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Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence Heart and Vascular Institute Co-Medical Director, Providence Valve Center June 7, 2015 © 2012 Abbott. All rights reserved. NPL03994 Rev. A (10/2012) CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. © 201 2012 Abbott. All rights reserv served. NPL03994 Rev. A (10/2012) CAUTION: Investigational de vice. Lim vice. Limited b ited by Federal (U.S.) law to investigatio ational use only. Disclosures Abbott Vascular: medical advisory board, speakers bureau, education Boston Scientific: medical advisory board Edwards Lifesciences: proctoring Medtronic: speakers bureau Terumo: speakers bureau, education We will be discussing off-label uses of FDA approved devices. 83 y/o M, CAD, CHF EF 45%, DM2, HTN Lives independently with wife 3 months of R foot ulcer and osteomyelitis ABI noncompressible Aggressive wound care, iv abx Angiogram by vascular surgeon A Case…

Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

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Page 1: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Critical Limb Ischemia:

Keeping a Leg Up on This Disease

Ethan Korngold, MD

Medical Director of Cardiovascular Research

Providence Heart and Vascular Institute

Co-Medical Director, Providence Valve Center

June 7, 2015

© 2012 Abbott. All rights reserved. NPL03994 Rev. A (10/2012) CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.© 2012 © 2012 Abbott. All rights reserved. eserved. NPL03994 Rev. A (10/2012) CAUTION: Investigational detional device. Limvice. Limited by Fited by Federal (U.S.) law to investigationaligational use only.

Disclosures

• Abbott Vascular: medical advisory board, speakers bureau, education

• Boston Scientific: medical advisory board

• Edwards Lifesciences: proctoring

• Medtronic: speakers bureau

• Terumo: speakers bureau, education

We will be discussing off-label uses of FDA approved devices.

• 83 y/o M, CAD, CHF EF 45%, DM2, HTN

• Lives independently with wife

• 3 months of R foot ulcer and osteomyelitis

• ABI noncompressible

• Aggressive wound care, iv abx

• Angiogram by vascular surgeon

A Case…

Page 2: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Angiogram

Procedure Note:

“Right LE Angiography

reveals patent arteries to

the right foot, with severe

small-vessel disease.

There is no option for

intervention.”

Occluded R tibioperoneal trunk

Subtotal occlusion R anterior tibial

• 3 months later, sees me for followup

• Wants any option to save his leg

A Case…

Angiogram

0.014” Command Wire 4x20mm Angiosculpt balloon

Page 3: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Angiogram

Final Images

• Ulcer heals 2-3 weeks later

• ABI at one month: 0.9 (mildly abnormal)

One Wire, One Balloon

• Common

• Systemic disease with high risk of

cardiovascular mortality and morbidity

• Requires systemic therapy

• Modern peripheral vascular interventions are

safe and effective

• There is no such thing as “small vessel

disease”

Peripheral Arterial Disease

Page 4: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

0% 5% 10% 15% 20% 25% 30% 35%

29%PARTNERS5

Age >70, or between 50-69 with diabetes or smoking

11.7%San Diego2

Mean Age=66

19.8%Diehm4

Age ≥65

19.1%Rotterdam3

Age >55

14.5%NHANES1

Age ≥70

4.3%

Documented Presence of PAD

When common risk factors were included, the prevalence of PAD was ~1/3 of patients

1. Selvin E, Erlinger TP. NHANES. Circulation. 2004;110:738-743.2. Criqui MH, et al. Circulation. 1985;71:510-515.3. Diehm C, et al. Atherosclerosis. 2004;172:95–105. 4. Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192. 5. Hirsch AT, et al. JAMA. 2001;286:1317-1324.

NHANES1

Age >40

0

20

40

60

55-59 60-64 65-69 70-74 75-79 80-84 85-89

Rotterdam Study (ABI <0.9) San Diego Study (PAD by noninvasive tests)

Prevalence of PAD Increases With Age

Figure adapted from Creager M, ed. Management of Peripheral Arterial Disease. Medical, Surgical and Interventional Aspects. 2000.

Pati

en

ts w

ith

PA

D (

%)

Age Group (y)

Vascular Disease is a Systemic Disease

Bhatt DL, et al. REACH Investigation. Presented at: American College of Cardiology Annual Scientific Session; March 8, 2005; Orlando, FL. Abstract 1127-96.

PAD

36.9%

9.5%

39.4%

14.2%

CVD

CAD

N=7013

Page 5: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Natural History of PAD:

5-year Outcomes

Stable Claudication

70-80%

Worsening Claudication

10-20%

Critical Limb Ischemia

1-2 %

Limb MorbidityLimb Morbidity

Non-CV Causes 25%

CV Causes 75%

Mortality 15-30%

Nonfatal CV Events 15-30%

Cardiovascular Morbidity and Mortality

Weitz et al.

PAD Survival Curve

Criqui MH, et al. N Engl J Med. 1992;326:381–386.

Normal Subjects

Asymptomatic PAD

Symptomatic PAD

Severe Symptomatic PAD

100

75

50

25

0 2 4 6 8 10 12

Surv

ival (%

)

Year

Critical Limb Ischemia (CLI): Fate of Patients After Initial Treatment

Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296.

Summary of 19 studies on 6-month outcomes

tients After Initial Treatment

Summar6-m

Sumon 6-m

Dead

20%

Alive Without Amputation

45%

Alive with Amputation

35%

Page 6: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

• History

• Physical exam

• Non-invasive assessments

• Invasive angiography

Establishing the diagnosis

of PAD

• Asymptomatic

• Intermittent claudication

– Discomfort, ache, cramping in leg with exercise

– Resolves with rest

• Critical limb ischemia

– Rest pain

• Pain or paresthesias in foot or toes, worsened by leg elevation and improved by dependency

– Ischemic ulceration and gangrene

Clinical Manifestations of

PAD

Elevation Pallor

Dependent Rubor

Page 7: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Critical Limb Ischemia (CLI)

Non-invasive assessments of CAD and PAD are similar

Peripheral Arterial Disease

- ABI

- PVR, Segmental Pressures

- Treadmill Test

- Duplex US, CTA, MRA

Coronary Artery Disease

- EKG

- Echo

- Stress Test

- Angiography

The Ankle-Brachial Index (EKG)

• Simple, painless, accurate, highly reproducible

• Clinical utility

–Diagnosis of PAD

–Prognosis: predictor of MACE

Page 8: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

ACC/AHA 2006 PAD Management Guidelines Diagnostic Methods: Ankle-Brachial Index (ABI)

The resting ABI should be used to establish the lower extremity PAD

diagnosis in patients with suspected lower extremity PAD, defined as

individuals:

• with exertional leg symptoms,

• with nonhealing wounds,

• who are 70 years and older,

• or who are 50 years and older with a history of smoking or diabetes.

I IIa IIb III

C

Adapted from Hirsch AT, et al. J Am Coll Cardiol. 2006:47:1239-1312.

Ankle systolic pressure

Brachial systolic pressure

ABI =

• Ankle and brachial systolic pressures taken using a hand-held Doppler instrument

• The ABI is 95% sensitive, 99% specific for PAD

The Ankle-Brachial Index

Normal 0.90 -1.30

PAD < 0.90

Pain/Ulceration < 0.40

Non-Compressible > 1.30

ABI Limitations

• ABI may be elevated in patients with

noncompressible arteries, such as those who

are elderly or have diabetes

• Resting ABI is insensitive to mild aortoiliac

occlusive disease

• Some symptomatic patients have normal

resting ABI (like an EKG)

Page 9: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Diagnostic Algorithm for PAD

History, Physical Examination Suggestive of PAD?

No!Search for Alternate Diagnosis

Yes?

<0.9

PAD

>0.9

Still Suspicious?

>1.30

Vascular Lab Referral •segmental pressures, PVR •graded treadmill test

Anatomic Assessment: DUS, CTA, MRA

Ankle-Brachial Index

Therapies for PAD

Preventing Death, MI, Stroke

• Antiplatelets

• Cholesterol lowering – statins

• ACE Inhibitors

Pre

•••

Reducing Claudication Symptoms

• Exercise

• Cilostazol

• Endovascular interventions

• Surgery

Saving Limbs in CLI

• Endovascular interventions

• Surgery

Therapies for PAD

Preventing Death, MI, Stroke

• Antiplatelets

• Cholesterol lowering – statins

• ACE Inhibitors

Pre

•••

Page 10: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Risk of Occlusive Vascular Events in High-Risk Patients: Antithrombotic Trialists’ Collaboration

Antithrombotic Trialists’ Collaboration. BMJ. 2002;324:71-86.

APT=antiplatelet therapy with aspirin, clopidogrel,

dipyridamide, or a glycoprotein IIb/IIIa antagonist

N=9706

Intermittent

claudication (N=26)

Reduced Increased

Risk versus Control

1.0 1.5 2.00.50.0

6.4 7.9

Peripheral

grafting (N=12)5.4 6.5

Peripheral

angioplasty (N=4)2.5 3.6

All PAD trials (N=42) 5.8 7.1

Risk Category

(number of trials) APT Control

Patients with Event (%)

Intermittent

claudication (N=26)

Reduced IncreasedReduced Increased

6.4 7.9

Peripheral

grafting (N=12)5.4 6.5

Peripheral

angioplasty (N=4)2.5 3.6

All PAD trials (N=42) 5.8 7.1

Risk Category

(number of trials)

Efficacy of Clopidogrel vs Aspirin in MI, Ischemic Stroke, or Vascular Death

Months of Follow-Up

Cum

ula

tive

Event R

ate

(%

)

0

4

8

12

16

Clopidogrel

Aspirin

Overall Relative Risk

Reduction

8.7%*

0 3 6 9 12 15 18 21 24 27 30 33 36

Aspirin

5.83%

5.32%

Clopidogrel

*ITT analysis.CAPRIE Steering Committee. Lancet. 1996;348:1329-1339.

Mean Follow-up = 1.91 years

N=19,185

Heart Protection Study: Vascular Event by Prior Disease

Heart Protection Study Collaborative Group. Lancet. 2002;360:7-22.

MI - myocardial infarction; CHD - coronary heart disease; CVD - cerebrovascular disease; PAD - peripheral arterial disease; CI -

confidence interval; SE - standard error

Previous MI 23.5 29.4

Other CHD 18.9 24.2

No prior CHD or CVD 18.7 23.6

Peripheral arterial disease 24.7 30.5

Diabetes 13.8 18.6

All patients 19.8 25.2

1.0 1.2 1.40.80.60.4

24% Reduction

(p<0.0001)

Existing DiseaseStatin Control

Incidence of Events

(n=10,269)(n=10,267) Statin Favored Placebo

Risk versus Control

Page 11: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Statins Now Have Been Shown to Reduce Adverse Events After Revascularization

Lower MACCE

Better Long Term Patency After Infrapoplital Interventions

Westin GG et al., JACC 2014

HOPE Study Investigators. N Engl J Med. 2000;342:145-153.

HOPE Trial: Ramipril Benefits in

CV Risk Subgroups

NHANES database, 7458 patients, age >40

Pande et al., Circulation 2011

Prevalence of PAD: 5.9%

0%

25%

50%

75%

100%

ASA Statin ACE/ARB

24%30%

36%

PAD patients receiving therapy (%)

PAD Patients are Undertreated

Page 12: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

PAD Patients are Common and Undertreated

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

ASA Statin ACE/ARB

5,400,0005,000,000

4,500,000

Number of patients not receiving therapy (US)

NHANES database, 7458 patients, age >40

Pande et al., Circulation 2011

CLI Patients are Undertreated

Westin GG et al., JACC 2014

Therapies for PAD

Reducing Claudication Symptoms

• Exercise

• Cilostazol

• Endovascular interventions

• Surgery

Page 13: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

140

Effects of Exercise Training on Claudication Meta-analysis of 21 Studies

Gardner AW, Poehlman ET. JAMA. 1995;274:975-980.

Exercise Training

Control

80

200

0

20

40

60

100

120

160

180

Onset of Claudication Pain

Maximal Claudication Pain

Ch

an

ge i

n T

read

mil

l

Walk

ing

Dis

tan

ce (

%)

Therapy of Intermittent Claudication:Magnitude of Functional Improvement

Pentoxifylline

Cilostazol

Supervised Exercise

Improvement Over Baseline After 90 to 180 Days (%)

Gardner AW, Poehlman ET. JAMA. 1995;274:975-980; Girolami B, et al. Arch Intern Med. 1999;159:337-345.Hiatt WR. N Engl J Med. 2001; 344;1608-1621.

0 50 100 150 200

Therapies for PAD

Reducing Claudication Symptoms

• Exercise

• Cilostazol

• Endovascular interventions

• Surgery

Saving Limbs in CLI

• Endovascular interventions

• Surgery

Sav

Page 14: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

• Claudication – Disabling

– Lifestyle limiting

• Critical Limb Ischemia – Tissue loss/ulceration/ischemia

– Rest pain

– Refractory infection

PAD: Indications for Intervention

Analogy: Angina

Urgency: Whenever

Analogy: ACS

Urgency: Now!

Case: Critical Limb Ischemia

• 91 y/o F

–HTN, elevated cholesterol, CVA, CAD, CHF, COPD

• Two months of rest pain, ulceration of right foot,

despite supportive care

• ABI: non-compressible vessels

• PVR: flat

Physiologic Assessment

• ABI or Segmental Pressures

Anatomic Assessment

• Duplex ultrasound

• CTA or MRA

• Angiogram

CLI: What Evaluation is Needed

Page 15: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

• Wound healing requires 6 times as much blood flow as baseline metabolic needs

• Typically multisegment infrainguinal disease

• Often chronic occlusions

• Goal: inline blood flow to foot to facilitate healing

• Safest possible way (high risk patients)

Critical Limb Ischemia: Goals

Tefera et al., JVS 2005

Is long term patency reallyneeded for healing in CLI?

Optimal Perfusion

Actual Perfusion

Metabolic Demand

Trauma

Revascularization

Patent

Restenosis

Time needed for healing

Adapted from: Vermassen F 2010 and S. McDonald 2011

Ulcer

Healing

Page 16: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Traditional Surgical Bypass Has Significant Morbidity and Mortality

• Mortality 2-5%

• Myocardial Infarction 1.9-3.4%

• Hemorrhage 2%

• Graft Thrombosis 2-7%

• Wound Infection 8-19%

• Surgical Revision >20%

TransAtlantic Inter-Society Consensus (TASC) JVS 2000; 31(1;2)

Femoral-Popliteal Bypass: 5 Year Primary Patency

JAMA 1995: 274: 71

0%

25%

50%

75%

100%

Claudication Critical Limb

47%

75%

66%

80%

Vein PTFE

5 year primary patency, pooled data, 1194 cases

Vein Bypass for SFA Disease: 2 year Patency

0%

25%

50%

75%

100%

Femoral-Popliteal Femoral-Tibial

55%

69%

51%

66%

Primary Patency Secondary Patency

24 month followup, 243 patients

Becquemin NEJM 1997: 337:1726

Page 17: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

CryoVein Bypass for CLI:

Primary Patency

0%

25%

50%

75%

100%

Months

0 3 6 9 12 15 18

89%

63%

30%

17%9%

Zehr BP et al., Annals of Vascular Surgery, 2011

Cook Zilver PTX Drug Coated SFA Stent: 5 Year Data

0%

25%

50%

75%

100%

2 year 5 year

83%87%

66%

75%

Patency Freedom from TLR

Presented at VIVA 2014

Abbott Supera SFA Stent: 3 Year Data

0%

25%

50%

75%

100%

1 year 2 year 3 year

82%84%89%86%

PatencyFreedom from TLR

Presented at VIVA 2014

Non-Restenosis Rate by Lesion Length (12 months SUPERB TRIAL)

Page 18: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Infrapopliteal Angioplasty: Meta-analysis

0%

25%

50%

75%

100%

1 month 6 months 1 year 2 years 3 years

82%85%89%91%95%

63%64%68%

74%

83%

49%51%58%

65%

77%

Patency Secondary Patency Limb Salvage

Romiti M, et al., JVS 2008

Disconnect Between Patency and Salvage

Romiti M, et al., JVS 2008

Endovascular First Approach for Critical Limb Ischemia is Effective for Limb Salvage

• Dorros, Jaff, et al., Circ 2001

• Feiring et al., JACC 2004

• Tefera et al., JVS 2005

• Kudo et al., JVS 2005

• May KK, VES 2014

0%

25%

50%

75%

100%

Dorros Feiring Tefera Kudo May

78%

89%84%

90%91%

Limb Salvage at 1-5y

813813 Total Limbs

Page 19: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Infrapopliteal Intervention: Low Complication Rates

0%

2%

4%

6%

8%

10%

Gro

in h

emat

oma

Thom

bosis

Embo

lism

Perfo

ratio

n

Diss

ectio

n

PSA

GIB

Oth

erEm

erge

ncy

Surg

ery

1.3%

0.2%0.2%0.3%0.1%0.7%1.0%

2.1%

3.2%

Emer

g

Emer

g

Little “clinical penalty” in starting with an endovascular approach

Romiti M, et al., JVS 2008

1743 Interventions Analyzed

BASIL Trial: Infrainguinal Critical Limb Ischemia

• 452 patients with CLI, randomized 1:1 to bypass or angioplasty first

• Primary Outcome

–Amputation free survival

–Death

Adam et al., Lancet 2005: 366; 1925

BASIL Trial: Primary Outcomes

Adam et al., Lancet 2005: 366; 1925

BAP

BSX

Surv

ival

(%

)

100

80

40

20

60

0

0 1 2

Time after randomisation (years)

3 4 5

Number at risk

Angioplasty

Surgery224

228

149

148

51

64

100

108

19

23

2

7

Amputation Free Survival

BAP

BSX

Surv

ival

(%

)

100

80

40

20

60

0

0 1 2

Time after randomisation (years)

3 4 5

Number at risk

Angioplasty

Surgery224

228

173

169

63

71

116

120

25

26

6

7

All-Cause Mortality

Page 20: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

BASIL Trial: Conclusions

• No difference in primary endpoint: amputation-free

survival at 6 months

• No difference in health-related QOL

• Higher early morbidity with surgery

• Hospital costs one-third higher with bypass first

– Increased LOS, intensive therapy, wound infection

• Endovascular therapy first is considered a

reasonable approach for critical limb ischemia

Adam et al., Lancet 2005: 366; 1925

Meta-Analysis of Open versus Endovascular Approach to CLI

Hinchliffe RJ et al., Diabetes/Metabolism Research and Reviews 2012

0%

25%

50%

75%

100%

Limb Salvage at 1 Year

78%85%

Open Endovascular

49 Reports, 1980-2010

Comparison of Open Versus Endovascular Approach in CLI Patients: 5 Year Followup

Garg K et al., JVS 2014

0%

25%

50%

75%

100%

Mortality Repeat Procedures Limb Salvage

85%

55%

42%

83%

68%

48%

Open Endovascular

Page 21: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Trends in Revascularization 1996-2011

Goodney PP et al., JAMA Surgery 2015

Trends in Amputation 1996-2011

Goodney PP et al., JAMA Surgery 2015

Page 22: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

How Do We Achieve Success in CLI?

Revascularization

Wound Care Medical Therapy

• What is the safest way of achieving a good result for this anatomy in this patient?

• Which vessels need to be opened?

• How durable of a result is needed?

• If different options: safest, least invasive approach first

• Don’t burn bridges to future options

CLI Management in Practice

Page 23: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Modern Limb Salvage Intervention

Angiosome Guided 0.014” and 0.018” Wires

Tibial/pedal Access

CTO and Re-Entry Devices

Page 24: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Angiosomes of the Foot and Ankle

Attinger, et al. Plast Reconstr Surg. 2006;117 (suppl): 261S–293S. Images courtesy of Dr. Mehdi H. Shishehbor

• Retrospective analysis, 203 limbs (177 patients) with ischemic ulcerations who underwent endovascular therapy

• Patients were classified into direct and indirect revascularization based on the angiosome concept

• Limb salvage was 86% when patients were directly revascularized versus 69% when indirectly revascularized (P = 0.03) for up to 4 years post-procedure

0

20

40

60

80

100

120

0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51

Fre

ed

om

fro

m A

mp

uta

tio

n (

%)

Months

Direct

Indirect

Months 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51

At Risk D 118 82 62 53 48 39 31 23 22 13 11 8 6 3 3 2 2

I 85 59 44 31 27 19 14 11 9 9 4 4 2 2 2 2 2 1

% D 100 91.2 87.6 87.6 85.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9

I 100 88.3 80.4 74.4 69.3 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1 64.1

SE D 0.000 0.028 0.034 0.034 0.038 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.045 0.045

I 0.000 0.037 0.048 0.055 0.062 0.067 0.067 0.067 0.067 0.067 0.067 0.067 0.067 0.067 0.067 0.067 0.067

P value 0.03 0.029 0.029 0.029

Iida , et al. Catheter Cardiovasc Interv .2010; 75:830–836.

Endovascular Therapy for CLI

Based on the Angiosome Principle

Downsize Wires!

Iliac: 0.035”

Femoral/Popliteal:

0.018” or 0.035”

Tibial/Peroneal:

0.014” or 0.018”

Page 25: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Slippery

Intraluminal Crossing DevicesIntraluminal Crossing Devices

TruePath™ TruePath™ CTO Device

CROSSER™ CROSSCROSSER™Catheter

Frontrunner™ XP CTO

Catheter

Wildcat™ WildcWildcat™ Catheter

ces

Viance™ Crossing CrossCrossing ing Catheter

Page 26: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Occluded Anterior Tibial and Posterior Tibial Arteries

Antegrade R Leg Angiogram

CTO Crossing with Avinger KittyCat

Final

Baseline

Final Angiography:

After AT and PT CTO Crossing and Angioplasty

Page 27: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Re-Entry Devices

OffRoad™ Re-Entry ntryntryCatheter

Pioneer™ LTD Catheter

Outback™ Catheter

Enteer™ Catheter

Case: SFA Occlusive Disease

• Antegrade L femoral artery

stick

• Mid SFA total occlusion

with reconstitution in

popliteal

• Two vessel runoff

Subintimal Tracking and Re-entry (STAR)

Crossed the occluded segment, but difficulty re-entering lumen

Page 28: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Potential Solution:

Re-enter true lumen by utilizing a re-entry device

Scenario: Guidewire enters

subintimal space but subisubintimntimal spacepace but fails to re-enter true

lumen

Pioneer Used to Facilitate Reentry Into Distal Lumen

True lumen with Chroma Flo feature

Needle trajectory indicator

Pioneer catheter tip in subintimal space

Intima

Adventitia

> Enhanced ImagingIVUS transducer

> PositioningDual-wire system

> TargetingCurved-needle housing

> AccuracyAdjustable needle depth (1–7)

> ControlDouble-braided shaft

Pioneer adjacent toreconstituted vessel

Wire into true lumen of reconstituted vessel

Intervention with PTA/Stent

True lumen2-vessel runoff

Angioplasty5x150mm balloon

2 overlapping SE stents6x150mm x2

Page 29: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Final Angiography

Baseline Final

Options for CTO Access

The Front Door (antegrade)

The Side Door (subintimal & collateral)

The Back Door (retrograde)

Extensive Collateral Network

Page 30: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Balloon From Above, Withdraw Loop

Final Images, after PTA and Supera Stent

Page 31: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

• Ultrasound or fluoro guidance

• Distal 1/3 of leg

• Access to tibials is easier than peroneal

• Start with micropuncture kit

• 0.014” or 0.018” wire

• Remove access as soon as feasible

• Nitro 100-300mcg per sheath

Tibial/Pedal Access

Technical Success and Safety

of Tibiopedal Access

Bazan H et al., JVS 2014; Mustapha JA et al., CCI 2014

Technic

al S

uccess

0%

25%

50%

75%

100%

Bazan H et al., 2014 Mustapha JA et al., 2014

95%

69%

13 Patients

23 Patients

No Major Access Complications

Fluoro Access

Works well with

• Suboptimal ultrasound images

• Calcified lesions

• Disease near entry site

Spectranetics Quick-Access Needle Holder

Page 32: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Ultrasound

Access

No radiation

Easy to distinguish arteries

from veins

Learning curve

Mustapha JA, et al, EV Today 2014

4F Cook Micropuncture

+/- Tuohy

Wire crossing

4F Terumo

Pinnacle Precision

Supportive wire crossing

Intervention: 0.014” balloon

1.25mm Diamondback

Not Sheathless!

Draping

Page 33: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Hemostasis: External

Courtesy of of Dr. J. Wang

Hemostasis: Internal

Courtesy of of Dr. J. Wang

Balloon inflation

3-5 minutes

Techniques for Retrograde Crossing and ConnectingRetrograde CART Reverse CART Double Balloon

FacilitatedReentry

Page 34: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Occluded Anterior Tibial, Posterior Tibial, and Peroneal Arteries

Crossover R Leg Angiogram: 83 y/o M with Ulcers

CTO Crossing from Posterior Tibial Retrograde Access

Angioplasty of Posterior Tibial

• Vascutrak 3x250mm scoring balloon

Page 35: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

FinalBaseline

Final Angiography

Reverse CART Technique

Long SFA Total Occlusion Reverse CARTFinal ImagesPost Stents

85 y/o F

Not diabetic

R foot ulcer x 2y

Page 36: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Retrograde AT access

Unable to pass into Unable to pass into

popliteal true lumen

Double Balloon:

5x20mm and

4x30mm Fox SV

Wired from above

with Steelcore

4.5 x 60mm Supera stent in popliteal

4 x 40mm Chocolate in popliteal-AT 4 x 40mm Chocolate in popliteal-AT

3 x 40mm Armada 0.014” PTA in AT

Heavily Calcified SFA Complex Lesion

Page 37: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Subintimal with Wire…

Subintimal with Wire…Outback Re-entry…Failed…

Retrograde AT Access, Unable to Connect Wires

Page 38: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Retrograde PTA to Facilitate Outback Re-entry

Antegrade PTA and Supera Stent

Final Angiogram

Page 39: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Modern Limb Salvage Intervention: ATK Treatment

Atherectomy

Drug Coated Balloons

Newer SFA Stents

Specialty Balloons

Atherectomy Devices

Silverhawk

Jetstream

Diamondback

LASER

12-Month Primary Patency (K-M) for Superficial Femoral Artery Endovascular Therapies

Page 40: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Modern Limb Salvage Intervention: BTK Treatment

Long 0.014” Balloons/Long Inflation Times

Atherectomy

Coronary DES (as Bailout)

Specialty Balloons

Atherectomy

93 y/o F

R foot ulcer x 4 mos

Not diabetic

ABI non-comp

Orbital Atherectomy

1.25mm solid crown

Adjunctive PTA

Angiosculpt Balloon: Recalcitrant Lesions

Page 41: Korngold-Critical Limb Ischemia - Oregon ACC · Critical Limb Ischemia: Keeping a Leg Up on This Disease Ethan Korngold, MD Medical Director of Cardiovascular Research Providence

Chocolate Balloon: Popliteal

Modern Limb Salvage Intervention: Treatment

Specialty BalloonsSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecSpecialtialtialtialtialtialtialtialtialty Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Bay Balloolloolloolloolloolloolloolloolloolloolloolloolloonsnsnsnsns

Multiple options

Little comparative data

Tailor to anatomy

• Be vigilant for PAD

• Systemic disease requires systemic treatment

• Medical therapy

• Wound care

• Cardiovascular risk assessment

• Consider revascularization early

• There is no such thing as “small vessel

disease”

Critical Limb Ischemia:

Conclusions