“Quality of life after Abdominal Aortic Aneurysm (AAA) intervention: Open
vs Endovascular Aneurysm Repair (EVAR)”
Ana Filipa Pinho, anapinho@netc.pt; Ana Rita Rebelo, dolphime@hotmail.com;
Carla
Brandão,
carla_s_brandao@hotmail.com;
shadygirll_@hotmail.com;
Joana
Oliveira,
Elisabete
Ribeiro,
joana_cp_oliveira@hotmail.com;
João Sousa, j.p_sousa@hotmail.com; Mariana Carvalho, otsiravi@hotmail.com;
Luís
Coutinho,
luix_coutinho@hotmail.com;
Pedro
Saldanha,
pitersaldanha@hotmail.com; Sara Vale, sara_vale@msn.com
Head teacher: Prof. Doutor Altamiro da Costa Pereira
Supervisor: Dr. Sérgio Sampaio
Turma 20
ABSTRACT:
Introduction: Abdominal Aortic Aneurysm (AAA) is one of the most studied
aneurysms because of its big incidence in the world’s population. Management
options include open surgical repair and endovascular repair. Although open
surgery has been considered for years the gold standard for prevention of AAA
rupture, the use of endovascular grafts has attracted wide attention over the last
decade motivated by its less invasive nature.
Purpose: To compare quality of life between open and endovascular aortic
repair of abdominal aneurysms (AAA).
Material: We analyzed 28 references and abstracts from Medline (Pubmed),
The Controlled Trials Register (The Cochrane Library) and ISI Web of
Knowledge online database and, at the end, five papers were elected for
inclusion.
Methods: References related to our query were searched through Medline
(Pubmed), The Controlled Trials Register (The Cochrane Library) and ISI Web
of Knowledge online database. Abstracts and titles were reviewed. The
resulting papers were reviewed and excluded according to exclusion criteria.
Results: In the early postoperative period there is a small yet significantive QoL
advantage of EVAR compared to OR. At 2 months and beyond, patients
reported a better QoL after OR than after EVAR.
Conclusion: Both treatment modalities were associated with an initial
postoperative decline in some SF-36 domains which significantly impaired in the
early postoperative period. However, EVAR resulted in lower general scores in
the mid-term than OPEN repair, with a quicker return to preoperative scores in
selected domains of the SF-36 beyond 6 months.
KEY WORDS:
abdominal aortic aneurysm; AAA; endovascular aneurysm repair; endovascular
repair; Endoluminal Repair; EVAR; open repair; surgery repair; quality of life;
Health Care Quality Indicators; health survey questionnaire; SF-36; systematic
review.
INTRODUCTION: BACKGROUND AND JUSTIFICATION
The Society of Cardiovascular Surgery and the Chapter North-American
of The International Cardiovascular Society defines aneurysm as a permanent
localized dilatation of an artery, having at least a 50% increase in diameter
compared with the expected normal diameter1. If there is no adjacent normal
artery segment, this definition must rely on an estimate of the expected normal
diameter2. Normal arterial diameter depends on age, gender, body size, and
other factors.
Untreated, the major complication is rupture leading to death. Aneurismal
rupture is directly related to aneurysm size, according to LaPlace’s Law that
tension on the aortic wall is the product of the artery’s radius times blood
pressure3. Indications for repair in
patients with AAA include4 diameter
of 5 cm or larger (4.5 to 5.0 for
women), growht rate > 10 mm/year,
symptoms related to the aneurysm.
The abdominal aortic aneurysm
is one of the most studied because
of
its
bigger
incidence
on
the
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population (it affects about 5% to 7% of world population), and it’s more
common in men than in women, generally over 40 years old.
Treatment can be done by different types of surgery: open surgery and
EVAR.
Open surgery was reported firstly in 1951 and has evolved and
significant improvement in mortality and morbidity rates has been achieved.
However, even in low risk patients, open repair of AAA is associated with a
mortality rate of 0 to 5%5. The use of endovascular grafts has attracted wide
attention over the last decade because of the less invasive nature of procedure.
Choose which one is recommended for this type of pathology is a hard work,
which needs to analyse a list of different aspects, such as the quality of life,
precedents pathology and clinical history of the patient, etc. Nevertheless, there
is controversy on this matter.
Recent studies suggest that EVAR surgery can reduce recovery time to
two or three days, but it carries more needs of vigilance and secondary reinterventions than open surgery. Besides, it’s more expensive. Other studies
claim that, after one year, the level of quality of life among patients submitted to
open and EVAR surgery is not so different6. Early mortality data for EVAR have
been generally less than 3%. Some studies, such as AneuRx phase I, II, III7
and EUROSTAR have shown that mortality resultant of EVAR is less than that
of open surgical repair8. However, when the matter is long-term survival, open
repair related studies are more well defined than EVAR studies.
Quality of life is obviously difficult to define and measure. The World
Health Organisation defines “health” as a state of physical, mental and social
well-being, not merely the absence of disease.
9
According to the published
literature, a difference of less than 10% in QOL measures is not clinically
important and meaningful.
Quality of life assessment tools such as the SF-36 can help surgeons
evaluate a patient’s perception of his or her health and well being before and
after surgery.10,11 The standardized SF-36 health survey is a valuable
instrument to measure patient – perceived quality of life owing to its high
validity, reliability, psychometric property.12,13 The American College of
Surgeons and the American Society of Vascular surgery have both promoted
the use of SF-36 in the surgical population,14 and the SF-36 has been validated
for patients with vascular diseases.15
RESEARCH QUESTION AND AIM:
This systematic review is going to answer to the question: “Are there any
differences in quality of life of patients above forty years submitted to EVAR and
open surgery, in order to treat Abdominal Aortic Aneurysms?”
The aim is to compare quality of life of patients aged above forty years
after Open or Endovascular Aortic Repair of abdominal aneurysm. Some
specific aspects of quality of life will be analysed and compared such as
emotional health, capability to daily activities and social life. In order to solve
this problem, it is necessary to establish the sequence of steps that will be
developed through the academic year, which are written above in methods.
Purpose: To compare quality of life between open and endovascular aortic
repair of abdominal aneurysms (AAA) in patients aged above forty years. In
order to obtain more specific and objective results, it won´t be compared quality
of life in general, but some of its parameters, such as: emotional health,
capacity to perform day life activities (dressing, bathing, lifting objects, moving a
table, housework) and social activities ( with friends, family and other groups).
Methods:
Data Search and Trial Selection
Based on the aim of our study, it was performed a systematic review
using Medline (Pubmed), The Controlled Trials Register (The Cochrane Library)
and ISI Web of Knowledge online databases. Besides the following query, a
few restrictions and limits have been introduced during our research.
Query:
(“Abdominal Aortic Aneurysm” [MeSH] OR “AAA”) AND (“Quality of
Life” OR “Health Care Quality Indicators” [MeSH] OR “QOL”) AND
(“Endovascular Repair” OR “Endoluminal Repair” [MeSH] OR
“EVAR”) AND (“Open Repair” OR “Surgery Repair”)
Language: English
Limits:
Humans or animals: humans
It was used this language limit because all Portuguese papers usually
exist also in English. As EVAR is a very recent technique (less than 10 years), it
was not necessary to establish years or date of publication limits.
All the papers found with the query (from the earliest available until
December 2007) were reviewed and selected to be included in our study if they
respected all the inclusion criteria defined.
Exclusion and Inclusion Criteria
The first phase of papers selection consisted on the application of the
inclusion criteria in all the articles found. Five groups, composed by two
reviewers, included the papers that respected the following criteria: compare
quality of life after EVAR and OPEN repair; include patients over forty years in
the sample analysed; use SF-36 to evaluate quality of life parameters; mention
the methods used and results; studies in humans. As a strategy of solving
disagreement points it was incorporate a third element of the group (third
reviewer).
On the following stage, other five groups composed by two reviewers
continued the selection by reading the full text and excluding the papers which:
were not directly related to the aim of our review; compare both techniques
(EVAR and OPEN) but do not refer pos-operative quality of life or focus on
parameters that don’t relate it directly; papers written in an inaccessible
language; articles in which only abstract is available and it’s not possible to
obtain the complete article. In the same way, as a strategy of solving
disagreement points it was incorporate a third element of the group (third
reviewer).
Finally, five papers were obtained.
Outcomes
The considered outcomes were, primarily, the comparison of quality of
life, between evar and open repair obtained from SF-36 total scores; and
secondarily, comparison of singular parameters scores from SF-36 between
open and EVAR.
At the end, six papers were obtained.
Statistical Analysis and data aggregation
Previously to the elaboration of the systematic review, a statistical
analysis was performed using the SPSS software. The data from the final
included articles was aggregated to compare final scores of SF-36 after Open
and EVAR repair, calculating the arithmetic difference between open and EVAR
scores. This way, we compared both procedures. A positive result corresponds
to a higer score to OPEN repair, that is a better quality of life for patients
undergoing to this type of surgery. A negative result corresponds to a better
quality of life for patients submitted to EVAR. The differences obtained were
summarized using several graphs corresponding to each moment of the followup period analysed (first month, third month, sixth month and one year – the
ones more frequently referred through papers analysed). In order to take a
general view of all papers, we built another graph showing the mean evolution
of the total scores in both procedures through follow-up period.
Results:
Table 1
Difference between general scores obtained by patients undergoing open or evar
intervention
Paper*
Badr Aljabri
Timothy Wit
Greenhalgh
Rainier Aquino
Patricia Lottman
Prinseen
1 month
3 months
6 months
1 year
-1,90
-
13,60
-
-
-
4,00
-
-
0,06
-
-0,21
-2,50
-
-
2,00
-15,50
15,38
-
-
-
5,00
5,00
8,50
At first month, all differences are negative: to papers 1, 4 and 5, it was
obtained a score difference of -1.90, -2.50 e -15.50, respectively. This shows
that, a month after surgery, EVAR provided a higher score than OPEN repair,
according to SF-36 means.
Three months later, it has been verified the reverse situation: to papers 3,
5 and 6 the difference of scores was 0.06, 15.38 e 5.00, respectively. It was
seen that, tree months after surgery, OPEN repair provided positive effects and
a better quality of life than EVAR.
Six months later, these results were maintained, indicating that OPEN
repair is still providing a better quality of life than EVAR. To papers 1, 2 and 6
the differences of scores were 13.60, 4.00 e 5.00.
After one year, there are divergent results, but the majority still points out
a better quality of life to OPEN repair group. To papers 3, 4 and 6 the
differences of results were0.21, 2.00 e 8.50.
Within this graph, it can be
observed
that
postoperative
till
second
month,
patients
undergoing EVAR have better
quality of life. Patients undergoing
EVAR have lower QOL scores
from 2 months after surgery than
do patients undergo OR.
Graph 2 – Relation between SF-36 scores obtaiend by patiens
undergoing open and evar interventions in preoperative and
postoperativ period of 1 year.
Table 2
Health and Fuctional Status of AAA Patients Treated With Open (O) or Endovascular (E) Techniques
Baseline
1 week
3 weeks
1 month
6 weeks
2 months
3 months
6 months
Measure
O
E
O
E
O
E
O
E
O
E
O
E
O
E
O
E
O
E
Physical
Funcion
71,1
69,0
35,3
41,4
44,0
53,0
55,6
50,8
62,0
64,0
93,0
89,0
76,5
70,0
72,0
58,0
84,5
76,0
Social
Function
80,7
78,4
60,9
58,9
41,0
51,0
68,4
69,7
62,0
68,0
99,0
95,0
80,5
72,0
81,5
68,5
92,8
83,0
Role
Physical
60,3
58,8
13,2
21,9
9,0
27,1
22,6
48,3
22,0
39,0
75,0
91,0
54,3
59,0
64,6
51,7
72,0
75,4
Role
Emotional
72,7
48,6
67,5
66,3
41,0
50,0
61,1
69,8
56,0
69,0
96,0
94,0
70,5
75,5
80,6
66,4
94,4
82,0
Mental
Health
77,2
74,8
79,0
77,3
69,1
69,0
77,0
78,3
74,0
72,0
95,0
95,0
77,5
72,7
77,1
74,5
89,0
83,0
Vitality
68,1
61,9
42,6
43,5
47,2
49,0
62,8
57,7
53,0
56,0
78,0
79,0
65,5
61,0
64,5
55,8
72,0
69,9
Bodily
Pain
70,3
68,7
54,7
45,6
58,0
54,3
49,7
62,7
62,5
68,5
50,0
50,0
80,5
81,2
77,0
70,8
65,9
62,4
General
Health
65,7
64,9
71,5
63,9
61,5
60,0
68,5
61,4
63,0
60,7
85,5
84,0
55,5
62,1
68,1
58,8
82,5
73,0
In the parameter physical function, it is observed that pacients
undergoing open have better scores in the post operative period of one month
and beyond, observing that till one month the situation is reversed.
1 year
Concerning to social function it is observed that till the first week, patients
undergoing open intervention enclose better scores than those undergoing
evar. It is observed the reversal situation between 3 and 6 weeks. At the second
month in the post operative period and beyond patients undergoing open have,
again, better social function scores than those submitted to evar.
When comparing role physical, it can be noticed that, until the third
month of post operative time, patients undergoing evar get netter scores. The
situation is reversed since that moment.
Role emotional and mental health are very similar between the two
intervation, existing periods of pos operative time that patients urdergoin evar
have better scores and other periods were it is reversed.
Patients undergoing evar have lesser scores in vitality at 3 first weeks. At
the first month open intervention gives better scores. From six weeks to two
months the situation is reversed. From three months and beyond patients
undergoing open intervention, have higher scores that those undergoing evar
intervention.
When analysing bodily pain we can observe that between the
preoperative period and the third week and since the sixth month, patient
undergoing open suffer more bodily pain that those undergoing evar. In the
other period of time the inverted situation is observed.
Finally, when observing general health patients undergoing open have
better scores, excepted in the third month, where the situation is reversed.
Image 1. 8 graphs comparing single SF-36 parameters scores between patients undergoind evar
or open intervention; blue line represents open intervention, green line represent evar
intervention.
Discussion:
AAA are associated with considerable morbidity, mortality and healthcare costs. Elective Open repair has traditionally been considered the
intervention of choice to reduce the risk of rupture and improve survival in
individuals at high risk of rupture. Nevertheless, EVAR has become widely used
based on belief that it may provide long-term prevention of ruptures with low
intervention morbidity and mortality and improved length and quality of life.
When comparing the absolute scores between both procedures (first
outcome), at 1 month the OR group had significantly lower scores on physical
function, social functioning, role-emotional, mental health, bodily pain and
general health. At 6 months postoperatively physical function, social functioning,
mental health, vitality, bodily pain and general health scores in the OR was
significantly higher than in the EVAR group. At 12 months, the physical-function,
social-functioning, role-physical, mental health, vitality, bodily pain and general
health scores were significantly higher in the OR group.
On the other side, when analysing the parameters one by one (second
outcome) we see that in what concerns to physical function the papers agree to
state that until the first month the scores on patients submitted to OR were
lower than on patients submitted to EVAR. However in the first month there is a
change showing a better quality of life in the parameter physical function in
patients submitted to OR. In the parameter social function there was no
unanimity between papers, but a greater percentage of them support that
scores in patients submitted to OPEN are lower than in that ones submitted to
EVAR until the first six weeks. After the sixth week there is an inversion of the
results with the patients submitted to OR having higher scores in what concerns
to social function. In the role physical, the patients submitted to OR have lower
scores than the patients submitted to EVAR during all the postoperative period,
except at the sixth month. A great divergence was noticed when analyzing the
parameter role emotional in what concerns to postoperative scores, with periods
of time that patients treated with OR had higher scores (1 week, 2 months, 6
months and 1 year), and with the other periods analyzed that patients submitted
to EVAR had higher scores.
In mental health there is a great similarity of
scores in patients submitted to OR or to EVAR. Analyzing the vitality, until the
first three months after the surgery there are some periods that patients
submitted to EVAR had higher scores (1 week, 3 weeks, 6 weeks and 2
months), and periods that this patients had lower scores. After the third month,
there are better scores of vitality on patients submitted to OR. Checking now the
parameter bodily pain, the papers agree that the patients submitted to OR have
higher scores than that ones submitted to EVAR. Finally, in the last parameter
general health the papers agree in showing that patients submitted to OR had
higher scores until the second month after surgery. There is a change at the
third month, when patients submitted to EVAR presented higher scores. After
the sixth month, once more patients treated with OR had higher scores.
In that way, we can say that the parameters role emotional and mental
health are not affected by the kind of surgery (OR or EVAR).
It’s good to notice that to higher scores should be given different
meanings. So higher scores of physical function, social function, role physical,
role emotional, mental health, vitality and general health are benefits to the
patient, however an higher score on bodily pain it is not a benefit.
As was expected, the results of the second outcome are in agreement
with the results of the first outcome: in the postoperative period, until the first
two/three months there is a better quality of life on patients submitted to EVAR,
but the situation changes after this moment.
One limitation to our study is that the data provided by each one of the
analysed papers was collected in different stages of post-operative period
nevertheless they had few common points. Moreover, some papers include only
SF-36 global scores and didn’t analyse individual score criteria making it difficult
to perform an analysis focused on the differences between each domain (e.g.
mental health, pain, …)
Conclusion:
In conclusion, both treatment modalities were associated with an initial
postoperative decline in some SF-36 domains which significantly impaired in the
early postoperative period. The EVAR treatment is associated with a less
invasive operative procedure, a more favourable perioperative hospital course
and a lower postoperative complication rate. However, it resulted in lower
general scores in the mid-term than OPEN repair, with a quicker return to
preoperative scores in selected domains of the SF-36 beyond 6 months.
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