Retrograde access via the popliteal artery to facilitate the re-entry technique for recalcitrant superficial femoral artery Chronic total occlusions

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Catheterization and Cardiovascular Interventions 78:625–631 (2011)

Retrograde Access via the Popliteal Artery to Facilitate the Re-entry Technique for Recalcitrant Superficial Femoral Artery Chronic Total Occlusions Reji Pappy, MD, Thomas A. Hennebry, MB BCH BAO, FACC, FSCAI, and Mazen S. Abu-Fadel,* MD, FACC, FSCAI Subintimal recanalization is beneficial in selected patients with peripheral chronic total occlusions (CTO). However, in complex cases, re-entry into the true arterial lumen may prove to be unsuccessful with a conventional guidewire or a re-entry catheter when using standard femoral artery access. Our case series describes these technical dilemC 2011 V mas along with strategies that can be utilized to overcome these challenges. Wiley-Liss, Inc.

Key words: peripheral vascular disease; restenosis; intravascular ultrasound

INTRODUCTION

Subintimal recanalization, or percutaneous intentional extraluminal recanalization (PIER), has been described as a reasonable treatment strategy for peripheral chronic total occlusions (CTO) [1]. Re-entry of the true arterial lumen can be achieved either with a conventional guidewire or if needed, a re-entry catheter. However, in cases where PIER is not feasible after standard transfemoral artery access, then retrograde popliteal artery catheterization (RPAC) can be effective. A creative approach utilizing RPAC to intervene on the proximal superficial femoral artery (SFA) in the setting of bilateral common femoral artery (CFA) occlusion using the Outback LTD re-entry catheter (Cordis Corporation, Miami, FL) was first described in 2006 [2]. We report the first case series describing four complex cases of peripheral CTO of the SFA that was successfully managed with re-entry catheters. The Pioneer (Medtronic, Minneapolis, MN) catheter was used in one case and the Outback catheter in three of the cases, all were performed via popliteal artery access.

6-month duration. One month previously, she underwent intervention in an attempt to assist with the healing of the right lower extremity ulcer. At that time, left CFA access was obtained and angiography revealed two sequential 95% lesions in the right external iliac artery (EIA) and this was treated with a nitinol selfexpanding stent. The right SFA was found to have a CTO (Fig. 1) which was approximately 90 centimeters (cm) in length, with reconstitution via collaterals at the distal SFA near the adductor canal with two-vessel runoff distally. Despite the use multiple wires and catheters, the CTO could not be crossed. The Outback catheter was also used, however, re-entry into the true lumen distally was unsuccessful despite multiple attempts. The pushability and torquability of the Outback catheter was limited from the retrograde contralateral femoral artery approach, and this was thought to be secondary to the presence of an acute aortic Department of Medicine, Section of Cardiovascular Medicine, University of Oklahoma Health Sciences Center, Oklahoma city, Oklahoma Conflict of interest: Nothing to report.

CASE SERIES Case 1 A 70-year-old woman with a medical history of hypertension (HTN), cerebrovascular accident (CVA), and peripheral arterial disease (PAD) presents electively for peripheral angiography and intervention for management of Rutherford category five symptoms of C 2011 Wiley-Liss, Inc. V

*Correspondence to: Mazen S. Abu-Fadel, MD, FACC, FSCAI, 920 S.L. Young Blvd., WP 3010, Oklahoma City, Oklahoma. E-mail: [email protected] Received 30 October 2010; Revision accepted 31 January 2011 DOI 10.1002/ccd.23039 Published online 6 June (wileyonlinelibrary.com)

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Fig. 1. Case 1: Proximal CTO of the right SFA with a small stump (arrow).

Fig. 2. Case 1: Angiogram demonstrating restoration of excellent flow in the right SFA (arrow).

bifurcation. An ipsilateral antegrade femoral artery approach was not attempted as the patient had an ostial occlusion (lack of proximal stump) of the right SFA. Therefore, the patient was rescheduled for intervention of the right SFA lesion via popliteal artery access. After obtaining right popliteal artery access, the Quickcross catheter (Spectranetics, Colorado Springs, CO) was used to traverse the CTO of the SFA using the subintimal technique. Once the wire was in proximity to the nub of the proximal SFA, it would not enter into the true lumen. Concern for further propagation of the subintimal channel led to using the Outback catheter. The six French Outback catheter was used for reentry into the true lumen at the level of the profunda femoral artery-SFA junction. Two LifeStents (Bard Peripheral Vascular, Tempe, AZ) were deployed into the proximal and distal right SFA. Final angiogram revealed no residual stenosis and excellent blood flow was restored (Fig. 2). The anti-platelet regimen included aspirin and clopidogrel at the time of discharge. At 1-year clinical follow-up, the patient remains symptom-free with excellent exercise capacity and sustained resolution of the ulcer.

Case 2

A 63-year-old man with coronary artery disease (CAD), HTN, dyslipidemia, and chronic nicotine use returns for elective intervention for CTO of the left SFA. The patient reports severe claudication (Rutherford category four symptoms). A aortofemoral runoff (AFR) performed via right CFA access, revealed CTO of bilateral proximal SFA with reconstitution via collaterals at the distal SFA near the adductor canal with the presence of two vessel runoff to both feet. The patient was offered surgery at that time but declined it. Due to the presence of greater symptoms in the left lower extremity, we proceeded to intervene on the left SFA occlusion (Fig. 3) which was approximately 90 cm in length. Despite the use of multiple wires and catheters the CTO could not be crossed. The Outback catheter was also used and unable to re-enter the true lumen distally despite multiple attempts. The patient was rescheduled to return for intervention via popliteal artery access. After obtaining left popliteal artery access (Fig. 4), the Quickcross catheter was used for subintimal recanalization. Next, the Outback catheter was used to achieve

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

SFA CTO Managed Retrogradely with Re-entry Catheters

Fig. 3. Case 2: Proximal CTO of the left SFA with a small stump (arrow).

re-entry into the true lumen at the level of the proximal left SFA (Fig. 5). Two LifeStents were deployed in the left SFA with restoration of excellent blood flow (Fig. 6). The anti-platelet regimen included aspirin and clopidogrel at the time of discharge. One month later, the CTO of the right SFA was successfully treated with stenting after obtaining access via left CFA. Two years later, the patient remains symptom free.

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Fig. 4. Case 2: Left popliteal artery access.

above, therefore, the patient was rescheduled to have this lesion treated from a popliteal approach. After obtaining right popliteal artery access, the Quickcross catheter was used for subintimal recanalization and then the Outback catheter had to be used to achieve re-entry into the true lumen of the right SFA. A LifeStent was deployed in the right SFA. Final angiogram revealed excellent blood flow (Fig. 7). The anti-platelet regimen included aspirin and clopidogrel at the time of discharge. At 1-year follow-up, the patient remains symptom free.

Case 3

A 74-year-old man with a medical history of CAD, congestive heart failure (CHF), HTN, dyslipidemia, and chronic nicotine use presents for elective AFR. The patient reports bilateral calf pain (Rutherford category 4) for the previous 6 months. ABI was 0.53 and 0.59 on the left and right, respectively. One month previously, an AFR revealed bilateral CTO of the SFAs and the left SFA was stented after use of the Outback catheter. The presence of large sidebranches at the level of the CTO, which provided the distal run-off, precluded aggressive intervention of the right SFA (which was approximately 100 cm in length) from

Case 4 A 65-year-old man with a history of PAD and right SFA stenting 1 year previously has Rutherford category four symptoms and presents electively for intervention via right popliteal access for CTO of the right SFA (Fig. 8) which was approximately 130 cm in length. The CTO involved both the previously stented region and a portion of the vessel proximal to the occluded stent. One month previously attempts to cross this lesion from above was unsuccessful despite the use of multiple catheters and wires. In fact, the

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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Pappy et al.

Fig. 6. Case 2: Restoration of excellent flow in the left SFA. Fig. 5. Case 2: Subintimal recanalization and re-entry into true lumen.

catheters and wires that were used repeatedly passed behind the stent instead of through the occluded stent lumen. After obtaining right popliteal artery access (Fig. 10) the Berenstein catheter (Boston Scientific, Natick, MA) and the stiff Glidewire (Terumo Medical Corporation, Somerset, NJ) were used to the cross the chronically occluded stent lumen of the right SFA. After passing through the occluded stent lumen, subintimal recanalization was achieved proximally to traverse the remaining CTO. However, subsequent re-entry into the true lumen could not be achieved. Therefore, the 6 French Pioneer catheter with IVUS guidance was used to confirm that the catheter had passed through and not behind the occluded stent and to also achieve re-entry (Fig. 9) into the true lumen. Two LifeStents were deployed in the right SFA and the final angiogram revealed excellent blood flow (Fig. 10). The anti-platelet regimen included aspirin and clopidogrel at the time of discharge. At 1-month follow-up, the patient remains symptom free.

Fig. 7. Case 3: Restoration of excellent blood flow in the right SFA (arrow).

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

SFA CTO Managed Retrogradely with Re-entry Catheters

Fig. 8. Case 3: Occluded stent lumen of the right SFA (arrow).

DISCUSSION

Subintimal angioplasty (SA) during percutaneous intervention for femoropopliteal occlusions was first described by Bolia in 1987 [3]. Since then, this technique’s success has seen its use extended to treatment of stenotic and occlusive lesions in the iliac and popliteal arteries, trifurcation, and crural vessels where it has found an important role in the management of critical limb ischemia. The potential advantage of this method is that thrombogenic atheroma is ‘‘isolated’’ during subintimal intervention. Moreover, the false lumen which is created by this technique is free from both endothelium and atheroma and may lead to potentially improved long-term results since re-stenosis is frequently due to either neointimal hyperplasia or atheroma formation. Endovascular treatment of PAD is not always feasible from the standard transfemoral artery approach, therefore, an alternative technique is to use a retrograde transpopliteal approach by obtaining access via the ipsilateral popliteal artery. This technique was first described in 1988 [4] and since then has been utilized

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Fig. 9. Case 3: Subintimal recanalization and re-entry into true lumen.

for various indications (Table I). This approach is useful when a CFA approach is not possible, especially in cases of an absent femoral pulse due to iliac or CFA occlusions or where an antegrade approach to a SFA lesion has failed. Crossing flush SFA occlusions from an antegrade ipsilateral or retrograde contralateral femoral approach is often difficult as the guidewire/support catheter is often deflected and repeatedly enters the profunda femoral artery rather than the SFA. Similarly, in lesions with large collateral vessels arising from the point of occlusion the guidewire may pass into the collateral rather than through the occlusion. A contralateral approach may be successful, especially with an ‘‘up and over’’ sheath, but problems can occur with acutely angled aortic bifurcations and lack of forward force necessary to cross some lesions. When utilizing the transpopliteal approach, it is important to have enough space at the proximal CFA-SFA junction to reenter, as an inappropriate re-entry site can lead to stenting over the origin of the profunda femoral artery (PFA). Relative contraindications to the popliteal approach include acute occlusions of approximately less than 3 months where there is a risk of distal

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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Pappy et al. TABLE I. Reported Indications for Transpopliteal Access Absent femoral pulse secondary to an iliac or common femoral artery occlusion Severe calcification Combined ipsilateral iliac and femoral lesions Occlusion or a high take-off of the origin of the superficial femoral artery Groin scar tissue Obesity Graft prosthesis Flush SFA occlusion Large collaterals arising from the occlusion point Acutely angled aortic bifurcation Less than 5-mm stump of the proximal SFA

Fig. 10. Case 3: Restoration of excellent flow in the right SFA.

embolization from relatively fresh thrombus, presence of popliteal artery aneurysm, and the lack of patent run-off vessels distally. Moreover, the use of transcutaneous ultrasound guidance has been advocated to achieve popliteal artery puncture to decrease complications [5]. In addition to deciding on the optimal access site before intervention, careful evaluation of the anatomy of the lesion is crucial in devising a management strategy. For instance, a challenging condition during percutaneous management is the presence of CTOs, which are cited as one of the primary reasons for procedural failure in peripheral interventions. Using the stiff end of a guidewire has demonstrated some success for subintimal passage and re-access of the true lumen. However, it has been demonstrated that true lumen re-entry is impossible with the sole use of the guidewire in approximately 20% of the cases [6], therefore, re-entry catheters were designed to mitigate this challenge. The Outback and Pioneer catheters are the two most widely used re-entry catheters. The Outback LTD catheter is a 6 French compatible catheter with a hollow 22-gauge needle for distal vessel entry using fluoroscopic imaging. The device is

delivered to the distal subintimal space adjacent to the reconstitution of the vessel and two orthogonal angiographic views are taken. The proprietary locate, tune, and deploy technique is used to increase successful distal re-entry. An L-shaped fluoroscopic marker provides reproducible orientation of the tip toward the re-entry target site. The ‘‘T’’une fluoroscopic marker, combined with a 90 orthogonal view, confirms the desired alignment to fine tune positioning at the target re-entry site. Finally, the 22-gauge, nitinol re-entry cannula is plunged into the distal vessel to re-enter into the true lumen [7]. The Pioneer catheter is also now a 6 French compatible catheter with two wire ports, each 0.014-inch compatible, one with a hollow core nitinol needle that is guided by an integrated 64-element, phased-array intravascular ultrasound device and is connected to a Volcano IVUS (Volcano Corporation, Rancho Cordova, CA) console, enabling vessel imaging. The device is delivered through the subintimal plane and is placed with the distal tip at the level of the SFA re-entry site. By slowly rotating the catheter, the ultrasound image is maneuvered until the tip of the nitinol needle is oriented toward the true lumen and is lined up at the 12o’clock position on the ultrasound image. Finally, the needle is plunged into the true lumen at a controlled depth [8]. In our case series, a re-entry catheter was utilized because the conventional guidewire technique was not successful in achieving re-entry into the true arterial lumen. After multiple unsuccessful attempts to re-enter the true lumen the retrograde transpopliteal access via ultrasound guidance was utilized. It is possible that the presence of an acute aortic bifurcation (Cases 1 and 2) lead to limited pushability and torquability of the re-entry catheter resulting in unsuccessful re-entry into the true lumen when the contralateral transfemoral approach was utilized. In fact, the pushing force

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

SFA CTO Managed Retrogradely with Re-entry Catheters

required to traverse these occlusions led to the catheter buckling in the aorta. In case 3, the presence of a large sidebranch at the level of the occlusion, which provides the distal run-off to the lower extremity precluded an aggressive approach from above as inadvertent injury to this branch would have potentially resulted in dire consequences. In case 4, we chose to use the Pioneer catheter with the Volcano IVUS (Volcano Corporation, San Diego, CA) as it is available in a 6 French size and also has the additional imaging modality that enables confirmation of catheter passage through the chronically occluded stent lumen and assures that the catheter was not advanced behind the stent. The ipsilateral antegrade femoral approach was not utilized primarily due to the presence of a very small stump of the proximal SFA (cases 1 and 2), which does not allow for optimal guidewire and catheter manipulation. It is recommended that at least a 5-mm stump be present at the origin of the SFA for ipsilateral antegrade femoral access. Moreover, many SFA occlusions such as the ones in our cases have a shorter stump, therefore, entry is commonly achieved either from the contralateral femoral approach or if not feasible from the transpopliteal approach. Some authors have advocated the use of the brachial approach to intervene on peripheral lesions, however, if the distance from the left or right brachial artery to the reconstitution of the SFA is >120 cm, then this approach may not be feasible as the shaft length of many current interventional devices limits this. Overall, endovascular treatment for CTOs of the SFA is now feasible in greater than 90% of cases [9]. However, despite the use of current interventional tools, the long-term patency after intervening on these lesions remains suboptimal but continues to improve. A recent retrospective study reported a 54.9% re-stenosis rate at 12 months when utilizing the retrograde transpopliteal approach during intervention for CTOs of the SFA [10]. Although our patients had lesions classified as TASC (TransAtlantic Intersociety Consensus) II C and met candidacy for surgical revascularization, we proceeded with percutaneous management because all four patients declined surgical revascularization after being evaluated by our surgery colleagues. Complex peripheral CTOs require persistent innovation regarding access, options, and equipment. Understanding the available techniques of SA along with familiarity with re-entry devices such as the Outback or Pioneer catheter will allow safe and successful recanalization of SFA occlusions. A case series

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describing retrograde re-entry with re-entry catheters after transpopliteal access has not been previously described to the best of our knowledge. This approach was both necessary and successful in all three cases. Safety issues of avoiding the profunda femoral artery on re-entering and avoiding a larger sheath were achieved by using a re-entry catheter. CONCLUSION

RPAC with either the Outback or Pioneer re-entry catheter is a reasonable alternative in cases where PIER is unsuccessful or non-feasible from a standard transfemoral approach in the management of CTOs of the SFA. Randomized controlled trials which evaluate long-term patency after this specific type of approach have yet to be designed. REFERENCES 1. Bolia A, Miles KA, Brenan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357–363. 2. Das, TS. Complex chronic total occlusion treatment using a re-entry catheter. Endovascular Today 2006:67–70. 3. Bolia A, Brennan J, Bell PR. Recanalization of femoro-popliteal occlusions: Improving success rate by subintimal recanalisation. Clin Radiol 1989;40:325. 4. Tonnesen KH, Sager P, Karle A, Henriksen L, Jorgensen B. Percutaneous transluminal angioplasty of the superficial femoral artery by retrograde catheterization via the popliteal artery. Cardiovasc Intervent Radiol 1988;11:127–131. 5. Yilmaz S, Sindel T, Lu¨leci E. Ultrasound-guided retrograde popliteal artery catheterization: Experience in 174 consecutive patients. J Endovasc Ther 2005;12:714–722. 6. Spinosa DJ, Leung DA, Harthun NL, et al. Simultaneous antegrade and retrograde access for subintimal recanalization of peripheral arterial occlusion. J Vasc Interv Radioli 2003;14:1449– 1454. 7. Hauseger KA, Georgieva B, Portugaller H, et al. The outback catheter: A new device for true lumen re-entry after dissection during recanalization of arterial occlusions. Cardiovasc Intervent Radiol 2004;27:26–30. 8. Casserly IP, Sachar R, Bajzer C, et al. Utility of IVUS-guided transaccess catheter in the treatment of long chronic total occlusion of the superficial femoral artery. Catheter Cardioavasc Interv 2004;62:237–243. 9. Conrad MF, Cambria RP, Stone DH, et al. Intermediate results of percutaneous endovascular therapy of femoropopliteal occlusive disease: A contemporary series. J Vasc Surg 2006;44:762– 769. 10. Noory E, Rastan A, Schwarzwalder U, Sixt S, Beschorner U, Burgelin K, Neumann FJ, Zeller T. Retrograde transpopliteal recanalization of chronic superficial femoral artery occlusion after failed re-entry during antegrade subintimal angioplasty. J Endovasc Ther 2009;16:619–623.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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