The Dissection Reentry Concept Technique Results and Practical

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The Dissection Reentry Concept: Technique, Results and Practical Recommendations CTO Forum February 21, 2010

The Dissection Reentry Concept: Technique, Results and Practical Recommendations CTO Forum February 21, 2010 Nelson Lim Bernardo, MD Washington Hospital Center

DISCLOSURES Nelson L. Bernardo, MD Honoraria – The Medicines Company, Cordis, a Johnson &

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

PAD & Chronic Total Occlusions (CTOs) • CTOs of the superficial femoral artery (SFA)

PAD & 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). • Treatment of CTO in peripheral arterial disease (PAD): Ø Medical therapy to relieve symptoms Ø Percutaneous endovascular intervention Ø Bypass surgery

PAD & CTO: Percutaneous Approach • Percutaneous Endovascular Intervention (PEI) as the initial approach

PAD & CTO: Percutaneous Approach • Percutaneous Endovascular Intervention (PEI) as the initial approach to treatment of PAD and CTO; vs surgical revascularization • Challenge: Cross the CTO safely and efficiently Ø Both for the patient and operator Ø Appropriate Ø Do use of devices & drugs not ‘burn’ the surgical option

RG: Worsening claudication • 80 y. o. WM with PAD; angio in 2000 showed

RG: Worsening claudication • 80 y. o. WM with PAD; angio in 2000 showed bilateral SFA CTO. Refused surgery. • Recent lifestylelimiting claudication (~100 feet); Right > Left. • ABI: Right = 0. 5 Left = 0. 6 Right SFA

DFA RG: Worsening claudication SFA Popliteal A. Right SFA

DFA RG: Worsening claudication SFA Popliteal A. Right SFA

DFA RG: PEI SFA Popliteal A. Right L. E. run-off Guidewire - Subintimal

DFA RG: PEI SFA Popliteal A. Right L. E. run-off Guidewire - Subintimal

CTO: Recanalization pitfalls • Unsuccessful procedure ~ 20% Ø Inability to re-enter the ‘true’

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 Fluoroscopy time • ‘Burning’ the surgical revascularization option Ø Distal extension of the dissection/subintimal plane

Subintimal course of guidewire • Subintimal course of guidewire or device will happen. •

Subintimal course of guidewire • Subintimal course of guidewire or device will happen. • Use of CTO device does not assure one of staying inside the lumen and not taking a subintimal route. Distal Right SFA - Subintimal

Subintimal course of guidewire • Subintimal course of guidewire or device will happen. •

Subintimal course of guidewire • Subintimal course of guidewire or device will happen. • Use of CTO device does not assure one of staying inside the lumen and not taking a subintimal route. • ‘Accidental’ lost of wire access during procedure – subintimal course on rewiring. Distal Right SFA - Subintimal

Subintimal course of guidewire What are the options? 1. Wire, wire …. . 2.

Subintimal course of guidewire What are the options? 1. Wire, wire …. . 2. Retrograde approach from the popliteal artery Distal Right SFA - Subintimal

Subintimal course of guidewire What are the options? 1. Wire, wire …. . 2.

Subintimal course of guidewire What are the options? 1. Wire, wire …. . 2. Retrograde approach from the popliteal artery 3. Re-entry device allows one to get back into the “true” lumen at the distal end of the totally occluded segment. Distal Right SFA - Subintimal

Tackling CTO: Re-entry Devices • “True Lumen” Re-entry devices Ø Outback Ø Pioneer device

Tackling CTO: Re-entry Devices • “True Lumen” Re-entry devices Ø Outback Ø Pioneer device

Outback® LTDTM Re-Entry Catheter • Device Specifications: Ø 5. 9 F profile Ø 6

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

Pioneer Re-Entry Catheter • Device Specifications: Ø 6 F sheath compatible Ø 0. 014”

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

Pioneer Re-Entry Catheter

Pioneer Re-entry catheter Volcano IVUS Guidance Needle/Wire in True Lumen

Pioneer Re-entry catheter Volcano IVUS Guidance Needle/Wire in True Lumen

Outback® LTDTM Re-Entry Catheter: Positioning

Outback® LTDTM Re-Entry Catheter: Positioning

RG: Re-entry from Subintimal space • ‘Confirm’ subintimal location of guidewire Do not advance

RG: Re-entry from Subintimal space • ‘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

RG: Re-entry from Subintimal space • ‘Confirm’ subintimal location of guidewire • Exchange out

RG: Re-entry from Subintimal space • ‘Confirm’ subintimal location of guidewire • Exchange out “wire” to an 0. 014” coronary guidewire • May need to dilate at points of resistance in the subintimal space Calcification Distal Right SFA - Subintimal

RG: Re-entry from Subintimal space • ‘Confirm’ subintimal location of guidewire • Exchange out

RG: Re-entry from Subintimal space • ‘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

RG: ‘Positioning’ of Device • Pull guidewire back into the catheter • Inject contrast

RG: ‘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”

RG: ‘Positioning’ of Device • Rotate Image Intensifier 90 O orthogonally • If device

RG: ‘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”

RG: Re-entry • With the “L” pointing towards the artery • Deploy needle “fully”

RG: Re-entry • 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

RG: Re-entry • Advance support catheter or balloon catheter over 0. 014” wire •

RG: Re-entry • 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

RG: Successful intervention Baseline

WHC Experience: CTO and Re-Entry Use • Single center experience, consecutive patients with CTO

WHC Experience: CTO and Re-Entry Use • Single center experience, consecutive patients with CTO 2007 2008 2009 158 130 159 Re-entry Device Use 31 (19. 6%) 30 (23. 1%) 27 (16. 9%) Procedural Success 98. 7% 98. 4% 100% 2 O Success 100% 99. 2% No. of CTO • Complications: Perforations, etc. = 0 WHC. Unpublished data.

Re-entry Failure • Problems: Ø “Acuteness” of Iliac bifurcation Ø Non-compliance of vessels •

Re-entry Failure • Problems: Ø “Acuteness” of Iliac bifurcation Ø Non-compliance of vessels • Solution: Ø “Bigger” sheath size Ø Re-direct catheter tip Ø Advance device with the sheath as a unit

Pitfalls and Tricks in the use of Re-entry/Outback • “Large” subintimal space Ø If

Pitfalls and Tricks in the use of Re-entry/Outback • “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/Outback • “Large” subintimal space Ø If

Pitfalls and Tricks in the use of Re-entry/Outback • “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 Distal Left SFA - Outback

Pitfalls and Tricks in the use of Re-entry/Outback • “Large” subintimal space Ø If

Pitfalls and Tricks in the use of Re-entry/Outback • “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/Outback • “Large” subintimal space Ø If

Pitfalls and Tricks in the use of Re-entry/Outback • “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

Re-Entry Devices: Conclusions • Use of Re-entry device to access the “true” lumen of

Re-Entry Devices: Conclusions • Use of Re-entry device to access the “true” lumen of the artery is safe and effective. • Re-entry devices have significantly improved the success rates of treating CTO. • Recanalization of long CTO segments can now be safely and easily done with the proper use of devices. • Proper training and appropriate case selection are critical to optimize outcomes and minimize complications.

Thank you. Have a Good Day! On the road to Mount Everest Yamdro Yumtso

Thank you. Have a Good Day! On the road to Mount Everest Yamdro Yumtso Lake