Jean-Baptiste RiccoVascular service

Hospital Jean BernardUniversity of Poitiers, France

CHRONIC CRITICAL LIMB ISCHEMIA

DIFFICULT PATIENTS TO TAKE CARE

82 y.o. man s/p aortic tube graft 12 years ago

Rest pain, gangrene of the right toe

Chronic heart failure

THIS MAN IS LIKE AN OLD BRIDGE

WHY WE SHOULD REVASCULARIZE THESE PATIENTS WITH CLI

5 -YEAR SURVIVAL - After revascularisation 70 %- After a major Amputation 26 %

Difference is highly significant: p = 0.014

TASC 2000

NEED FOR GUIDELINES

TASC 2000

The original TransAtlantic InterSociety

Consensus (TASC) published in 2000 was the

first international consensus on the diagnosis

and treatment of PAD

TASC II primarily designed to provide

guidance for primary care physicians

Easy-to-read document (67 vs. 296 pages)

Not intended for vascular specialists !

TASC II - 2007

A number of aspects are not updated

It is not exhaustively referenced

Recommendations are deliberately simplified

Fails to recognize that more can be done with

endovascular and open techniques

2007 TASC LITE…

TASC II CLASSIFICATION

INTEROBSERVER DISAGREEMENT

TASC A

TASC B

TASC C

TASC D

TASC A

TASC B

TASC C

TASC D

Definition for stenosis? > 50 %?

Heavy calcified lesion?Absence of tibial vessels?

Total poplital artery occlusion?

Poplital artery stenosis?

?

?

?

?

HOW DO YOU CLASSIFY THIS LESION?

HOW DO YOU CLASSIFY THIS LESION?

?

Diabetics

Patients with CLI

Graziani L et al. EJVES 2007;33:453-60

BELOW THE KNEE LESIONS ?

36%36%

11%11% 27%27%

74%Lesions located

in crural arteries

TASC II Classification for femoropopliteal lesions

allows wide individual interpretations and therefore,

the common use of this classification as a basis of

decision making and reporting outcome can be

questioned.

FEMOROPOPLITEAL LESIONS

TASC II B

TASC II B [2011]TASC II B [2011]

• Not endorsed by the SVS and by the ESVS

• Recommendations were not the product of rigorous

scientific scrutinity

• TASC II B advocates an endovascular first option even

in patients with claudication secondary to an isolated

tibial artery disease while there is no Grade A/B

supporting this conclusion

TASC II B [2011]TASC II B [2011]

TASC II B guidelines adopt a primarily

anatomical approach, which pays

insufficient attention to the clinical

symptoms and risk factors

European Journal of Vascular & Endovascular Surgery

EL

SE

VIE

R

JournalEuropean Journal ofVascular & Endovascular Surgery

Celebrating our Silver Jubilee ...

ww

w.ejves.compp. S1 - S90 Volum

e 42 Supplement 2 Decem

ber 2011

Volume 42 Supplement 2 December 2011 ISSN 1078-5884

YEJVS_v42_i5_COVER.indd 1 10/1/2011 12:40:04 PM

Management of

Clinical Practice Guidelinesof the

European Society for Vascular Surgery

Critical Limb Ischaemia and Diabetic Foot

OPEN SURGICAL TECHNIQUES

FOR CLI PATIENTS

BYPASS WITH THE SAPHENOUS VEIN

The best that can happen to a patient with CLI !

PROXIMAL ANASTOMOSIS

DISTAL ANASTOMOSIS

BYPASS WITH FREE VASCULAR FLAP

• Short autogenous bypass• Perigeniculate collateral arteries

PERIGENICULATE ARTERY BYPASS

Barral et al. Eur J Vasc Endovasc Surg

PROSTHETIC BYPASS FOR CLI

PROSTHETIC BYPASS + DVP

Devine et al.

Devine et al.

EXTREME BYPASS&

ADJUNCT WOUND THERAPY

73 years old male, diabetic, and living at home

TCPO2 = 32ABI = 0.7

PEDAL BYPASS

NEGATIVE PRESSURE WOUND THERAPY

NEGATIVE PRESSURE WOUND THERAPY

promotes healing after revascularization

NEGATIVE PRESSURE WOUND THERAPY

DEAD FOOT ?

AK-FEMOROPOPLITEAL BYPASSPROSTHESIS vs. GREAT SAPHENOUS VEIN

STUDIES Pereira2006 Meta-analysis

Pereira2006 Meta-analysis

PatientsFollow-up

1713 / 580 5 years

2431 / 7035 years

Symptoms Claudication Critical Ischemia

Prim. Pat. PTFE 57.4% 48.3%

Prim. Pat. SV 77.2%p<0.05

69.4%p<0.05

Sec. Pat. PTFE 73.2% 54.0%

Sec. Pat. SV 80.1%p<0.05

71.9%p<0.05

A Saphenous vein

PERFORMS better than A prosthesis

EVEN ABOVE THE KNEE

AK-FEMOROPOPLITEAL BYPASSPTFE vs. POLYESTER

STUDIES Jensen2007 RCT (2 ans)

Takagi2010 Meta-analysis (5

ans)

Patients PTFE/Polyester PTFE/Polyester

Symptoms 65% Cl / 35% CLI NA

Primary Pat. PTFE 57% 38.4%

Primary Pat. Polyester 70%p=0.02

49.2%

Secondary Pat. PTFE 65% NA

Secondary Pat. Polyester 76%p=0.04

NA

ABOVE THE KNEE

POLYESTER IS COMPARABLE TO PTFE

BK-FEMORO-POPLITEAL BYPASSGREAT SAPHENOUS VEIN vs. PROSTHESIS

STUDIES Pereira2006 (5 years)

Albers2003 (5 years)

Patients 3779 43 studies

Symptoms Cl 35% / CLI 65% NA

Graft used SAPHENOUS VEIN PROSTHESIS

Primary Patency 64.8% Cl68.9% CLI

30.5%

Secondary Patency 79.7% Cl77.8% CLI

39.7%

Limb Salvage NA 55.7%

BELOW THE KNEE A Saphenous vein

IS better than A prosthesis

STUDIES Albers 2005 (5 years)

Albers2003 (5 years)

Patients 2618 43 études

Symptoms Cl 3% /CLI 97% NA

Graft used ARM VEIN PROSTHESIS

Primary Patency 46.9% 30.5%

Secondary Patency 66.5% 39.7%

Limb Salvage 76.4% 55.7%

BELOW THE KNEE ANY vein

IS better than A prosthesis

BK-FEMORO-POPLITEAL BYPASSPROSTHESIS vs. ALTERNATIVE VEIN

STUDIES Griffiths 2004 RCT (3years)

Laurila2004 RCT (2 years)

Procedures 46 cuff/ 44 31 AV Fistula / 28

Symptoms Cl 10% / CLI 90% CLI 100%

Adjunct VENOUS CUFF A.V. FISTULA

Sec. Pat.  with Adjunct 45% 40%

Sec. Pat.  PTFE Alone 19%p= 0.02 40%

Limb Salv.  + Adjunct 78% 65%

Limb Salv +  PTFE Alone 61%p= 0.08 68%

DISTAL VENOUS cuff CAN HELP

BK-FEMORO-POPLITEAL BYPASSPROSTHESIS ± ADJUNCT

INFRA-POPLITEAL BYPASSREVERSED VEIN OR IN-SITU ?

STUDIES Albers 2006 (5 years)

Albers 2006 (5 years)

Albers2006 (5 years)

Patients 1024 908 2320

Symptoms 100% CLI 100% CLI 100% CLI

Technique IN SITU REVERSED GLOBAL

Primary Patency 58.5% 65.9% 63%

Secondary Patency 66.5% 73.2% 70.7%

Limb Salvage 75.3% 79.7% 77.7%

BOTH TECHNIQUES GIVE COMPARABLE RESULTS

STUDIES Albers2004 M

Albers2004 M

Albers2004 M

Albers2004 M

Albers2003 M

PatientsFollow-up

6875 years

2185 years

1575 years

12545 years

43 studies5 years

Symptômes CLI CLI CLI CLI CLI

MATERIAL Venous Allograft

cryopreserved

Arterial Allograft

cryopreserved

VenousAllograft

Fresh

Ombilical Vein

PROSTHESIS

Primary Patency NA NA NA NA 30.5%

Secondary Patency

19% 21% 24% 30% 39.7%

Limb Salvage 60% 68% 39% 55% 55.7%

An ALLOGRAFT IS NOT BETTER THAN a PROSTHESIS

TIBIAL BYPASS - ALLOGRAFT

ENDOVASCULAR TECHNIQUES

FOR CLI PATIENTS

TIBIAL ANGIOPLASTY

TIBIAL ANGIOPLASTY - RESULT

PRE PER POST

SUBINTIMAL RECANALIZATION

SUBINTIMAL RECANALIZATION

CUTTING BALLOON

CRITICAL LIMB ISCHEMIA

M Desvergnes et al. University of Poitiers, non-published data, 2013

RISK FACTORS ENDOVASCULARN=140

OPEN BYPASSN=105

P

Age (mean) 78 70 P<0.05

Sex ratio M/W 79 / 61 79 / 22 NS

Diabetes 91 (65%) 42 (41,6%) P<0.05

HTA 136 (97,1%) 96 (95%) NS

Dyslipidemia 103 (73,6%) 81 (80,2%) NS

Smoking 79 (56,4%) 86 (85,1%) NS

Coronary disease 69 (49,3%) 50 (49,5%) NS

Cardiac insufficiency 43 (30,7%) 19 (18,8%) NS

Renal insufficiency 74 (52,9%) 35 (34,6%) P<0.05

Pulmonary disease 30 (21,4%) 39 (38,6%) NS

CRITICAL LIMB ISCHEMIA

M Desvergnes et al. University of Poitiers, non-published data, 2013

PRIMARY PATENCY

ENDO OPEN

ENDOVASCULAR PROCEDURES

TASC ? N (%)

A 1 (0,6%)

B 61 (34,9%)

C 75 (42,9%)

D 38 (21,7%)

RUN-OFF [LEG] N (%)

0 23 (13,1%)

1 94 (53,7%)

2 52 (29,7%)

3 6 (3,4%)

M Desvergnes et al. University of Poitiers, non-published data, 2013

SECONDARY PATENCY

ENDO OPEN

LIMB SALVAGE

ENDO OPEN

PATIENT ALIVE WITHOUT AN AMPUTATION

ENDO OPEN

PRIMARY PATENCY FOR ENDOVASCULAR

SIMPLE ANGIOPLASTY IS BETTER THAN STENT

AND SUBINTIMAL ANGIOPLASTY IS BEHIND

BASIL: MAJOR ENDPOINTS

Amputation free survival (AFS) overall survival (OS, years)

For patients surviving > 2 years, a bypass first strategy was associated with an increase in overall survival of 7.3 months (p=0.02) and an increase in amputation-free-survival of 5.9 months (P=0.06) during a follow-up of 3.1 years.

• 27% of all PTAs failed within 8 weeks after randomisation vs. surgery 7%(p<0.001)

• 75% of all failed PTAs were treated surgically

• Surgery after failed PTA had a significant worse AFS than initial bypass surgery (p=0.006)

• Amputation free survival was significantly better with vein grafts (p=0.003)

BASIL: FURTHER RESULTS

ANGIOSOMES

A NEW CONCEPT FOR CLI ?

PLANTAR ARCH AND ANGIOSOMEPLANTAR ARCH AND ANGIOSOME

ANGIOSOME

CONNECTED

ANGIOSOME

NO ARCH BUT CONNECTED

ANGIOSOME

NOT CONNECTED

NOT CONNECTED

ANGIOSOME

ANGIOSOME

NO ARCH AND NOT CONNECTED

ANGIOSOMES – CLI PATIENTS

CHU POITIERS175 ENDOVASCULAR

PROCEDURES

ANGIOSOME DIRECT (N=134)

ANGIOSOME INDIRECT

(N=41)p

MEAN AGE 77 [42-97] 77,4 [43-89] 0,98

SEX RATIO (M/F) 49,2% 68,9% 0,01

DIABETES 61,9% 78,04% 0,05

RENAL FAILURE 56,7% 48,7% 0,37

HTA 97,7% 97,5% 0,94

CORONARY DISEASE 46,2% 82,9% 0,01

SMOKING 55,9% 58,5% 0,77

CHU POITIERS175 ENDOVASCULAR

PROCEDURES

ANGIOSOME DIRECT (N=134)

ANGIOSOME INDIRECT

(N=41)p

LOCALISATIONSFA-POPSFA-POP-TIBIALTIBIAL

70%16%14%

057%43%

<0,001

RUN OFF01>2

11%51%38%

20%63%17%

0,012

TECHNIQUEANGIOPLASTYSTENTINGSUBINTIMAL

53%21%26%

76%7%17%

0,012

ANGIOSOMES - TECHNIQUES

ANGIOSOMES - RESULTS

0 1 2 3 4 5 YEARS

42% vs. 39%

38% vs. 39%

PR

IMA

RY

PA

TE

NC

Y

P=0,931

Angiosome DirectAngiosome Indirect

0 1 2 3 4 5 YEARS

81% vs. 80%

80% vs. 79%

P=0,856

LIM

B S

AL

VA

GE

Angiosome DirectAngiosome Indirect

No difference in patency or limb salvage between angiosome-direct or indirect endovascular procedures

CHU POITIERS175 ENDOVASCULAR PROCEDURES

CHU POITIERS175 ENDOVASCULAR PROCEDURES

ANGIOSOMES – DATA PUBLISHED

• Retrospective studies, heterogeneity of data• No propensity analysis