Indications for Carotid Stenting

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Indication for Carotid Stenting
G. M. Biasi MD, FACS, FRCS University of
Milano-Bicocca, Milan President of the ISVS
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Carotid endarterectomy
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Guidelines for CEA
January 1998
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Emerging risk factors
Formerly focused on luminal narrowing due to the
bulk of atheroma, our current concepts recognize
the biological attributes of the atheroma as key
determinants of its clinical significance. Libby,
Nature, 2002
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Imaging in carotid atherosclerosis

• Magnetic resonance
• Ultrasound

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Ultrasound pros

• Good spatial resolution
• Cheap widely available
• Availability of intravascular probes virtual
  histology

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Ultrasound pros

• Availability of new tools, as the Gray Scale
  Median (GSM).
• The GSM is independent from the operator and the
  duplex-scanner

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Ultrasound and GSM
Grey Scale Median (GSM) computer-assisted
quantitative and objective index of echogenicity.
GSM 48
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Take home message
In 2008, how modern is the evidence based
medicine not including carotid plaque morphology?
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Take home message
The GSM should always be calculated! Please refer
to the ICAROS paper to start with GSM (Biasi,
Circulation 2004) In case of assistance
gsm_at_unimib.org
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Carotid stenting
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Carotid Stenting
Any randomized evidence for indication to
treatment???
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2004 SAPPHIRE

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SAPPHIRE

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SAPPHIRE
Final message carotid stenting is superior to
carotid endarterectomy in high risk
patients. !FDA approval!
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2006 EVA3S
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EVA-3S

• EVA-3S may represent what could happen in the
  real world following implementation of CAS into
  routine practice.
• Cerebral protection devices are no panacea
  (30-day death and stroke rate of 7)

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EVA-3S

• Low technical expertise required for
  interventional physicians to join the trials (12
  CAS).
• Physicians who did not fill these requirements
  were nevertheless accepted, provided that the
  procedures were performed under the supervision
  of an experienced tutor .

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2006 SPACE
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SPACE

• Stopped prematurely (1183 in stead of 1900 pts).
• A quarter of potential SPACE collaborators were
  rejected after review of their track record
  (although the reader is not informed what
  rejection criteria were used).

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SPACE

• Cerebral protection devices were not obligatory
• 30-day death or stroke was 77 after CAS and
  65 after CEA (high complication rate, compared
  to AHA standards).

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SPACE take-home message
SPACE has provided surgeons and interventionists
with evidence to support their personal
prejudices.
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Indications to Carotid Stenting
Have we got level I evidence to perform carotid
stenting?
NO!!!
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When to Stent a Carotid Stenosis
Based on Level 1 Evidence NEVER
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When to Stent a Carotid Stenosis
Based on Levels 2 3 Evidence In Selected
Cases
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Indications to Carotid Stenting
Based on Anatomical Conditions Comorbidities Fea
tures of the Plaque
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Indications to Carotid Stenting

• Anatomical Conditions
• Restenosis
• Previous neck irradiation or neck surgery
• High bifurcation
• Contralateral laryngeal palsy
• Occlusion of contralateral ICA or Willis
  abnormalities

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Indications to Carotid Stenting

• Comorbidities
• congestive heart failure
• open heart surgery needed within 6 weeks
• recent myocardial infarction
• unstable angina
• severe pulmonary disease

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Medical conditions CAS vs CEA
The presence of the above-mentioned conditions
should not be considered per se a reason to
abandon CEA in favour of CAS, as the superiority
of CAS over CEA in these patients is not
demonstrated. Both CEA and CAS can be performed.
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Medical conditions CAS vs CEA
For patients at extremely high risk (several
medical comorbidities at the same time),
especially if asymptomatic, the best treatment
could be the best current medical therapy (with
antiplatelet agents, statins and beta-blockers),
in stead of invasive intervention.
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Indications to Carotid Stenting
1. Neurological Symptoms 2. Percentage of
Stenosis 3. Features of the Plaque
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Carotid plaque characteristics
Can we accurately study carotid plaques? Carotid
plaque imaging can be correlated to therapy and
prognosis?
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Carotid plaque characteristics
Can we accurately study carotid plaques? Carotid
plaque imaging can be correlated to therapy and
prognosis?
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Ultrasound Imaging
Quantitative analysis degree of stenosis
Qualitative analysis Gray Scale Median (GSM)
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Ultrasound Imaging computerized analysis

• Related to histological content
• echolucent (black, low GSM) plaques lipids,
  hemorrhage and macrophages.
• echogenic (white, high GSM) plaques collagen
• GSM index of carotid plaque echogenicity
• PEP number of echolucent points

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Ultrasound and CT
Correlation between echographic and CT images
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Ultrasound and CT
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Ultrasound and CT
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PET imaging
PET identification of metabolic activity related
to numbers of macrophages can identify plaque
inflammation
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PET and CT
Correlation between PET and CT images
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Ultrasound - CT - PET
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Conclusion 1
Carotid plaque imaging can be accurately evaluated
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Carotid plaque characteristics
Can we accurately study carotid plaques? Carotid
plaque imaging can be correlated to therapy and
prognosis?
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GSM natural history studies in asymptomatics

• Higher risk of future strokes in asymptomatic
  patients with echolucent carotid plaques treated
  with medical therapy.
• 14 (echolucent) vs. 1 (echogenic) _at_ 7ys
• Nicolaides. VASCULAR 2005

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GSM natural history studies in asymptomatics
echogenic
1115 pts
echolucent
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GSM stroke during CAS
Echolucent carotid plaques with low GSM values
have a higher risk of stroke during carotid
stenting (ICAROS Study). Biasi GM, et al.
CIRCULATION 2004
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GSM stroke during CAS
Rate of stroke in different GSM value subsets (?
25 vs. gt25)
7.1 vs. 1.5, p0.005
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GSM stroke during CAS
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ESVS Guidelines on Carotid Disease
Plaque morphology should be assessed in all cases
before invasive treatment B.
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GSM brain protection
Carotid plaque echolucency, measured by GSM,
allows to identify the best BPD for each
patient. Hyperechoic plaques ? distal
filter Echolucent plaques ? proximal device
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GSM stent design
Results confirmed by sub-analysis
SPACE-trial (Prof. Jansen)
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Carotid EndoarterectomiesPersonal Experience
(April 1996 - September 2008)

• Total 1225
• Complications
• - TIAs
  51 (4.2 )
• - Stroke
  20 (1.6)
• - Neurological Death
  5 (0.4)
• - Non Neurological Death (M.I.) 1 (0.08)

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Carotid StentingPersonal Experience209
procedures (April 1996 - September 2008)

• Mean Age 75.6ys.
• M/F ratio 3.45 (162/47)
• Symptomatic 84 (40.2)
• Carotid restenosis 57 (27.3)

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Carotid Stenting Personal ExperienceEarly (30
days) Complications in 209 procedures
- TIAs
7 (3.3 ) - Stroke
3 (1.4) -
Neurological Death 1
(0.4 )
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Carotid EndoarterectomyPersonal Experience Early
(30 days) Complications in the last 209 cases

• Complications
• - TIAs 8 (3.8 )
• - Stroke 2 (1.0 )
• - Neurological Death 0 (0.0)

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Carotid StentingStent

• Wallstent 106/209 (50.7).
• Acculink 88/209 (42.1)
• Cristallo Ideal 15/209 (7.2)

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Carotid StentingBrain Protection System

• Distal Occlusion 14/209 (6.7).
• Proximal Occlusion 46/209 (22.0)
• Distal Filter 149/209 (71.3)

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Carotid Stenting Personal ExperienceFollow up
- Restenosis lt 50
9/209 (4.3 ) - Restenosis gt 50 e lt
80 2/209 (0.9) - Restenosis
gt80 0/209 (0.0)
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Carotid Stenting Conclusions
No randomized evidence Selected indications to
treatment Aortic arch anatomy Carotid plaque
morphology Medical comorbidities Brain protection
Learning curve training Endovascular devices
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Carotid Stenting
CAS can be performed only if the Centre
performing CAS relies on procedure-related risk
certification through an external audit of a
neurologist with experience in cerebrovascular
diseases. Outside clinical trials or in case of
absence of external audit, CAS has no indication
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Contraindications to Carotid Stenting

• Long and multifocal lesions
• Severe tortuosity or calcification or plaques of
  the aortic arch
• Heavy calcification of the ICA
• Echolucent plaques with a GSM value less than 25

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Carotid Stenting Emerging Frontiers
In case of echolucent (GSMlt25) plaques in
patients at increased risk due to anatomical and
medical conditions (see above), an endovascular
procedure can be performed using a proximal brain
protection device and stents with a closed-cell
design
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Take home message

• Indication based on
• Neurological symptomatology
• Degree of carotid stenosis
• Medical comorbidities
• Vascular and local anatomical features
• Carotid plaque morphology

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