“Quality of life after Abdominal Aortic Aneurysm (AAA) intervention: Open vs Endovascular Aneurysm Repair (EVAR)”
Ana Filipa Pinho, ; Ana Rita Rebelo, ; Carla Brandão, ; Elisabete Ribeiro, ;Joana Oliveira, ; João Sousa, ; Mariana Carvalho, ; Luís Coutinho, ; Pedro Saldanha, ; Sara Vale,
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 CareQuality 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 diameter[1]. If there is no adjacent normal artery segment, this definition must rely on an estimate of the expected normal diameter[2]. 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 pressure[3]. Indications for repair in patients with AAA include[4] 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 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 re-interventions 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 different[6]. Early mortality data for EVAR have been generally less than 3%. Some studies, such as AneuRx phase I, II, III[7] and EUROSTAR have shown that mortality resultant of EVAR is less than that of open surgical repair[8]. 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:
Limits:
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 follow-up 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 1Difference between general scores obtained by patients undergoing open or evar intervention
Paper* / 1 month / 3 months / 6 months / 1 year
Badr Aljabri / -1,90 / - / 13,60 / -
Timothy Wit / - / - / 4,00 / -
Greenhalgh / - / 0,06 / - / -0,21
Rainier Aquino / -2,50 / - / - / 2,00
Patricia Lottman / -15,50 / 15,38 / - / -
Prinseen / - / 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 were-0.21, 2.00 e 8.50.
Table 2
Health and Fuctional Status of AAA Patients Treated With Open (O) or Endovascular (E) Techniques
Measure / Baseline / 1 week / 3 weeks / 1 month / 6 weeks / 2 months / 3 months / 6 months / 1 year
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
WIn 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.
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.
Discussion:
AAA are associated with considerable morbidity, mortality and health-care 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.
Whencomparing 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.