critical limb ischemia
DESCRIPTION
The lack of blood flow resulting in gangrene, rest pain and non-healing wounds make up the disease state known as critical limb ischemia.TRANSCRIPT
CRITICALLIMB
ISCHEMIA
STEVE HENAO MDNEW MEXICO HEART INSTITUTE
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arteries carry blood rich with oxygen and nutrients
from your heart to the rest of the body
ischemiaoccurs when the
arteries that carry blood become narrowed
or blocked
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Plaque is made up of
cholesterol, calcium and fibrous tissue
As more plaque forms, your arteries can narrow and stiffen. Eventually, enough plaque builds up to reduce blood flow to
your arteries.
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when plaque build up accumulates to reduce
flow to your legs, this is called PAD or
Peripheral Arterial Disease
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THIS IS UNFORTUNATELY A PROGRESSIVE DISEASE
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Steve Henao MD
CLI: DEFINED - NON HEALING WOUND - REST PAIN - GANGRENE
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most common presentation
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50 % of individuals that suffer an amputation secondary to PAD
are DEAD IN 12 TO 24 MONTHS
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pad is caused byatherosclerosis
risk factors:
- SMOKING- HIGH CHOLESTEROL-HIGH BLOOD PRESSURE-OBESITY-FAMILY HISTORY OF CARDIOVASCULAR DZ- END STAGE RENAL
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Yost ML. PAD interventional market analysis by vascular territory. Atlanta (GA): THE SAGE GROUP; 2008.
CRITICAL LIMB ISCHEMIA U.S. NUMBERS
Commonly Quoted Incidence per Million 300-1,000
2006 Calculations 87,046 to 290,000 New Cases
Prevalence = 261,000 to 870,000*
Commonly Quoted Incidence per Million 300-1,000
2006 Calculations 87,046 to 290,000 New Cases
Prevalence = 261,000 to 870,000*
*Assumes 20% annual mortality
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WHO PAYS THE PAD BILL?
Medicare67
Medicaid8
Private20
Other5
2009 PAD Patient Discharges by Payer
Yost. The Real Cost of Peripheral Artery Disease. THE SAGE GROUP. 2011.
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PAD PATIENTS IN MEDICARE
7%-10% Medicare Patients Treated for PAD(2001-2005)
$25,400-$62,700* Expenditure per Patient(Range reflects definition of PAD and types of treatments included, i.e. LT Care)
AK Amputation Third Most Commonly Performed Procedure
Total Medicare PAD Bill $67-$185B*
*in 2010 $Hirsch. Vasc Med 2008;13:209. Jaff. Ann Vasc Surg 2010;24:577. THE SAGE GROUP.
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CLI INTERVENTIONAL TREATMENT
THE PATHWAY TO AMPUTATION(2003-2006)
Medicare CLI Patients Who Underwent Major Amputation (n = 20,464)
71% NO REVASCULARIZATION46% NO DIAGNOSTIC ANGIOGRAM
Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94.
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CLI—LOCAL VARIATIONS IN VASCULAR CARE
Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94.
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PAD $164 B CAD $129 CVD $41
*Annual outpatient medication costs + inpatient interventions †U.S. REACH population inpatient costs + outpatient medication: PAD $9,298 X 17.6 M; CAD $7,920 X 16.3 M and CVD $5,854 X 7.0M
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THE MACROECONOMIC COST OF PAD IS HIGH
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THE MACROECONOMIC COST OF PAD IS HIGH
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS
AMPUTATION CONTINUES TO BE THE FIRST TREATMENT FOR CLI IN MANY LOCATIONS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS
AMPUTATION CONTINUES TO BE THE FIRST TREATMENT FOR CLI IN MANY LOCATIONS
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THE MACROECONOMIC COST OF PAD IS HIGH
HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS
HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS
AMPUTATION CONTINUES TO BE THE FIRST TREATMENT FOR CLI IN MANY LOCATIONS
2010 COSTS OF PAD EXCEEDED CAD AND CVD
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STEVE HENAO MD
Tests
• Ankle Brachial Index (ABI)• which compares the
blood pressure in your arms and legs
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STEVE HENAO MD19Wednesday, October 23, 13
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TREATMENT
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The Role of Atherectomy BTK
Steve Henao MDNew Mexico Heart Institute
Albuquerque, NM
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• Regarding tibial atherectomy, there has been a number of single-center or multicenter studies, but all self-reported without core lab or Clinical Event Committee (CEC) adjudication.
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DEFINITIVE LE Determination of Effectiveness of the SilverHawk® Peripheral Plaque Excision System (SilverHawk Device) for the Treatment of Infrainguinal Vessels / Lower Extremities
12 Month Final Results
- the largest independently-adjudicated study of peripheral atherectomy performed to date
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• 800 patients
• Prospective, non-randomized, global/multicenter
• Claudicants and CLI
• Diabetics v non-diabetics
• Primary patency & limb salvage
• SFA, popliteal and tibial
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Lesion Assessment - core lab reported
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Infrapopliteal Subgroup
• 145 patients
• 75 with claudication
• 70 with CLI
• 189 lesions
• 93 in claudicant group
• 96 in CLI group
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infrapopliteal baseline lesion characteristics - Core Lab Reported
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Tibial Data
• 189 infrapopliteal lesions (18%)
•Limb salvage 95% 1 year
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Tibial Data (1 year)
• 189 infrapopliteal lesions (18%)
• Primary patency
• Claudicant subgroup
•90%, lesion length 5.5 cm
• CLI subgroup
• 78%, lesion length 6 cm
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Tibial Patency in Claudicants after atherectomy
Primary Patency by Vessel Claudicant Cohort
75% 77%
90%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
SFA Popliteal InfrapoplitealMean length : 8.1 cm 6.0 cm 5.5 cm Number of Lesions: 536 114 93
Pat
ency
- P
SV
R <
2.4
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tibial patency by lesion length (Claudicants)
Infrapopliteal Primary Patency by Lesion Length in Claudicant Cohort
Pat
ency
- P
SV
R <
2.4
Mean length : 1.8 cm 6.2 cm 13.4 cm Number of Lesions: 34 42 12
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tibial patency for CLIPrimary Patency (PSVR ≤ 2.4)
Infrapopliteal lesions in CLI Cohort
Infrapopliteal: 70 patients, 96 lesions Mean length = 6.0 cm
Baseline stenosis = 76.8% Patency = 78.1%
Infrapopliteal or popliteal: 108 patients, 144 lesions
Mean length = 5.8 cm Baseline stenosis = 76.9%
Patency = 74.3%
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tibial patency in CLI
Infrapopliteal Primary Patency by Lesion Length in CLI Cohort
Mean length : 1.8 cm 6.2 cm 13.4 cm Number of Lesions: 31 34 14
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atherectomy vs PTA-BMS-DES
12 Month Primary Patency in infrapopliteal lesions was higher than published PTA, BMS
and DES, despite a longer mean lesion length.
DESTINY YUKON
DESTINY- Bosiers JVS 2011 Yukon- Rastan et al. EU 2011 ACHILLES- Scheinert JACC 2012 EXCELL- Rocha-Singh 2012
ACHILLES EXCELL
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Periprocedureal complications all infrapopliteal patients
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bail-out stent rate: 2.7% (4/145)
• Claudicants: 4.3%
• (3/70)
• CLI group: 1.3%
• (1/75)
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summary
• Effective for short, medium and long lesions in claudicants and CLI
• Diabetics perform equally well when treated with directional atherectomy to non-diabetics for claudicants
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• Directional atherectomy is a safe and effective treatment option for infrapopliteal disease
• Low complication rate
• Low distal embolic event rate 1.4%
• Low bail-out stent rate 2.7% (1.3% in CLI patients)
• High patency rate
• 90% Primary Patency in Infrapopliteal lesions (5.5 cm) in claudicants
• 78% Primary Patency in Infrapopliteal lesions (6.0 cm) in CLI patients
• 73% Primary Patency in long Infrapopliteal (13.4 cm) in CLI patients
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“an up front debulking strategy is not only safe but is now proven effective and may be the best first
approach—to leave nothing behind—in our patients with symptomatic disease.”
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“Future” treatment:drug-coated
balloonangioplasty
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multi-centerrandomized trial:to compare the safety and
efficacy of drug coated balloon to standard angioplasty for the
treatment of CRITICAL LIMB ISCHEMIA
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• actively ENROLLING
• NMHI is one of 50 sites WORLD-WIDE
• randomized 2:1 for DCB or standard PTA
LUTONIX - DRUG COATED BALLOON(BELOW THE KNEE TRIAL)
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criticallimb ischemia
STEVE HENAO MDNEW MEXICO HEART INSTITUTE
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