| S 13-1 |
The benefit of carotid endarterectomy
over medical therapy is
small in symptomatic patients with 50%-69% stenosis (NNT=22 to prevent
one ipsilateral stroke, non significant NNT to prevent disabling
stroke and death) and noticeable for 70%-99% stenosis (NNT=6 and 14
respectively), provided that there in no near-occlusions. The
benefit from endarterectomy is marginal in patients with carotid
near-occlusion. The benefit of endarterectomy is still greater in
patients with a high risk score according to the current models (NNT=3)
and questionable in patients with low risk score (NNT=100). |
R 13.1 Grade A |
Carotid endarterectomy
is recommended for patients
with symptomatic stenosis equal to or greater than 70% (NASCET
criteria). |
R 13.2 Grade A |
Carotid endarterectomy
is not recommended for
patients with symptomatic stenosis less than 50% (NASCET criteria). |
R 13.3 Grade
A |
Carotid endarterectomy
is recommended for patients
with symptomatic stenosis of 50%-69% (NASCET criteria) – even though
the benefit vs. medical therapy is small, at least during the first years of follow-up
while increasing in the subsequent years – in particular among
patients considered at high risk, such as those recent ischaemia,
with hemispheric and not ocular symptoms, with complicated plaques,
elderly, males, non diabetics. |
R 13.4 Grade
A |
In case of
stenosis greater than 50% (NASCET criteria) and TIA or minor stroke,
early - i.e. within the two weeks from the event -
endarterectomy
is recommended. |
R 13.5 *GPP |
By convention
derived from clinical trials, a carotid stenosis is defined as "symptomatic"
when the last ischemic cerebral or ocular event occurred in the
previous 6 months. Based on recent reassessments of the same studies,
this interval should be reduced
to not more than 3 months. |
| S 13-2 |
The benefit
from carotid endarterectomy has been determined in patients with
asymptomatic stenosis. Nevertheless, systematic reviews ought to
identify the subsets of patients at risk of ipsilateral stroke and
expected to have a greater benefit from carotid surgery, taking into
account that the benefit is evident and increasing only from the
third year after the procedure. |
R 13.6 Grade A |
Carotid endarterectomy
is recommended for patients
with asymptomatic stenosis greater than 60% (NASCET criteria)
only
in centres with very low (at least less than 3%) perioperative (within
1 month) complication rate.
The benefit, expressed as absolute risk reduction, is
small (1% per year) and increases with the years of follow-up. |
R 13.7 Grade
D |
In patients who are candidates to carotid
endarterectomy, coronary angiography is recommended when there is
clinical or non-invasive instrumental evidence of severe coronary
artery disease. |
R 13.8 Grade
D |
In patients who are candidate to carotid
and coronary re-vascularization, it is recommended to
give priority to the clinically most affected district.
If carotid revascularization is planned first, then stenting is recommended
in presence of a severe symptomatic coronary disease, whilst
endarterectomy is recommended in
presence of a moderate coronary disease. |
R 13.9 *GPP |
In patients
with concurrent carotid and coronary disease, a multi-disciplinary
approach (cardiological, neurological, vascular/endovascular
surgical, cardiosurgical, anaesthesiological) is recommended
in order to select which district should take precedence and which
carotid revascularization (endarterectomy or stenting) is most
appropriate. |
R 13.10
Grade C |
The timing of
carotid surgery in patients with symptomatic carotid stenosis
should be selected based on the
clinical profile of the event as well as the brain CT or MRI. |
|
R 13.11 Grade C |
Carotid endarterectomy is not recommended
for patients with disabling stroke. |
R 13.12 Grade B |
Carotid Doppler ultrasonography,
if validated and therefore of controlled reliability,
is recommended as a
first-choice investigation to select possible candidates to carotid endarterectomy. |
R 13.13 Grade B |
Carotid Doppler ultrasonography,
if validated,
is recommended as the sole
preoperative measurement of carotid stenosis in patient with TIA
or minor stroke during the last week and with carotid stenosis
greater than 70% (NASCET criteria).
In addition to Doppler sonography also an angio MRI with contrast
media or, if not available, an angio-CT as long as validated,
should be performed in patients:
- with TIA or minor stroke occurred beyond last week or with
carotid stenosis of less than 70%;
- when there are doubts on the extent of carotid stenosis,
especially if symptomatic;
- when a higher or a lower lesion in relation to the
carotid bifurcation, or multiple lesions of the supra-aortic
vessels are suspected.
|
|
S 13-3 |
Available data
support, with some caution, the reliability of non-invasive tests (carotid
echo-Doppler, angio-CT and angio MRI with contrast media) to diagnose
a carotid stenosis between 70% and 99%, as long as used by experts
in carotid imaging. There are insufficient data, and funther
confirmatory studies are required, for stenoses between 50% and 69%. |
|
S 13-4 |
Studies
comparing more than one non-invasive technique with traditional
angiography are missing. Angio MRI with contrast media appears to have a better
sensibility and specificity profile than echo-Doppler, angio-CT and
angio MRI (which are substantially superposed). However, the external
validity of these results, taken from selected studies, may be
modest. Indeed, the applicability of non-invasive techniques varies
across centres in terms of available instruments and of operators'
expertise. It may therefore be hypothesised that in specific centres
a different technique than angio MRI with contrast media offers
greater guarantee of sensibility and specificity. |
R 13.14 ®GPP |
Conventional angiography should be
limited to cases where Doppler ultrasonography and angio MRI with
contrast media or CT
angiography yield discordant results or if they are not feasible
and ultrasonography results unreliable |
R 13.15 Grade
D |
Intra-operative monitoring of cerebral functions by
means of reliable techniques (EEG, Somatosensory Evoked Potentials) is recommended during general anaesthesia. |
R 13.16 Grade
D |
Loco-regional anaesthesia
is recommended in performing
endarterectomy because it
allows a more reliable monitoring of cerebral functions and it is
associated with a lower perioperative risk of lethal and nonlethal
vascular events and of respiratory complications, compared with
general anaesthesia. |
R 13.17 Grade D |
Transcranial
echo-Doppler of controlled reliability
is complementary for the
perioperative cerebral monitoring during carotid surgery. |
R 13.18 Grade D |
Temporary selective
intraluminal shunting
is recommended for
cerebral protection during carotid endarterectomy. |
|
S 13-5 |
In spite of a
trend, in randomised studies, in favour of carotid patching in
lowering the incidence of perioperative stroke and death, thrombosis
or restenosis, no conclusive data are available yet.
Further evidence is needed from randomised trials comparing primary
closure with routine patching and with selective patching, which is
currently the most frequently used.
To date, no indication can be given as to the material most suitable
for patching, even though synthetic material is currently preferred
over the biological one. |
R 13.19 Grade
A |
Being the
current evidence still insufficient, it is
not recommended to systematically replace endarterectomy
with endovascular procedures for the elective correction of carotid
stenosis. |
R 13.20 Grade B |
Carotid
stenting, if performed with adequate procedural quality levels and
adequate cerebral protection - unless contraindicated in the
individual patient - is recommended
in presence of severe vascular and/or cardiac comorbidities as well
as in presence of special conditions such as contralateral laryngeal
nerve palsy, cranial stenosis of the internal carotid or common carotid lesions below the clavicle.
By convention, severe cardiac comorbidities include:
- congestive heart failure and/or severe left ventricular
dysfunction;
- a cardiosurgical intervention in the previous six weeks;
- a myocardial infarction in the previous four weeks;
- unstable angina.
|
|
R 13.21
Grade C
|
Carotid
stenting, if performed with adequate procedural quality levels and
adequate cerebral protection - unless contraindicated in the
individual patient - is recommended
in selected cases, such as: restenosis, post-irradiation
stenosis , previous tracheostomy, rigid or "hostile" neck, as well
as - thoogh with modest benefit over endarterectomy, in case of
contralateral internal carotid occlusion. |
R 13.22
Grade C |
Carotid
stenting is not recommended when
the presence of endoluminal thrombotic or thromboembolic material is
suspected, and/on in presence of important calcifications or of markedly
tortuous supra-aortic vessels, bovine aortic arch, important
peripheral arterial comorbidity of the access point. |
R 13.23
®GPP |
Whenever
the indication to carotid re-vascularization in not definite in
favour of endarterectomy or stenting, the following options
are particularly recommended:
 | a multi-disciplinary integrated approach by specialists
competent in cerebrovascular disease, cardiovascular disease,
diagnostic imaging, traditional as well as endovascular surgical
procedures; |
 | take into account the training and expertise of the involved
operators; |
 | adopt co-ordinated standard operating procedures shared with
all other health personnel; |
 | consider the option of medical therapy alone, especially in
case of asymptomatic carotid stenosis and/or patient at high
surgical risk; |
 | consider the randomisation of the patient into prospective
randomised controlled trials comparing endarterectomy and
stenting. |
|
|
S 13-6 |
Advanced age
(>80 years) alone, unless associated with relevant comorbidities,
does not justify in itself an indication to carotid stenting. From
the analysis of retrospective studies it appears instead that the
risk-to-benefit ratio among these patients is more in favour of
endarterectomy than of stenting and more for the symptomatic (the
prevalence of which is markedly greater than among younger patients)
rather then the asymptomatic stenosis. For this last, the
risk-to-benefit ratio becomes the more in favour of medical rather
than surgical therapy, the more advanced is the age. |
R 13.24 Grade
A |
Both conventional and eversion carotid
endarterectomy are recommended for patients with carotid
stenosis, provided that they are performed in centres with a
perioperative complication rate (all strokes and death) of less
than 3%. |
R 13.25 Grade
B |
Centres performing carotid endarterectomy
should assess and disclose their own perioperative
complication rate (all strokes and death), since this could have
an impact on decision about carotid surgery especially in patients
with asymptomatic carotid stenosis. |
R 13.15 Grade
D |
During carotid endarterectomy, the intraoperative
assessment of defects is recommended
for possible repair and
quality control.
The intraoperative control is associated to a
significant reduction of peri- and post-operative complications
including
re-stenosis and long-term recurrence of stroke. |
R 13.27 Grade
A |
The antiplatelet therapy
is recommended before and after surgical
correction of carotid stenosis, unless it is contra-indicated. |
R 13.28 Grade D |
In case of
restenosis or recurrent restenosis of high-grade and responsible of
definitely correlated neurological symptoms, surgical correction
is recommended. |
R 13.29 Grade D |
For the follow-up after carotid surgery.
an early ultrasonographic
control is recommended within 3
months from intervention then, in absence of significant homo-
or contralateral evolution, after 6 months, 1 year and every year thereafter. |