Mahmood Razavi, MD, FSIRDirectorCenter for Clinical TrialsVasc Interv Specialists of Orange

Planning BTK Interventions for CLI: Approach & Toolbox Options

Disclosures

Scientific Advisory Board• 480 Biomedical, Abbott Vascular, Bard, Boston

Scientific, Covidien, EmboMedix, Javlin, Mercator, Neuravi, Reflow Medical, Trivascular, Veneti, Walk Vascular

Consultant• Cordis

Grants• NIH, WL Gore

Limb-Specific Treatments of CLI

Pain control Management of ulcer and gangrene

• Infection control• Local tx & pressure relief

Revascularization Amputation

Endovascular Treatment of CLI

Complex problem!• Frequent involvement of multiple segment

Typical scenario:• Treatment of more than one vascular beds• Application of multiple tools and technologies

Outcome related to multiple anatomic & physiologic parameters

Claudication

Rest pain

Tissue loss

SurvivalLimb salvageRecurrence of sxProgression of sx1º or 2 º PatencyRe-intervention rate Maintenance of independence

Indication vs. Outcome

Taylor et al. J Am Col Surg. 2009;208:770

• RB-4(5%-15%)

• RB-5(50%-70%)

• RB-6(10%-20%)

All seg5%

3%A/I1%

A/I+ fem

4%fem

30%Fem+pop/tib

Pop/tib55% Rueda CA et al. JVS 2008;47:995

Endovascular Strategy

• To the extent possible, all treatable lesions should be treated to obtain in-line flow to the foot & affected area

• Choice of tibial revascularization depends on patients’ anatomy and symptoms (angiosome concept)

ToolboxCritical to Outcome

• Access• Support catheters • Wires• Balloons• Other adjunctive devices/techniques

– Atherectomy, stenting, thrombectomy, etc.

Access

• Antegrade vs retrograde CFA– Pts body habitus & status of SFA in sx limb

• Pedal (when antegrade crossing fails)– Always use ultrasound– AT vs PT, vs high DP (peroneal not desirable) – Rule of thumb: entry close to ankle

• Pedal loop/ transcollateral– Alternative to above but not always possible

Ultrasound image of dorsalis pedis during pedal access

Access

• Tip of sheath/guidecath as close to knee as possible– Improves pushability– Decreases contrast dose while improving image

quality– Makes wire/cath exchanges easier/faster

Support Catheters

• May use balloons as support catheter to advance wire

• Support catheters useful in crossing lesions or for exchanging wires

• Trackability, torque control, pushability, visibility

Wires: Critical to Success

• Popliteal artery: 0.035"; 0.018"; 0.014"– True lumen passage preferred in CTOs (choose

carefully) – limited re-entry opportunity• Tibial vessels:

– 0.014” advantageous- more options available on this platform: balloons, atherectomy, stents, support catheters, aspiration devices, EPDs, etc.

Specialty Wires

• CTO wires– Heavier tip loads

• Finesse wires (multiple tandem lesions)– Torque control & crossability

• Support (workhorse wires)• Atherectomy compatible wires

Robust tip (hydrophylic), good torque control, good support

73-Y-O male withDM, s/p resection of2nd & 3rd distal phalanges. Now has1st toe osteomyelitisToe press= 22 mmHg

Balloons

• OTW preferred – Better trackability & pushability– Ability to change wire if needed

• Match balloon length to lesion– Length up to 220 mm available

• Tapered balloons could be useful

Do not undersize balloons. Higher risk of failure!

Undersizedballoon?

Stents Bare stents (for suboptimal

PTA results) DES (better patency than

PTA alone)• Longest device in U.S. 38

mm• Limited by cost

Early Failures BTK

Razavi M et al J Vasc Surg in press

Results of Meta-Analysis

Razavi et al J Vasc Surg in press

Debulking Devices

• MiniHawk & RockHawk (ev3/Covedien)• JetStream (Pathway Medical)• DiamondBack 360 (CSI)• Turbo Elite excimer laser (Spectranetics) • Phoenix (Atheromed)

Enabling devices

• 74-year-old female with DM & right 1st toe non-healing ulceration

Conclusion

• “Endo first” is the strategy of choice for BTK revascularization

• Toolbox critical to both acute success and improved clinical outcome

• Devices for endo-tx of CLI improving• Thorough familiarity with their

performance characteristics necessary