A Primer to Percutaneous Endovascular intervention Re-Entry Devices

A Primer to Percutaneous Endovascular intervention Re-Entry Devices Nelson Lim Bernardo, MD Director, Peripheral Vascular Laboratory Medstar Heart Institute at Washington Hospital Center Washington, D. C.

Nelson L. Bernardo, MD Honoraria: Abbott Vascular Cook Group Incorporated Cordis Corporation Covidien Medtronic, Inc. Terumo Cardiovascular Systems Group

Faculty Disclosure • Abbott Vascular – Training Site • Cook Medical – Training Site • Cordis Endovascular – Training Site • Covidien/e. V 3 – Training Site • Medtronic – Training Site • No conflict of interest related to this presentation

Percutaneous Endovascular Intervention • Percutaneous endovascular intervention (PEI) for treating PAD has greatly evolved in the past two (2) decades. • ‘Growth’ of PEI procedures: Ø Acceptance of this treatment option – efficacy and high success rates Ø Continued development of new devices and better techniques

CTO: Recanalization pitfalls • Unsuccessful procedure ~ 20% Ø Inability to re-enter the ‘true’ lumen distally after going through a subintimal route (of the occluded segment) • Time consuming attempts to re-enter the ‘true’ lumen distally Ø Increased Fluoro Time = Radiation exposure • ‘Burning’ the surgical revascularization option Ø Distal extension of the dissection/subintimal plane

Subintimal course of guidewire • Getting the guidewire back into the lumen: Ø Retrograde approach v Distal SFA ‘stick’ v Popliteal artery v Distal pedal access Ø Re-entry device § allows one to get back Distal R SFA - Subintimal wire into the “true” lumen at the distal end of the totally occluded segment

Re-entry Device • “True-Lumen” re-entry devices Ø Re-direct guidewire from the sub-intimal space back into the ‘true-lumen’ of the vessel Subintimal True Lumen Longitudinal Axis Transverse Axis Subintimal True Lumen

Re-entry Devices • Available “True-Lumen” Re-Entry devices Ø Outback Re-entry - Cordis Ø Pioneer Re-entry - Medtronic Ø Enteer Re-entry - Covidien e. V 3 Boston Scientific (Bridgepoint) Stingray

Re-entry Device • “True-Lumen” re-entry devices Ø Re-direct guidewire from the sub-intimal space back into the ‘true-lumen’ of the vessel Subintimal True Lumen Longitudinal Axis Transverse Axis Subintimal True Lumen • Imaging guidance needed to direct ‘needle’ Ø Ultrasound (IVUS) v Pioneer Ø Angiographic/Fluoro v Outback Re-entry v Enteer Re-entry

Pioneer Re-Entry Catheter • Device Specifications: Ø 6 F sheath compatible Ø 0. 014” guidewire compatible Ø Two Wires Integrated curved needle for delivery of a 2 nd wire Ø Requires IVUS for guidance (Volcano®)

Pioneer Re-Entry Catheter

Re-entry Device: Pioneer catheter Volcano IVUS Guidance Needle/Wire into True Lumen

Tricks & Pitfalls: Pioneer Re-entry IVUS Guidance Subintimal True Lumen • Needle deployment Ø At 12 o’clock position on the IVUS image

Tricks & Pitfalls: Pioneer Re-entry Subintimal True Lumen • IVUS transducer Ø ~7 mm distal to needle Ø Ensure IVUS and needle are on the same plane Scenario #1

Tricks & Pitfalls: Pioneer Re-entry Scenario #1 Branch vessel or Vein Subintimal True Lumen • IVUS transducer Ø ~7 mm distal to needle Ø Ensure IVUS and needle are on the same plane Scenario #2

Outback® LTDTM Re-Entry Catheter • Device Specifications: Ø 5. 9 F profile Ø 6 F sheath compatible Ø 0. 014” guidewire compatible Ø Single Ø 120 Ø 22 Detail A Wire cm length gauge re-entry cannula Catheter shaft Catheter “LT” Directional Marker Band & Nosecone Distal end port Distal Housing & Nosecone Assembly

Outback® Re-Entry Catheter: Positioning

Outback® Re-Entry Catheter: Positioning Subintimal True Lumen

Re-entry Technique: Step-by-step • ‘Confirm’ subintimal location of guidewire Do not advance wire (loop-wire) beyond lumen of ‘true’ reconstitution • Exchange-out “wire” to an 0. 014” coronary guidewire Distal Right SFA - Subintimal

Re-entry Technique: Step-by-step • ‘Confirm’ subintimal location of guidewire • Exchange out “wire” to an 0. 014” coronary guidewire Distal Right SFA - Subintimal • May need to dilate at points of resistance in the subintimal space Calcification (Especially with Pioneer catheter)

Re-entry Technique: Step-by-step • ‘Confirm’ subintimal location of guidewire • Exchange out “wire” to an 0. 014” coronary guidewire • Advance Outback device over 0. 014” wire to the level of true lumen

Re-entry Technique: ‘Positioning’ of Device • Pull guidewire back into the catheter • Inject contrast media • Rotate Image Intensifier to ‘place’ catheter on top of the artery • Torque device to achieve “T” position Outback – “T”

Re-entry Technique: ‘Positioning’ of Device Subintimal True Lumen Image Intensifier AP Im ag e. I nte ns ifie 45 r d deg RA O

Re-entry Technique: ‘Positioning’ of Device Subintimal True Lumen Im ag e. I nte ns ifie 45 r d deg RA O

Re-entry Technique: ‘Positioning’ of Device b- all b Su ttiim Su m iin e ue n n Tr me Tr m Lu Lu e ag Im r ie f si n te In 45 eg d AO L

Re-entry Technique: ‘Positioning’ of Device • Rotate Image Intensifier 90 O orthogonally • If device “L” not pointing towards artery, rotate 180 O • Deploy needle Looking for Outback – “L”

Re-entry Technique: Step-by-step • With the “L” pointing towards the artery • Deploy needle “fully” • Advance wire • Retract Needle before removing the device • Remove device and leave wire in true lumen Outback – “L” – Re-entry

Re-entry Technique: Step-by-step • Advance support catheter or balloon catheter over 0. 014” wire • Remove wire and inject to confirm intraluminal location • Insert workhorse wire and proceed with intervention Successful Crossing

RG: Successful intervention Baseline

Tricks & Pitfalls: Device advancement • Problems: Ø “Acuteness” of Iliac bifurcation Ø Non-compliance of iliacs • Solutions: Ø “Bigger” sheath size Ø Re-direct catheter tip Ø Advance device with the sheath as a unit Ø Pioneer > Outback Ø Outback: 0. 018” wire

Pitfalls and Tricks in the use of Re-entry • “Large” subintimal space Ø If using the subintimal technique, make the ‘wire loop’ as small as possible Distal Left SFA - Outback

Pitfalls and Tricks in the use of Re-entry • “Large” subintimal space Ø If using the subintimal technique, make the ‘wire loop’ as small as possible • Calcified/fibrotic vessel wall Ø Avoid calcified area Ø ‘One’ single push, avoid ‘jabbing’ Distal Left SFA - Outback

Pitfalls and Tricks in the use of Re-entry • “Large” subintimal space Ø If using the subintimal technique, make the ‘wire loop’ as small as possible • Calcified/fibrotic vessel wall Ø Avoid calcified area Ø ‘One’ single push, avoid ‘jabbing’ Ø If through-and-through, retract needle slowly and advance guidewire Outback Needle

Pitfalls and Tricks in the use of Re-entry • “Large” subintimal space Ø If using the subintimal technique, make the ‘wire loop’ as small as possible • Calcified/fibrotic vessel wall Ø Avoid calcified area Ø ‘One’ single push, avoid ‘jabbing’ Ø If through-and-through, retract needle slowly and advance guidewire • Visualization of vessel with contrast prior to deployment Distal Left SFA - Outback

Enteer® Re-Entry System • Catheter - flat shape on balloon inflation: • Two balloon sizes: Ø ATK = 3. 75 mm - 135 cm Ø BTK = 2. 75 mm - 150 cm • Wire (0. 014”): Ø Standard stiff Ø Flexible

Enteer® Re-Entry System • Catheter’s flat shape on balloon inflation: Ø self-orients in the subintimal space for true lumen targeting Transverse Axis Subintimal True Lumen

Enteer® Re-Entry System • Catheter’s flat shape on balloon inflation: Ø self-orients in the subintimal space for true lumen targeting Transverse Axis Subintimal Ø 180 O opposed and offset exit ports enable selective guidewire re-entry probe at the guidewire tip engages intima to enter true lumen True Lumen Ø Angled Subintimal True Lumen Longitudinal Axis

60 y. o. AAM with CLI/Rutherford 5 Left SFA Left Popliteal artery

60 y. o. AAM with CLI/Rutherford 5 • Proceeded with PEI of iliac stenoses and recanalization of the totally occluded left SFA • Subintimal course of the guidewire at the distal SFA segment Left SFA – distal subintimal Ø Need for re-entry

Enteer Re-entry: Step-by-step Inflate Balloon Advance ‘Re-entry Wire ‘Wide’ Enteer device Orthogonal view Balloon inflated ‘Narrow’

Enteer Re-entry: Step-by-step Re-entry Wire Proximal Hole Enteer device Re-entry Wire Angiographic Distal Hole confirmation

WB: PEI for CLI Left SFA – distal subintimal Successful Enteer Re-entry

WB: Successful PEI for CLI Left SFA – Pre-treatment Left SFA - Post

Summary: Use of Re-Entry Devices • Use of Re-entry device to access the “true” lumen of a vessel is safe and effective. • Re-entry devices have significantly improved the success rates of treating chronic total occlusions. • Proper training and appropriate case selection are critical to optimize outcomes and minimize complications.

A Primer to Percutaneous Endovascular intervention Thank You