26 CASE REPORT MAY 2016

Critical Limb Ischemia: Revascularization Techniques to Optimize Endovascular Therapy in Complex Cases Using the JETSTREAM Atherectomy System

Figure 1. Diagnostic angiogram showing flow in the superficial femoral artery (A), popliteal (B), and tibial circulation (C), and revealing a chronic total occlusion (CTO) of the popliteal, along with occlusive tibial disease.

Pictured above is the latest-generation JETSTREAM atherectomy system. The device has been successfully iterated seven times since its launch in 2008.

Fadi Saab, MD, FACC, FASE, FSCAI, Cardiovascular Medicine-Interventional Cardiology, Associate Director of Cardiovascular & Endovascular Laboratories, Associate Director of Pulmonary Embolism andVenousThrombosis Services, Clinical Assistant Professor-Michigan State University, School of Medicine, Figure 2. Extravascular ultrasound (EVUS) showing the .035-inch support catheter Metro Health Hospital,Wyoming, Michigan traveling through the chronic total occlusion (CTO) in the popliteal artery.

may not be adequate candidates for surgi- valve replacement five years prior.There cal bypass. Endovascular therapy has been were no other significant co-morbidities. fueled by continuous innovation in tech- His clinical exam revealed a cold right Introduction niques and devices.6 The JETSTREAM™ lower extremity with no palpable pulses. The prevalence of peripheral vascu- Atherectomy System (Boston Scientific) The clinical workup included a 2-dimen- lar disease (PVD) has been increasing is a rotational device, featuring front-cut- sional echo with an ankle-brachial index worldwide.The number of patients suf- ting, expandable blades. JETSTREAM (ABI). Echo revealed his left ventricular fering from PVD is expected to increase is also the only atherectomy system with function to be preserved, with no val- by 15% in western countries and 30% in active aspiration.The rotational aspect of vular or wall motion abnormalities. The developing countries.1 This increase is a the device allows for plaque modification right-side ABI was significantly abnormal reflection of other co-morbidities driv- and debulking.The device is engineered at 0.4.The patient did not have any his- ing the rise in numbers. Patients with to predictably treat multiple morpholo- tory of deep venous thrombosis or pul- PVD suffer from higher morbidity and gies, such as calcium, plaque or thrombus, monary embolism, nor was there any his- mortality.2,3 Multiple modalities exist to commonly found in total occlusions.We tory of arterial thrombosis. A diagnostic evaluate and treat patients with PVD. will present a case that demonstrates the angiogram revealed evidence of multi- Endovascular revascularization of pa- versatility of the device in treating a com- level disease involving the right lower tients with PVD is becoming a front-line plex clinical and anatomical situation in a extremity.The lesion appeared to extend strategy adopted by several disciplines, patient with critical limb ischemia (CLI). from the distal popliteal artery into the including vascular surgery, radiology, and posterior tibial and tibio-peroneal trunks. cardiology. Bypass surgery is an excel- Case presentation The patient had an anomalous high take- Fadi Saab, MD, FACC, FASE, FSCAI lent procedure in appropriately selected A 54-year-old male originally present- off of the right posterior tibial (Figure 1). patients.4,5 However, many PVD patients ed with complaints of life-limiting clau- dication, placing him at Rutherford class Clinical course The physician was compensated by Boston Scientific for his time associated with III.The patient’s past medical history was Due to the complex nature of this oc- this article. significant for hypertension and diabetes. clusion, therapy options included medi- He underwent a bio-prosthetic aortic cal therapy, single-vessel tibial bypass, MAY 2016 CASE REPORT 27

or endovascular therapy. The lesion case required multi-vessel, multi-level burden extending from the peroneal to involved the trifurcation of all tibial intervention, and antegrade access af- the popliteal artery (Figure 4). EVUS im- vessels where the distal posterior tibial forded the operator superior pushability, ages provided similar information. The artery was the only runoff to the foot. trackability,and torquability.We use ul- hypo-echogenic appearance suggested After discussing the options with our trasound (US) guidance in gaining access soft plaque.The JETSTREAM System patient, the decision was made to at- to any vascular conduit. We started with features active aspiration, making it well- tempt medical therapy. The patient was a 5 French Pinnacle Precision sheath suited for the thrombotic-component of placed on antiplatelet therapy with as- (Terumo) and after crossing, upsized to a this lesion. Its rotational blades also pro- pirin. Aggressive lipid-lowering therapy 7 French Destination Pinnacle 45-centi- vide plaque modification and debulking, was also initiated. The patient was not meter sheath (Terumo). making JETSTREAM an ideal solution able to tolerate cilostazol. He contin- for this type of lesion morphology. ued with a self-administered walking CTO crossing. The use of ultrasound program. In addition, we placed the pa- (US) in gaining access to any vascular bed Alternative access. The nature of tient on anticoagulation with warfarin has been shown to be safe and effective. the occlusion in this case highlights the in an attempt to treat what we felt was In addition, it is our experience that extra necessity of alternative access. The le- a thrombotic component on top of the vascular US (EVUS) can also guide CTO sion extended from the popliteal into atherosclerotic disease. Despite treating crossing and therapy delivery. In this case, the posterior tibial/tibio-peroneal trunk/ the patient for 3 months with the above- a .035-inch Navicross catheter (Terumo) peroneal arteries.The angiogram showed mentioned regimen, the patient’s symp- was used to advance through the CTO in a flush occlusion of the posterior tibial toms continued to worsen. The patient a rotational fashion. EVUS allowed us to with reconstitution. Retrograde posterior started complaining of intermittent rest guide the catheter and navigate the CTO tibial US-guided access was the only op- pain, placing him at Rutherford class IV. (Figure 2).We were successful in crossing tion to gain access into the distal patent At this point, we decided to proceed the CTO in the popliteal and peroneal portion (Figure 5).We placed a low-pro- with endovascular therapy in an effort arteries. Once crossing to the distal pero- file Cook tibiopedal sheath (2.9 French) to preserve tibial vessels. neal was confirmed (Figure 3), we started (Cook Medical). Using an .018-inch preparing for therapy. CXI support catheter (Cook Medical), Revascularization steps we advanced an .014-inch Glidewire Access. For any intervention requir- Lesion assessment. There are mul- Advantage wire (Terumo). Crossing into ing the crossing of a chronic total occlu- tiple modalities beyond angiography the true lumen of the popliteal artery in Figure 3. Selective angiography sion (CTO) or treatment of tibial vessels, that permit the operator to evaluate the a retrograde fashion was relatively simple. of the distal peroneal artery after it is our opinion that operators should nature of the atherosclerotic disease. In Using a 7 mm snare, we were able to crossing the occlusion. strongly consider antegrade access. This this case, we utilized EVUS and intra- trap the Glidewire Advantage wire and vascular US (IVUS). The IVUS catheter reverse access (Figure 6). After reversing (Volcano Corporation) was advanced to access, the wire in the posterior tibial ar- the distal peroneal artery. An automated tery was now flossed through the sheath. pullback is preferred to ensure that no The posterior tibial sheath acted as an segments within the vessel are missed. embolic protection system.The peroneal The IVUS image revealed evidence artery CTO was crossed in an antegrade of significant hypo-echogenic plaque fashion and the wire was placed in the

Figure 4. IVUS assessment of the popliteal artery, showing significant hypo- echogenic plaque burden.

Figure 5. Ultrasound-guided access of the right posterior tibial artery. Note the wire inside the posterior tibial (arrow). Figure 6. Snare system used to capture the retrograde posterior tibial wire (arrow). 28 CASE REPORT MAY 2016

Figure 7. JETSTREAM activation in the popliteal artery under ultrasound and fluoroscopy.

Figure 8. JETSTREAM 1.85 mm tibial device activated in the peroneal (Panel A) and posterior tibial arteries (Panel B).

distal peroneal artery. An embolic pro- to listen to the pitch of the device.A tection device was deployed in the dis- depressed pitch suggests that the device tal peroneal artery. In an effort to protect rotation has slowed down, and the opera- the distal posterior tibial, we accessed the tor should then carefully pull the device posterior tibial and crossed the occlusion back and re-advance.The operator must after performing atherectomy of the pop- not allow the aspirational capabilities liteal artery. In addition, we did not want of the device to be overwhelmed. After to use the larger JETSTREAM device successful atherectomy “blades-down,” in the popliteal while there was another a “blades-up” run was then performed wire present. with the JETSTREAM device (Figure 7). During the second stage of atherectomy, Atherectomy with JETSTREAM. the peroneal and posterior tibial arteries Atherectomy was performed in two stag- required further therapy. For this stage, we es. During the first stage,we had wire obtained posterior tibial access, crossed access from the popliteal to the peroneal the posterior tibial CTO, and snared the artery. Before crossing from the posterior posterior tibial wire. We proceeded with tibial, we wanted to treat the popliteal/ the use of a 1.85 mm JETSTREAM de- peroneal segment. A 2.4 mm/3.4 mm vice.The tibial device has the rotational JETSTREAM atherectomy device was capabilities without the “blades-up” fea- advanced into the popliteal and acti- ture, and also features active aspiration, vated.The device must be activated with like the larger JETSTREAM devices. the blades down. A pilot channel will We were able to atherectomize the pos- remove some of the plaque.The device terior tibial and peroneal arteries (Figure Figure 9. Kissing balloon angioplasty of the popliteal/peroneal and posterior is advanced at a rate of no more than 1 8).Angiographic images post atherectomy tibial vessels. mm per second. The operator will need demonstrate significant plaque reduction. MAY 2016 CASE REPORT 29

Atherectomy featuring active aspira- tion offers multiple advantages in treat- ing atherosclerotic disease.JETSTREAM is the only atherectomy system offering active aspiration combined with plaque modification and debulking. The device can treat multiple morphologies such as calcium, plaque, or thrombus.The front- cutting expandable blades are designed to deliver concentric lumens. In addition, active aspiration is occurring at the same time as use, helping minimize the risk of distal embolization.Zeller et al showed its safety and efficacy in treating PVD in dif- ferent vascular beds. The JETSTREAM device was successful in treating 99% of lesions.The rate of target vessel revascu- larization was 26% in lesions as long as 10 cm.13 The device was recently evalu- Figure 11. Brisk bleeding at pedal access site (arrow) post sheath removal ated in calcified vessels. IVUS assessment from the posterior tibial artery. showed the JETSTREAM atherectomy Figure 10. Angiogram post system removed and modified severe to JETSTREAM atherectomy in the Clinical follow-up. The patient was arterial disease.The diagnosis is clinical moderate superficial calcium to achieve popliteal prior to balloon angioplasty, discharged home the next day. On 30-day in nature and is classified as Fontaine significant lumen gain. Adjunctive bal- demonstrating impressive reduction follow-up, the patient reported complete stages III or IV,or Rutherford classifi- loon angioplasty showed further lumen of plaque burden within the vessel. resolution of his symptoms.ABI was nor- cation 4, 5, or 6. increase without major complications.14 malized at 1.The patient was maintained Anatomically, CLI is characterized by After atherectomy, we proceeded with on dual antiplatelet therapy with aspirin multi-level and multi-vessel, infraingui- Conclusion kissing balloon angioplasty of the popli- and clopidogrel. nal and tibial-pedal arterial stenosis and PVD is an epidemic that impacts a teal/peroneal and posterior tibial arteries occlusions, compromising viability and large number of patients worldwide. (Figure 9). Angiography of the popliteal Discussion threatening limb loss. It is estimated The disease is complex in nature, with artery post atherectomy showed significant CLI represents the terminal stage of that 1.5 million people in Europe and multi-vessel and multi-level disease.The improvement (Figure 10). After removal PVD and occurs when the capillary 2 million people in the United States JETSTREAM atherectomy system is de- of the pedal sheath, brisk flow was noted beds are inadequately perfused and un- over age 50 manifest symptoms of CLI. signed to allow clinicians to treat a vari- (Figure 11).The procedure was concluded able to sustain tissue viability. CLI is de- One-year mortality and major ampu- ety of morphologies, including calcium, with the resolution of the stenosis from fined by the presence of rest pain and/ tation rates range from 20% to 50%.7-9 plaque or thrombus.The current body the popliteal artery and restoration of flow or tissue loss for at least 2 to 4 weeks CLI occurs in approximately 1-3% of of evidence shows a high rate of success in two tibial vessels (Figure 12). that can be attributed to occlusive all PVD cases.10-12 with a low rate of complications. n

Figure 12. Angiography of the popliteal (A), tibial (B), and plantar circulation (C), showing restoration of blood flow.

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. 30 CASE REPORT MAY 2016

References the knee in patients with critical JETSTREAM CATHETERS COMBINED WITH CONSOLE limb ischemia using drug eluting 1. Fowkes FG, Rudan D, Rudan CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx stents. J Cardiovasc Surg (Torino). I, Aboyans V, Denenberg only. Prior to use, please see the complete “Instructions for Use” for more information on Indica- 2010; 51(2):183-191. JO,McDermott MM, et al. tions, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 9. Siablis D, Karnabatidis D, Katsanos Comparison of global estimates Catheter INDICATIONS K, Diamantopoulos A, Christeas of prevalence and risk factors for The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to N, Kagadis GC. Infrapopliteal peripheral artery disease in 2000 break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not application of paclitaxel-eluting and 2010: a systematic review and intended for use in coronary, carotid, iliac or renal vasculature. stents for critical limb ischemia: analysis. Lancet. 2013; 382(9901): Console INDICATIONS midterm angiographic and clini- 1329-1340. The PV Console is designed for use only with the Jetstream Catheter and Control Pod. See the cur- cal results. J Vasc Interv Radiol. 2. Patel MR, Conte MS, Cutlip rent revision of the applicable Catheter and Control Pod Instructions for Use for further information. 2007; 18(11): 1351-1361. DE, Dib N, Geraghty P, Gray W, CONTRAINDICATIONS 10. Lambert MA, Belch JJ. Medical et al. Evaluation and treatment No known contraindications. management of critical limb isch- of patients with lower extremity Catheter WARNINGS/PRECAUTIONS aemia: where do we stand today? J peripheral artery disease: consen- •The Jetstream Catheter and Control Pod may only be used with the PV Console. Intern Med. 2013; 274(4): 295-307. sus definitions from Peripheral •Take care to avoid being pinched when closing the aspiration and infusion pump doors. 11. HirschAT, Haskal ZJ, Hertzer NR, Academic Research Consortium •Use room temperature infusate only. Use of heated infusate may lead to wrinkling, ballooning Bakal CW, Creager MA, Halperin (PARC). J Am Coll Cardiol. 2015; and/or bursting of the outer catheter sheath. JL, et al. ACC/AHA 2005 guide- 65(9): 931-941. •Do not bend or kink the Catheter during setup or during the procedure. This may damage the lines for the management of pa- 3. Rooke TW,Hirsch AT,Misra device and lead to device failure. tients with peripheral arterial S, Sidawy AN, Beckman JA, •Operating the Catheter over a kinked guidewire may cause vessel damage or guidewire fracture. disease (lower extremity, renal, Findeiss L, et al. Management •During treatment, do not allow the Catheter tip within 10.0 cm of spring tip portion of the guide- mesenteric,and abdominal aor- of patients with peripheral ar- wire. Interaction between the Catheter Tip and this portion of the guidewire may cause damage tic): executive summary a collab- tery disease (compilation of to or detachment of the guidewire tip or complicate guidewire management. orative report from the American 2005 and 2011 ACCF/AHA •The guidewire must be in place prior to operating the Catheter in the patient. Absence of the Association for Vascular Surgery/ Guideline Recommendations): a guidewire may lead to inability to steer the Catheter and cause potential vessel damage. Society for Vascular Surgery, report of the American College •Do not inject contrast while the device is activated. Society for Cardiovascular of Cardiology Foundation/ •If the guidewire is accidentally retracted into the device during placement or treatment, stop use, Angiography and Interventions, American Heart Association Task and remove the Catheter and the guidewire from the patient. Verify that the guidewire is not Society forVascular Medicine and Force on Practice Guidelines. J damaged before re-inserting the guidewire. If damage is noticed, replace the guidewire. Biology, Society of Interventional Am Coll Cardiol. 2013; 61(14): •Check the infusate bag frequently and replace when needed. Do not run the JETSTREAM Radiology, and the ACC/AHA 1555-1570. System without infusate as this may cause device failure. Task Force on Practice Guidelines 4. Leather RP, Shah DM, Chang • Hold theguidewire firmlyduringCatheterretractionprocess. Failuretodosomay result in guide- (Writing Committee to Develop BB, Kaufman JL. Resurrection of wire rotation within the vessel. Guidelines for the Management the in situ saphenous vein bypass. •Do not manipulate the Catheter against resistance unless the cause for that resistance has of Patients With Peripheral 1000 cases later. Ann Surg. 1988; been determined. Arterial Disease) endorsed by 208(4): 435-442. •Use only listed compatible guidewires and introducers with the Jetstream System. The use of any the American Association of 5. Taylor LM,Jr.,Edwards JM,Porter supplies not listed as compatible may damage or compromise the performance of the Jetstream Cardiovascular and Pulmonary JM. Present status of reversed vein System. Rehabilitation; National Heart, bypass grafting: five-year results Priortouse of theJetstreamSystem,confirmthe minimum vessel diameter proximal to thelesion Lung, and Blood Institute; of a modern series. J Vasc Surg. per the following: Society for Vascular Nursing; 1990; 11(2): 193-205; discussion Jetstream SC Atherectomy Catheter 1.6 Minimum Vessel Diameter Proximal to Lesion 2.5 mm TransAtlantic Inter-Society 205-206. Jetstream SC Atherectomy Catheter 1.85 Minimum Vessel Diameter Proximal to Lesion 2.75 mm Consensus; and Vascular Disease 6. Jaff MR, White CJ, Hiatt WR, Jetstream XC Atherectomy Catheter2.1-3.0 Minimum Vessel Diameter, Blades Down 3.0 mm; Foundation. J Am Coll Cardiol. Fowkes GR, Dormandy J, Razavi Minimum Vessel Diameter, Blades Up 4.0 mm 2006; 47(6): 1239-1312. M, et al. An update on methods Jetstream XC Atherectomy Catheter2.4-3.4 Minimum Vessel Diameter, Blades Down 3.5 mm; 12. Gottsater A. Managing risk factors for revascularization and expan- Minimum Vessel Diameter, Blades Up 4.5 mm for atherosclerosis in critical limb sion of the TASC lesion classi- Console WARNINGS/PRECAUTIONS ischaemia. Eur J Vasc Endovasc fication to include below-the- • WARNING: To avoid the risk of electric shock, this equipment must only be connected to a sup- Surg. 2006; 32(5): 478-483. knee arteries: a supplement to ply mains with protective earth. 13. Zeller T, Krankenberg H, the Inter-Society Consensus for • Do not open either pump door during operation of the System. Doing so could result in loss of Steinkamp H, Rastan A, Sixt S, the Management of Peripheral aspiration and/or infusion and will halt device activation. Schmidt A, et al. One-year out- Arterial Disease (TASC II): The • Ensure the PV Console display is visible during the entire procedure. come of percutaneous rotational TASC Steering Comittee. Ann • Observe normal safety practices associated with electrical/electronic medical equipment. atherectomy with aspiration in Vasc Dis. 2015; 8(4): 343-357. • Avoid excessive coiling or bending of the power cables during storage. infrainguinal peripheral arterial 7. Bosiers M, Scheinert D, Peeters • Store the PV Console using appropriate care to prevent accidental damage. occlusive disease: the multicenter P, To rsello G, Zeller T, Deloose • Do not place objects on the PV Console. pathway PVD trial. JEndovasc K, et al. Randomized compari- • Do not immerse the PV Console in liquids. Ther. 2009; 16(6): 653-662. son of everolimus-eluting versus ADVERSE EVENTS 14. Maehara A, Mintz GS, Shimshak bare-metal stents in patients with Potential adverse events associated with use of this device and other interventional catheters TM, Ricotta JJ, 2nd, Ramaiah V, critical limb ischemia and infrap- include, but are not limited to the following (alphabetical order): Foster MT, 3rd, et al. Intravascular opliteal arterial occlusive disease. Abrupt or sub-acute closure ultrasound evaluation of J Vasc Surg. 2012; 55(2): 390-398. Amputation JETSTREAM atherectomy re- 8. Balzer JO, Zeller T, Rastan A, Bleeding complications, access site moval of superficial calcium in pe- Sixt S, Vogl TJ,Lehnert T, et al. Bleeding complications, non-access site ripheral arteries. EuroIntervention. Percutaneous interventions below Death 2015; 11(1): 96-103. Dissection Distal emboli Hypotension Infection or fever Perforation Restenosis of the treated segment Vascular complications which may require surgical repair Thrombus Vasospasm

Results from case studies are not necessarily predictive of results in other All Trademarks are the property of their respective owners. © 2016 Boston Scientific Corpora- cases. Results in other cases may vary. tion or its affiliates. All rights reserved. PI-389932-AA APR2015