Vascular and Endovascular Surgery Unit - University of Siena

Surgery has a limited role for PAD with current

endovascular techniques

Vascular and Endovascular Unit,

University of Siena, Italy

Carlo SetacciFull Professor of Vascular Surgery

October 29, 2011

Gianmarco de DonatoAssistant Professor of Vascular Surgery

Vascular and Endovascular Surgery Unit - University of Siena

Grade Category Clinical Description Objective Criteria

00

Asymtomatic – no hemodinamically

significant occlusive disease Normal treadmill*

or reactive hyperthermia test1 Mild claudication

I2 Moderate claudication Resting AP<60mmHg, ankle or

metatarsal PVR flat or barely

pulsatile; TP < 40mmHg3 Severe claudication

II 4 Ischemic rest pain

Complete treadmill exercise;

AP after exercise >50 mmHg

≥20mmHg lower than resting

value

III

5Minor tissue loss – nonhealing ulcer;

focal gangrene with diffuse pedal

ischemiaResting AP<60mmHg, ankle or

metatarsal PVR flat or barely

pulsatile; TP < 40mmHg6

Major tissue loss – extending

transmetatarsally; functional foot no

longer salvageableAP= ankle pressure; PVR = pulse volume recording; TP= toe pressure. *Treadmill protocol: miles per hour, 12% constant grade

Rutherford-Becker Classification

Vascular and Endovascular Surgery Unit - University of Siena

Risk of amputation @ 1 yearif untreated

• Rutherford III = 0-2%

• Rutherford IV = 5-20%

• Rutherford V = 30-70%

• Rutherford VI ≅ 100%

Vascular and Endovascular Surgery Unit - University of Siena

Ruth 5&6 straight-line flow to the foot

- Christopher E. et Al. Angiosomes of the foot and ankle and clinical implications for limb salvagePlastic & Reconstructive Surgery 2006;117: 261s - 293s- Setacci C, de Donato G, Setacci F, Chisci E. Ischemic foot: definition, etiology and angiosomeconcept. J Cardiovasc Surg. 2010; 51: 223-31.

- Wound related artery

revascularization

- Angiosome concept

Vascular and Endovascular Surgery Unit - University of Siena

How can we achieve a straight-line flow to the foot?

endovascular Surgery

Which is the most appropriate first-line treatment for CLI

Vascular and Endovascular Surgery Unit - University of Siena

MilestonesEndovascular therapy

Dotter CT. Transluminal treatment of atherosclerotic obstruction :

description of a new technique. Circulation 1964; 30: 654-670

Palmaz JC. Intraluminal stents in atherosclerotic iliac artery

stenosis. Radiology 1988; 168: 727-31.

Vascular and Endovascular Surgery Unit - University of Siena

Type A Type DType CType B

Percutaneous

STRIVETM

Surgery

Lesion Stratification

Milestones TASC I TASC II

Norgren L et al, EJVES 2007;33:S1-S75

Vascular and Endovascular Surgery Unit - University of Siena

TASC IIb (unpublished)

will it ever be?

April 2011

Vascular and Endovascular Surgery Unit - University of Siena

Iliac recanalization

High Technical success

Vascular and Endovascular Surgery Unit - University of Siena

Endovascular solutions

Vascular and Endovascular Surgery Unit - University of Siena

Atherosclerosis & CLI

- Aortoiliac

- Femoropopliteal

- Infrapopliteal

Vascular and Endovascular Surgery Unit - University of Siena

Chronic total occlusion

SFA

Endovascular materials

idrophilic guidewire

catheter

Vascular and Endovascular Surgery Unit - University of Siena

Percutaneous access

Retrograde approach from

distal SFA, popliteal, BTK

vessel

Antegrade

approach

Vascular and Endovascular Surgery Unit - University of Siena

Techniques – crossing CTO

subintimal recanalization

Vascular and Endovascular Surgery Unit - University of Siena

Techniques – crossing CTO

LT

True lumen re-entry devices

Outback catheter

Vascular and Endovascular Surgery Unit - University of Siena

Current endovascular solutions

Bare stent / covered stentdebulking

Drug eluting/drug coated

Vascular and Endovascular Surgery Unit - University of Siena

BTK and pedal vessels

Plantar-loop technique. M Manzi

Vascular and Endovascular Surgery Unit - University of Siena

From a technical point of view, assuming the

operators are skilled, we can push the limit of

endovascular therapy,

but …

does it mean that we SHOULD recommend

- endovascular for all lesions,

- and give a limited role to sugery?

Guidelines for CLI & Diabetic foot

Chairman : Prof. Setacci

Co-Chairman : Prof Ricco

Co-authors:

Gianmarco de Donato, Martin Teraa, Frans L Moll, Francois Becker, Helia Robert-Ebadi, Piergiorgio Cao, Hans Henning Eckstein, Paola De Rango, Nicolas Diehm, Jürg

Schmidli, Florian Dick, Alun H Davies, Mauri Lepäntalo, Jan Apelqvist

EJVES special issue, in press

General consideration

Since there are almost no RCT

exclusively among CLI patients, most of

the lessened recommendation are

based on evidence from subgroup

analyses of “PAOD” trials (extrapolation

from RCT), or from prospective cohorts.

Where data originates from a RCT,

the level of evidence is given by that

study design (i.e level 1a or 1b).

Where results of subgroup analysis

are applied to a particular

recommendation, it has been

downgraded (i.e. grade A grade B)

The concept of downgrading

recommendations based on

extrapolation from higher level studies

may be considered a limitation of these

guidelines, but we accept it, since

evidence for the subset of CLI tends to

be extremely poor

General considerationThe validation of a new technique (Endovasc)

not only on a comparison with the

traditional technique (open surgery)

but on the results that can be obtained by this

treatment with regard to the objectives for

the treatment of CLI.

Vascular and Endovascular Surgery Unit - University of Siena

General consideration

These objectives (limb salvage etc)

can clearly be reached with the new

technique and therefore there is

evidence for its use, but with a

downgraded recommendation.

Vascular and Endovascular Surgery Unit - University of Siena

To require that the evidence

depends on the presence of direct

comparisons with the traditional

technique could also be reversed:

General consideration

there is no absolute evidence for the

traditional technique as there are no RCTs

comparing this to the new technique

Treatment options• Pharmacological:

– Prostanoids

• Surgical:– Endarterectomy– Bypass

• Endovascular:– PTA– PTA with stent or stent graft

• Hybrid• Non-reconstructive

Guidelines and Classifications

• Classifications and guidelines aim at:

– Standardized care

– Evidence based medicine

– Highlighting gaps in current knowledge

• TASC-classification widely used, but:

– Complex loco-regional classification

– Quickly out-dated due to fast technical developments

– Poor inter-observer consensus

• New and simplified classification based on arterial segment and lesion length is preferred

EJVES special issue, in press

ESVS Guidelines - Treatment by segment

• Aortoiliac

• Infrainguinal:

– Common Femoral Artery (CFA)

– Deep Femoral Artery (DFA)

– Superficial Femoral Artery (SFA)

• Popliteal

• Infrapopliteal

EJVES special issue, in press

Aortoiliac Obstructive Disease (AIOD)

• Endovascular lower long-term primary patency (PP),

but similar secondary patency (SP)

• 5-year PP of open procedures in CLI:

• AFB, IFB, and AIE approximately 75-80%

Treatment choice:

• First-line: PTA with provisional stenting (Level 3a, Grade C)

• Diffuse lesions: Aorto-(bi)femoral bypass (Level 2a, Grade B)

• Extra-anatomical bypass reserved for high risk patient or hostile

abdomen (Level 4, Grade C)

EJVES special issue, in press

Common Femoral Artery (CFA)

• CFA steno-occlusive disease:

– Endarterectomy (potential for hybrid procedure)

– PTA (with stent)

Treatment choice:

• First choice: endarterectomy (5-year PP 91% SP 100%) (Level 4, Grade C)

• Provides acces to perform hybrid revascularization of parallel iliac, or SFA pathology with good results (Level 3b, Grade C)

EJVES special issue, in press

Deep Femoral Artery (DFA)

• Recanalization of the DFA:

– Rarely performed as isolated procedure for limb salvage

– Limb salvage rates:

• 67%, 49% and 36% at 1, 3, and 5 years

– Profundoplasty can be of value to preserve the kneejoint when amputation is necessary

Treatment choice:

• First choice: surgical profundoplasty

(Level 3b, Grade C)

EJVES special issue, in press

Superficial Femoral Artery (SFA)

• SFA steno-occlusive disease:– Short lesions (<5 cm)– Intermediate lesions (5-15 cm)– Long lesions (>15 cm)

• Long-term patency of PTA in CLI is much lower than in claudicants

• Different attempts to reduce low patency due to:– Recoil– Dissection– Intimal hyperplasia

EJVES special issue, in press

Options for stenting• Self-expandable stent

• Stent graft

• Drug eluting stent

Target recoil and dissection

Aim at reduction of intimal hyperplasia

• Short lesions (>5cm):

– PTA with provisional stenting (Level 1a, Grade B)

• Intermediate lesions (5-15 cm):

– PTA with self-expandable stent (Level 1b, Grade B)

• Long lesions (>15 cm):

– Venous bypass

– Synthetic bypass

– Thrupass for pts at high risk for open (Level 3b, Grade C)

– (Hybrid and Remote Endarterectomy) (Level 2b, Grade B)

Especially beneficial in patients withlife-expectancy >2 years (Level 1b,

Grade B)

EJVES special issue, in press

Superficial Femoral Artery (SFA)Choice of treatment

Sup

erfi

cial

Fem

ora

lArt

ery

(SFA

)

EJVES special issue, in press

Infrapopliteal disease• Infrapopliteal PTA and crural/pedal bypass:

– Similar long-term clinical and procedural successrates (Level 4, Grade C)

• PTA is preferred when it does not precludefuture surgical intervention

• Primary stenting beneficial?

– In case of short lesions drug eluting stents are beneficial (Level 2b, Grade B)

• Vein (single-segment or composed) is the preferred bypass material in BTK bypass (Level 3b, Grade B) EJVES special issue, in press

• CLI has a major impact on:– Patient

– Physician

– Health care system

• Treatment consists of endovascularand surgical options with an increasingtrend towards an endovascular firstapproach

Conclusions

EJVES special issue, in press

Conclusions• Principle first-line treatment:

– AIOD: PTA with provisional stenting

– CFA: Endarterectomy

– DFA: Endarterectomy

– SFA:• Short lesion: PTA with provisional stenting

• Intermediate: PTA with self-expandable stent

• Long lesion: Venous bypass / stentgraft / hybrid

– Infrapopliteal: PTA (with DES in short lesions, and promising results for DEB)

EJVES special issue, in press

Vascular and Endovascular Surgery Unit - University of Siena

Vascular and Endovascular Unit,

University of Siena, Italy

Carlo SetacciFull Professor of Vascular Surgery

October 29, 2011

Gianmarco de DonatoAssistant Professor of Vascular Surgery

Surgery has a limited, but crucial role for PAD

with current endovascular techniques

ENDOTRAINING 2008 – 42

CONCLUSION

• Endovascular

strategy is the

primary approach

for the majority of

CLI patients

– Excellent procedural

success rates

– Increasing primary

& secondary

patency

ENDOTRAINING 2008 –

but…..Endovascular first-line

treatment only makes

sense if it does not

preclude

future surgical intervention

options

because no intervention lasts

forever, and there is always

a possibility that the

patient may require a

surgical treatment in the

future

Vascular and Endovascular Surgery Unit - University of Siena4

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