Research Article
Cost-effectiveness of Carotid Bifurcation Resection and Interposition of a Polytetrafluoroethylene Graft versus Carotid Endarterectomy in Belgium: A Preliminary Study
Philippe De Vleeschauwer1*, Ian Diebels1,2 and Marc Dubois1
1Department of Thoracic and Vascular Surgery, Heilig-Hartziekenhuis, Belgium
2Department of Medicine and Health Sciences, University of Antwerp, Belgium
*Corresponding author: Philippe De Vleeschauwer, Department of Thoracic and Vascular Surgery, Heilig-Hartziekenhuis, Mechelsestraat 24, Lier 2500, Belgium
Published: 10 Feb, 2017
Cite this article as: De Vleeschauwer P, Diebels I, Dubois
M. Cost-effectiveness of Carotid
Bifurcation Resection and Interposition
of a Polytetrafluoroethylene Graft
versus Carotid Endarterectomy in
Belgium: A Preliminary Study. Clin Surg.
2017; 2: 1300.
Abstract
Introduction: Cerebrovascular disease is an important global health problem. The economic
burden of stroke involves the direct hospital cost and the indirect long-term cost. In Europe the cost
of ischemic stroke during the acute phase (first year) has been estimated to be 18,000-20,000 Euros.
Moreover, the lifetime cost of stroke is approximately 50,000 Euros. If the stroke is due to significant
carotid artery disease, different treatments are available. We present our preliminary results on the
cost-effectiveness of Carotid Bifurcation Resection and Interposition of a Polytetrafluoroethylene
Graft (BRIG) versus Carotid Endarterectomy (CEA).
Methods: A total of 60 patients were included, 30 BRIG and 30 Carotid endarterectomies (CEA).
All CEA were performed by one surgeon, Dubois M. All BRIG procedures were performed by a
single surgeon, Ph. De Vleeschauwer. Analysed costs were divided in total cost of hospital stay, the
resource cost and pharmaceutical cost.
Results: The results show that the total cost of hospital stay was similar in both groups: 3,124.90 for
CEA vs. 3,178.46 for BRIG (p=0.81). The total hospital stay cost of the BRIG group was 53.56 Euros
(1.7%) more than in the CEA group; however this result was statistically not significant. Nevertheless
in Belgium we have to make a distinction in the choice of room namely between a single and twin
room. If this single room group is ignored, the total hospital stay cost of the BRIG group is 480.92
Euro (19%) more expensive than the CEA group. There was a significant difference in material cost
both as regards to the total cost as the cost for the patient and the national health insurance (150.64
Euro vs. 600.62 Euro, p< 0.01). On the other hand, the pharmaceutical expenses in the CEA group
were 15.34 euro (11%, p=0.01) significantly higher compared to the BRIG group.
Conclusion: The BRIG procedure has a higher overall cost, mainly due to the more expensive graft.
However, the lower hospital morbidity and mortality as compared to the CEA are promising and
suggest an overall cost reduction concerning stroke prevention. These preliminary results justify
further research of the BRIG procedure.
Introduction
Cerebrovascular disease is the fourth most common cause of death in the USA [1]. The annual
incidence of stroke rises with age, however the incidence in the high income countries shows an
overall decrease [2]. The economic burden of stroke includes direct and indirect costs (Table 1).
The median proportion of indirect cost was 32% of the total stroke cost as shown in the systematic
review by Joo et al. [3]. The direct cost of stroke is largely determined by the length of hospital stay
which in turn is significantly determined by medical complications [4]. In Belgium, the cost of
stroke during the acute phase has been estimated to be 44.600 euro [5]. This is not confirmed in
other studies.
About 85 percent of strokes are ischemic strokes caused by progressive stenosis of the cerebral
arteries. Nevertheless strokes are to be avoided. Carotid surgery is one of the possibilities if the
significant carotid artery disease has been identified.
Since 1953 carotid endarterctomy (CEA) is considered the golden standard. The first case in the
medical literature was published in The Lancet in 1954. The surgeon was Felix Eastcott [6]. However,
since 10 years we are performing an alternative surgical technique
to CEA namely carotid bifurcation resection and interposition of a
PTFE graft (BRIG). Primary outcome results are promising and have
been published previously [7,8].
In this study, we evaluated the cost and effectiveness of the BRIG
technique versus the CEA technique in our hospital.
Table 1
Methods
A total of 60 patients undergoing elective CEA (n =30) or BRIG
(n=30) for the treatment of significant carotid artery stenosis were
included. All preoperative examinations were performed in an
ambulatory setting including: clinical laboratory examinations,
Duplex ultrasound, CT- or MRI-angiography and cardiologic
diagnostic examinations. These pre-procedure costs were the same
for both groups. The day prior to surgery, the patient was admitted to
the hospital and seen by the anaesthesiologist.
Significant stenosis was defined as more than 70% luminal
narrowing as assessed by duplex-ultrasound examination and
confirmed by CT-angiography. A magnetic resonance imaging (MRI)
was only performed in patients with an iodine contrast allergy.
At our hospital, 2 fulltime vascular surgeons are part of the
Department. Either has chosen in the meantime the BRIG technique
as a standard procedure [7]. The other vascular surgeon used only the
CEA technique.
All CEA procedures were performed under general anaesthesia
and continuous blood pressure monitoring. After dissection of the
carotid bifurcation, 7500 IU systemic heparin was administered
after which the common, internal and external carotid arteries
were clamped. During the CEA, a shunt was never used. After the
endarterectomy, the distal intima was fixed by interrupted 6/0
polydiaxanone (PDS) sutures. The arteriotomy was closed with a
Dacron patch using a running 6/0 polypropylene (Prolene) suture.
On the first postoperative day, 100 mg acetylsalicylic acid was started
once a day.
All BRIG procedures were also performed by a single surgeon.
Anaesthesia and blood pressure monitoring were the same as with
the CEA. Dissection of the carotid bifurcation was performed via a
CEA approach. However, after systemic heparinization with 7500
IU, the carotid arteries were clamped and the carotid bifurcation
(common, internal and external carotid artery) was resected. An
interposition of a 6 mm polytetrafluoroethylene graft was created
between the common and internal carotid artery after ligature of the
external carotid artery. Surgical details of the BRIG procedure have
been described previously [7]. On the first postoperative, 100 mg
acetylsalicylic acid was also started once a day.
The complete invoice of all included patients was collected.
Hospital costs were divided in three parts: total cost of stay, the
resource cost and pharmaceutical cost.
On the one hand, it’s important to know how much the total cost
of the hospital stay is and on the other hand to find out which part is
paid by the patient and the national health insurance. The resource
cost included the cost of the prosthesis and surgical material. The preprocedure
costs were the same for both groups and were therefore not
considered to be important. In Belgium a distinction must be made
between patients who choose explicitly for a single room and those
who do not. In the case of a single person room, both the surgeon
and the anaesthesiologist charge mostly a 100% extra fee on their
provided medical service. This extra fee is not covered by the national
health insurance. Neither follow-up cost after discharge nor total one
year cost were included because these data are almost impossible to
obtain in Belgium.
Statistical methods
Variables were divided in continuous and categorical. Continuous
variables were expressed as mean with a minimum and maximum
range value and were analysed with the student’s T-test. Categorical
values were expressed in absolute numbers and percentages. A
p-value ≤ 0.05 was considered to be statistically significant, a p-value
< 0.1 as marginally significant.
Table 2
Table 3
Table 4
Results
There was no significant difference in the average hospital stay for
the BRIG group and CEA group, which was respectively 4, 82 and 5
days (p-value 0.48). The total hospital stay cost and pharmaceutical
cost are summarized in Table 2 and 3. The costs were divided
according to the room choice and to whom (the patient or national
health insurance) the costs were charged.
The resource cost was mainly determined by the use of a Dacron
patch (CEA) or PTFE 6 mm graft (BRIG), and was the same in every
patient. The cost for a Dacron patch and PTFE graft was respectively
165.16 euro and 660.67 euro. The patient was charged 9.1% (15.01
euro for the patch and 60.06 euro for the graft), the remaining
cost respectively 150.64 euro (patch) and 600.62 euro (graft) was
reimbursed by the national health insurance (Table 4). There was a
significant difference in material cost both with regard to the total
cost on the one hand and the cost for the patient and the national
health insurance on the other hand (p< 0.01) (Table 5).
The results show that the total cost of hospital stay was similar in
both groups: 3,124.90 euro for CEA group vs. 3,178.46 Euro for the
BRIG group (p=0.81). The total hospital stay cost of the BRIG group
was 53.56 Euros (1.7%) more than in the CEA group; however this
result was statistically not significant at present.
Nevertheless in Belgium we have to make a distinction in the
choice of room namely between a single and twin room. In a single
room, the total hospital stay cost for respectively CEA and the BRIG
group was 1,535.43 Euro (60%) and 1,400.00 Euro (46%) more
expensive than in a twin room. The extra cost is mainly due to the
additional fees for the surgeon and anaesthesiologist as mentioned
previously.
If this single room group is ignored, the total hospital stay cost
of the BRIG group was 480.92 Euro (19%) more expensive than the
CEA group. This additional cost (495,51 Euro) was mainly due to the
higher PTFE graft cost.
On the other hand, the pharmaceutical expenses in the CEA
group were 15,34 Euro (11%, p=0.01) significantly higher compared
to the BRIG group. It is striking that for the CEA group – BRIG group
resp. 31%-34% of the total cost of pharmaceutical specialties, must be
paid by the patient and resp. 71%-90% of those cost are due to only
2 specialties namely phenylephrine 1% (30 Euro) and protamine (8
Euro).
Table 5
Table 6
Table 7
Table 8
Table 8
Results of large randomised controlled trials comparing carotid endarterectomy to carotid artery stenting and our results with the BRIG produce.
Table 9
Discussion
Stroke is an important cause of disease burden and health
expenditure. The average cost first year after stroke and the lifetime
cost of stroke are similar for different countries and continents (Table
6 and 7) [9-14].
In Europe, the cost of hospitalization represents about 25% to
45% of the sum spent during the first year after stroke [5]. The average
cost of hospitalization for stroke related disorders in 2007 amounted
6,188 Euro in Belgium. Preventing strokes is therefore financially
very important. Among the ischemic strokes, patients with significant
carotid artery stenosis suffer from rates of disabling or fatal stroke
that are twice that of the general population.
Since the introduction of CEA in 1954 for the treatment of
carotid artery stenosis, CEA is considered as the golden standard for
the treatment of symptomatic or significant asymptomatic carotid
stenosis. Condition is that the surgical centre has a low hospital
morbidity and mortality. For example in 2002 the Dutch Stroke
Guidelines of The Dutch Institute of Healthcare Improvement (CBO)
for CEA of carotid stenosis are as follows:
1. Combined operative morbidity and mortality less than 5%-7%
for CEA of 70%-99% symptomatic carotid stenosis.
2. 2% morbidity and mortality for CEA of 50%-70% symptomatic
carotid stenosis.
3. <2% morbidity and mortality for CEA of >50% asymptomatic
stenosis [9]. The guidelines for CEA in the USA are similar [15].
Surgical morbidity and mortality less than 6% in symptomatic
carotid stenosis of good-risk patients and less than 3% in asymptomatic
carotid stenosis of good-risk patients.
The last decade stenting of the carotid arteries (CAS) becomes
more and more popular especially among the radiologist but the
results are still not convincing. Ciccone MM et al. [16] argue that
carotid artery stenting constitutes a good alternative to CEA in
carotid revascularization when the procedures are selected based on
patient-specific risk factors.
However, more important data (>1,500,000 procedures) from
contemporary administrative dataset registries suggest that stroke/
death rates following CAS remain significantly higher than after
CEA and often exceed accepted AHA (American Heart Association)
thresholds. There was no evidence of a sustained decline in procedural
risk after CAS [17].
Further a study in South Korea showed that the cost from
procedure onset to discharge including the resource cost was
significantly lower in the group of CEA compared to CAS [18]. The
cost was higher in the CAS group because the resource cost was
approximately three times higher in the CAS group than in the CEA
group. In another multicentre study by McDonald et al. used data
from the National Inpatient Sample to estimate hospital costs for
nearly 200,000 patients who underwent either CAS or CEA between
2001 and 2008 [19]. They found that hospital costs were nearly
$5,000/patient higher with CAS than CEA but their study did not
consider physician costs, which are substantially higher with CEA
(due to anaesthesiology services).
Therefore, the authors of this article consider the CAS technique
so far as no acceptable alternative for the treatment of carotid stenosis.
10 years ago we started with the BRIG procedure at our
department. At the beginning the BRIG technique was only used for
symptomatic restenosis and pseudoaneurysm after previous CEA.
At this time, it has becomes a routine procedure in the treatment
of carotid artery disease for this surgeon. Meanwhile, he has treated
more than 144 cases and he still has no major stroke with the BRIG
technique, furthermore only 2 cases with minor stroke and 1 death
(unpublished results).
If one wants to compare these two surgical techniques (BRIG
and CEA), then two things are of particular importance. Firstly the
hospital morbidity and mortality and secondly the restenosis rate
at medium-long term. As to the cost of the surgical procedure, the
hospital morbidity is especially important, and above all the stroke
rate. The BRIG technique scored up till now clearly better than the
CEA technique both in terms of hospital morbidity-mortality as
the restenosis rate [8]. It should however be noted that the groups
strongly differ in number.
Up till now we did not observe any major stroke in the BRIG group,
whose total cost in comparison to CEA group is 481 Euro higher.
This additional cost is mainly due to the difference in cost between a
Dacron patch (CEA) and PTFE graft (BRIG). Consequently, the extra
cost for 100 patients treated by the BRIG technique, is about 48,000
Euros, or 42,000 Euros paid by the national health insurance. If you
can avoid 1 stroke in 100 patients, treated with a different technique,
one can at least save the first year after stroke about 16,000 Euros and
roughly 50,000 Euros lifetime cost after stroke. On the basis of these
data, the hospital morbidity of the BRIG technique must be at least
1% lower than the CEA in order to have true financial benefit. So
far our, although limited experience with the BRIG technique shows
a more than 1% lower hospital morbidity than the CEA technique
and justifies to collect more data also from other countries (Table
8). But are randomized studies always necessary for this purpose? In
2005, following correspondence from John Wu was published in The
Lancet: “In this 100th year of celebration of Albert Einstein, I have
been thinking about his papers on theoretical physics, done purely
by deduction, and how they changed our view of the world. His way
of thinking is in sharp contrast to that of evidence-based medicine,
which has become almost a dogma in some medical circles. Yet if
everything has to be double-blinded, randomised, and evidencebased,
where does that leave new ideas? I do worry that if evidencebased
medicine becomes the dominant thinking, it could impede
advances in medicine” [28].
However, it makes sense to collect at least larger numbers of the
BRIG technique.
In our BRIG technique, a PTFE graft is used. Different materials
have been proposed. The use of autologous material led to an increased
restenosis rate and total occlusion [29]. The prosthetic materials show
a favourable outcome. A recent study on carotid replacement with
Dacron grafts showed a worse result then PTFE grafts as listed in
Table 9 [7,30]. Both studies show that the restenoses occur mainly
at the level of the proximal anastomosis. The infection risk is low
and only led to the replacement of the graft by an autologous greater
saphenous vein in the Dacron group.
The BRIG procedure shows a lower incidence of restenosis
than CEA, despite the small amount of cases (Table 8). The extent,
to which redo surgery and additional costs can be avoided, remains
though unclear because there is currently no gold standard for the
approach to carotid restenosis.
It is generally accepted that symptomatic restenosis needs surgery
but the incidence remains very low. In a multicentre regional registry,
Goodney P et al. [31] reported that restenosis occurred in 10% of the
patients and patients with 50-99% restenosis were asymptomatic
in most cases. Only 3 patients (1%) of 288 with restenosis were
symptomatic. In our department, only symptomatic restenosis were
treated by surgery.
The problem of asymptomatic significant restenosis is much
more complex. Indeed, it is very difficult to predict if and when such
restenosis becomes symptomatic. Therefore it is still quite difficult to
prove that the BRIG technique is cost-effective on the long term with
regard to symptomatic restenosis and redo surgery.
Conclusion
The BRIG procedure has a higher overall cost, mainly due to the more expensive graft. However, the lower hospital morbidity and mortality as compared to the CEA are promising and suggest an overall cost reduction with regard to the prevention of stroke. It is still very difficult to prove that the BRIG technique is cost-effective on the long term concerning symptomatic restenosis and redo surgery. The results of the BRIG technique require confirmation and justify further research of this procedure.
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