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Critical Limb Ischemia (CLI)

-NEW INTERVENTIONAL TECHNIQUES ARE

BREAKING THE LAST BARRIER-

G.Biamino

University of Leipzig Heart Center

Department of Clinical and Interventional AngiologyLeipzig, Germany

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Pathogenesis of PAOD,

clinical and economicalimpact of critical limb

ischemia (CLI)

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PAOD Prevalence Recently published data indicate that in

the mean time the age-adjustedprevalence od PAOD is approximately

12%

And that the disorder affects men andwomen equally.

W. Hiatt, NEJM,344,1608-1621,2001

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MAJOR PAOD RISK FACTORS

Older age (> 40 years) Smoking

Diabetes mellitus Hyperlipidemia

Hypertension

Male gender

Hyperhomocysteinemia

Am J Cardiol 2001; 87 (suppl): 3D-13DNEJM 2001; 344: 1608-1621

When risk factors coexist, the risk increases several-fold

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The population group > 65 years willnearly double in the US over the next 30

years

12,4% in 1993

22% n 2030

Natl. Acad. Press 1992

40 mil

Social impact of PAOD

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The severity of PAOD is closelyassociated with the risk of

Myocardial infarction

Ischemic stroke

Death from vascular cuases

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The lower the ankle-brachial index

the greater the risk of CV events!!

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Peripheral Arterial Disease

10-year-survival (ABI stratifi

cation)

McKenna M. Atherosclerosis 1991; 87: 119-28

Years

S u r v

i v a

l ( %

)

ABI > 0.85

ABI 0.4-0.85

ABI < 0.40

0 2 4 6 8 10

20

40

60

80

100* ABI: Ankle-Brachial-Index

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Critical Limb Ischemia Taking the assumption that 4 - 6 mill.Americans have a symptomatic PAOD,

approximately

10 %

of those suffer from CLI

M.Jaff,2003

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CRITICAL LIMB ISCHEMIA CLI

CLI is the clinical manifestation of an end-stage situation of PAOD

In CLI blood flow is so inadequate that

ulcerations and gangrene occur. Once PAOD has progressed to CLI, the

risks of limb loss and mortality increase:

At six months after diagnosis approximately20% of those with CLI will die;

another35% will experience amputation.

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Amputation is not onlyextremely undesirable from

the pateint`s viewpoint, it issocially undesirable in terms

of costs

THE SAGE GROUP Report ,Sept.04 (M.L.Yost)

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The inability of a large

percentage of these amputees to

live independently addssignificantly to the total cost

burden


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Only 40% of those undergoing

a below-the-knee operation, and

20% or less of those undergoingabove-the-knee amputation

achieve full mobility.


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Because of CLI in PAOD approximately

160,000 amputations

are performed annually in the U.S Depending on the patient population

Procedural mortality rates range from4% - 30%

Morbidity from 20 37 %

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Peripheral Artery Disease -PAOD

Source: Business Wire, Fri. Sept 10, 2004

According to THE SAGE GROUP report(www.thesagegroup.us.)

In USA, Related Amputation

Costs are Estimated around$ 10 BILLION per year.

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Eur J Vasc Endovasc Surg 1996;12:359

Cost of managing limb-threatening ischaemia

Sheffield, UK

115 consecutive patients (CLI)

treatment and rehabilitation costs in the first year

median costs (interquartile range)

Angioplasty (29) 9.917 (5.445 - 15.300) Euro

Surgery (52) 10.149 (6.505 - 14.150) Euro

Primary amputation (34)15.243 (11.841 - 19.539) Euro

No difference between angioplasty and surgical reconstruction.

Amputation with increased overall costs

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Surgical treatment for CLI (Finland):

5 year follow-up of socioeconomic outcome

Eur J Vasc Endovasc Surg. 1997;13:452

Reconstruction without later amputation:

43.750 Euro / patient

11.750 Euro/survival year

Reconstruction with a later amputation:

100.500 Euro/patient

37.000 Euro/survival year

Primary amputation :

78.250 Euro/patient

37.500 Euro/survival year.... resulting in institutional treatment in over 20% of the remaining

surviving days

Salvage - failure ratio to be minimised as they increase costs

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Rather than the reconstruction procedure itself, the

nursing and home healthcare constitute the main

reasons for high costs of CLI.

It often demands repeated interventions to achieve

good results. No difference between angioplasty andsurgical reconstruction.

On a cost/survival year basis, amputations carry higher

costs.

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Amputation

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Diagnostic Evaluation Prior toFirst Key Procedure

First Key Procedure

# Patientswith Lesion

AssessmentTotal # Patients in

Pathway Group

Percent of Patients ReceivingLesion Assessment Before

First Key Procedure

Amputation 138 281 49%

Bypass 67 96 70%

PTA 33 40 83%

Total 238 417 57%

Less than 1/2(49%) of the patients that eventually received a primary amputation

had any diagnostic evaluationprior to their amputation!

Not even a simple ABI!Courtesy of D.Allie

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mobility after primary reconstruction

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mobility after primary amputation

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GOALS OF TREATMENT

To relieve exertional symptoms andimprove walking capacity

To improve quality of life

To reduce total mortality as well as

cardiac and cerebrovascular morbidity

and mortality

NEJM 2001; 344: 1608-21

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MANAGEMENT

Risk factor modification Antiplatelet therapy

Medical therapy targeted at symptoms

Exercise therapy

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EXERCISE PROGRAM

Improves walking ability

Requires motivation and

personalised supervision

NEJM 2001; 344: 1608-21

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Symptomatic Patient Population withPAOD

The question of

Best Therapy

becomes more complex when thediscussion not only includes

procedural durability, but alsoconcommitant morbidity/mortality

and procedural repeatability.

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PRIMARY SITES

OF

INVOLVEMENT

Femoral & Poplitealarteries: 80-90%

Tibial & Peronealarteries: 40-50%

Aorta & Iliac arteries:30%

Harrisons Principles

of Int Med

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Critical Limb Ischemia

Arterial pressure at ankle-level < 40mmHg

ABI < 0.5

FontaineFontainegradegrade

IIIIII restrest painpain

IVIV ulcerulcer,, gangrenegangrene

RutherfordRutherfordclassificationclassification

4 rest pain

5 minor tissue loss

6 major tissue loss

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InfrapoplitealObstructions

33 vesselsvessels nono crit ical ischemia critical ischemiacrit ical ischemia critical ischemia

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Infrapopliteal PTA

Before PTA PTA

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post PTA

Infrapopliteal PTA

A i l f Tibi l A i

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Angioplasty of Tibial ArteriesAngioplasty of Tibial Arteries

A i l f Tibi l A iA i l t f Tibi l A t i

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A i l t f Tibi l A t iA i l t f Tibi l A t i

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2/100mm

- balloon

Pre PTA


Post PTA

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65 years, male

PAOD Fontaine IV

Art. Hypertonus, HLP

Diabetes mellitus

Insulin dependent since 10 Y.

Preterminale Renal Failure

Crea: 947 umol/ml

Hst: 36,7 mmol/l

Pressure at Rest ATP 30 mmHg

ATA 20 mmHg

Typical CLI

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PTA of the A. tibialis anterior

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pre post

PTA of the A. tibialis anterior

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Follow -upFollow -up

Complete healing left foot

Controlangio left (11 Mo)

PTA f th i ht A tibi li t i

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PTA of the right A. tibialis posterior

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Final Result

EXCIMER LASER

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First debulk,

then dilate !

EXCIMER LASER

ATHERECTOMY

2 0 mm Vitesse C vs Vitesse C

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2.0 mm 2.0 mm

22% larger lumen

62% greater

ablation area

Vitesse C

Beam

Profile

Vitesse COSBeam Profile

2.0 mm Vitesse C vs. Vitesse COS

Vitesse C 2.0mm

0.018 compatible

61 micron fibers

Vitesse Cos

0.014 compatible

61 micron fibers

Optimally

Spaced

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STEP by STEP TECHNIQUE

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DO WE HAVE

SCENTIFIC DATA ?

YES

LaserAngioplasty for Critical Limb

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LaserAngioplasty forCritical Limb

Ischemia TheLACI Clinical Trial

Arizona Heart 23Hertzentrum Leipzig 24

Hertzentrum Bad Kroz. 22

Greenville Memorial 19

Manatee Hospital 10Lankanau Memorial 8

Riverside Methodist 7

Glendale Memorial 7St. Josephs Paterson 6

Univ. Frankfurt 5Springhill Memorial 5

Washington HC 5Ochsner Clinic 1St. Lukes Milwaukee 1

P.I. : John Laird and Giancarlo Biamino

155 limbs in 145 patients at 14 sites

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LACI Phase 2 Registry

Included Poor surgical candidates only:

poor or absent vessel for outflow

anastamosis, or

absence of venous conduit, or

significant cardiac co-morbidity

Included 0.9 mm - 2.5mm

Spectranetics laser catheters

6-Month Results

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6-Month Results

Total enrollmentTotal enrollment 155 limbs155 limbs

deathdeath 1717lost to follow-uplost to follow-up 1111

Reached 6-month follow-upReached 6-month follow-up 127127

Major amputation among survivorsMajor amputation among survivors 99

Survival with limb salvageSurvival with limb salvage 118/127 = 93%118/127 = 93%

Final Results presented by J.Laird at TCT 2003

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Case Profile

45 year old female

Diabetes mellitus,morbid obesity

Distal popliteal

occlusion, tibial

disease

Painful, ischemic 2nd

toe

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SITE 009-WHC

PAT 005

6 MOS

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Lytic regime: Bolus of 10.000 I.U. Heparin +

7.0 mg rtPA,local. Systemic Infusion of 1000 I.U./hrHeparin + local Inf. of 2.0 mg/hr rtPA.

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Result after 36 hrs lytic

Therapy

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Indications and Resultsof Tibial Stenting

Indication and techniques for infrapopliteal

interventions

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Complex case:

Laser and stent implantationTTF chronic occlusion

distal run-off

interventions


interventions

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Complex case: Laser and stent implantationinterventions

after Excimer LaserOcclusion of TTF


interventions

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Complex case: Laser and stent implantation

Stenting of TTF Additional stenting of ATA

interventions


interventions

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Complex case: Laser and stent implantation

Final result

interventions

Stents in TTF + ATA

Stenting below the Knee

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Primary Technical Success Rate 100%.

Follow-Up : Mean 10.7 m (9-12). Angiographic Patency with a Restenosis < 50%

23 of 48 44.2 % Clinical Patency with mantained improvement

41 of 51 80 %

Successful Redilatation in 20 of 25

Primary Assisted Patency Rate : 84 %

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What about

Sirolimus coated

stents

in Tibial Arteries ???

Cypher versus Bare Stent

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below the knee

NS43Rutherford class. 3



NS16 (76,1%)13 (72%)Diabetes

NS13 (62%)11 (61%)male

7272age2118n

pControlCypher


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below the knee

1 (4,7%)0Reocclusion

3 (14,3%)0Restenosis

8 (38,1%)8 (44,4%)

n - 6-month follow-

up

Control(n=21)

Cypher(n=18)

Conclusion

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The role of PTA of infrapopliteal

arteries is increasing.

Dedicateddevelopment of stent

devices suitable forTIBIAL

arteries is urgently expected

Trials investigating the role of

drug-eluting stents in the

infrageniculate region are

mandatory

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My personal Conviction

Bypass grafting has beensupplanted by endoluminal

techniques in several vascularbeds.

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Reasons of Turf Battles

vascular surgery: ourdisease

radiology: ourprocedures

cardiology: ourpatients

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Final Remarks

POBA remains the principal tool for

desobstructions in PAOD.

Different techniques have been recently

introduced enlarging the interventional

armamenterium.

More scientific data demontrating the real

validity of the all these new tools in the day-

to-day praxis have to be generated .

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Unless you try to do something beyond what you

have already mastered, you will never grow

Patient Question to his

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Cardiologist

Can you open the

artery in my leg thesame way you opened

the artery in my heart ?

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76 Year-old male smoker with diabetesmellitus, hyperlipidemia and CHD

Claudication in the right leg after 50 m Baseline ABI = 0.53 at rest

Treadmill test refused

Baseline Images

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After Cryoplasty

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