endovascular techniques for limb salvage: how to succeed ......intravascular lithotripsy (ivl)...

Curtiss T. Stinis, M.D., F.A.C.C., F.S.C.A.I.Director, Peripheral Interventions

Director, Interventional Cardiology Fellowship Program

Scripps Clinic

La Jolla, CA

Endovascular Techniques for Limb Salvage:Endovascular Techniques for Limb Salvage:How to Succeed With Complex CasesHow to Succeed With Complex Cases

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PAD is Everywhere….

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CLI Affects

PAD and CLI: A Serious Problem!

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CLI AffectsApproximately20 MillionAmericansPer Year!

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Endovascular Therapy has Become theTreatment Strategy of Choice for CLI

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Endovascular Therapy vs. Vascular Surgery:Cost Effectiveness

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• Endovascular procedures for PAD cost the health payer less comparedwith open surgery and primary amputation

• Endovascular devices are more expensive, but the reduction in hospitaldays, ICU days, and hospital resources used results in a significantlylower mean total cost per admission

Journal of Endovascular Therapy, Vol 25, Issue 4, Mar 2018

Challenges for the Operator:Lengthy occlusionsFlush occlusions/Proximal cap ambiguityMulti-level diseaseHeavy calcification

Challenges for EndovascularProcedures for CLI

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Heavy calcificationOld occluded stentsAltered anatomy post-bypass

Challenges for the Healthcare System:Expensive “Toys”Cases can be quite long

Effective Endovascular Therapyfor CLI: Procedural Goals

MUST get inlineflow directly tothe affected area

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Vessel needs tostay open longenough to healthe wound solimb can returnto baseline

CTOs are Very Common in CLI Patients

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Old Habits are Hard to Break

“I tried to cross it with a V18 andit wouldn’t go, so I don’t think anendovascular approach ispossible”

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Critical Tools for Complex and BTK Work:

0.014 Wire Technology

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Command ES Wire (Abbot Vascular)-Works like a “Mini Glidewire”

Confienza Pro: 9g and 12g tips (Asahi)-Tapered tip to 0.009” for CTO crossing

Sion: (Asahi)-Highly torqueable, long transition fromfloppy to supportive body-Designed to navigate collaterals andextreme tortuosity

Critical Tools for Complex and BTK Work:

Microcatheter Technology

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Turnpike and Corsair Microcatheters- 0.014 based systems

•Hydrophilic coating

•Tapered flexible tip, braided supportive body

•Available in 135 and 150 lengths

Critical Tools for Complex and BTK Work:

Support Catheter Technology

+

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CXI Support Catheter: 0.035 (Cook Medical)-Braided, hydrophilic, tapered tip-Far lower profile than Vert or Kumpe

Stiff angledGlidewire 0.035(Terumo)

+

• Leading failure modality is the inability to cross andenter into the true lumen

• Antegrade attempts can fail in up to 40% of cases• Dedicated CTO devices marginally increase

success but add substantial cost

Peripheral CTO Crossing

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success but add substantial cost• Retrograde crossing increases success rates as

compared to antegrade only attempts• Combined antegrade and retrograde approaches

increase crossing success to nearly 100% (Scripps)

Typical Subintimal TechniqueTypical Subintimal Technique

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Challenges of the TraditionalSubintimal Technique

Excessive wireloop or probingleads to largeopening in

Extension ofintramuralhematoma with

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Collateral

Ideal locationfor re-entry

opening insubintimalspace whichbecomespressurized

hematoma withcompromise ofcollateral flow

Re-entry devices arefar less effectiveonce subintimalhematoma ispresent!!

Dedicated Re-entry Devices

NOT SEPARATELY REIMBURSED!

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True LumenTrue Lumen:Dedicated CTO Crossing Devices

LIMITED SUCCESS AND NOTSEPARATELY REIMBURSED!

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Truepath(BostonScientific)

Frontrunner(Cordis/Cardinal)

Crosser(Bard)

Wildcat(Avinger)

VianceCovidien/Medtronic)

Centercross(RoxwoodMedical)

Dedicated or “True Lumen”CTO Technologies

• NOT separately reimbursed

• Many require significant capital equipmentinvestment (costly consoles or upfront purchase ofcertain number of catheters)

• Typically no consignment

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• Typically no consignment

• Only work on relatively straightforward cases thatyou could have crossed with wire and cathetertechniques

• Often end in subintimal passage and require re-entry device adds substantial cost

• Don’t solve the issue of proximal cap ambiguity!

The Solution for Challenging CTO Cases:Access and Manage the Proximal and Distal Caps

• Highly complex cases can be performed with nearly100% procedural success by a combination of:

Well developed wire and catheter skills

Knowledge and understanding of CTO anatomy

Proper angiogram interpretation: correctly identify

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Proper angiogram interpretation: correctly identifyproximal and distal caps and collaterals

Obtaining access to the proximal and distal capsvia alternative access or collateral networks

Appropriate and selective use of advancedtechnologies

The Key To Success: SimultaneousManagement of the Proximal and Distal Cap

Performing wire re-entry within the occludedsegment avoids:

• Extension of dissection planes proximally ordistally to the occlusion

• Compromise of collaterals

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• Having to “chase” a dissection or increasing thearea that requires treatment

•• Preserves distal bypass targets

• Burns no bridges

Simultaneous management of the proximal anddistal cap also eliminates proximal cap ambiguity

Management of Proximal and Distal Cap:

Reverse CART Technique

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Accessing the Proximal Cap:Challenges for Antegrade Wire Passage

• Inability to navigate the wire past the proximal capdue to fibrosis or heavy calcium

• Proximal cap is ambiguous, but not flush occluded

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• Wire wont penetrate the proximal cap because it isalmost flush occluded and keeps going into sidebranch instead

• Flush occlusion- where is the proximal cap?

Problem:Wire unable tocross the proximalcap and enter the

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cap and enter thesubintimal space

Solution: Balloon-Assisted Push Technique

Wire tip pinnedby balloon

Pinned wire tipallows forfulcrum andadvancementof stiffer portionof the wire andanchoring of

Wire wontcross lesion,poor support

Prolapse wire,change supportcatheter forOTW balloon

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anchoring ofsystem

SOLUTION:Balloon-AssistedWire PushTechnique

Hydrophilic wirelooped with tip nextWire Tip Pinned

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to balloon surface

OTW ballooninflated to pin tip ofwire in place

Wire thenadvanced throughdifficult area

Wire Tip Pinned

Problem:Where is the ???

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proximal cap?

Solution:Use IVUS to

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determine locationof proximal cap

SFA

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Collateral

Solution:Wire passed intotrue lumen ofpopliteal artery

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popliteal arteryusing IVUSguidance

Problem:

Cant engageproximal cap

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proximal capbecause the wirekeeps sliding intoprofunda

SOLUTION:

Outback catheterused to “poke” intoproximal cap and

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proximal cap andprovide additionalsupport/penetrationpower so that wirecan be inserted intothe subintimal space

Problem:Proximal Cap is

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Proximal Cap isFlush Occluded

Solution A:Use IVUS to

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Locate theProximal Cap

IVUS left in placefor guidance

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Wire directed intoand throughproximal cap

Problem:

Proximal Cap isFlush Occluded

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Flush Occluded

SOLUTION B:

Use retrograde wirepassage to eliminateproximal cap

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proximal capambiguity

Retrograde wirepassed via profundacollaterals and up toproximal cap

SOLUTION B:

Use retrograde wirepassage to eliminateproximal cap

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proximal capambiguity

Pass second wireantegrade throughproximal cap

Problem:

Covered stent graftextending from

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extending fromCFABypassacross native SFAprevents wirepassage acrossproximal cap intonative SFA

Double Problem:

Covered stent graftextending from

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extending fromBypassPoplitealacross nativepopliteal preventswire passageretrograde too!

SOLUTION:

Direct antegradepuncture into

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puncture intooccluded SFA stents

SOLUTION:

Direct antegradepuncture into

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puncture intooccluded SFA stents

SOLUTION:

Antegrade wirepassage past distal

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passage past distalstent graft

SOLUTION:

Then retrogradewire passage past

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wire passage pastdistal stent graftthrough CXIcatheter

So.. Why UseCART? Can’t I JustGo Retrograde?

Use caution enteringdirectly from the

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directly from thesubintimal spaceeither antegrade orretrograde

RISK of CFAdissection and lossof profunda!

Primary entry fromretrograde subintimalspace

Looks good, right?

OOPS…..

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Good thing I didn’tballoon and stentthat!

Accessing the Distal Cap:Options for Retrograde Wire Passage

•Pedal Access:

Dorsalis pedis or posterior tibial distal tothe lower leg compartments

Avoid directly accessing the peroneal- risk

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Avoid directly accessing the peroneal- riskof compartment syndrome on exit

•Transcollateral Approaches:

Antegrade Transcollateral

Retrograde Transcollateral

Optimal Access via DP and ATAvoid Direct Peroneal Access

Peroneal arterylies deep betweentibia and fibulawithincompartmenttissues

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PT and DP arteriesare superficial inthe foot, easilycompressible, andnot in acompartmentspace

Pedal Access Technique

• Use ultrasound to find vessel

• Use 22 gauge Smart needle (doppler needle)to access vessel to be sure you are fully inthe lumen and not partially in the wall

• Use 300 length 0.14 soft tipped wire for initialwire passage

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wire passage

• After successful wire passage, use Corsaircatheter as support/sheath directly throughthe skin

• DO NOT insert a sheath- can be occlusive

• Use Verapamil generously to reducevasospasm and improve microcirculationflow

Correct Technique Incorrect Technique

Needle bevel notfully insertedthrough vesselwall, but insertedenough to getflash

Pedal Access Technique

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Wire advancedinto subintimalspace leading todissection

Problem:

How to access thedistal cap in theperoneal?

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peroneal?

DP cannot beaccessed due toinfected openwound

Peroneal accessvia transcollateralapproach viaoccluded PT

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Corsair navigatedthrough collateralsinto peronealusing Scion wire inorder to accessdistal cap

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distal cap

Access to distalcap via:

Posterior Tibial

Collaterals

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Collaterals

Peroneal

Problem:

How to get accessto the distal cap inthe peroneal?

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Open wound ontop of foot, PT toosmall to access

SOLUTION:

Antegradetranscollateralapproach

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Corsair and Scionwire

SOLUTION:

Antegradetranscollateralapproach

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Corsair and Scionwire

SOLUTION:

Antegradetranscollateralapproach

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Corsair and Scionwire

SOLUTION:

Antegradetranscollateralapproach

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Second Corsairand wire passedantegrade andreverse CARTcompleted

What About Calcium?A Major Challenge in CLI

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What About Atherectomy?

Additional Reimbursement!

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Atherectomy Devices:What Does the Data Show?

• Overall quality of the data is very poor

• Most devices have only been studied in smallnon-randomized registries

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• Thus far, only 5 randomized control trials ofatherectomy devices in the periphery have beenpublished (Silverhawk, CSI, Laser)

• And none present data past 12 months!

Traditional Atherectomy Devices:A Less Than Ideal Strategy

• Penetrate, denude, and injurethe intima

• Remove a very limited amountof superficial plaque andcalcium at best

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calcium at best

• No effect whatsoever on deepcalcium

• Substantial risk of distalembolization

• Time consuming

Better Treatment for Calcified Vessels:Intravascular Lithotripsy (IVL)

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IVL THERAPY

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Successful Treatment of CLI Patients:It Takes a Village!

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Progressive gangreneof right foot following2 failed lowerextremity bypasssurgeries

Told by his surgeon

47 year old Type I Diabetic

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Told by his surgeon“no other options”

Scheduled for belowthe knee amputation

Presents for secondopinion

1 week post complexendovascularintervention

Pre-procedure

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1 month post complexendovascularintervention

intervention

Pre-procedure

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1 week postcomplexendovascularintervention

4 weeks post

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6 weeks post

8 weeks post

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8 weeks post

Pre-procedure

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2 months post

9 weeks post

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• All wounds healed by 12weeks post-intervention

In Summary…

• PAD patients often present with complex multi-level diseasewhich can pose technical challenges for endovascular therapy

• Advanced lesion crossing techniques utilizing combinedantegrade and retrograde methods can markedly improve theprocedural success of endovascular procedures

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procedural success of endovascular procedures

• Dedicated CTO crossing technologies typically are not usefulin highly complex lesions, often require high capital equipmentcosts, and are not separately reimbursed

• Success in the treatment of CLI patients is best achieved via ateam approach with effective use of multiple resources andspecialists