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[ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]
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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4/8/192
Case Presentation
4/5/2019BTK for Claudication3
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?
4/5/2019BTK for Claudication4
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4/8/193
Claudication
§Body pain
§Walking impairment
§Progressive loss of independence
§Decline in physical conditioning
§Depression
Negative impact on Quality of Life
4/5/2019BTK for Claudication5
4/5/2019BTK for Claudication6
• 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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4/8/194
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
4/5/2019BTK for Claudication8
Natural History
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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
4/5/2019BTK for Claudication9
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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4/8/196
BTK for Claudication
4/5/2019BTK for Claudication11
BTK for Claudication
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3x 2x
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4/8/197
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?
4/5/2019BTK for Claudication13
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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4/8/198
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
4/5/2019BTK for Claudication16
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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?
4/5/2019BTK for Claudication17
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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4/8/1910
§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
SVS: goal > 50% primary patency at 2 years
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4/8/1911
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
4/21/18UCSF Vascular Symposium 21
J Am Coll Cardiol. 2014;64(15):1568–76.
4/21/18UCSF Vascular Symposium 22
J Am Coll Cardiol. 2014;64(15):1568–76.
Lesion length 10cm40% CTO SVS: goal > 50% primary patency at 2 years
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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
4/21/18UCSF Vascular Symposium 23
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
4/21/18UCSF Vascular Symposium 24
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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4/8/1913
Hammad TA Curr Cardiol; 2017 Jul;19(7):58.
Quality of Evidence is Suboptimal
4/21/18UCSF Vascular Symposium 25
Summary of Atherectomy
Device Selection Below the Knee
4/21/18UCSF Vascular Symposium 26
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4/8/1914
Risks of Intervention
§Accelerated progression and multiple re-interventions
§Risk of converting IC to limb threat
§Treatment failure are not innocuous
The Treatment Trap
4/5/2019BTK for Claudication27
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
4/21/18UCSF Vascular Symposium 28
Joels CS, York JW, et al.JVS 2008 vol. 47 (3) pp. 562-5
No free lunch!
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4/8/1915
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
4/5/2019BTK for Claudication29
Worse than the natural history of untreated disease
Is there any suitable anatomy? Every rule has an exception
4/5/2019BTK for Claudication30
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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
4/5/2019BTK for Claudication31
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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)