Below the Knee Interventions Are they ever justified for … › 2019 › MSU19003 › slides ›...

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4/8/191

Below the Knee InterventionsAre they ever justified for Claudication?

4/5/2019

Shant Vartanian, MDAssociate Professor of SurgeryDivision of Vascular and Endovascular SurgeryUniversity of California, San Francisco

Case Presentation

§Half block claudication

• Pain every day at work

• Walks every day

§Quit smoking > 10 years ago

§Taking atorvastatin, ASA

§Resting ABI 0.94

§Exercise ABI 0.73

• Unable to complete exercise ABI protocol (heel raise) due to calf pain

59 year old construction worker

4/5/2019BTK for Claudication2


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Case Presentation


Case Presentation

§A. Plain balloon angioplasty

§B. Vessel prep + Drug Eluting Balloon

§C. Oribital atherectomy

§D. Angioplasty with Drug Eluting Stent

§E. Rotational atherectomy

§F. Molding balloon

§G. Not interventional: Add Cilostazol and propose work modification

The next best treatment option for this patient is?



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Claudication

§Body pain

§Walking impairment

§Progressive loss of independence

§Decline in physical conditioning

§Depression

Negative impact on Quality of Life



• 1508 patients with claudication seen from 1947 – 1953• Most diagnosed with angiography• Seen every 3 months with treadmill walking test• No patients treated surgically• Diabetes in 4%

Bloor K.. Ann R Coll Surg Engl. 1961 Jan;28(1):36-52.2


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Atherosclerosis of the Lower Extremities


§Benefit persist over 5 years for those that live that long

§60% of mortality due to cardiac disease

Natural History

55% Improved

35% Stable

Atherosclerosis of the Lower Extremities


Natural History


4/8/195

Claudication: Practice Guidelines

§Medical therapy and Supervised Exercise

• Improved pain-free and total walking distance in IC compared

§Revascularization

• Estimate of disease-specific disability

• Lack of improvement with first-line measures (OMT + SET)

• Individualized risk-benefit analysis for the interventions under consideration

SVS and AHA


Clinical Trials in Claudication

§Pelvic collateral circulation ≠ geniculate collateral circulation

How much benefit can we extrapolate to infra-popliteal disease?

Primary Evidence


Trial Anatomic Location

CLEVER Aortoiliac

MIMIC Aortoiliac & Femoropopliteal

ERASE Aortoiliac or Femoropopliteal

Masari et al (Hull) Femoropopliteal

Bo et al Aortoiliac or Femoropopliteal


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BTK for Claudication




3x 2x


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§High technical success of endovascular interventions

§Trend to OBL, outpatient therapy

§Economic incentives for interventions

§We can do it. Should we?

Has the threshold for intervention lessened?


Goals of Treatment

§Relief of lower extremity pain

§ Improvement in ambulatory function

§Hemodynamic parameters correlate poorly with the degree of functional impairment

§Anatomic patterns of disease correlate poorly with symptom severity or limb prognosis

For Intermittent Claudication


Quality of Life


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State of the Evidence

§Objective and self-reported functional outcomes

• Walking Scores

• QOL

§No studies of BTK interventions with endpoints relevant to claudication

Endpoints of Relevance


State of the Evidence

§Anatomic patency is directly linked to hemodynamic improvement

• Necessary but not sufficient for functional gain

§Some threshold of durability for an invasive procedure should be expected

• SVS: goal > 50% primary patency at 2 years

§Weigh technical factors that affect interventional durability• Lesion length

• Calcification

• CTO vs stenosis

Endpoints of Relevance



4/8/199

BTK Interventions

§Device trials for regulatory approval are designed to test the devices, not address the GOC for claudication

§TLR• Device specific performance for repeat clinical procedures

§Clinically driven TLR

• Many patients who lose patency may not need or want a reintervention

§Repeat interventions of any kind are a major clinical event

Does anything work well enough?


Infra-popliteal PTA 439 limbs

4/21/18UCSF Vascular Symposium 18 Lo RC J Vasc Surg. 2013 Jun;57(6):1455–63.

1 yr primary patency < 50%

Worst patency outcomes with:

§Lesion length > 10cm

§Dense calcification

§ESRD

SVS: goal > 50% primary patency at 2 years


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§Limitations include variability as to how patency was assessed and defined

§At 1 year:

‒ Repeat interventions in 18%

‒ Major amputation 15%

‒ All cause mortality 15%

4/21/18UCSF Vascular Symposium 19

52 studies with 9399 infra-popliteal lesions in analysis

JA Mustapha. Circulation: Cardiovascular Interventions. 2016

Primary patency through 1 year with percutaneous transluminal angioplasty in infrapoplitealatherosclerotic lesions.

J.A. Mustapha et al. Circ Cardiovasc Interv. 2016;9:e003468



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Drug Eluting Balloons

§Mechanical disruption combined with drug delivery

§Paclitaxel (high concentration) + excipient

§ In.Pact-Deep Trial

• DCB vs PTA in 358 patients

• Patency endpoints broadly similar


J Am Coll Cardiol. 2014;64(15):1568–76.


J Am Coll Cardiol. 2014;64(15):1568–76.

Lesion length 10cm40% CTO SVS: goal > 50% primary patency at 2 years


4/8/1912

Drug Eluting Stents

§BMS bail out option for flow limiting dissection

§Loss of bypass targets

§Cost

§Do the benefits of DES in CAD also apply in the below knee arteries

• 5 randomized trials comparing DES vs PTA

• Mix of claudication and CLI


Hammad TA Curr Cardiol; 2017 Jul;19(7):58.

§Patency seems to favor DES over PTA or BMS

• Small numbers

• 12 month restenosis 25%

• 12 month primary patency 45%-75%

Sirolimus or Everolimus eluting stents


Yukon Achilles Destiny

Patients 161 200 140

Lesion Length 31 mm 27 mm 27 mm

Trial DES vs BMS DES vs PTA DES vs BMS

Drug Eluting Stents



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Hammad TA Curr Cardiol; 2017 Jul;19(7):58.

Quality of Evidence is Suboptimal


Summary of Atherectomy

Device Selection Below the Knee



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Risks of Intervention

§Accelerated progression and multiple re-interventions

§Risk of converting IC to limb threat

§Treatment failure are not innocuous

The Treatment Trap


Consequences of Failed PTA

§ Distal anastomotic site was negatively impacted in 28% of failed endovascular infrainguinal interventions

§ Risk of target site change is greater in CLI than claudication

• 42% vs. 11%

§ Decreased long term secondary patency


Joels CS, York JW, et al.JVS 2008 vol. 47 (3) pp. 562-5

No free lunch!


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First, do no harm…

§Medicare claims data

§1440 patients undergoing atherectomy for claudication

§Stratified by hospital based vs office based venue

§Tibial atherectomy for claudication

• 40% reintervention rate

• 6-11% any amputation

• 5-8% major amputation


Worse than the natural history of untreated disease

Is there any suitable anatomy? Every rule has an exception



4/8/1916

Summary

§Goal of Care for claudication ≠ chronic limb threat ischemia

§Revascularization considered only after optimization of 1st line therapies

§ Individualized risk/benefit assessment

• Know the limitations of BTK interventions

‒ Durability and Risk

• First do no harm

§Extremely selective (if ever) application of PVI for BTK in claudication

Below Knee Interventions for Claudication



4/8/1917

Specialty Balloons

§Chocolate Registry Study

§Single arm – 180 patients with infrapopliteal interventions

§<2% flow limiting dissection

§Short follow up with technical endpoints

§Unclear is any additional clinical value over traditional PTA4/21/18UCSF Vascular Symposium 33 J Am Coll Cardiol. 2014;64(15):1568–76.

Pathogenesis of the Limb Manifestations and Exercise Limitations in Peripheral Artery Disease, Volume: 116, Issue: 9, Pages: 1527-1539, DOI: (10.1161/CIRCRESAHA.116.303566)

Below the Knee Interventions Are they ever justified for … › 2019 › MSU19003 › slides ›...

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