloon (Cordis) and a 4.0 mm balloon in the peroneal. A dissection could not be resolved with balloon dilation and nitroglycerin and with resting symptoms, we felt obliged to optimize the distal profusion (Figure 1H). We noticed wire wrap, so we individually stented the anterior tibial artery with a 3.5 x 28 mm Alpine stent (Abbott Vascular) and the peroneal with a 4.0 x 23 mm Alpine stent. Angiography confirmed excellent patency of the popliteal, peroneal, and anterior tibial with two-vessel run-off (Figure 1I). Closure with Perclose was then performed. The fluoroscopy time was 47.1 minutes and 435 cc of contrast was used for this procedure. The patient left in good condition. Two months after this procedure, her claudication has resolved on the left foot.

Discussion

This patient has been closely followed by an alert primary care physician and podiatry physician who is extremely familiar with not only PAD, but CLI. It is important that this team approach be utilized in CLI patients. Luckily, this patient had not yet suffered from any ulcers or any more serious limb-threatening symptoms or signs. Utilization of the physical exam, ABIs, and less-invasive imaging is helpful, but in cases of resting pain, an angiogram and rapid revascularization are necessary. Her symptoms had been present for several weeks when she presented to the primary care physician, who rapidly had her seen and revascularized. Interestingly, as with many patients with severe PAD, the ABI was relatively normal. We frequently perform an antegrade approach for patients with known popliteal occlusion with CLI; however, since we had not defined the anatomy, we chose the contralateral approach, which was effective. If this patient had not been successfully racanalized, we might have approached the anterior tibial vessel via the pedal arteries; however, the pedal vessels did not look ideal from the initial angiogram. 

Physicians have many support catheters at their disposal for peripheral CTO. We have increasingly utilized techniques to maintain intraluminal position rather than passing a hydrophilic .035˝ wire, which is many times effective, but frequently can result in a subintimal passage. This, in turn, can result in a large and long dissection, which is particularly difficult to treat in the infrapopliteal territory. The CrossLock has a distinct advantage of keeping one central in the lumen and also has very firm support to allow passage of a balloon catheter or other device. There is no reason to think it would not be effective with the Avinger device or other similar devices that have been effective in CTOs. We have also utilized the CrossLock in a patient with a right coronary artery CTO. The patient had two failed antegrade attempts as well as one failed retrograde attempt prior to successful treatment with the CrossLock. In this case, we crossed the CTO with a stiff .014˝ wire and a .9 mm laser with an excellent result.

Study limitations. The CrossLock device is currently an 8 Fr device, which is larger than most support catheters; however, in this case with a bifurcated lesion, it was actually ideal to have this large lumen to work with. The CrossLock can be used for coronary applications; however, until larger sheathless guides are available, this catheter will be difficult to use for transradial CTO interventions, which is what we almost uniformly utilize for these complex PCI procedures.

References 

1.    Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004;10:783-743.

2.    Criqui MH, Fronek A, Barrett-Connor E, et al. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985;71:510-515.

3.    Diehm C, Schuster A, Allenberg JR, et al. High prevalence of peripheral arterial disease and comorbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004;172:95-105.

4.    Meier WT, Hoes AW, Rutgers D, et al. Peripheral arterial disease in the elderly: the Rotterdam study. Aterioscler Thromb Vasc Biol. 1998;18:185-192.

5.    Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001;286:1317-1324.

6.    Hirsch AT, Haskal ZJ, Flertzer NK, et al. American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart Lung and Blood Institute; Society of Vascular Nursing; Trans-Atlantic Inter-Society Concensus; Vascular Disease Foundation; ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology Society of Interventional Radiology, and the ACC/AHA task force on practice guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung and Blood Institute; Society for Vascular Nursing; Trans-Atlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006;47:1239-1312.

7.    Moualla S, Khan S, Heuser RR. Anchoring improved: introduction of a new over-the-wire support balloon. J Invasive Cardiol. 2014;26:E130-E132.

8.    Heuser RR. Prodigy: not just for hearts. A case of anterior tibial occlusion treated with a time-saving device. Vascular Disease Management. September 2014. Blog, available at https://www.vasculardiseasemanagement.com/blog/prodigy-not-just-hearts-case-anterior-tibial-occlusion-treated-time-saving-device.

9.    Heuser RR. CrossLock™ crosses the CTO. Vascular Disease Management. April 2015. Blog, available at https://www.vasculardiseasemanagement.com/blog/crosslock-crosses-cto.

____________________________________________

From St. Luke’s Medical Hospital and Medical Center, Cardiology, Phoenix, Arizona.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Heuser holds patents 6,464,681 and 7,179,250, and is the codeveloper of the CrossLock and Prodigy catheters. The remaining authors report no disclosures regarding the content herein.

Manuscript submitted and accepted April 24, 2015.

Address for correspondence: Richard R. Heuser, MD, FACC, FACP, FESC. FASCI, St. Luke’s Medical Hospital and Medical Ctr, Cardiology, 555 N. 18th Street, Suite 300, Phoenix, AZ 85006. Email: rheuser@iasishealthcare.com