EVERSION VERSUS PATCH CLOSED CAROTID ENDARTERECTOMY: MORBI-MORTALITY
ONE YEAR AFTER SURGERY
AUTHORS:
Bárbara
Silva
Soeiro
(mimed08035@med.up.pt),
Joana
Brandão
Silva
(mimed08101@med.up.pt), Jorge Araújo Monteiro (mimed08131@med.up.pt), Mafalda Martins
Barbosa (mimed08153@med.up.pt), Marco Batista Assunção (marco_ma@med.up.pt), Pedro
Ribeiro Tavares (mimed08196@med.up.pt), Rodrigo Ferreira Monteiro (mimed08228@med.up.pt),
Rosário Barbosa Monteiro (rosariom@med.up.pt), Tiago Melo Alves (mimed08234@med.up.pt)
ADVISER: Professor Sérgio Sampaio, CLASS N. 20
ABSTRACT
BACKGROUND: Carotid endarterectomy (CEA) with patch closure and eversion CEA are currently
considered the best surgical procedures to correct carotid stenosis. However, doubt remains on
whether one of the procedures is superior over the other and well designed studies that analyse this
question are lacking.
AIM: This study aimed to compare reports on mortality, neurological morbidity and risk of restenosis
for both procedures one year after surgery and determine if one surgical procedure may have
advantages over the other.
METHODS: We performed a meta-analysis starting with a literature review of articles published
regarding one or the other surgical procedures in PubMed, Scopus and ISI Web of Knowledge using
appropriate search terms. Studies reporting the proposed outcomes for at least one year after
surgery were reviewed and data concerning the outcomes was collected and analysed. Articles that
reported both techniques simultaneously (n = 8) were analysed for heterogeneity and overall effect
using RevMan. Studies reporting only one of the techniques (n = 46), after pooling data from all
studies and including results from studies reporting both procedures into groups of eversion or patch
CEA, were analysed by calculating the prevalence of each outcome, relative risk and comparing with
chi-square tests. Combined outcomes for neurological morbidity (transient ischemic attack (TIA) +
stroke) and morbimortality (neurological morbidity + death) were also calculated and analysed.
RESULTS: Pooled data analysis revealed that, for all outcomes analysed, eversion CEA seems to be
associated with fewer risks (restenosis RR = 0.332, P < 0.01; TIA RR = 0.551, P < 0.01; stroke RR =
0.504, P < 0.01; neurological morbidity RR = 0.605, P < 0.01; death RR = 0.337, P < 0.01;
morbimortality RR = 0.472; P < 0.01). When studies reporting both procedures were analysed, the
same was observed for neurological morbidity and death (RR = 0.30, 95% CI [0.11, 0.81], P = 0.02
and RR = 0.41, 95% CI [0.22, 0.77], P < 0.01, respectively) and there was an equal trend for data on
stroke (RR = 0.34, 95% CI [0.11, 1.05], P = 0.06). However, this analysis seemed to attribute fewer
cases of restenosis to patch closure CEA (RR = 1.31, 95% CI [0.96, 1.78], P = 0.09).
CONCLUSION: Eversion CEA is associated with fewer cases of neurological morbidity and death
and may result in less cases of stroke one year after surgery. However, CEA with Dacron patch
closure may be more effective in preventing restenosis.
KEYWORDS: Carotid endarterectomy, mortality, stroke, transient ischemic attack, restenosis,
eversion, patch closure
INTRODUCTION
Carotid artery stenosis occurs as a consequence of hardening and atherosclerotic deposition of
oxidized lipoproteins within the inner layers of the carotid artery(1, 2). This substantially reduces lumen
size, increasing the occurrence of blood clotting at that point with subsequent higher likelihood of
thrombus formation and embolism(2, 3). Since the carotid artery is the main blood supplier to the
brain(2-4), the occlusion of brain vessels with ischemic lesion of adjacent brain areas is increased in
subjects bearing carotid stenosis. These events are termed strokes also known as cerebrovascular
accidents, and result in impairment of the brain area affected and inability to perform its normal
functions (usually sight, speech and movement of one side of the body are affected)(4, 5). If the
neurological dysfunction is brief and lasts no more than 24 h, then it is termed transient ischemic
attack (TIA)(4).
There are currently several surgical techniques being used to correct extracranial carotid stenosis (6).
Among them, carotid endarterectomy (CEA) has been shown to have excellent results in the
reduction of the risk of stroke(7-10). Since it was first established, several advances have been made
to the surgical procedure to improve the clinical results and long-term durability of CEA(9). Despite
having evolved from a somewhat different procedure described in 1954(11), the standard surgical
approach to endarterectomy consisted of performing a longitudinal arteriotomy to gain access to the
lumen of the artery followed by resection of the atheromatous plaque and primary closure after
surgery(9,
10).
Notwithstanding, it has been determined that although very efficient, this technique
involved some risk of restenosis of the carotid artery(9,
12),
which led to the development of slightly
modified procedures for CEA. One of them involves basically the same procedure, but using a
fragment of vascular tissue removed from superficial veins, usually from the lower limbs, to close the
section, avoiding reduction of vessel lumen after closure(9, 10). This has further evolved to the use of
synthetic prosthetic materials, obtaining a similar result but sparing the superficial lower limb
vessels(9,
10, 13, 14).
In parallel with this patch closure procedure, a new technique was introduced,
consisting of the transection of the common carotid artery, eversion of the limits of the vessel,
performing the removal of the damaged inner layer of the artery and restoring the vessel with closure
of both extremities of the resected vessel(9, 10).
This later technique, called eversion CEA, has been considered by some surgeons a simpler, faster
procedure and has been suggested to be related with fewer post-surgery complications, lower risk of
stroke and death than the remaining(15,
16).
However, there is still no exact knowledge on which
technique, eversion CEA or CEA with patch closure, is the most effective and is related with lower
mortality and fewer complications(8, 17).
In this work, we aimed at evaluating both surgical techniques through a meta-analysis comparing
main outcomes: mortality, occurrence of neurological morbidity and restenosis one year after surgical
treatment. Specific research questions are: is mortality different in patients subjected to eversion CEA
in comparison to patients treated with CEA with patch closure? Does one of the procedures represent
lower risk of neurologic morbidity? What is the combined risk of mortality and neurological morbidity
for each technique? Which technique is associated with lower risk of restenosis?
METHODS
After indentifying adequate keywords and respective medical subject headings (MeSH) terms a query
algorithm was built to perform searches of articles in PubMed, Scopus and Isi Web of Knowledge
databases. Main search terms were: CEA, mortality, stroke, TIA, restenosis, eversion, patch closure
(or equivalent terms). The query algorithm used for database search was: carotid AND
(endarterectomy OR endarterectomies) AND (eversion OR patch) AND (mortality OR death OR
"neurologic morbidity" OR stroke OR "vascular accident" OR "brain vascular accident" OR
"cerebrovascular accident" OR CVA OR restenosis OR "transient ischemic attack" OR “transient
brainstem ischemia" OR "cerebral ischemia" OR TIA). Search was limited to articles published in
English from January 1st, 1990 to November 30th, 2008. The upper time limit was chosen to avoid
disparities due to independent factors (evolution in pharmacotherapy used in atherosclerotic patients
to decrease the risk of complications that may have impact on measured outcomes, and grade of
evolution of surgical techniques). Repeated references were eliminated from the retrieved lists of
references and remaining abstracts were selected by two investigators according to a predefined list
of exclusion criteria. Disagreements were resolved by consensus.
Eligibility criteria
Articles that fitted one or more exclusion criteria were excluded. Succinctly, an article that: 1) was not
a complete or consecutive patient series or clinical trial; 2) did not refer endarterectomy with Dacron
patch closure or eversion; 3) did not mention post-operative neurological morbidity or mortality; 4) did
not present outcomes for both techniques separately or 5) had a follow-up lower than one year, was
excluded. From the 1242 references initially retrieved (346 from PubMed, 506 from Scopus and 390
from ISI Web of Knowledge), 709 remained after elimination of repeated references. From these, 619
were excluded (211 for criterion 1, 280 for 2, 37 for 3, 72 for 4 and 19 for 5), whereas 90 were
considered candidate studies. After abstract selection, the complete articles were gathered, either
through retrieval online or through contacts of local libraries or article authors. Only 72 full-text
articles were retrieved of the 90 references. Articles were read by two researchers and either
included or excluded using the same predefined eligibility criteria. A total of 52 articles were included
after full text reading as 1 were excluded for criterion 1, 8 for 2, 1 for 3, 8 for 4 and 2 for 5. In studies
performed by the same group of researchers the articles was carefully read to determine if the data
referred to the same case series and if it was the case, the article presenting the largest, usually most
recent, series would be used.
Variable description and statistical analysis
Data were collected from the studies, namely descriptive data (e.g. number of patients subjected to
the procedure of interest), methodological data (e.g. was the intervention randomized) and outcome
data (e.g. TIA, stroke, death, restenosis, stenosis criteria). Combined outcomes for neurological
morbidity (TIA + stroke) and morbimortality (neurological morbidity + death) were also calculated and
analysed. Only 8 articles(16-23) had information about both techniques and these were introduced in
RevMan software (version 5.0.18)(24). Test for overall effects was performed through MantelHaenszel fixed effects model and relative risks (RR) are shown with 95% confidence intervals (CI).
Heterogeneity of the measures obtained from elected studies was assessed through a Chi2 test,
allowing us to determine if there is variation across studies was due to differences in surgical
procedure, study subjects or design rather than chance. Studies reporting only one of the techniques
(n = 46)(15, 25-62), after pooling data from all studies and including results from studies reporting both
procedures into groups of eversion or patch CEA, were analysed by calculating the prevalence of
each outcome, RR and comparing with Chi2 tests on SPSS software (version 17.0.0)(63). Differences
were considered statistically significant when P < 0.05.
RESULTS
Data was analysed in two stages, as described previously. Data from studies reporting either Dacron
patch OR eversion CEA (n = 46) were pooled into two groups of results regarding each technique.
From studies which had information about both techniques, data from Dacron patch or eversion CEA
were grouped with data of the corresponding group collected from studies that described either
procedure. This is referred to as “pooled data”. Afterwards, the 8 studies that reported simultaneously
results from Dacron patch and eversion CEA were analysed separately using more sophisticated and
powerful analysis. This later group is referred to as “studies with patch and eversion”
Pooled data
A total of 25 studies reported outcomes for Dacron patch CEA, involving a total number of operations
of 4110, while 32 presented outcomes for eversion CEA representing 20998 operations. In studies
reporting Dacron patch CEA, 16 studies defined a carotid artery stenosis criteria as at least 50%
occlusion of the lumen of the vessel, 1 study used 60%, 3 studies considered 70% and 3 studies
used 80% and the remaining did not define stenosis criteria. Studies reporting eversion CEA, 3
defined restenosis as an occlusion lower than 50%, 12 defined restenosis as 50% occlusion or
higher, 2 considered 60, 1 defined 70%, 3 used 80% and the remaining did not define stenosis
criteria. Pooled data analysis revealed that, for all outcomes analysed, eversion CEA seems to be
associated with fewer risks (Table 1). Restenosis, at least one year after surgery occurred in 8.85%
(n = 300) of patients undergoing Dacron Patch CEA (n = 3390) and in 2.94% (n = 574) of patients
undergoing eversion CEA (n = 19184). The RR of restenosis associated with eversion CEA in
comparison to Dacron Patch CEA was 0.332 (P < 0.01). Eversion CEA was also associated with
fewer cases of TIA (2.97 and 1.97%, respectively) as compared to CEA with patch closure (5.93 and
3.91, respectively), the RR of suffering the outcomes being 0.551 (P < 0.01) and 0.504 (P < 0.01).
Combining the data from these two outcomes and computing the new variable neurological morbidity
we found a RR of 0.605, (P < 0.01) for this outcome when undergoing eversion in comparison to
patch CEA. The same protective effect of the surgical procedures through eversion was associated
with mortality (RR = 0.337, P < 0.01) and for the outcomes of death and neurological morbidity
combined as morbimortality (RR = 0.472; P < 0.01).
Studies with patch and eversion CEA
When studies reporting both procedures were analysed, we found no significant difference between
the two surgical procedures regarding the outcome restenosis (Figure 1). However, this analysis
tended to attribute fewer cases of restenosis to patch closure CEA (RR = 1.31, 95% CI [0.96, 1.78], P
= 0.09). Furthermore, there was statistically significant heterogeneity among studies (P < 0.01).
Regarding the risk of occurrence of TIA one year after surgery, we found no statistical difference
between the two procedures (RR = 0.27, 95% CI [0.05, 1.64], P = 0.16) although only two studies
were used in this analysis as only these two provided information on both techniques (Figure 2). In
respect to stroke (Figure 3), although the difference between studies did not reach statistical
significance (P = 0.06) there was trend showing more favorable results with eversion CEA (RR =
0.34, 95% CI [0.11, 1.05]). On the other hand, the test for overall effect using the studies which
presented simultaneously data from both techniques showed a lower RR for neurological morbidity
(Figure 4) and death (Figure 5) in patients undergoing patch CEA in comparison to those patients
undergoing correction of carotid stenosis through the eversion technique (RR = 0.30, 95% CI [0.11,
0.81], P = 0.02 and RR = 0.41, 95% CI [0.22, 0.77], P < 0.01, respectively). Furthermore, no
statistical significance (P = 0.12) was found when assessing the heterogeneity of samples
strengthening the statistical approach used. When the outcomes neurological morbidity and death
were analysed in combination as morbimortality, there was no significant difference between the two
surgical procedures (RR = 0.9, 95% CI [0.58, 1.39], P = 0.64) and there was significant heterogeneity
among studies (P < 0.01).
DISCUSSION
Although several surgical procedures to correct stenosis of the carotid artery are currently performed,
including CEA with synthetic patch angioplasty and eversion CEA there is still controversy on which
technique is related to poorer post-operative or long-term complications and whether or not it applies
to all clinical situations(51). Thus, surgeon preference and experience with one of the procedures is
the reason that often dictates which technique to choose for operation (51). On the other hand, it is
more consensual that primary closure CEA results in higher numbers of peri-operative and postoperative complications, including stroke and death(64). As there are many other surgical techniques
to perform stenosis correction(9), we were faced with the fact that most studies selected for the
present investigation report only one of the techniques that we have aimed to analyze and a different
one (for example CEA with saphenous vein patch closure or using synthetic materials other than
Dacron to perform angioplasty). We have found only 8 studies that were designed to compare our
target procedures and all 46 remaining studies were designed to compare either Dacron patch or
eversion CEA with a different technique. For this reason, we chose to perform our analysis in two
steps, first pooling data from each procedure and calculating relative risks manually. Afterwards, as
we believe should be more informative and reliable, we have compared in a separate analysis
studies reporting both techniques at the same time using appropriate computer software. The
reasons supporting the assumption that the results from this analysis may be more reliable are that,
although only few studies, and consequently a small number of operations, fitted this category, the
fact that they were designed specifically to compare these techniques has prompted that ideally this
is the single characteristic varying between case groups. Furthermore, most of them were
prospective randomized trials, meaning that the decision to perform Dacron patch closure CEA or
eversion had no criterion other than random choice.
In the pooled data analysis, we found that in patients undergoing CEA eversion all outcomes were
significantly less prevalent than in patients treated with Dracon patch CEA. As mentioned there is
controversy in the current literature on which one of these two techniques is related to between
outcomes(7, 22). The present results show that eversion is associated with fewer cases of restenosis,
TIA, stroke, death and the combined outcomes neurological morbidity and morbimortality. However, it
is necessary to bear in mind that data collected from studies reporting Dacron patch CEA totalized
4110, while for eversion CEA 20998 operations contributed to this analysis. This disparity in number
of operations may also have played in favour of supporting the eversion procedure. Although we
attribute more value to the analysis obtained with studies reporting simultaneously both techniques,
for the reasons presented earlier, we should mentioned that we were settled to find that the same
evidence or tendency was obtained for most outcomes analysed. The most surprising finding was
that concerning restenosis. Even though the result obtained was not significant, we found that
restenosis occurrence tended to be less frequent in CEA with patch angioplasty. One of the possible
explanations for this discrepancy lies in the fact that criteria for stenosis was strongly uneven among
groups of eversion and patch CEA, and usually the criteria for stenosis was more loose in patch CEA.
As a consequence, since restenosis was considered only after 50%, 60%, 70% or 80% artery
occlusion in patients operated with patch CEA, in the case of eversion CEA, some studies considered
a 35% occlusion as restenosis. We believe that this may be one of the strongest reasons to explain
this apparent lack of consistency. Concerning the outcomes TIA and morbimortality, no statistically
significant difference between the two surgical techniques was found. In the later case, the
heterogeneity of the study may have contributed to the lack of a statistically significant association.
However, regarding stroke, eversion CEA tended to be related with less cases of this complication.
Perhaps the most interesting results obtained are related to neurological morbidity and death that
were significantly less in patients operated with eversion CEA. Although those results may seem to
be in contrast with those obtained for restenosis, one should remember that for the occurrence of
neurological events the diameter of the blood vessel is not the only variable to take into account(40).
We propose that, independently of artery lumen diameter, the reactivity of the components of the
blood to Dacron could be different, possibly enhanced, compared to when the vessel is restored after
eversion, which may be associated with a higher number of thromboembolic events.
We should stress that this systematic review and meta-analysis was methodologically challenging
because of the variations in definition of stenosis as well as other differences in design among
studies. Other factors that may obscure the results obtained in the present analysis is that in studies
used in the analysis did not take into account surgeon preferences(64). This would be important as
individual surgeons tend to use the technique they are more comfortable with, what makes it difficult
and artificial to separate the effects of the technique from those of the surgeon.
Notwithstanding, in the present study we found that eversion CEA is associated with fewer cases of
neurological morbidity and death and may result in less cases of stroke one year after surgery.
However, concerning restenosis there is still doubt on which surgical procedures may offer
advantage.
Acknowledgments
We would like to acknowledge the fundamental scientific advices in every manuscript production
phase of Prof. Sérgio Sampaio that were pivotal to the conveyance of the present study. We would
also like to thank the helpful criticisms of Prof. Altamiro Pereira.
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TABLES
Table 1 – Summary of results from the comparison of studies reporting outcomes related to restenosis, neurological
morbidity and mortality associated with Dacron patch CEA or eversion CEA.
Pooled data
Studies with Patch and Eversion
Prevalence
Restenosis
TIA
Stroke
Stroke+TIA
Death
Morbi-mortality
number of events/total
Relative
%
risk*
Patch
Eversion
300 / 3390
574 / 19184
8.85%
2.94%
58 / 1077
383 / 12940
5.39%
2.97%
107 / 2738
360 / 18499
3.91%
1.97%
175 / 2620
745/18602
6.68%
4.02%
98 / 2310
294 / 20512
4.24%
1.43%
275 / 2620
1044 / 20998
10.5%
4.96%
Pa
Relative risk*
[95% CI]
Pb
0.332
< 0.01
1.31 [0.96, 1.78]
0.09
0.551
< 0.01
0.27 [0.05, 1.64]
0.16
0.504
< 0.01
0.34 [0.11, 1.05]
0.06
0.605
< 0.01
0.30 [0.11, 0.81]
0.02
0.337
< 0.01
0.41 [0.22, 0.77]
< 0.01
0.472
< 0.01
0.90 [0.58, 1.39]
0.64
*Risk involving eversion carotid endarterectomy in comparison to endarterectomy with patch closure. aChi2; bMantelHeanszel fixed effects. TIA - transient ischemic attack, CI – confidence interval.
FIGURES
Figure 1 – Forest plot showing the relative risk calculated from data collected from the 8 selected studies that presented
outcomes for restenosis both after patch and eversion carotid endarterectomy. Data was analysed using Mantel-Haenszel
fixed effects model and heterogeneity of the measures obtained from selected studies was assessed through a Chi 2 test.
Differences were considered statistically significant when P < 0.05.
Figure 2 – Forest plot showing the relative risk calculated from data collected from the 2 selected studies that presented
outcomes for transient ischemic attack both after patch and eversion carotid endarterectomy. Data was analysed using
Mantel-Haenszel fixed effects model and heterogeneity of the measures obtained from selected studies was assessed
through a Chi2 test. Differences were considered statistically significant when P < 0.05.
Figure 3 – Forest plot showing the relative risk calculated from data collected from the 7 selected studies that presented
outcomes for stoke both after patch and eversion carotid endarterectomy. Data was analysed using Mantel-Haenszel
fixed effects model and heterogeneity of the measures obtained from selected studies was assessed through a Chi 2 test.
Differences were considered statistically significant when P < 0.05.
Figure 4 – Forest plot showing the relative risk calculated from data collected from the 7 selected studies that presented
outcomes for neurological morbidity (transient ischemic attack and stroke combined) both after patch and eversion carotid
endarterectomy. Data was analysed using Mantel-Haenszel fixed effects model and heterogeneity of the measures
obtained from selected studies was assessed through a Chi2 test. Differences were considered statistically significant
when P < 0.05.
Figure 5 – Forest plot showing the relative risk calculated from data collected from the 7 selected studies that presented
outcomes for death both after patch and eversion carotid endarterectomy. Data was analysed using Mantel-Haenszel
fixed effects model and heterogeneity of the measures obtained from selected studies was assessed through a Chi2 test.
Differences were considered statistically significant when P < 0.05.
Figure 6 – Forest plot showing the relative risk calculated from data collected from the 7 selected studies that presented
outcomes for morbimorbidity (neurological morbidity and death combined) both after patch and eversion carotid
endarterectomy. Data was analysed using Mantel-Haenszel fixed effects model and heterogeneity of the measures
obtained from selected studies was assessed through a Chi2 test. Differences were considered statistically significant
when P < 0.05.