Below the Knee Interventions Are they ever justified for - - PDF document

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Below the Knee Interventions Are they ever justified for Claudication?

4/5/2019

Shant Vartanian, MD Associate Professor of Surgery Division of Vascular and Endovascular Surgery University 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

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Case Presentation

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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

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• 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

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§ 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

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Natural History

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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

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Clinical Trials in Claudication

§ Pelvic collateral circulation ≠ geniculate collateral circulation How much benefit can we extrapolate to infra-popliteal disease? Primary Evidence

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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

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BTK for Claudication

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3x 2x

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BTK for Claudication

§ 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?

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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

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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

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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

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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?

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Infra-popliteal PTA 439 limbs

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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%

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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 infrapopliteal atherosclerotic lesions.

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

SVS: goal > 50% primary patency at 2 years

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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

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

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

Lesion length 10cm 40% CTO SVS: goal > 50% primary patency at 2 years

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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

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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

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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

SVS: goal > 50% primary patency at 2 years

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

Quality of Evidence is Suboptimal

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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

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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

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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

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Worse than the natural history of untreated disease

Is there any suitable anatomy?

Every rule has an exception

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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

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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 PTA

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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)