Revascularization of Superficial Femoral Artery Chronic Total Occlusion

Friday, 03/30/12 | 7634 reads
Author(s): 

Jon C. George, MD

ABSTRACT: Emerging technologies constantly redefine the clinical landscape in the treatment of peripheral arterial disease. We describe a case utilizing the adjunctive therapy of the Wildcat catheter with the motorized Juicebox console (Avinger, Inc.) in crossing a complex chronic total occlusion lesion in the superficial femoral artery, allowing for wire advancement and therapeutic intervention.

VASCULAR DISEASE MANAGEMENT 2012:9(4):E48-E50

____________________________________________

Case Report

A 69-year old male with history of coronary artery disease presented with lifestyle-limiting claudication of the left lower extremity. Physical examination revealed non-palpable left dorsalis pedis and posterior tibial pulses, which were both present on Doppler. Angiography with runoff of the left lower extremity confirmed a 110 mm chronic total occlusion (CTO) in the proximal superficial femoral artery (Figure 1), with reconstitution of the distal superficial femoral artery via collaterals (Figure 2) and 3-vessel runoff into the left foot.

The proximal cap of the CTO was directly engaged using a Wildcat catheter (Avinger) (Figure 3), but manual rotation of the catheter tip met stiff resistance mid-lesion. The Juicebox motorized console (Avinger) was then attached to the Wildcat catheter, and with a constant tip rotation of 100 rpm, the remainder of the CTO was crossed. A distal popliteal angiogram through the Wildcat catheter central lumen confirmed intraluminal position (Figure 4). A 5 mm x 100 mm Angiosculpt scoring balloon (AngioScore, Inc.) was utilized to predilate the occluded segment and 2 overlapping Supera 5 mm x 120 mm self-expanding stents (IDEV Technologies) were deployed in the left SFA. The final angiogram revealed brisk flow with 3-vessel runoff into the left foot (Figure 5). The patient tolerated the procedure well without complications and was discharged home the following day after observation post-intervention.

Discussion

The portfolio of medical devices available for the successful revascularization of CTOs in the peripheral vasculature is evolving to enable efficient true-lumen crossing. These tools allow physicians to percutaneously revascularize lesions that were once solely stratified to open surgical intervention. Lesion modifiers such as length, degree of calcification, and prior intervention are less absolute contraindications to minimally invasive surgery moving forward. The variability in success for crossing CTOs highlights the need for continued advancements in crossing therapeutics for the most challenging lesions.1,2

The Wildcat CTO catheter (Figure 6) was initially studied in the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial to evaluate the safety and effectiveness of the catheter to cross de novo or restenotic femoropopliteal CTOs.3 A total of 88 patients were enrolled (mean age: 69.5 years; male: 53%; smokers: 80.7%; hypertension: 86.4%) for treatment of variable lesion characteristics (mean length: 174 mm; de novo: 88.6%; moderately calcified: 53.4%). The device met both the primary safety (composite of major adverse events) and primary efficacy endpoints with a 95.2% safety rate and 89.3% success rate for crossing CTOs.

In this case, the Wildcat CTO crossing device was coupled with a snap-on motorized Juicebox accessory (Figure 7) to enable crossing of the 11 cm lesion while avoiding the need for re-entry or subintimal crossing. The use of this device is recommended as the initial effort in crossing a CTO in order to avoid the engagement of subintimal channels created by previous wire attempts. Juicebox equips the Wildcat catheter with a small onboard motor to provide automatic rotation of the crossing blades in the aggressive (clockwise) and non-aggressive (counter-clockwise) rotational directions. This accessory effectively enables hands-free rotation of the Wildcat catheter, thus allowing for enhanced tactile feedback during advancement. While the list price of the Wildcat catheter with Juicebox is $1895, the cost is meager when taking into account the savings from an increased technical success rate, reduced multiple catheter use, and faster crossing times. With patients placing a high value on non-operative approaches to managing PAD,4,5 adaptive technologies like the Wildcat catheter with Juicebox console show promise for maximizing safe and effective options for limb salvage using minimally invasive modalities.

References

  1. Gandini R, Volpi T, Pipitone V, Simonetti G. Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system. J Endovasc Ther. 2009;16(1):23-27.
  2. Joye J. The PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study results. Am J Cardiol. 2007;100(Supp 1):S24.
  3. Pigott JP, Raja ML, Davis T. Connecting the True Lumen: A Multicenter Experience Evaluating Chronic Total Occlusion Crossing with the Wildcat Catheter (CONNECT Study). Midwestern Vascular Surgical Society Annual Meeting. 2011 Sept 17.
  4. 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(4):762-769.
  5. Dippel E, Shammas N, Takes V, Coyne L, Lemke J. Twelve-month results of percutaneous endovascular reconstruction for chronically occluded superficial femoral arteries: a quality-of-life assessment. J Invasive Cardiol. 2006;18(7):316-321.

____________________________________________

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. George reports money earned from Avinger, Inc.
Manuscript submitted February 10, 2012, provisional acceptance given February 27, 2012, final version accepted March 6, 2012.
Address for correspondence: Jon C. George, MD, Director of Clinical Research, Division of Cardiovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ, 08015, USA. Email: [email protected]

Case Files by Dr. George

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Revascularization of Superficial Femoral Artery Chronic Total Occlusion

Friday, 03/30/12 | 7634 reads
Author(s): 

Jon C. George, MD

ABSTRACT: Emerging technologies constantly redefine the clinical landscape in the treatment of peripheral arterial disease. We describe a case utilizing the adjunctive therapy of the Wildcat catheter with the motorized Juicebox console (Avinger, Inc.) in crossing a complex chronic total occlusion lesion in the superficial femoral artery, allowing for wire advancement and therapeutic intervention.

VASCULAR DISEASE MANAGEMENT 2012:9(4):E48-E50

____________________________________________

Case Report

A 69-year old male with history of coronary artery disease presented with lifestyle-limiting claudication of the left lower extremity. Physical examination revealed non-palpable left dorsalis pedis and posterior tibial pulses, which were both present on Doppler. Angiography with runoff of the left lower extremity confirmed a 110 mm chronic total occlusion (CTO) in the proximal superficial femoral artery (Figure 1), with reconstitution of the distal superficial femoral artery via collaterals (Figure 2) and 3-vessel runoff into the left foot.

The proximal cap of the CTO was directly engaged using a Wildcat catheter (Avinger) (Figure 3), but manual rotation of the catheter tip met stiff resistance mid-lesion. The Juicebox motorized console (Avinger) was then attached to the Wildcat catheter, and with a constant tip rotation of 100 rpm, the remainder of the CTO was crossed. A distal popliteal angiogram through the Wildcat catheter central lumen confirmed intraluminal position (Figure 4). A 5 mm x 100 mm Angiosculpt scoring balloon (AngioScore, Inc.) was utilized to predilate the occluded segment and 2 overlapping Supera 5 mm x 120 mm self-expanding stents (IDEV Technologies) were deployed in the left SFA. The final angiogram revealed brisk flow with 3-vessel runoff into the left foot (Figure 5). The patient tolerated the procedure well without complications and was discharged home the following day after observation post-intervention.

Discussion

The portfolio of medical devices available for the successful revascularization of CTOs in the peripheral vasculature is evolving to enable efficient true-lumen crossing. These tools allow physicians to percutaneously revascularize lesions that were once solely stratified to open surgical intervention. Lesion modifiers such as length, degree of calcification, and prior intervention are less absolute contraindications to minimally invasive surgery moving forward. The variability in success for crossing CTOs highlights the need for continued advancements in crossing therapeutics for the most challenging lesions.1,2

The Wildcat CTO catheter (Figure 6) was initially studied in the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial to evaluate the safety and effectiveness of the catheter to cross de novo or restenotic femoropopliteal CTOs.3 A total of 88 patients were enrolled (mean age: 69.5 years; male: 53%; smokers: 80.7%; hypertension: 86.4%) for treatment of variable lesion characteristics (mean length: 174 mm; de novo: 88.6%; moderately calcified: 53.4%). The device met both the primary safety (composite of major adverse events) and primary efficacy endpoints with a 95.2% safety rate and 89.3% success rate for crossing CTOs.

In this case, the Wildcat CTO crossing device was coupled with a snap-on motorized Juicebox accessory (Figure 7) to enable crossing of the 11 cm lesion while avoiding the need for re-entry or subintimal crossing. The use of this device is recommended as the initial effort in crossing a CTO in order to avoid the engagement of subintimal channels created by previous wire attempts. Juicebox equips the Wildcat catheter with a small onboard motor to provide automatic rotation of the crossing blades in the aggressive (clockwise) and non-aggressive (counter-clockwise) rotational directions. This accessory effectively enables hands-free rotation of the Wildcat catheter, thus allowing for enhanced tactile feedback during advancement. While the list price of the Wildcat catheter with Juicebox is $1895, the cost is meager when taking into account the savings from an increased technical success rate, reduced multiple catheter use, and faster crossing times. With patients placing a high value on non-operative approaches to managing PAD,4,5 adaptive technologies like the Wildcat catheter with Juicebox console show promise for maximizing safe and effective options for limb salvage using minimally invasive modalities.

References

  1. Gandini R, Volpi T, Pipitone V, Simonetti G. Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system. J Endovasc Ther. 2009;16(1):23-27.
  2. Joye J. The PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study results. Am J Cardiol. 2007;100(Supp 1):S24.
  3. Pigott JP, Raja ML, Davis T. Connecting the True Lumen: A Multicenter Experience Evaluating Chronic Total Occlusion Crossing with the Wildcat Catheter (CONNECT Study). Midwestern Vascular Surgical Society Annual Meeting. 2011 Sept 17.
  4. 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(4):762-769.
  5. Dippel E, Shammas N, Takes V, Coyne L, Lemke J. Twelve-month results of percutaneous endovascular reconstruction for chronically occluded superficial femoral arteries: a quality-of-life assessment. J Invasive Cardiol. 2006;18(7):316-321.

____________________________________________

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. George reports money earned from Avinger, Inc.
Manuscript submitted February 10, 2012, provisional acceptance given February 27, 2012, final version accepted March 6, 2012.
Address for correspondence: Jon C. George, MD, Director of Clinical Research, Division of Cardiovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ, 08015, USA. Email: [email protected]

Case Files by Dr. George

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