No Option CLI- A Rising Epidemic and an Overview of Solutions
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1 No Option CLI- A Rising Epidemic and an Overview of Solutions Dr. M. Manzi Interventional Radiology Unit Foot & Ankle Clinic Policlinico Abano Terme Regional Center of Reference for Diabetic Foot Treatment Abano Terme (PD) ITALY
2 DISCLOSURE: Marco Manzi, MD Abbott Vascular: Angiodroid: BARD: BBraun CID/ALVIMEDICA: COOK: Boston Scientific: TERUMO: Consultant/Advisory Boarder Consultant Consultant Consultant Advisory Boarder Consultant Consultant Proctor Consultant
3 CLI: A fast growing Public Health challenge Higher Life Expectancy Aging Population CLI Diabetes Epidemic CLI a Global Epidemic >3.8M patients in US & EU 1 23% increase in Incidence in 10 years 43% increase in Prevalence by 2030 Multiple risk and growth factors Explosion in Diabetes (2.5% CAGR: ) Aging Baby Boomers (3.2% CAGR: ) Increased Life expectancy Heavy Economic Burden Sources: (1) CDC (2) Wild et al., Diabetes Care, 2004 (3) US Census, (4) Barshes et al., Journal of the American College of Surgeons, 2011 (5) CLI Volume I, USA 2016 Supplement, Sage Group (6) Salomon du Mont L. et al. (RMS, 2014) ESC (EHJ, 2017) Norgren L. et al. EJVES, 2007 **
4 The NO Option Patient Population No Option patients cannot be treated Endovascularly or Surgically because: Disease Progression ( Desert Foot ) or Failed Interventions ( Angioplasty Frequent Flyers ) Severe Ischemia 1. These patients have no remaining acceptable target vessels for intervention 2. Patients with Ischemic Foot Wounds typically do not heal without successful reperfusion. 3. Amputation is the only remaining therapeutic option 4. No Option Patients represent 14-20% of CLI population* Chronic Wounds * Schreve et al. Ann Vasc Surg Jul;28(5):1123-7
5 Prognosis of untreated CLI 2 meta-analyses, 24 studies, patients: 12-month results 20% healed wounds 20% deaths 25% amputations 35% persistent wounds Low healing rate with conservative treatment Improvement needed for 4 out of 5 patients Benoit et al. JVS 2011, Meta-analysis on control group of no option critical limb ischemia Abu Dabrh et al. JVS 2015, Meta-analysis on natural history of untreated severe or critical limb ischemia
6 Avoiding Limb Amputation Up to 10% die before hospital discharge 20-37% have major complications Average 19 Hospital Admissions / year $800k in per patient direct healthcare cost Mortality Rates Post-Amputation (5 Year Horizon) 6 out of 10 patients with a PAD/Diabetes combination will be dead one-year after amputation 5-year Survival rate post amputation is similar to that of pancreatic cancer No 6Diabetes/PAD With Diabetes With Diabetes & 2017 PADLimFlow
7 B A D SAD Failure of the distribution system of the forefoot (Ca++ DM+Dialysis + Prolonged Corticosteroid Therapy
8 Create a comunication between artery and vein in BTK; Destroy valves; Solutions for real SAD NO-Option : DVA Waiting for arterialization; Open Surgery (P.MutiranguraTechnique); Percutaneous Lim Flow (S.Kum Technique); Hybrid (R. Ferraresi Technique);
9 Solutions for real SAD NO-Option : DVA
10 Solutions for NO-Option : in the middle of DVA King of Lim-Flow King of Hybrid
11 C.S. 56 yo Diabetes, Hypertension CLI,TcPO2 =3 mmhg Gangrene I, II and III toes TUC 3D Two consecutive antegrade failures Solutions for Desert Foot in BAD
12 The Very First Good case
13 Acute years fu Dismission 2014/03
14 Lim Flow Leverage proven techniques Fully percutaneous procedure Reproducible therapy
15 Images curtesy of Dr. R. Ferraresi, Bergamo, Italy Lim Flow 74 yy old male Chronic Myeloid Leukemia, responsive to current treatment Rest pain and 1-2 toe suffering TcPO2 5 mmhg
16 45 days Acute 90 days
17 5 months after PDVA 3.5 months after TMT amputation
18 Courtesy of R.Ferraresi Hybrid Technique
19 Courtesy of R.Ferraresi
20 Courtesy of R.Ferraresi
21 Abano DVA in SAD
22 CONCLUSIONS DVA can be considered a promising solution for NO-Option Patients; Needs changing in foot surgeons mind; Surgical and Hybrid need Vascular Surgeons ; Percutaneous for all the others?
23
24 No Option CLI- A Rising Epidemic and an Overview of Solutions Dr. M. Manzi Interventional Radiology Unit Foot & Ankle Clinic Policlinico Abano Terme Regional Center of Reference for Diabetic Foot Treatment Abano Terme (PD) ITALY
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