Critical Limb Ischemia

CRITICALLIMB

ISCHEMIA

STEVE HENAO MDNEW MEXICO HEART INSTITUTE

1Wednesday, October 23, 13

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

2Wednesday, October 23, 13

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.

3Wednesday, October 23, 13

when plaque build up accumulates to reduce

flow to your legs, this is called PAD or

Peripheral Arterial Disease

4Wednesday, October 23, 13

THIS IS UNFORTUNATELY A PROGRESSIVE DISEASE

5Wednesday, October 23, 13

Steve Henao MD

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

6Wednesday, October 23, 13

7Wednesday, October 23, 13

most common presentation

8Wednesday, October 23, 13

50 % of individuals that suffer an amputation secondary to PAD

are DEAD IN 12 TO 24 MONTHS

9Wednesday, October 23, 13

pad is caused byatherosclerosis

risk factors:

- SMOKING- HIGH CHOLESTEROL-HIGH BLOOD PRESSURE-OBESITY-FAMILY HISTORY OF CARDIOVASCULAR DZ- END STAGE RENAL

10Wednesday, October 23, 13

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

11Wednesday, October 23, 13

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.

12Wednesday, October 23, 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.

13Wednesday, October 23, 13

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.

14Wednesday, October 23, 13

CLI—LOCAL VARIATIONS IN VASCULAR CARE

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

15Wednesday, October 23, 13

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

16Wednesday, October 23, 13

17Wednesday, October 23, 13

17Wednesday, October 23, 13

17Wednesday, October 23, 13

THE MACROECONOMIC COST OF PAD IS HIGH

17Wednesday, October 23, 13

THE MACROECONOMIC COST OF PAD IS HIGH

17Wednesday, October 23, 13

THE MACROECONOMIC COST OF PAD IS HIGH

HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS

17Wednesday, October 23, 13

THE MACROECONOMIC COST OF PAD IS HIGH

HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS

17Wednesday, October 23, 13

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

17Wednesday, October 23, 13

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

17Wednesday, October 23, 13

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

17Wednesday, October 23, 13

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

17Wednesday, October 23, 13

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

17Wednesday, October 23, 13

STEVE HENAO MD

Tests

• Ankle Brachial Index (ABI)• which compares the

blood pressure in your arms and legs

18Wednesday, October 23, 13

STEVE HENAO MD19Wednesday, October 23, 13

20Wednesday, October 23, 13

21Wednesday, October 23, 13

22Wednesday, October 23, 13

23Wednesday, October 23, 13

24Wednesday, October 23, 13

25Wednesday, October 23, 13

26Wednesday, October 23, 13

27Wednesday, October 23, 13

28Wednesday, October 23, 13

29Wednesday, October 23, 13

TREATMENT

30Wednesday, October 23, 13

31Wednesday, October 23, 13

The Role of Atherectomy BTK

Steve Henao MDNew Mexico Heart Institute

Albuquerque, NM

32Wednesday, October 23, 13

• 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.

33Wednesday, October 23, 13

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

34Wednesday, October 23, 13

• 800 patients

• Prospective, non-randomized, global/multicenter

• Claudicants and CLI

• Diabetics v non-diabetics

• Primary patency & limb salvage

• SFA, popliteal and tibial

35Wednesday, October 23, 13

Lesion Assessment - core lab reported

36Wednesday, October 23, 13

Infrapopliteal Subgroup

• 145 patients

• 75 with claudication

• 70 with CLI

• 189 lesions

• 93 in claudicant group

• 96 in CLI group

37Wednesday, October 23, 13

infrapopliteal baseline lesion characteristics - Core Lab Reported

38Wednesday, October 23, 13

Tibial Data

• 189 infrapopliteal lesions (18%)

•Limb salvage 95% 1 year

39Wednesday, October 23, 13

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

40Wednesday, October 23, 13

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

41Wednesday, October 23, 13

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

42Wednesday, October 23, 13

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%

43Wednesday, October 23, 13

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

44Wednesday, October 23, 13

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

45Wednesday, October 23, 13

Periprocedureal complications all infrapopliteal patients

46Wednesday, October 23, 13

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

• Claudicants: 4.3%

• (3/70)

• CLI group: 1.3%

• (1/75)

47Wednesday, October 23, 13

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

48Wednesday, October 23, 13

• 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

49Wednesday, October 23, 13

“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.”

50Wednesday, October 23, 13

“Future” treatment:drug-coated

balloonangioplasty

51Wednesday, October 23, 13

52Wednesday, October 23, 13

multi-centerrandomized trial:to compare the safety and

efficacy of drug coated balloon to standard angioplasty for the

treatment of CRITICAL LIMB ISCHEMIA

53Wednesday, October 23, 13

• 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)

54Wednesday, October 23, 13

criticallimb ischemia

STEVE HENAO MDNEW MEXICO HEART INSTITUTE

55Wednesday, October 23, 13