Peripheral Artery Advanced SFA-CTO Techniques in the CTO Forum February 21, 2010 Nelson Lim Bernardo, MD Washington Hospital Center

Nelson L. Bernardo, MD DISCLOSURES Honoraria The Medicines Company, Cordis, a Johnson & Johnson company, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership

50% in patients with intermittent claudication Nadal et al. Techniques in Vascular and Interventional Radiology. 2004;7:16-22. Chronic Total Occlusions (CTOs) CTOs of the superficial femoral artery (SFA) occur in up to 50% of patients presenting with symptoms of peripheral arterial disease (PAD). These patients often have coexistent cardiovascular and cerebrovascular disease which increases the 5-year mortality rate by: 50% in patients with intermittent claudication 60%-70% in patients with CLI (critical limb ischemia)

CTO: Treatment options Surgical revascularization Percutaneous endovascular intervention (PEI)

CTO: Treatment options Surgical revascularization Femoro-Popliteal artery bypass Long/Total occlusions Unfavorable anatomy Patient’s preference Percutaneous endovascular intervention (PEI)

CTO: Treatment options Surgical revascularization Femoro-Popliteal artery bypass Long/Total occlusions Unfavorable anatomy Patient’s preference Percutaneous endovascular intervention (PEI) Initial approach to the treatment of PAD and CTO Cognizant of the “pitfalls” Challenge: Cross the CTO safely and efficiently

Opening CTO: Percutaneous Approach Percutaneous Endovascular Intervention (PEI) as the initial approach to the treatment of PAD and CTO - “Nothing to lose” Challenge: Cross the CTO safely and efficiently Both for the patient and operator Appropriate use of devices & drugs Do not ‘burn’ the surgical option

Tackling CTO: Percutaneous Endovascular Intervention Cross or ‘break’ the proximal and distal caps of the totally occluded segment Cross with the guidewire - ‘loop-wire’ technique Subintimal angioplasty - percutaneous intentional extra- luminal recanalization (PIER) Excimer laser - ‘step-by-step’ technique Frontrunner XP CTO catheter - ‘blunt’ dissection Crosser High-frequency ultrasound - ‘hammer-through’ Safe-cross (with OCR) - ‘guide-through’ Tornus catheter - ‘screw-through’ CiTop guidewire system - ‘inch-through’

Tackling CTO: PEI Options CTO devices - ‘niche’ role; improves acute success. There is ‘paucity’ of good data to favor any particular treatment modality. We have more “toys” in the Peripheral lab vs. Coronary lab. Improved ‘acute’ outcome ≠ ‘chronic’ long term patency.

CTO: Recanalization pitfalls Unsuccessful procedure ~ 20% Inability to re-enter the ‘true’ lumen distally after going through a subintimal route (of the occluded segment)

CTO: Recanalization pitfalls Unsuccessful procedure ~ 20% Inability to re-enter the ‘true’ lumen distally after going through a subintimal route (of the occluded segment) Inability to identify and cannulate the “flush” occluded superficial femoral arteries that show no residual “ostial stumps” angiographically

CTO: Recanalization pitfalls Unsuccessful procedure ~ 20% Inability to re-enter the ‘true’ lumen distally after going through a subintimal route (of the occluded segment) Inability to identify and cannulate the “flush” occluded superficial femoral arteries that show no residual “ostial stumps” angiographically ‘Burning’ the surgical revascularization option Distal extension of the dissection/subintimal plane

Duplex Ultrasound Duplex ultrasound has long proven to be a valuable tool for guidance in a variety of medical interventions. As of late, duplex ultrasound has shown its utility in providing imaging assistance during balloon angioplasty and stent implantation in the peripheral artery. Valuable in patients with impaired renal function.

Angiogram vs. Duplex Ultrasound Visualization of any structure on angiography is totally dependent on blood flow. Total occlusion = NO flow = NO images Duplex Ultrasound: Ultrasound - shows the structure of the vessel Doppler - shows the movement of red blood cells Even in the absence of blood flow, i.e. totally occluded vessel which can not be visualized on angiography, ultrasound scanning can still provide images of the vessel (structure of the vessel wall).

Right SFA “flush” occluded AH: Lifestyle limiting claudication 66 y.o. WM with PAD and recent worsening of symptoms. “Failed” Cilostazol. (+) CAD. (+) HTN. (+) DM. (+) lipids. (+) unilateral RAS – Med Tx. Asymptomatic right CAS. (+) smoker. ABI: Right = 0.56 Left = 0.75 Right SFA “flush” occluded

AH: Right SFA – Ostial “flush” total occlusion Right SFA - distal segment Right SFA - proximal segment

Right SFA - flush occlusion CTO: Ostial “flush” occlusion Right SFA - flush occlusion

Right SFA - flush occlusion CTO: Ostial “flush” occlusion Dilemma: Where is the ostium of the occluded SFA? PEI Approaches: “Mirror image” - Look at the location of the ostium of the contralateral SFA Retrograde approach - access via popliteal artery Right SFA - flush occlusion

CTO: Ostial “flush” occlusion Right SFA - ostium

CTO: Ostial “flush” occlusion Ultrasound - Right CFA Right SFA - ostium

CTO: Recanalization under US guidance “Breaking” of proximal ‘CTO cap’ using the Frontrunner CTO catheter under ultrasound guidancs Ultrasound - Right CFA

CTO: Recanalization under US guidance Frontrunner CTO catheter “Breaking” of proximal ‘CTO cap’ using the Frontrunner CTO catheter under ultrasound guidancs

CTO: Recanalization under US guidance “Breaking” of proximal ‘CTO cap’ using the Frontrunner CTO catheter under ultrasound guidancs

Right SFA - successful crossing CTO: Crossing of ostial “flush” occlusion Right SFA - successful crossing

Right SFA - flush occlusion CTO: Balloon angioplasty Right SFA - flush occlusion

Right SFA - Pre-treatment CTO: Successful intervention Right SFA - Pre-treatment

CTO: Successful intervention Right BTK Right SFA - Post-PEI Right Foot

Duplex Ultrasound Guidance in CTO Allows direct visualization of ‘occluded’ vessel Guide catheter placement and wire/device access into “flush” occluded artery Real time anatomical information while cannulating the occluded vessel Verify that the wire/device is tracking intraluminally Avoids potential catastrophic complications Perforation - vs ‘blindly’ advancing guidewire/device Subintimal plane/Spiral dissection

Duplex Ultrasound Guidance: Tools Ultrasound imaging Expanded and important role of the RVT “Blind spot” at the Hunter’s adductor canal Frontrunner CTO device Sonographically “brighter” - vs guidewire Shapeable tip allows directionality “Breaks” the proximal ‘cap’ of the CTO

RP: Recurrent resting pain 59 y.o. WM s/p multiple right L.E. revascularization procedures, with recurrent resting claudication. s/p 3 arterial bypass of the right lower extremity; the last one in 2002 using a venous conduit. Duplex: Occluded SFA + grafts, reconstitute BTK. (+) HTN. (+) DM. (+) lipids. AB: Right = 0.35 Left = 0.56 Right SFA - Proximal

RP: Recurrent resting pain Which “knob” Is this ?? Right SFA - Ostium

RP: Recurrent resting pain Which “knob” Is this ?? AP View LAO View Right SFA - Ostium

RP: Right SFA Right SFA - Ostium Right SFA - Distal

RP: Critical limb ischemia Right BTK arteries Right SFA - Distal

RP: Critical limb ischemia BTK T-P Considerations: Which one to recanalize – SFA vs graft Where is the knob of the “native” SFA or grafts ? Where is the distal anastomosis of each bypass graft? SFA Popliteal Foot

RP: PEI of right L.E. CLI Right SFA - Ostium

RP: Duplex scan to access “knob” Right SFA - Ostium

CTO device “crossing” SFA stump RP: Duplex scan to access SFA “knob” CTO device “crossing” SFA stump

CTO device crossing “stump” RP: PEI using duplex guidance CTO device crossing “stump”

RP: Successful recanalization to BTK Right peroneal artery

RP: Successful PEI of CLI Right SFA – Post Right BTK – Post

RP: Successful PEI of CLI Right Plantar – Post Right BTK – Post

Duplex Ultrasound Guidance in CTO Allows direct visualization of ‘occluded’ vessel Guide catheter placement and wire/device access into “flush” occluded artery Real time anatomical information while cannulating the occluded vessel Verify that the wire/device is tracking intraluminally In-situ saphenous graft – ensure that the guidewire has not ‘tracked-off’ into side branches Avoids potential catastrophic complications Perforation - vs ‘blindly’ advancing guidewire/device Subintimal plane/Spiral dissection

WHC Experience: SFA CTO and US Guidance Single center experience, consecutive patients with CTO 2007 2008 2009 No. of CTO 158 130 159 “Flush” Occlusion 4 (2.5%) 7 (5.4%) 6 (3.8%) Re-entry Device 31 (19.6%) 30 (23.1%) 27 (16.9%) Procedural Success 98.7% 98.4% 100% 2o Success 99.2% 3o Success Complications: Perforations, etc. = 0

Conclusions: This adjunctive imaging modality further improves our success in the ‘recanalization’ of chronic total occlusions involving the femoro-popliteal artery. Duplex ultrasound still cannot replace contrast angiography but used in conjunction provides an additional tool to ensure the best outcome in patients undergoing percutaneous endovascular intervention. Proper training and appropriate case selection are critical to optimize outcomes & minimize complications.

Thank you. Have a Good Day! On the road to Mount Everest ‘Touching the Bells’