Critical Limb Ischemia

CRITICAL
LIMB
ISCHEMIA
STEVE HENAO MD
NEW MEXICO HEART INSTITUTE

Wednesday, October 23, 13

1

arteries
carry blood rich with
oxygen and nutrients
from your heart to the
rest of the body

ischemia
occurs when the
arteries that carry
blood become narrowed
or blocked


2

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.


3

when plaque build up
accumulates to reduce
ﬂow to your legs, this is
called PAD or
Peripheral
Arterial
Disease


4

THIS IS UNFORTUNATELY A
PROGRESSIVE DISEASE


5

CLI: DEFINED
- NON HEALING WOUND
- REST PAIN
- GANGRENE

Steve Henao MD

6

most common
presentation


8

50 % of individuals that suffer an
amputation secondary to PAD

are DEAD IN 12 TO 24
MONTHS


9

pad is caused by
atherosclerosis
risk factors:
- SMOKING
- HIGH CHOLESTEROL
-HIGH BLOOD PRESSURE
-OBESITY
-FAMILY HISTORY OF
CARDIOVASCULAR DZ
- END STAGE RENAL


10

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*
*Assumes 20% annual
mortality

Yost ML. PAD interventional market analysis by vascular territory. Atlanta (GA): THE SAGE GROUP;
2008.

11

WHO PAYS THE PAD BILL?

2009 PAD Patient Discharges by Payer
Other
5

Private
20

Medicare
67

Medicaid
8

Yost. The Real Cost of Peripheral Artery Disease. THE SAGE GROUP. 2011.

12

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.

13

CLI INTERVENTIONAL
TREATMENT
THE PATHWAY TO AMPUTATION
(2003-2006)

Medicare CLI Patients Who Underwent Major Amputation
(n = 20,464)
71% NO REVASCULARIZATION
46% NO DIAGNOSTIC ANGIOGRAM
Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94.


14

CLI—LOCAL VARIATIONS
IN VASCULAR CARE

Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94.

15

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

16

 THE MACROECONOMIC COST OF PAD IS HIGH


17

 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS


17

TOTAL PAD COSTS
 HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY
CARDIOVASCULAR AND NON-PAD EVENTS


17

TOTAL PAD COSTS
AMPUTATION CONTINUES TO BE THE FIRST
TREATMENT FOR CLI IN MANY LOCATIONS


17

TOTAL PAD COSTS
AMPUTATION CONTINUES TO BE THE FIRST
TREATMENT FOR CLI IN MANY LOCATIONS
2010 COSTS OF PAD EXCEEDED CAD AND CVD


17

Tests

• Ankle Brachial Index (ABI)
• which compares the
blood pressure in your
arms and legs

STEVE HENAO MD

18

STEVE HENAO MD

19

TREATMENT


30

The Role of
Atherectomy BTK
Steve Henao MD
New Mexico Heart Institute
Albuquerque, NM


32

• 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.


33

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


34

• 800 patients
• Prospective, non-randomized, global/
multicenter
• Claudicants and CLI
• Diabetics v non-diabetics
• Primary patency & limb salvage
• SFA, popliteal and tibial


35

Lesion Assessment core lab reported


36

Infrapopliteal Subgroup
• 145 patients
• 75 with claudication
• 70 with CLI
• 189 lesions
• 93 in claudicant group
• 96 in CLI group


37

infrapopliteal baseline lesion
characteristics - Core Lab Reported


38

Tibial Data

• 189 infrapopliteal lesions (18%)

•Limb salvage 95% 1 year


39

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


40

Tibial Patency in Claudicants after
atherectomy
Primary Patency by Vessel
Claudicant Cohort
100%

90%

90%
Patency - PSVR < 2.4

80%

75%

77%

70%
60%
50%

40%
30%

20%
10%
0%

SFA
Mean length :
8.1 cm
Number of Lesions: 536


Popliteal
6.0 cm
114

Infrapopliteal
5.5 cm
93

41

tibial patency by lesion
length (Claudicants)

Patency - PSVR < 2.4

Infrapopliteal Primary Patency by
Lesion Length in Claudicant Cohort

Mean length :
1.8 cm


6.2 cm
42

13.4 cm
12

42

tibial patency for CLI
Primary 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%


43

tibial patency in CLI
Infrapopliteal Primary Patency by
Lesion Length in CLI Cohort

Mean length :
1.8 cm


6.2 cm
34

13.4 cm
14

44

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

ACHILLES

YUKON
EXCELL

DESTINY- Bosiers JVS 2011
Yukon- Rastan et al. EU 2011
ACHILLES- Scheinert JACC 2012
EXCELL- Rocha-Singh 2012


45

Periprocedureal complications
all infrapopliteal patients


46

bail-out stent rate: 2.7%
(4/145)

• Claudicants: 4.3%
• (3/70)
• CLI group: 1.3%
• (1/75)


47

summary

• Effective for short, medium and long lesions
in claudicants and CLI
• Diabetics perform equally well when treated
with directional atherectomy to nondiabetics for claudicants


48

• 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

49

“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.”


50

“Future”
treatment:
drug-coated
balloon
angioplasty


51

multi-center
randomized trial:
to compare the safety and
efficacy of drug coated balloon
to standard angioplasty for the
treatment of
CRITICAL LIMB ISCHEMIA


53

LUTONIX - DRUG COATED BALLOON
(BELOW THE KNEE TRIAL)

• actively ENROLLING
• NMHI is one of 50 sites WORLD-WIDE
• randomized 2:1 for DCB or standard
PTA


54

critical
limb ischemia
STEVE HENAO MD
NEW MEXICO HEART INSTITUTE


55

Critical Limb Ischemia

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