What is an Interventionalist? Limb Salvage : Early Identification Through • Interventional Cardiologist: a specialist who treats coronary artery disease, peripheral artery disease Risk Assessment and all aspects of atherosclerosis • Vascular Surgeon: a specialist of surgical interventions of arteries and veins and of Alan J. Block, DPM, MS, FACFAS therapies for the peripheral vascular system Director of Foot & Ankle • Interventional Radiologist: a sub-specialist of The Ohio State University radiology who performs minimally invasive Assistant Professor Dept. of Orthopedics procedures using image guidance The Ohio State University Residency Director PMS-36 • All have similar skill sets to perform peripheral interventions Treating PVD Treatment for severe PVD Video Clip in the 1800’s 1
Treating PVD Treating PVD Treatment for severe • Despite advanced interventional PVD in 2008 techniques to restore straight-line flow, amputation continues to be a common “therapy” for CLI • 200,000 amputations estimated in Europe and the USA annually 2
Igantz Simmelweis “I marvel that a society would pay a surgeon a large sum of 1849 money to remove a patient’s leg…but nothing to save it.” George Bernard Shaw Actual Operative Louis Pasteur Report Date of Procedure: 08/24/04 3
“There is no patient that would not intervene on that was scheduled for an amputation” Craig M. Walker, M.D. Medical Director Cardiovascular Institute of the South Darwin’s Survival of PAD Amputations the Fittest • Less than half of amputees ever walk again • Less than 25% if it is an above the knee amputation • 5 – 9% die in the hospital • 25% require nursing home placement • One third of amputees lose the remaining leg within 18 mos. • In the United States, the amputation rate is increasing. 4
FoxHollow SilverHawk Plaque Excision “ You See What You Look for and You Recognize What You Totally occluded Dorsalis Pedis Artery is Know ’’ choking off the blood supply to Jamie’s foot, creating a non healing foot ulcer. Lawerence Harkless, DPM ’ Plaque excised from Jamie’s occluded Dorsalis Pedis Artery using the FoxHollow SilverHawk plaque excision system Restored blood flow to Jamie’s foot after plaque was excised from occluded Dorsalis Pedis Artery Amputation Impact!! ABI 0.2 ABI .75 • 20%-25% (1/4) all diabetics-lifetime • 30 Day perioperative mortality � BKA - 5-8% � AKA - 8-12% • 18 - 24 month overall mortality - 40-50% • Amputations are NOT benign! 5
FoxHollow SilverHawk Plaque Excision Which Would You Rather? Percutaneous Surgical Thomas’ Super Femoral Artery is occluded, limiting blood flow to his entire leg and creating an ischemic foot. Blood flow restored to Thomas’ Super Femoral Artery after FoxHollow SilverHawk plaque Large quantities of plaque were excised from Thomas’ excision peripheral arteries using the FoxHollow SilverHawk FoxHollow SilverHawk Plaque The SFA is Unique Excision POST PRE Pre-Procedure Angiogram reveals a totally Post-Procedure Angiogram reveals a widely patent occluded Popliteal Artery and Below the Knee Popliteal Artery and Below the Knee Arteries, Arteries, preventing blood flow to Robert’s foot. providing blood flow to Robert’s foot! (Pre-SilverHawk Plaque Excision) (Post-SilverHawk Plaque Excision ) Knee Extension Knee Flexion 6
Forces Exerted On Table For Four Stents In SFA 1. Extension / Contraction 2. Flexion 4. 3. Torsion Compression Darwins Theory of Distal PT/Calcaneal Evolution??? Device used On the wire Pre Peri Post 7
Amputations ` • Less than 20% get an angiogram • Only 50% get an ABI • Most of these patients do have limb salvage options • It is not conservative treatment to amputate! Boxing Video Clip 8
ABI’S “For some reason, it is considered conservative treatment to chop someone’s leg off and aggressive treatment to even do an angiogram” “Craig M. Walker, M.D.” Medical Director Cardiovascular Institute of the South 9
However… American Diabetes Association • Remember 50-75% patients are asymptomatic, • Of 85% of primary care or present with physicians that treat the diabetic, only 15% ask the atypical patient to remove socks and symptoms. shoes for foot exams. Mortality in Patients I’m Dead Sexy With Severe* PAD Relative 5 -Year Mortality 1 0 0 1 0 0 Patients ( % ) 8 0 8 0 5 6 4 7 6 0 6 0 3 8 4 0 4 0 1 4 2 0 2 0 0 0 Breast Colon/ Rectal Non- PAD 1 Cancer 2 Cancer 2 Hodgkin’s Lym phom a 2 * Ankle Brachial Index <0.4 1 McKenna M et al. Atherosclerosis . 1991;87:119-128. 2 Ries LAG et al. SEER Cancer Statistics Review, 1973-1998. National Cancer Institute. September 2000. 10
Vascular Disease and Amputation Impact Neuropathy • International Diabetes Federation estimates that somewhere in the world, a leg is lost to diabetes every 30 seconds. 1 • Leg/foot cramps • In a 2001 study, only 49% of those receiving amputations had any diagnostic vascular • Numbness evaluation prior to amputation. 2 feet/legs/toes • Each year there are 150,000 lower extremity amputations with a $270 million price tag. 3 • Decrease skin temp. • Comprehensive foot care programs can reduce amputation rates by 45-85%. 4 • Sores that don’t heal 1. International Diabetes Federation Time to Act: diabetes and foot care; International Diabetes Federation; 2005 2. Allie, David, “Critical Limb Ischemia: A Global Epidemic. A Critical Analysis of Current Treatment Unmasks the Clinical and Economic Costs of CLI.” Eurointervention, May 2005 3. Smith, DG Fergason, J. Transtibial Amputations Clinical Orthopaedics 1999; 1999:108. 4. Complications of diabetes in the U.S., diabetes.org Risk Factors for Atherosclerosis • PVD • CAD � Smoking � Smoking � Diabetes � Diabetes � Hypertension � Hypertension Video Clip � Dyslipidemia � Dyslipidemia � Sedentary life style � Sedentary life style � Age >50 � Age >50 � Obesity � Obesity � PVD (carotid � PVD (carotid stenosis, AAA) stenosis, AAA) • African Americans, Hispanics, and diabetics have the highest prevalence of PVD 11
Tissue Capture from Recent SFA Cases Heat Map 293 mg 380 mg 261 mg ACC/AHA Guidelines for Analysis of Plaque Gene Expression the Management of PAD • The high prevalence of atherosclerotic risk factors place these patients at a “markedly” increased risk of atherosclerotic ischemic events, including MI and stroke • All patients with lower extremity PAD should achieve risk reduction and specific treatment Patient Plaque Plaque Microarray Excision Analysis targets comparable to those of individuals with established coronary artery disease. 12
Results Patient Background - #1 80 yr old male • Patient’s foot warm on • Coronary Artery Disease follow-up • Hypercholesterolemia • Former smoker • Patient walking • No rest pain daily without leg pain • Claudication • Tissue loss – great toe nail, • Healing of great slightly gangrenous, toe wound – nail painful to touch regrowth Pre 2 mos. Post • Left ABI – 0.61 Performed By: Dr John Paul Runyon, Christ Hospital, Cincinnati, OH Performed By: Dr John Paul Runyon, Christ Hospital, Cincinnati, OH Patient Background - #7 Plaque Excision Procedure • 90 yr old female • Non-healing toe wound • Rest pain • Claudication Pre Pre Post Post • Left ABI – 0.34 Multiple passes in SFA with SilverHawk TM LS catheter; Multiple passes in TPT with SilverHawk SS catheter Performed By: Dr John Paul Runyon, Christ Hospital, Cincinnati, OH Performed By: Dr. Lakshmikumar Pillai, West Virginia University Medical Center, Ruby Memorial Hospital, Morgantown, WV 13
Plaque Excision Procedure Patient Background - #6 • Roadrunner wire, Bernstein catheter, Mailman wire, and 83 yr old female Microglide catheters used to cross total • Non-healing toe wound, occlusion in popliteal tissue loss, gangrenous • Rest pain • Plaque excised in popliteal with • Smoker SilverHawk TM SS catheter • Left ABI – 0.40 • Stent in renal artery • Plaque excised in Pre Post SFA with SilverHawk TM LS catheter Performed By: Dr. Lakshmikumar Pillai, West Virginia University Medical Center, Ruby Memorial Hospital, Morgantown, WV Performed By: Dr. Mark Picone, Heart Hospital of Austin, Austin, TX Plaque Excision Procedure Results • Plaque excision using SilverHawk TM catheters from left SFA, popliteal, and TPT vessels • Post SilverHawk TM procedure: Good flow through prior SFA occlusion, Pre Post into popliteal and TPT Pre 30-days post • SFA: Occluded � 20% residual stenosis Good distal flow to toes, resulting in healing of toe ulcer • TPT: Occluded � 25% residual stenosis Patient reports left toe pain resolved completely Performed By: Dr. Lakshmikumar Pillai, West Virginia University Medical Center, Ruby Memorial Hospital, Morgantown, WV Performed By: Dr. Mark Picone, Heart Hospital of Austin, Austin, TX 14
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