0
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
arte...
Plaque
is made up of
cholesterol, calcium
and fibrous tissue

As more plaque forms,
your arteries can narrow
and stiffen. ...
when plaque build up
accumulates to reduce
flow to your legs, this is
called PAD or
Peripheral
Arterial
Disease

Wednesday,...
THIS IS UNFORTUNATELY A
PROGRESSIVE DISEASE

Wednesday, October 23, 13

5
CLI: DEFINED
- NON HEALING WOUND
- REST PAIN
- GANGRENE

Steve Henao MD
Wednesday, October 23, 13

6
Wednesday, October 23, 13

7
most common
presentation

Wednesday, October 23, 13

8
50 % of individuals that suffer an
amputation secondary to PAD

are DEAD IN 12 TO 24
MONTHS

Wednesday, October 23, 13

9
pad is caused by
atherosclerosis
risk factors:
- SMOKING
- HIGH CHOLESTEROL
-HIGH BLOOD PRESSURE
-OBESITY
-FAMILY HISTORY ...
CRITICAL LIMB ISCHEMIA
U.S. NUMBERS
Commonly Quoted
Incidence per Million 300-1,000

2006 Calculations
87,046 to 290,000 N...
WHO PAYS THE PAD BILL?

2009 PAD Patient Discharges by Payer
Other
5

Private
20

Medicare
67

Medicaid
8

Yost. The Real ...
PAD PATIENTS IN MEDICARE
7%-10% Medicare Patients Treated for PAD
(2001-2005)

$25,400-$62,700* Expenditure per Patient
(R...
CLI INTERVENTIONAL
TREATMENT
THE PATHWAY TO AMPUTATION
(2003-2006)

Medicare CLI Patients Who Underwent Major Amputation
(...
CLI—LOCAL VARIATIONS
IN VASCULAR CARE

Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94.
Wednesday, October 23, 13

15
PAD $164 B
CAD $129
CVD $41

*Annual outpatient medication costs + inpatient interventions
†U.S. REACH population inpatien...
Wednesday, October 23, 13

17
Wednesday, October 23, 13

17
Wednesday, October 23, 13

17
 THE MACROECONOMIC COST OF PAD IS HIGH

Wednesday, October 23, 13

17
 THE MACROECONOMIC COST OF PAD IS HIGH

Wednesday, October 23, 13

17
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS

Wednesday, October 2...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS

Wednesday, October 2...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS
 HOSPITAL COSTS ARE ...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS
 HOSPITAL COSTS ARE ...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS
 HOSPITAL COSTS ARE ...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS
 HOSPITAL COSTS ARE ...
 THE MACROECONOMIC COST OF PAD IS HIGH
 HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF
TOTAL PAD COSTS
 HOSPITAL COSTS ARE ...
Tests

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

STEVE HENAO MD
Wednesday, O...
STEVE HENAO MD
Wednesday, October 23, 13

19
Wednesday, October 23, 13

20
Wednesday, October 23, 13

21
Wednesday, October 23, 13

22
Wednesday, October 23, 13

23
Wednesday, October 23, 13

24
Wednesday, October 23, 13

25
Wednesday, October 23, 13

26
Wednesday, October 23, 13

27
Wednesday, October 23, 13

28
Wednesday, October 23, 13

29
TREATMENT

Wednesday, October 23, 13

30
Wednesday, October 23, 13

31
The Role of
Atherectomy BTK
Steve Henao MD
New Mexico Heart Institute
Albuquerque, NM

Wednesday, October 23, 13

32
• Regarding tibial atherectomy, there has been a
number of single-center or multicenter studies,
but all self-reported wit...
DEFINITIVE LE Determination of Effectiveness
of the SilverHawk® Peripheral Plaque Excision
System (SilverHawk Device) for ...
• 800 patients
• Prospective, non-randomized, global/
multicenter
• Claudicants and CLI
• Diabetics v non-diabetics
• Prim...
Lesion Assessment core lab reported

Wednesday, October 23, 13

36
Infrapopliteal Subgroup
• 145 patients
• 75 with claudication
• 70 with CLI
• 189 lesions
• 93 in claudicant group
• 96 in...
infrapopliteal baseline lesion
characteristics - Core Lab Reported

Wednesday, October 23, 13

38
Tibial Data

• 189 infrapopliteal lesions (18%)

•Limb salvage 95% 1 year

Wednesday, October 23, 13

39
Tibial Data (1 year)
• 189 infrapopliteal lesions (18%)
• Primary patency
• Claudicant subgroup

•90%, lesion length 5.5 c...
Tibial Patency in Claudicants after
atherectomy
Primary Patency by Vessel
Claudicant Cohort
100%

90%

90%
Patency - PSVR ...
tibial patency by lesion
length (Claudicants)

Patency - PSVR < 2.4

Infrapopliteal Primary Patency by
Lesion Length in Cl...
tibial patency for CLI
Primary  Patency  (PSVR  ≤  2.4)  
Infrapopliteal lesions in CLI Cohort
Infrapopliteal:
70 patients...
tibial patency in CLI
Infrapopliteal Primary Patency by
Lesion Length in CLI Cohort

Mean length :
1.8 cm
Number of Lesion...
atherectomy vs PTA-BMS-DES
12 Month Primary Patency in infrapopliteal
lesions was higher than published PTA, BMS
and DES, ...
Periprocedureal complications
all infrapopliteal patients

Wednesday, October 23, 13

46
bail-out stent rate: 2.7%
(4/145)

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

Wednesday, October 23, 13

47
summary

• Effective for short, medium and long lesions
in claudicants and CLI
• Diabetics perform equally well when treat...
• Directional atherectomy is a safe and effective treatment option
for infrapopliteal disease
• Low complication rate
• Lo...
“an up front debulking strategy is not only safe but
is now proven effective and may be the best first
approach—to leave n...
“Future”
treatment:
drug-coated
balloon
angioplasty

Wednesday, October 23, 13

51
Wednesday, October 23, 13

52
multi-center
randomized trial:
to compare the safety and
efficacy of drug coated balloon
to standard angioplasty for the
t...
LUTONIX - DRUG COATED BALLOON
(BELOW THE KNEE TRIAL)

• actively ENROLLING
• NMHI is one of 50 sites WORLD-WIDE
• randomiz...
critical
limb ischemia
STEVE HENAO MD
NEW MEXICO HEART INSTITUTE

Wednesday, October 23, 13

55
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Critical Limb Ischemia

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The lack of blood flow resulting in gangrene, rest pain and non-healing wounds make up the disease state known as critical limb ischemia.

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Transcript of "Critical Limb Ischemia"

  1. 1. CRITICAL LIMB ISCHEMIA STEVE HENAO MD NEW MEXICO HEART INSTITUTE Wednesday, October 23, 13 1
  2. 2. 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 Wednesday, October 23, 13 2
  3. 3. 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. Wednesday, October 23, 13 3
  4. 4. when plaque build up accumulates to reduce flow to your legs, this is called PAD or Peripheral Arterial Disease Wednesday, October 23, 13 4
  5. 5. THIS IS UNFORTUNATELY A PROGRESSIVE DISEASE Wednesday, October 23, 13 5
  6. 6. CLI: DEFINED - NON HEALING WOUND - REST PAIN - GANGRENE Steve Henao MD Wednesday, October 23, 13 6
  7. 7. Wednesday, October 23, 13 7
  8. 8. most common presentation Wednesday, October 23, 13 8
  9. 9. 50 % of individuals that suffer an amputation secondary to PAD are DEAD IN 12 TO 24 MONTHS Wednesday, October 23, 13 9
  10. 10. pad is caused by atherosclerosis risk factors: - SMOKING - HIGH CHOLESTEROL -HIGH BLOOD PRESSURE -OBESITY -FAMILY HISTORY OF CARDIOVASCULAR DZ - END STAGE RENAL Wednesday, October 23, 13 10
  11. 11. 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. Wednesday, October 23, 13 11
  12. 12. 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. Wednesday, October 23, 13 12
  13. 13. 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. Wednesday, October 23, 13 13
  14. 14. 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. Wednesday, October 23, 13 14
  15. 15. CLI—LOCAL VARIATIONS IN VASCULAR CARE Goodney. Circ Cardiovasc Qual Outcome 2012; 5:94. Wednesday, October 23, 13 15
  16. 16. 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 Wednesday, October 23, 13 16
  17. 17. Wednesday, October 23, 13 17
  18. 18. Wednesday, October 23, 13 17
  19. 19. Wednesday, October 23, 13 17
  20. 20.  THE MACROECONOMIC COST OF PAD IS HIGH Wednesday, October 23, 13 17
  21. 21.  THE MACROECONOMIC COST OF PAD IS HIGH Wednesday, October 23, 13 17
  22. 22.  THE MACROECONOMIC COST OF PAD IS HIGH  HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS Wednesday, October 23, 13 17
  23. 23.  THE MACROECONOMIC COST OF PAD IS HIGH  HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS Wednesday, October 23, 13 17
  24. 24.  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 Wednesday, October 23, 13 17
  25. 25.  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 Wednesday, October 23, 13 17
  26. 26.  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 Wednesday, October 23, 13 17
  27. 27.  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 Wednesday, October 23, 13 17
  28. 28.  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 Wednesday, October 23, 13 17
  29. 29. Tests • Ankle Brachial Index (ABI) • which compares the blood pressure in your arms and legs STEVE HENAO MD Wednesday, October 23, 13 18
  30. 30. STEVE HENAO MD Wednesday, October 23, 13 19
  31. 31. Wednesday, October 23, 13 20
  32. 32. Wednesday, October 23, 13 21
  33. 33. Wednesday, October 23, 13 22
  34. 34. Wednesday, October 23, 13 23
  35. 35. Wednesday, October 23, 13 24
  36. 36. Wednesday, October 23, 13 25
  37. 37. Wednesday, October 23, 13 26
  38. 38. Wednesday, October 23, 13 27
  39. 39. Wednesday, October 23, 13 28
  40. 40. Wednesday, October 23, 13 29
  41. 41. TREATMENT Wednesday, October 23, 13 30
  42. 42. Wednesday, October 23, 13 31
  43. 43. The Role of Atherectomy BTK Steve Henao MD New Mexico Heart Institute Albuquerque, NM Wednesday, October 23, 13 32
  44. 44. • 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. Wednesday, October 23, 13 33
  45. 45. 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 Wednesday, October 23, 13 34
  46. 46. • 800 patients • Prospective, non-randomized, global/ multicenter • Claudicants and CLI • Diabetics v non-diabetics • Primary patency & limb salvage • SFA, popliteal and tibial Wednesday, October 23, 13 35
  47. 47. Lesion Assessment core lab reported Wednesday, October 23, 13 36
  48. 48. Infrapopliteal Subgroup • 145 patients • 75 with claudication • 70 with CLI • 189 lesions • 93 in claudicant group • 96 in CLI group Wednesday, October 23, 13 37
  49. 49. infrapopliteal baseline lesion characteristics - Core Lab Reported Wednesday, October 23, 13 38
  50. 50. Tibial Data • 189 infrapopliteal lesions (18%) •Limb salvage 95% 1 year Wednesday, October 23, 13 39
  51. 51. 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 Wednesday, October 23, 13 40
  52. 52. 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 Wednesday, October 23, 13 Popliteal 6.0 cm 114 Infrapopliteal 5.5 cm 93 41
  53. 53. tibial patency by lesion length (Claudicants) Patency - PSVR < 2.4 Infrapopliteal Primary Patency by Lesion Length in Claudicant Cohort Mean length : 1.8 cm Number of Lesions: 34 Wednesday, October 23, 13 6.2 cm 42 13.4 cm 12 42
  54. 54. 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% Wednesday, October 23, 13 43
  55. 55. tibial patency in CLI Infrapopliteal Primary Patency by Lesion Length in CLI Cohort Mean length : 1.8 cm Number of Lesions: 31 Wednesday, October 23, 13 6.2 cm 34 13.4 cm 14 44
  56. 56. 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 Wednesday, October 23, 13 45
  57. 57. Periprocedureal complications all infrapopliteal patients Wednesday, October 23, 13 46
  58. 58. bail-out stent rate: 2.7% (4/145) • Claudicants: 4.3% • (3/70) • CLI group: 1.3% • (1/75) Wednesday, October 23, 13 47
  59. 59. 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 Wednesday, October 23, 13 48
  60. 60. • 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 Wednesday, October 23, 13 49
  61. 61. “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.” Wednesday, October 23, 13 50
  62. 62. “Future” treatment: drug-coated balloon angioplasty Wednesday, October 23, 13 51
  63. 63. Wednesday, October 23, 13 52
  64. 64. multi-center randomized trial: to compare the safety and efficacy of drug coated balloon to standard angioplasty for the treatment of CRITICAL LIMB ISCHEMIA Wednesday, October 23, 13 53
  65. 65. 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 Wednesday, October 23, 13 54
  66. 66. critical limb ischemia STEVE HENAO MD NEW MEXICO HEART INSTITUTE Wednesday, October 23, 13 55
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