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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
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
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