(CEA) with either primary closure (PC) or patch angioplasty (PAT) performed by single center vascular surgeons. Methods: Between November 1994 and March ...
J Korean Surg Soc 2010;78:314-319 DOI: 10.4174/jkss.2010.78.5.314
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Comparison of Outcomes between Primary Closure vs. Patch Angioplasty in Carotid Endarterectomy Departments of Surgery, 1Neurology and 2Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Woo-Sung Yun, M.D., Dong-Ik Kim, M.D., Kyung-Bok Lee, M.D., Ui-Jun Park, M.D., 1 1 Young-Wook Kim, M.D., Gyeong-Moon Kim, M.D. , Chin-Sang Chung, M.D. , 1 2 Oh Young Bang, M.D. , Keon-Ha Kim, M.D. Purpose: The aim of this study was to compare the short and long-term outcomes following carotid endarterectomy (CEA) with either primary closure (PC) or patch angioplasty (PAT) performed by single center vascular surgeons. Methods: Between November 1994 and March 2008, a total of 366 patients underwent 401 consecutive primary CEA procedures at our institution. We retrospectively reviewed patients’ medical records. Two vascular surgeons prefer routine PC and one vascular surgeon prefer routine patch closure using bovine pericardial patch. Postoperative neurologic complications were determined by clinical neurologists. Restenosis was defined as ＞50% stenosis on follow-up duplex scan. Data was analyzed to compare the early (≤30 days) and late results of CEA between PC group and PAT group. Results: The mean follow-up duration was significantly longer in the PC group than that in the PAT group (61.7 months vs. 41.2 months, P＜0.001). Coronary artery disease and combined CEA with coronary artery bypass were more common in the PAT group (39% vs. 55%, P＜0.002; 4% vs. 12%, P＜0.004). Perioperative ipsilateral TIA/stroke rates in the PC and PAT groups were 1.5% and 0.7% (PC=4/270 vs. PAT=1/131, P=0.564). Regarding late outcomes, Kaplan-Meier analysis failed to show any difference between 2 groups on freedom from ipsilateral transient ischemic attack (TIA)/stroke, freedom from restenosis and TIA/stroke-free survival (P=0.851, P=0.232, P=0.103, log-rank test). Conclusion: Our results suggest that PC following CEA is not necessarily inferior to PAT for experienced surgeons. (J Korean Surg Soc 2010;78:314-319) Key Words: Carotid endarterectomy, Primary closure, Patch anigoplasty (PAT) reduces the perioperative stoke rate and the restenosis rate.(1-6) Other authors, however, have reported
INTRODUCTION
PAT is not superior to primary closure (PC).(7-9) Carotid endarterectomy (CEA) is the gold standard to
Carotid lesions in Asians have unique characteristics
reduce stroke. However, there is controversy among the
when compared with those in the West. The athero-
method of arterial wall closure following CEA. Previous
sclerotic plaque tends to involve the more distal internal
clinical studies have shown closure with patch angioplasty
carotid artery (ICA).(10) For this reason, PAT would seemingly be superior to PC, especially in Asians. However,
Correspondence to: Dong-Ik Kim, Division of Vascular Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50, Irwon-dong, Gangnam-gu, Seoul 135-710, Korea. Tel: 02-3410-3467, Fax: 02-3410-0040, E-mail: dikim @skku.edu Received December 14, 2009, Accepted January 25, 2010 This article was presented in the 60th annual meeting of the Korean Surgical Society on Nov, 2008.
few studies in Asian patients report the outcome after PAT vs. PC. In the earlier paper, we reported equivalent results of PC when compared with others’ results of PAT.(11) We noted also that in the previous randomized studies com-
314
Woo-Sung Yun, et al：Primary Closure vs. Patch Angioplasty
315
paring PAT and PC, the surgeon experience was rarely
group or the PAT group. Demographic and clinical data
considered. CEAs might be performed by not only experi-
of the groups were compared, including comorbidities,
enced surgeons, but also by trainees. We hypothesized that
previous history of TIA or stroke, and contralateral ICA
the surgeon experience may influence the outcome of CEA
occlusion. Data was analyzed to compare early (≤30 days)
with PC. In this study, we aimed to compare the
and late results following CEA in the two groups.
perioperative and long-term outcomes between PC and
Categorical variables were compared using chi-square tests
PAT performed by experienced surgeons at our institution.
or Fisher’s exact test, and the continuous variables were examined using Student t-test. Freedom from ipsilateral
METHODS
TIA/stroke, freedom from any TIA/stroke, freedom from restenosis and TIA/stroke-free survival were calculated by
Between November 1994 and March 2008, a total of
Kaplan-Meier method and compared by log-rank test. P-
366 patients underwent 401 consecutive primary CEA
values＜0.05 were considered to be statistically significant.
operations at Samsung Medical Center. We retrospectively reviewed the patients’ medical records. The indications for
RESULTS
CEA were previously described by us,(11) and summarized here.(1) symptomatic stenosis of ＞70%,(2) symptomatic
Table 1 shows the demographic and clinical data of the
stenosis of 50∼69% with type C plaque ulcer (more than
2 groups. The mean follow-up duration was longer in the
2
40 mm in plaque ulcer),(3) asymptomatic stenosis of ＞
PC group (61.7 vs. 41.2 months, respectively, P＜0.001).
70% with contralateral ICA occlusion, and(4) asymptomatic
Coronary artery disease (39% vs. 55%, respectively, P=
stenosis of ＞70% with type C plaque ulceration. Degree
0.002) and combined CEA＋coronary artery bypass surgery
of stenosis was calculated according to the method of
(4% vs. 12%, respectively, P=0.004) was more common in
NASCET (North American Symptomatic Carotid Endar-
the PAT group. There were no other significant differences.
terectomy Trial). All CEAs were performed by three senior
Table 2 shows early and late outcomes following CEA
vascular surgeons under general anesthesia and routine
according to closure type. Perioperative (＜30 days) ipsila-
shunting using a Pruitt-Inahara carotid shunt (Number
teral TIA/stroke rate in the PC and PAT groups were
2004-49, LeMaitre Vascular, St. Petersburg, FL, USA). Two
noted to be 1.5% and 0.7%, respectively (PC=4/270 vs.
vascular surgeons prefer routine PC and one vascular
PAT=1/131, P=0.564). There was no significant difference
surgeon prefer routine patch closure using bovine peri-
between the two groups in postoperative incidence of
cardial patch.
hyperperfusion syndrome, cranial nerve palsy, myocardial
All the patients underwent postoperative evaluation by
infarction and postoperative bleeding. One perioperative
both vascular surgeons and neurologists. Duplex ultrasound
stroke due to thrombosis occurred in the PAT group.
scanning was performed postoperatively at 1 month, 3
Emergency angiography revealed ICA thrombosis, and
months and 6 months, then every 6 months thereafter.
catheter-directed thrombectomy and thrombolytic therapy
Postoperative neurologic complications such as transient
was performed. This revealed underlying ICA stenosis
ischemic attack (TIA), stroke and cranial nerve palsy were
which was treated with a carotid stent. In the PC group,
determined clinically by the neurologist. Restenosis was
there were two perioperative deaths caused by vertebral
defined as ≥50% stenosis on a duplex scan; ICA peak
artery thrombosis in one and pneumonia followed by
systolic velocity ≥125 cm/s and diameter reduction ≥
respiratory failure in a second patient.
50%. Aspirin (100 mg/day) was routinely administered life-long after surgery. All CEA patients were categorized to either the PC
During the late follow-up, ipsilateral TIA/stroke was detected in 2 patients (0.7%) who underwent PC; there was no TIA/stroke in the PAT group. Freedom from ipsilateral
316 J Korean Surg Soc. Vol. 78, No. 5 Table 1. Demographic and clinical data of the patients Primary closure (n=270) (%) Mean follow-up duration, mo (range) Age, y (range) Gender, male Smoking Comorbidity Hypertension Diabetes mellitus Coronary artery disease Hyperlipidemia Indications for CEA Asymptomatic Symptomatic (within 6 months) Contralateral ICA occlusion Synchronous coronary artery bypass *Mann-Whitney test;
†
t-test;
61.7±40.9 66.5±6.9 240 178
P-value
41.2±32.3 (1∼139) 66.5±7.0 (49∼83) 115 (88) 83 (63)
＜0.001* † 0.920 0.745‡ 0.579‡
205 106 105 124
(76) (39) (39) (46)
100 57 72 63
(76) (44) (55) (48)
133 137 18 12
(49) (51) (7) (4)
67 64 8 16
(51) (49) (6) (12)
‡
0.928 0.416‡ 0.002‡ 0.683‡ 0.723‡
‡
0.831 0.004‡
‡
Chi-square test.
Table 2. Comparison of the early outcomes (≤30 days) between primary closure and patch angioplasty Primary closure (n=270) (%) Early outcomes (＜30 days) Ipsilateral TIA/stroke Ipsilateral TIA Ipsilateral stroke Hyperperfusion syndrome Cranial nerve palsy Hypoglossal nerve Facial nerve Postoperative bleeding Mortality
(1∼173) (46∼81) (89) (66)
Patch angioplasty (n=131) (%)
4 (1.5) 2 2 11 (4.1) 10 (3.7) 7 3 4 (1.5) § 2 (0.7)
Patch angioplasty P-value (n=131) (%) 1 (0.7) − † 1 5 (3.8) 7 (5.3) 4 3 3 (2.3) −
regular follow-up without secondary intervention. Five-year, 10-year TIA/stroke-free survival rates were slightly higher in PAT group, however, they were not statistically significant (87%, 69% vs. 78%, 58%, P=0.103, log-rank test).
0.564*
DISCUSSION 0.902‡ 0.445‡
Recently, the European Society for Vascular Surgery (ESVS) guidelines of invasive treatment for carotid stenosis
0.687* 1.000*
† ‡ *Fisher’s exact test; Due to ICA thrombosis; Chi-square test; § Caused by vertebral artery thrombosis and acute respiratory distress syndrome.
suggested that PAT is preferable to PC.(12) The rationale for performing PAT is that it increases the diameter of the arterial and this can reduce the effect of intimal hyperplasia, which can cause restenosis.(13) Further, a wider lumen serves the superior flow characteristics of the internal carotid artery in terms of not generating early
TIA/stroke and freedom from any TIA/stroke were not
thrombosis and hyperplasia.(14)
different between 2 groups (Fig. 1). Six (2.2%) and three
The clinical outcomes of the previously published rando-
(2.3%) restenoses occurred in the PC and PAT groups,
mized trials comparing arteriotomy closure are illustrated
respectively. Fig. 2 demonstrates Kaplan-Meier analysis of
in Table 3. In some trials, the perioperative stroke rate and
restenosis-free rate and TIA/stroke-free survival rate. Five-
restenosis rate was significantly lower following PAT
year, 10-year restenosis-free rates were 98%, 97% in PC
compared to PC.(1-6) AbuRahma et al.(15) compared the
group and 95%, 95% in PAT group (P=0.232, log-rank
outcomes following bilateral CEAs in the patients who
test). For the treatment of restenosis, one redo CEA and
underwent PC on one side and PAT on the contralateral
two carotid stent procedures were performed for the 3
side. They reported that PAT showed superior result
patients of the PC group. All other patients are undergoing
compared to PC for the same systemic condition. However,
Woo-Sung Yun, et al：Primary Closure vs. Patch Angioplasty
317
Fig. 1. Kaplan-Meier curves comparing freedom from ipsilateral TIA/stroke (A) and freedom from any TIA/stroke (B).
Fig. 2. Kaplan-Meier curves comparing freedom from restenosis (A) and TIA/stroke-free survival (B).
in other trials, the results of PAT were not superior to
synthetic type of vascular smooth muscle cells (VSMCs)
those of PC.(7-9) Therefore, some authors have suggested
rather than the type of closure (e.g., PC and PAT), on the
conducting a large multicenter randomized controlled trial
basis of microscopic examination of the endarterectomized
in order to obtain reliable evidence on the risks and
ICA wall. Although our results after PC were satisfactory
benefits of PAT compared to PC.(16)
in the previous study, we wanted to know if PAT could
In terms of selective PC, some authors have reported that
result in a potentially superior outcome at our institution.
PAT of a larger carotid artery is unnecessary(17) and others
Given a lack of significant difference in both the early and
showed that PC is safe and durable when the arteriotomy
late complications between the groups, there appears to be
and endarterectomy end points are within the carotid
no benefit to PAT at our institution.
bulb.(18) Byrne et al.(19) suggested that PC can be safely
In previous randomized studies, the surgeon experience
practiced in large-caliber ICAs (＞6 mm). Still, no
was not considered. Vascular surgery is highly dependent
randomized control trial has yet been performed.
on the surgeon’s skill and experience. Pearce et al.(20)
We have previously reported excellent outcomes from
reported a doubling of surgeon volume was associated with
our institution following CEA with PC, when compared
a 4% reduction in the risk for an adverse outcome
with others’ results of CEA with PAT.(11) We assumed
following CEA. Cowan et al.(21) also showed that the
that postoperative restenosis is related to the remnant
mortality rate and the perioperative stroke rate were
318 J Korean Surg Soc. Vol. 78, No. 5 Table 3. Clinical outcomes of the randomized trials and our previous study regarding the types of arteriotomy closure First author Eikelboom (1988) Clagett (1989) Lord (1989) Ranaboldo (1993) De Letter (1993) Myers (1994) Katz (1994) AbuRahma (1998) AbuRahma (1999) Kim (2007)
Method †
PC ‡ PAT PC PAT PC PAT PC PAT PC PAT PC PAT PC PAT PC PAT PC PAT PC
No. 62 67 60 62 50 § 90 109 104 62 67 64 61 51 49 135 ∥ 264 74¶ 74¶ 166
Early outcomes (%)
Late outcomes (%)
TIA*/stroke
Stroke/death
TIA/stroke
Restenosis
− − 3.3 1.6 10.0 2.2 7.3 4.8 4.8 1.5 3.1 1.6 7.8 4.1 7.4 3.8 4.1 0 1.8
6.4 4.5 − − − − − − 6.4 4.5 − − − − − − − − 2.4
− − 5.0 4.8 − − 2.8 10 − − 4.7 8.2 0 0 3.7 0.8 8.1 1.4 0.6
22.9 3.5 1.7 12.9 17.0 0 19.5 6.1 27.4 11.9 7.8 14.3 3.9 0 33.3 5.3 44.6 6.8 3.0
† ‡ § *TIA = transient ischemic attack; PC = primary closure; PAT = patch angioplasty; 43 saphenous vein patches and 47 polytetrafluoroethylene ∥ ¶ (PTFE) patches; 70 saphenous vein patches, 60 jugular vein patches and 134 PTFE patches; Bilateral carotid endarterectomies with primary closure on one side and patch angioplasty on the other side.
significantly lower in the CEAs performed by high-volume
limitations, however, mostly stemming from retrospective
surgeons (≥30 procedures/year).
design and its relatively small sample size for statistical
In this study, all the CEAs were performed by experi-
analysis. Another is a discrepancy of follow-up duration
enced vascular surgeons rather than by surgeons in train-
between two groups. In the future, a prospective rando-
ing. Based on our results, we assume that closure type does
mized study is warranted and surgeon experience should
not correlate with postoperative stroke or restenosis rates.
be considered in such a study.
PAT can, however, reduce the effect of technical errors. PAT is currently more popular than PC, so surgeons gene-
ACKNOWLEDGEMENTS
rally have more experience with this technique when in training. This inexperience with PC in concern over
We thank Dr. BB Lee, one of the senior surgeons in
restenosis and ultimately has led to a preference for PAT
this study. Now, he is a professor of Surgery & Director,
restenosis despite the potential disadvantages of PAT such
Center for Vein, Lymphatics and Vascular Malformation,
as the increased the clamp and shunt time, the risk of
Georgetown University School of Medicine, Washington,
patch rupture, pseudoaneurysm formation, patch infection
DC, USA.
and thromboembolism from aneurismal carotid dilatation.(8,22,23) In summary, our results suggest that for experienced surgeons, PC following CEA is not necessarily inferior to PAT. PC is a safe and durable procedure and routine patching is not necessary. This study has important
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