Multidisciplinary Approach for a Successful CLI Management Program

Multidisciplinary Approach for a Successful CLI Management Program Michael R. Jaff, DO, FACC Paul and Phyllis Fireman Endowed Chair in Vascular Medicine Professor of Medicine Harvard Medical School Boston, Massachusetts

Michael R. Jaff, DO Conflicts of Interest • Consultant – Abbott Vascular (non-compensated) – Boston Scientific (non-compensated) – Cardinal Health – Cordis Corporation (non-compensated) – Covidien (non-compensated) – Ekos Corporation (DSMB) – Medtronic (non-compensated) – Micell, Inc – Primacea • • Equity – Access Closure, Inc – I. C. Sciences, Inc – Janacare, Inc – MC 10 – Northwind Medical, Inc. – PQ Bypass, Inc – Primacea – Sano V, Inc. – Vascular Therapies, Inc Board Member – VIVA Physicians (Not For Profit 501(c) 3 Organization) • www. vivapvd. com • CBSET February 2015 2

CLI: Defining the Problem • Critical reduction of blood flow to the lower extremity resulting in… – Rest pain (RC IV) – Tissue loss and ulceration (RC V) – Gangrene (RC VI) • May present as multilevel disease or preserved flow through to the popliteal artery with tibial obstruction TASC WG/Management of peripheral arterial disease. J Vasc Surg. 2000; 31: S 168–S 170.

Prognosis/Costs of CLI • One year after diagnosis of CLI, ~25% of patients will have died and 30% are still alive but have had a major amputation • Patients with chronic CLI have a 3 -year limb-loss rate of ~40% • CLI patients have quality-of-life indices similar to patients with terminal cancer Endovascular Today, May 2014

Mechanisms of Impaired Macrocirculatory Blood Flow in CLI • Atherosclerotic plaques, and related thrombotic occlusions, decrease perfusion pressure and blood flow in the limb • Compensatory mechanisms include collateral blood vessel development and local autoregulatory phenomenon that induce vasodilation in resistance vessels D Patterson, JJF Belch, in Creager, Dzau. Loscalzo (eds). Vascular Medicine, Elsevier, 2006 SA Arain, CJ White. Vascular Medicine. 2008; 13: 267

Mechanisms of Impaired Microcirculatory Blood Flow in CLI Abnormal vasomotion Endothelial swelling Interstitial edema Microthromboses Red blood cell and leukocyte plugging • Platelet aggregates • • • D Patterson, JJF Belch, in Creager, Dzau. Loscalzo (eds) Vascular Medicine, Elsevier, 2006

Circ Cardiovasc Qual Outcomes Jan 2012 8

Circ Cardiovasc Qual Outcomes Jan 2012 9 9

Circ Cardiovasc Qual Outcomes Jan 2012 10 10

re We Are He Circ Cardiovasc Qual Outcomes Jan 2012 11 11

Updated PAD Guidelines: Critical Limb Ischemia 12 J Am Coll Cardiol 2011; epub September 29

How Well Do We Do with CLI Management? • Data on 41, 882 patients from largest German insurer from 2009 -2011 EHJ 2015; Feb 2.

How Well Do We Do with CLI Management? EHJ 2015; Feb 2.

How Well Do We Do with CLI Management? EHJ 2015; Feb 2.

What Data Do We Have? The BASIL Trial Lancet 2005; 366: 1925 -34 16

Intervention or Surgery: The BASIL Trial • • 452 patients with severe ischemia Randomized to angioplasty vs. surgical bypass (1999 -2004) with 5. 5 years follow up Primary outcome: amputation free survival Procedural mortality: 3% PTA vs. 5% bypass (P=NS) Morbidity: 41% PTA vs. 57% bypass(P<0. 05) Re-intervention: 26% PTA vs 18% bypasss( P<0. 05) • Amputation free survival better for PTA up to 6 months and better for bypass beyond 2 years. Lancet 2005; 366: 1925 -34 17

Outcomes: Intermediate • • 21 % reintervention by 1 yr. 290/1404 Up to 30% of grafts required reintervention J Vasc Surg 2007; 46: 1173 -9 18

Challenges in Infrapopliteal Intervention Short Occlusions Diffuse Disease Calcified Lesions Variable Diameters

Meta-Analysis of PTA in Infrapopliteal Arteries • 30 studies of infrapopliteal PTA – Compared to surgery in meta-analysis of poplitealpedal bypass grafts J Vasc Surg 2008; 47: 975 20

Meta-Analysis of PTA in Infrapopliteal Arteries J 21 Vasc Surg 2008; 47: 975 21

Catheter Cardiovasc Intervent 2012 22

Xcell Trial Design • 120 patients/140 limbs – 212 implanted stents (Abbott Vascular) Catheter Cardiovasc Intervent 2012 23

Amputation Free Survival Catheter Cardiovasc Intervent 2012 24

12 -Month Limb Salvage Rate Catheter Cardiovasc Intervent 2012 25 25

Wound Healing Rates Catheter Cardiovasc Intervent 2012 26 26

And Ultimately, CLI Intervention Requires Innovation and Courage…. 27

76 yo WF with Diabetes Mellitus

Relatively Unimpressive Findings Harbor Bad Things….

IMPRESSION: Cortical irregularity and fragmentation surrounding the fifth MTP joint with adjacent soft tissue swelling, suspicious for septic arthritis.

Antegrade access: failure to cross

DP access: Micro. Puncture, 0. 018” wire

Occlusion crossed retrograde

PTA result

The Evolution of CLI Therapy is Promising o… • Endovascular intervention for CLI is. Grapidly o T advancing due to improvements y in technology a W g • PTA on L a e • Bare Metal Stents. Hav ll i t S • Drug-Devicee Combination Products W t – Drug. Bu. Eluting Stents – DCB • Atherectomy 35