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

Below the Knee Interventions Are they ever justified for Claudication? Shant Vartanian, MD Associate Professor of Surgery Division of Vascular and Endovascular Surgery University of California, San Francisco 4/5/2019 Case Presentation 59 year old construction worker § 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 2 BTK for Claudication 4/5/2019 1 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Case Presentation 3 BTK for Claudication 4/5/2019 Case Presentation The next best treatment option for this patient is? § 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 4 BTK for Claudication 4/5/2019 2 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Claudication Negative impact on Quality of Life § Body pain § Decline in physical conditioning § Walking impairment § Depression § Progressive loss of independence 5 BTK for Claudication 4/5/2019 • 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 6 BTK for Claudication 4/5/2019 3 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Atherosclerosis of the Lower Extremities Natural History 55% Improved 35% Stable § Benefit persist over 5 years for those that live that long § 60% of mortality due to cardiac disease 7 BTK for Claudication 4/5/2019 Atherosclerosis of the Lower Extremities Natural History 8 BTK for Claudication 4/5/2019 4 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Claudication: Practice Guidelines SVS and AHA § 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 9 BTK for Claudication 4/5/2019 Clinical Trials in Claudication 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 § Pelvic collateral circulation ≠ geniculate collateral circulation How much benefit can we extrapolate to infra-popliteal disease? 10 BTK for Claudication 4/5/2019 5 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

BTK for Claudication 11 BTK for Claudication 4/5/2019 BTK for Claudication 2x 3x 12 BTK for Claudication 4/5/2019 6 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

BTK for Claudication Has the threshold for intervention lessened? § High technical success of endovascular interventions § Trend to OBL, outpatient therapy § Economic incentives for interventions § We can do it. Should we? 13 BTK for Claudication 4/5/2019 Goals of Treatment For Intermittent Claudication § Relief of lower extremity pain Quality of Life § 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 14 BTK for Claudication 4/5/2019 7 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

State of the Evidence Endpoints of Relevance § Objective and self-reported functional outcomes • Walking Scores • QOL § No studies of BTK interventions with endpoints relevant to claudication 15 BTK for Claudication 4/5/2019 State of the Evidence Endpoints of Relevance § 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 16 BTK for Claudication 4/5/2019 8 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

BTK Interventions Does anything work well enough? § 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 17 BTK for Claudication 4/5/2019 Infra-popliteal PTA 439 limbs 1 yr primary patency < 50% Worst patency outcomes with: § Lesion length > 10cm § Dense calcification § ESRD SVS: goal > 50% primary patency at 2 years 18 UCSF Vascular Symposium 4/21/18 Lo RC J Vasc Surg. 2013 Jun;57(6):1455–63. 9 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

52 studies with 9399 infra-popliteal lesions in analysis § 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% JA Mustapha. Circulation: Cardiovascular Interventions. 2016 19 UCSF Vascular Symposium 4/21/18 Primary patency through 1 year with percutaneous transluminal angioplasty in infrapopliteal atherosclerotic lesions. SVS: goal > 50% primary patency at 2 years J.A. Mustapha et al. Circ Cardiovasc Interv. 2016;9:e003468 10 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

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. 21 UCSF Vascular Symposium 4/21/18 Lesion length 10cm 40% CTO SVS: goal > 50% primary patency at 2 years J Am Coll Cardiol. 2014;64(15):1568–76. 22 UCSF Vascular Symposium 4/21/18 11 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

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 23 UCSF Vascular Symposium 4/21/18 Drug Eluting Stents 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 § Patency seems to favor DES over PTA or BMS • Small numbers • 12 month restenosis 25% • 12 month primary patency 45%-75% SVS: goal > 50% primary patency at 2 years Hammad TA Curr Cardiol; 2017 Jul;19(7):58. 24 UCSF Vascular Symposium 4/21/18 12 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Summary of Atherectomy Quality of Evidence is Suboptimal Hammad TA Curr Cardiol; 2017 Jul;19(7):58. 25 UCSF Vascular Symposium 4/21/18 Device Selection Below the Knee 26 UCSF Vascular Symposium 4/21/18 13 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Risks of Intervention The Treatment Trap § Accelerated progression and multiple re-interventions § Risk of converting IC to limb threat § Treatment failure are not innocuous 27 BTK for Claudication 4/5/2019 Consequences of Failed PTA No free lunch! Joels CS, York JW, et al. JVS 2008 vol. 47 (3) pp. 562-5 § 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 28 UCSF Vascular Symposium 4/21/18 14 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

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 Worse than the natural history of • 5-8% major amputation untreated disease 29 BTK for Claudication 4/5/2019 Is there any suitable anatomy? Every rule has an exception 30 BTK for Claudication 4/5/2019 15 4/8/19 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]