Interventional Treatment First for CLI

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Interventional Treatment First for CLI Patrick Alexander, MD, FACC, FSCAI Interventional Cardiology Medical Director, Critical Limb Clinic Providence Heart Institute, Southfield MI 48075

Disclosures Consultant Cardiovascular Systems Inc, (CSI) Abbott Vascular Speaker AstraZeneca

Objectives Impact of Critical Limb Ischemia (CLI) Current guideline recommendations for CLI Who s getting revascularized What is the best initial strategy Angiosome guided revascularization Direct versus indirect revascularization

PAD Classification Schemes FONTAINE RUTHERFORD STAGE CLINICAL GRADE CATEGORY CLINICAL I Asymptomatic 0 0 Asymptomatic IIa Mild Claudication 0 1 Mild Claudication IIb Moderate/Severe I 2 Moderate III Rest Pain II, III 3 Severe IV Ulcer/Gangrene III 4 Rest pain 5 Minor tissue loss 6 Major tissue loss Gangrene

Critical Limb Ischemia is equivalent to a heart attack. It s the heart attack of the legs! - - Patrick Alexander

Impact of Critical Limb Ischemia (CLI) Peripheral Arterial Disease: Current Insight Into the Disease and Its Diagnosis and Management. Mayo Clin Proc. July 2010;85(7):678-692.

JACC Vol. 61, No. 14, 2013 2005/2011 Recommendations Class I indications for Tx of CLI

Trends in Endovascular Interventions, major amputation, and lower extremity bypass surgery, 1996-2006 Goodney et al., 2009

Geographic Revascularization Rates - USA 2003 to 2006 Variation in the Use of Lower Extremity Vascular Procedures for Critical Limb Ischemia Goodney et al., Circ Cardiovasc Qual Outcomes. 2012;5:94-102.

Amputation without Vascular Evaluation Variation in the Use of Lower Extremity Vascular Procedures for Critical Limb Ischemia Goodney et al., Circ Cardiovasc Qual Outcomes. 2012;5:94-102.

Amputation First Approach EuroIntervention. May 2005. Vol 1;No 1; 75-84.

Medicare Population: 1999-2001 417 patients with at least one infrainguinal amputation identified (2.5 million patients) Analyzed clinical data and medical cost claims for 18 continuous months (12 month prior, 6 mo post) Treatment pathways PTA: Angioplasty IBS: Infrainguinal bypass graft PA: Primary amputation EuroIntervention. May 2005. Vol 1;No 1; 75-84.

PA = 67% IBS = 23% PTA = 10% Initial Treatment & Outcomes Majority of wound complications (80%) and MI 7/9 (77.7%), stroke 13/16 (81.2%), and death 2/2 (100%) occurred in the PA group. Only 35% with an ABI and only 16% angiography before PA. EuroIntervention. May 2005. Vol 1;No 1; 75-84. PA (primary amputation), IBS (infrainguinal bypass surgery), PTA (percutaneous transluminal angioplasty.

Today s Challenges Limited Randomized Controlled Trials Comparing Endovascular versus Surgical Revascularization Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial: Multicenter, randomized controlled trial. Lancet. 2005 Dec 3,366(9501):1925-34. 452 CLI patients in UK (PTA vs. SB) à No change in amputation free survival

Best Endovascular versus Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST- CLI) Anticipated completion 2018 CLI patients with adequate aortoiliac inflow Candidate for either endovascular or surgical approach 4 arm study Endo vs surgery in those with available vein conduit Endo vs surgery in those with need for alternative conduit

Algorithmic Approach to the Patient with Critical Limb Ischemia Surgery Versus Endovascular Revascularization in the Critical Limb Ischemia Patient Scott EC., Endovascular Today. May 2015

Angiosome Concept Introduced in 1987 by Taylor and Palmer* Divided the body into three- dimension vascular territories supplied by specific source arteries and drained by specific veins. Foot and ankle with 6 distinct angiosomes arising from the PTA, ATA, and peroneal artery. *Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applicatons. Br J Plast Surg. 1987;40:113-141.

86 y/o male with right heel ulcer AT TPT AT DP

Direct versus Indirect Revascularization Improved wound healing and limb salvage when revascularization is delivered to the appropriate angiosome (regardless of the method). Wounds do not always correspond to a single discrete angiosome. Only 1/3 rd of CLI patients in recent study by Kret et al. 1, with lesion corresponding to a single angiosome. 1 J Vasc Surg.2014;59:121-128.

Catheterization and Cardiovascular Interventions 75:830 836 (2010) Retrospective analysis Rutherford 5 or 6 177 patients (203 limbs)

86% 69% 1 2 3 Patent runoff vessels after EVT Catheterization and Cardiovascular Interventions 75:830 836 (2010)

Conclusion Critical Limb Ischemia represents a small but critical percentage of patients with PAD [Save A Leg Save A Life * ]. Primary amputation strategy is not free of CV morbidity and mortality Endovascular Tx options continue to grow with development of specialized crossing catheters, alternative access sites, along with dedicated training programs for endovascular intervention. BEST CLI trial may offer further insight on current state of practice with regards to endovascular vs. surgical intervention. *Save A Leg Save A Life Foundation

Interventional Treatment First for CLI Patrick Alexander, MD, FACC, FSCAI Interventional Cardiology Medical Director, Critical Limb Clinic Providence Heart Institute, Southfield MI 48075

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