Disclaimer
This information collection is a core HTA, i.e. an extensive analysis
of one or more health technologies using all nine domains of the HTA Core Model.
The core HTA is intended to be used as an information base for local
(e.g. national or regional) HTAs.
AAA Screening compared to not doing anything in the screening of Abdominal Aorta Aneurysm (AAA) in elderly at moderate risk of developing AAA
(See detailed scope below)
Authors: Daniela Pertl, Sophie Brunner-Ziegler
The main purpose of the present domain was to describe current screening strategies for abdominal aortic aneurysm (AAA) with special emphasis on the gold standard technical device, the ultrasound sonography device.
Generally, “screening” aims to identify pathological conditions in their preclinical and potentially curable stage. Basic criteria, published by the WHO in 1968, should ideally be fulfilled for a condition to qualify for screening. While population-based systematic screening concentrates systematically on the entire population or on subgroups of the entire population by using quality assured programmes, opportunistic screening practices are performed occasionally during individual routine healthcare examinations. Screening results of both types are used as a basis for potential further diagnostic assessments and therapies. Major limitations of screening involve the psycho-social burden of concerned people, and unnecessary investigations and treatment as a result of false positive results.
In the case of AAA current screening practices and funding policies differ between healthcare systems. With the exception of Sweden and the United Kingdom, no specific nationwide screening programmes have been implemented within European Countries. Instead, individualised care is strongly recommended for each patient. When the best-established and most used screening guidelines were compared, the highest rigor/quality score (AGREE score) was for the guidelines of the US Preventive Services Task Force from 2005 (score: nearly 80%), in contrast to the Society for Vascular Surgery practice guidelines, which scored only 25%.
According to the US Preventive Services Task Force, all men, aged 65 to 75 years, who have ever smoked in their lifetime, should be screened by abdominal ultrasonography.
The aim of the following domain is to give a short overview of screening in general and to characterise the technical details of the ultrasound sonography device, which has been internationally accepted as the gold standard methodology for abdominal aortic aneurysm (AAA) screening procedures. AAA is usually detected either during population based screening or during various opportunistic screening strategies.
First we consider the history, diverse definitions, strengths and limitations of screening in general, with special emphasis on the distinction between different screening strategies, such as population based and various opportunistic screening strategies. A survey of the different AAA screening approaches in the individual countries, in the context of their healthcare systems, was performed. The survey indicated that approaches vary not only in terms of the context in which screening takes place, but also in the target population, towards whom they are directed.
Second, technical details of ultrasound sonography are introduced: special features relevant to this technique, such as cut-off points and necessary material investments are discussed. Some information is described in detail in other domains, for example, qualifications needed, training and quality assurance processes and necessary investments.
The collection scope is used in this domain.
Technology | AAA Screening
DescriptionPopulation-based systematic abdominal aortic aneurysm (AAA)screening. This includes one single invitation for the whole target population to do one ultrasound scan examination. Purpose of use: Detect abdominal aortic aneurysm in unruptured phase in order to treat those aneurysms with high risk of rupture. |
---|---|
Intended use of the technology | Screening Screening programme for abdominal aortic aneurysm Target conditionAbdominal Aorta Aneurysm (AAA)Target condition descriptionAll men and women aged 64 or more Target populationTarget population sex: Any. Target population age: elderly. Target population group: Possible future health condition. Target population descriptionAll men and women aged 64 or more For: All men and women aged 64 or more. There is some international variance in the prevalence of AAA. In the western countries the prevalence varies between 5 to 10 % for the 65 – 74 years old men. In Japan the prevalence is 1 % for the same group of men. The prevalence increases with age. In England the prevalence is 2 % for men aged 50 – 64 year and 12 % for men aged 80 years or older. In Denmark the prevalence is 4 % for men aged 65 – 69 and 6 % for men aged 70 – 74 years old. The prevalence for women is significant lower than the prevalence for men. |
Comparison | not doing anything
DescriptionNo population-based AAA screening. This includes incidental detection of AAA without age or sex limitation while performing abdominal ultrasound examinations due to other/unclear clinical indications and various opportunistic AAA-screening practices |
Topic | Issue | Relevant | Research questions or rationale for irrelevance | |
---|---|---|---|---|
B0001 | Features of the technology | What is this technology? | yes | What is Screening? Are there different strategies for Abdominal Aorta Aneurysm Screening? Has any technical device for the detection of AAA established as internationally accepted golden standard? |
B0002 | Features of the technology | Why is this technology used? | yes | Why is Abdominal Aorta Aneurysm Screening used? |
B0004 | Features of the technology | Who will apply this technology? | yes | Which professionals use the technology and is there a difference between the screening strategies? |
B0016 | Features of the technology | To what population(s) will this technology be used on? | yes | To what population(s) will Abdominal Aorta Aneurysm Screening be used on? |
B0003 | Features of the technology | What is the phase of the technology? | yes | What is the background of the golden standard technical device? |
B0006 | Features of the technology | Are there any special features relevant to this technology? | yes | Are there any special features relevant to the golden standard technical device for Abdominal Aorta Aneurysm Screening? |
B0005 | Features of the technology | In what place and context is the technology intended to be used? | yes | In what place and context are Abdominal Aorta Aneurysm Screening strategies intended to be used? |
B0018 | Features of the technology | Are the reference values or cut-off points clearly established? | yes | Are the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established? |
B0017 | Features of the technology | Is this technology field changing rapidly? | no | Technology field is not changing rapidly. Even if technical details are minimally changing (by being updated), basic requirement of application does not change and there are no requirements fo re-training for the end-users. |
B0007 | Investments and tools required to use the technology | What material investments are needed to use the technology? | yes | What material investments are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening? |
B0009 | Investments and tools required to use the technology | What equipment and supplies are needed to use the technology? | yes | What equipment and supplies are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening ? |
B0010 | Investments and tools required to use the technology | What kind of data and records are needed to monitor the use the technology? | yes | What kind of information is needed to monitor the use of the technical device for Abdominal Aorta Aneurysm Screening ? |
B0008 | Investments and tools required to use the technology | What kind of special premises are needed to use the technology? | no | There is no need for special premises for the usage of the technology, as there is no radiation exposure associated with ultrasonography. There is no need for usage of contrast media and the technology is even authorized for application in pregnant women. However, the technical device requires a person (medical doctor, medical technician assistent), who is well trained and highly experienced with the assessment procedure. |
B0011 | Investments and tools required to use the technology | What kind of registers are needed to monitor the use the technology? | no | There is no need for the establishment of registers, as there are internationally consistent guidelines for diagnosis of AAA by ultrasonography. |
B0012 | Training and information needed to use the technology | What kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technology? | yes | What kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technical device for Abdominal Aorta Aneurysm Screening ? |
B0013 | Training and information needed to use the technology | What kind of training is needed for the personnel treating or investigating patients using this technology? | yes | What kind of training is needed for the personnel treating or investigating patients using the technical device for Abdominal Aorta Aneurysm Screening ? |
B0014 | Training and information needed to use the technology | What kind of training and information should be provided for the patient who uses the technology, or for his family/carer? | no | For ultrasonographic assessment of the abdomen persons should be in a fasten condition. Special medication to make the intestine free from gas might be applicated the day before the assessment. |
B0015 | Training and information needed to use the technology | What information of the technology should be provided for patients outside the target group and the general public? | no | Patients outside the target group are not invited for population based screening. |
The project scope is applied in this domain:
Technology description |
Population-based systematic abdominal aortic aneurysm (AAA) screening. This includes one single invitation for the whole target population to do one ultrasound scan examination. Purpose of use: Detect abdominal aortic aneurysm in unruptured phase in order to treat those aneurysms with high risk of rupture. Target condition: Abdominal aortic aneurysm (AAA) MeSH: ”Mass screening”. |
Intended use of technology |
For: All men and women aged 64 or more. There is some international variance in the prevalence of AAA. In the western countries the prevalence varies between 5 to 10 % for the 65 – 74 years old men. In Japan the prevalence is 1 % for the same group of men. The prevalence increases with age. In England the prevalence is 2 % for men aged 50 – 64 year and 12 % for men aged 80 years or older. In Denmark the prevalence is 4 % for men aged 65 – 69 and 6 % for men aged 70 – 74 years old. The prevalence for women is significant lower than the prevalence for men. |
Comparison |
No population-based AAA screening. This includes incidental detection of AAA without age or sex limitation while performing abdominal ultrasound examinations due to other/unclear clinical indications and various opportunistic AAA-screening practices. |
Outcome |
All |
Design |
Systematic Reviews HTA RCT national guidelines grey literature technical literature |
Information sources
Basic search strategy
A basic search strategy to identify systematic reviews and randomised controlled trials to suit the overall project definition was developed by investigators from the different domains. This search strategy combined MeSH terms on the intervention exclusively. The search was performed by a research librarian from the Norwegian Knowledge Centre for the Health Services (NOKC) in the Cochrane Library, HTA, CENTRAL, CRD, DARE, EMBASE, MEDLINE and ISI databases. The search resulted in 167 titles (41 Systematic Reviews/HTAs, 126 RCTs).
Selection of literature from the basic search
Abstracts were scanned by each of the two assessors (Sophie Brunner-Ziegler and Daniela Pertl). Articles were included if considered relevant by one of the assessors (based on title and eventual abstract). The literature scan resulted in a net list of six publications, which were distributed among the assessors for further assessment and eventual inclusion in the result cards.
(citations from peer reviewed literature, tertiary literature and technical literature)
The description and technical characteristics of the technology are rarely analysed within clinical studies, economic analysis, systematic reviews and HTA reports, so the analysis required additional search for national guidelines, grey literature and technical literature to answer the research questions of this domain.
Therefore, the Guidelines International Network (GIN), manufacturer’s websites and technical literature was scanned and 28 articles were included. Reports in the English and German languages were included. The search was done by Sophie Brunner-Ziegler and Daniela Pertl.
Furthermore, a questionnaire to EUnetHTA partners internationally was used to get information about technical aspects of the technology because this information was not fully available in the basic literature search. Survey questions concerning the TEC domain contained six relevant questions (screening strategies, gold technical device, national guidelines, responsibilities).
Quality assessment using criteria for clinical effectiveness is not pertinent in the investigation of this domain and other quality assessment criteria are not available. We therefore chose to use peer reviewed literature as the source.
We performed a descriptive analysis of the articles selected. The research questions were answered by cooperation between the two participants.
Result cards are covered by evidence issued from basic search, hand searched literature and survey results. Appendix TEC-1 provides the list of result cards of this domain, related result cards of other domains and following agreements on assessments.
Background information on screening as an intervention
The following table gives an overview of differences between screening practices. Details are described below.
Table 1: Overview and separation of screening strategies
What is the name of the intervention? |
Population-based systematic screening |
Various opportunistic screening practices |
Synonyms |
Mass/mass public health/selective/multiple/multiphasic screening for the whole population or of selected high risk groups in the population. |
Selective/individual/multiple screening for individuals/individual approach |
What is the objective of screening? |
To identify a disease or condition in its preclinical and therefore potentially curable stage in apparently healthy people or people believing themselves to be healthy. | |
What are the requirements for screening? |
Please see criteria in detail below. | |
How is it implemented? |
Please see details below. | |
How is the screening organised? |
Systematically |
Not systematically: a) Screening is done occasionally during routine healthcare examinations, while the patient has no symptoms of the disease for which screening is carried out. b) Screening is done only for those patients that consult the physician because of symptoms. |
How is it realised? |
a) Quality assured and evidence based screening programme that includes all relevant interventions to reduce risk. |
Individual medical investigations, including screening test and interventions. |
b) Individual medical investigations, including screening test and interventions. | ||
Who is screened? |
a) Every person in the entire population. |
Screening is not population based: only individuals are screened. |
b) Selective screening approaches: target subgroups of the population with a high prevalence of risk factors for a certain disease or condition. | ||
Where is screening done? |
a) Inpatient. b) Outpatient. |
Outpatient; Occasionally screening during routine healthcare examinations, such as periodic primary care visits (usual care). |
Who screens? |
a) Medical technical assistants, b) General practitioners, c) Medical doctors who specialise in internal medicine. |
a) General practitioners, b) Medical doctors who specialise in internal medicine. |
What are limitations of screening? |
Please see details below. | |
How is it financed? |
Depends on the screening strategies and healthcare systems (please see below). |
History of Screening
The first routine investigations in healthy people were done around 1860 concurrently in the UK and the USA. At that time the main purpose was to gain new scientific insights into diseases and their prevention. Routine investigations were rapidly accepted in the USA because of the endorsement of insurance companies, who wanted to minimise the health risk profiles of their members, employers who wanted to ensure a healthy workforce and increase productivity, and because of medical scientists, who wanted to continue their pioneering task even if neither the health-related, nor the financial benefit of such routine investigations was clear at the beginning. In Europe, the need for quality assured and informed screening programmes has become more accepted since 1960. Current and future challenges to screening involve the weakened traditional authority of medical science, the changing risk awareness of the population, the advancement of genetic research, the decentralisation of healthcare and the growing financial burden of healthcare costs. {1}
Definition of Screening
The definition of screening and what people really mean when they use the term screening varies widely between professional groups and with time and local conditions. The primary objective of medical screening is to identify a disease or condition in its preclinical and therefore potentially curable stage in apparently healthy people or people believing themselves to be healthy.
For identification of a disease or condition, individual screening tests or a quality assured and evidence based screening programme, which includes all relevant interventions to reduce risk, can be applied. Additionally, every person in the entire population, or a target subgroup of the population with a high prevalence of risk factors for a certain disease or condition, can be included for screening. Furthermore, screening can be implemented in the inpatient or outpatient sector and executed by different experts. On the basis of the screening results people may be offered information, further assessments and/or appropriate therapy. {2, 3}
Screening does not apply to investigations, performed at a time when signs and symptoms of a disease have already occurred. However, there are some tests and investigations, which are carried out in healthy people and fulfil some criteria of screening programmes, but are not defined as having screening as their primary intention, for example occupational investigations at a workplace, preliminary investigations before operation, epidemiological surveys, lifestyle and fitness assessments or investigations for secondary disease. {1}
Requirements for screening
Before starting to plan and implement screening practices for a condition or disease, it is important to check if the criteria for viability, effectiveness and appropriateness are fulfilled. In 1968, the World Health Organization published principles and practices of screening for disease and listed some basic criteria that should ideally be fulfilled: {4}
Additionally, detailed criteria, developed by the UK National Screening Committee, are available online http://www.screening.nhs.uk/criteria. {2}
Implementation of a screening programme
How a screening programme should be or is implemented depends on healthcare systems, strategies, medical services offered and financing of the screening programme. Essential elements that influence improvements in the health of a population as a result of implementing a screening programme are listed below. {1, 5}
Screening Practices
The following types of screening can be undertaken.
a) Population based approaches that attempt to systematically screen every person in the entire population.
b) Selective screening approaches that target subgroups of the population with a high prevalence of risk factors for a certain disease or condition.
The process of population-based systematic screening can be divided into the following stages {5}:
(a) The physician screens individuals occasionally during routine healthcare examinations (selective screening for individuals). The patient is presumed well or is not complaining of the disease for which screening is offered. The physician has no special reasons to suspect illness but complies with an accepted standard of good diagnostic practice.
(b) The physician examines only those patients who consult him or her because of some complaints.
For various opportunistic screening practices for AAA no specified screening process is defined. In most cases, it is done in the primary care setting as an add-on investigation to other primary prevention investigations, or an AAA may occasionally be detected when a different indication is primarily being examined by the practitioner.
Screening in practice
Population-based systematic screening and various opportunistic screening practices can consist of {1, 6}
(a) individual medical investigations, including screening tests and interventions which altogether result in a screening programme or
(b) quality assured and evidence based screening programmes, which include all relevant interventions to reduce risk.
The implementation, realisation and financing of screening vary between the different screening practices and healthcare systems {1}:
Additional Benefits of AAA-screening
Detection of AAA by any screening procedure may act not only as a decision tool for planning elective surgery but also as a tool to intensify and supervise lifestyle modifications for the patient (i.e. smoking cessation, optimising antihypertensive pharmacotherapy,…).
Limitations of AAA-screening
The implementation of screening practices has the potential to save lives or improve quality of life because of early diagnosis of serious diseases or conditions, but it cannot guarantee protection. In any screening practice, there is a potential for harms and adverse events for patients, e.g. during the screening test, during diagnosis or during treatment. There is, for example, the potential for false positive results in individual screening tests, which may be a considerable psycho-social burden for those concerned. Additionally, false positive results can result in unnecessary investigation and treatment. On the other hand, false negative results delay the detection and final diagnosis of a disease. During the screening test, patients could be exposed to radiation or chemicals or undergo discomfort, stress or anxiety, all of which could lead to adverse effects. Therefore it is essential to establish whether, in practice, screening a healthy (risk) population leads to an improvement of relevant outcomes. {2, 7}
Importance: Critical
Transferability: Partially
For abdominal aortic aneurysm screening different practices exist (population-based systematic and various opportunistic screening practices). In most countries no systematic and nationwide screening programme is implemented. Decisions about screening are made individually by primary care physicians. In addition, several cardiovascular societies have published recommendations concerning who should be screened and under which conditions. All of the recommendations require clinicians to individualise care and recommendations depending on the patient's risk and likelihood of benefit.
The following table gives an overview of the AAA screening strategies of various countries {8}.
Table 2: Overview of country-specific AAA screening practices
Country |
Screening practice |
Details |
Austria |
No specific screening programme for AAA. | |
Belgium |
No specific screening programme for AAA. | |
Croatia |
No specific screening programme for AAA. |
If AAA is occasionally found during other examinations, these patients will be referred to a vascular surgeon. |
Finland |
No specific screening programme for AAA. |
Population-based screening for AAA is currently under serious consideration, but no decisions have been made. |
Germany |
No specific screening programme for AAA. | |
Latvia |
No specific screening programme for AAA. | |
Lithuania |
Opportunistic screening. |
In individuals who have sought medical advice for a specific symptom or complaint the opportunity is taken to suggest screening. It is undertaken during a clinical consultation because of another health problem or condition. |
Spain |
No specific screening programme for AAA. | |
Sweden |
Population-based screening programme. |
Screening of a defined healthy population (based on a defined risk profile/eligible population) by invitation to a screening programme. |
United Kingdom |
Population-based screening programme. |
The NHS Abdominal Aortic Aneurysm (AAA) Screening Programme is being gradually introduced across England and will be fully in place at the end of 2013 (one-time ultrasound scan examination for men aged 65). In Northern Ireland, Scotland and Wales these screening programmes are currently in the preparatory stages. |
United States of America |
Population-based screening programme. |
Medicare covers one-time screening ultrasound for AAA if the patient gets a referral for it from a physician or other qualified non-physician practitioner as a result of the "Welcome to Medicare" preventive visit within the first 12 months of having Medicare Part B. Patients are eligible for AAA screening if they have a family history of AAA, and/or if they are a man, aged 65 to 75 who has smoked at least 100 cigarettes in his lifetime and has never had an AAA ultrasound screening paid for by Medicare. {9, 10} |
Published guidelines on AAA screening attempt to close the gap between the best available evidence and what physicians do in their practices. In their systematic review of guidelines on abdominal aortic aneurysm screening, Ferket et al. (2012) {11} identified seven relevant guidelines and the quality of development of each guideline included was determined by the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. The AGREE instrument is a validated tool to evaluate the process of practice guideline development and the quality of reporting. {12}
Table 3: Guidelines on AAA screening (Ferket et al. 2012) {11}
Guideline-Nr. |
Title (author, year) |
Country that guideline applies to |
AGREE rigour score |
1 |
Screening for abdominal aortic aneurysm: recommendation statement (US Preventive Services Task Force 2005) |
USA |
79% |
2 |
ACC/AHA 2005 practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Hirsch et al. 2006) |
USA |
63% |
3 |
Abdominal aortic aneurysm screening (UK National Screening Committee 2007) |
UK |
41% |
4 |
Screening for abdominal aortic aneurysm in Canada: review and position statement of the Canadian Society for Vascular Surgery (Mastracci et al. 2007) |
Canada |
40% |
5 |
Canadian Cardiovascular Society Consensus Conference: peripheral arterial disease 2 executive summary (Abramson et al. 2005) |
Canada |
38% |
6 |
The care of patients with an abdominal aortic aneurysm: the Society for Vascular Surgery practice guidelines (Chaikof et al. 2009) |
USA |
25% |
7 |
Screening for abdominal aortic aneurysm: a consensus statement (Kent et al. 2004) |
USA |
17% |
Details of guidelines on AAA screening included in the systematic review of Ferket et al. {11} are reported below.
Table 4: Details of Guidelines on AAA screening (Ferket et al. 2012) {11}
Guideline no. (for details see Table 3) |
Target group |
Screening practice |
Primary screening test |
Screening intervals |
Recommendation |
1 |
a) Men aged 65-75 who have ever smoked b) Men aged 65-75 who have never smoked c) Women |
Opportunistic screening/case-finding |
Abdominal ultrasonography |
One-time screening |
a) For men aged 65-75 who have ever smoked b) Not for, not against men aged 65-75 who have never smoked c)Against women |
2 |
a) Men aged ≥ 60 who are siblings/offspring of patients with AAAs b) Men aged 65-75 who ever smoked |
Not reported |
Abdominal ultrasonography; physical examination |
One-time screening |
For |
3 |
Men aged 65 |
Population-based/mass screening |
Abdominal ultrasonography |
One-time screening |
For |
4 |
a) Men aged 65-75, who are candidates for surgery and are willing to participate b) Women aged >65 and multiple risk factors (family history of AAA, smoking history, cerebrovascular disease, age >70) c) Women aged >65, adult population aged <65 years d) Men aged >75 years and multiple risk factors |
a) Population-based/mass screening b) Individualised investigation c) Population-based/mass screening d) Individualised investigation |
Abdominal ultrasonography |
No follow-up ultrasound is necessary before 3-5 years if aortic diameter <3.0 cm |
a) For b) Consider c) Against d) Consider |
5 |
a) Men aged 65-74 b) Women aged 65 with cardiovascular disease and positive family history of AAA c) Men aged ≥ 50 and positive family history of AAA |
Population-based/mass screening |
Abdominal ultrasonography |
Repeat ultrasound follow-up in 3-5 years if aortic diameter <3.0 cm |
For |
6 |
a) Men aged ≥65 b) Men aged ≥55 and family history of AAA c) Women aged ≥ 65 and family history of AAA or who have smoked |
Population-based/mass screening |
Abdominal ultrasonography |
One time screening if aortic diameter <2.6 cm |
For |
7 |
a) Men aged 60-80 b) Women aged 60-85 and cardiovascular risk factors c) Men and women aged >50 and family history of AAA |
Population-based/mass screening |
Abdominal ultrasonography |
One time screening if aortic diameter <3.0 cm |
For |
The US Preventive Services Task Force (USPSTF) {7} recommends one-time screening for abdominal AAA by ultrasonography in all men aged 65 to 75 years, who have smoked at least 100 cigarettes in their lifetime. This recommendation is based on the evidence that surgical repair of large AAAs (5.5 cm or more) on the basis of screening leads to decreased AAA-specific mortality and therefore outweighs screening-associated harms in this population group. The USPSTF states that the harms of AAA-screening in men aged 65 to 75 years, who have never smoked, in men aged more than 75 years and in women in general balance or outweigh the benefits. Men aged more than 75 years are at higher risk for AAAs, but the increased presence of comorbidities and limited life expectancy decreases the likelihood that they will benefit from screening.
Summarizing the systematic review of guidelines from Ferket et al. (2012) {11} shows that most of the seven included guidelines contain recommendations that favour one-time AAA screening for men aged 65 years and older. Every guideline reasoned that abdominal ultrasonography is the primary screening test. Only one guideline group (ACC) recommended physical examination as a useful screening tool in addition to ultrasonography. The guidelines did not agree on whether a smoking history should be present or not. Additionally, four guidelines (three of them had low AGREE scores) contained disparate recommendations on screening women and middle-aged men at elevated risk, whereas guidelines with higher AGREE scores did not. The criterion for elective surgical repair in elderly men for an abdominal aortic diameter of 5.5 cm was unanimously used but there was no consensus on the management of smaller AAAs.
Most of the guidelines give recommendations for surveillance of patients with aneurysms smaller than 5.5 cm in diameter but these recommendations vary in the intensity of follow up and the cut-off points of the aorta diameter. For example, some guidelines recommend that an annual abdominal ultrasound is acceptable if the AAA is 3.0 to 4.4 cm. Others recommend that if the AAA diameter is between 4.0 and 5.4 cm, surveillance should be done every 6 to 12 months. If the AAA is <3.0 cm, some guidelines recommend no follow-up surveillance before 3 to 5 years. Other guidelines say that aneurysms 3.0 to 3.9 cm in diameter should be surveyed every 2 to 3 years, and those 4.0 to 5.4 cm in diameter should be assessed every 6 months. {11}
The typical expansion rate of AAA is around 0.3-0.4 cm per year, on average. As the expansion rate of AAAs is positively correlated to size, surveillance intervals should depend on size. As a patient's health status may change during the surveillance period, continued AAA surveillance should occur only if the patient remains a good surgical candidate and has a reasonable life expectancy. If the first-time ultrasonography screening for AAA revealed normal aortic diameter, there is no need for re-screening, as negative results appear to virtually exclude the risk for future AAA rupture. {9}
In conclusion, even if the officially accepted cut-off point for elective surgery has been set to an aneurysm size of 5-5.5 cm, the final decision about going ahead with a surgical procedure must be considered individually taking into account the option of endovascular treatment, age, comorbidities and other factors.
Question refers partly to RC-CUR10, RC-EFF24.
Importance: Important
Transferability: Partially
Ultrasonography as gold standard
Ultrasonography has been established as the gold standard technical device for screening for AAA. Different investigations show that ultrasonography is a valid diagnostic technique for the detection of AAA with both sensitivity and specificity of nearly 100%. The test is non-invasive, relatively inexpensive and fast, and patients are not exposed to ionizing radiation. Additionally, this test is highly acceptable to patients. {13-17}
More than 80% of all AAAs are detected occasionally or through ultrasonography screening {18}. If an AAA is suspected or if an AAA is detected through ultrasonography screening, further medical investigations are carried out to verify the diagnosis and define treatment, for example, computed tomography (CT) or magnetic resonance imaging (MRI).
For detection of AAAs, other diagnostic technologies, besides ultrasonography, are also used. For example abdominal palpation, CT or MRI (see result card TEC 8, {8, 13, 19}) but ultrasonography is the detection method of choice for AAA screening {13-17}.
For ultrasonography various image-guided methods are available, such as the colour-coded duplex sonography that is most often used. In brief, colour-coded duplex sonography is an ultrasound-based imaging method, using high-frequency sound waves to reflect the structure of inner organs or blood vessels. A computer receives these reflected waves and uses them to create a picture, visualizing possible pathology. Most devices can additionally study the relative velocity of the blood flow or whether the blood flow is moving towards or away from the transducer. Such measurements are based on the Doppler effect (which, within certain limits allows the accurate assessment of the direction and velocity of the blood flow by calculating the frequency shift of the flow-wave and visualizing it in colour). However, currently no standards for the display of colour-coded duplex sonographic images are available. Some laboratories use red to display arterial vessels and blue to display venous vessels; others use colours to indicate the direction of the flow either towards the transducer or away from it. To interpret the results, knowledge of the physiology and pathophysiology of blood flow in the body is therefore important. {20}
Throughout Europe, Siemens Healthcare and GE Healthcare are currently the leaders in the distribution of colour-coded duplex-sonographic technical devices. {21} Figure 1 shows an example of such a device, including the monitor and keyboard.
Figure 1: Colour-coded duplex-sonographic technical device
Figure 2 shows the duplex sonographic documentation of the transverse diameter of an infrarenal abdominal aortic aneurysm. The black area within the arrows represents the lumen of the expanded aorta.
Figure 2: Duplex sonographic documentation of an AAA
Figure 3 illustrates the transverse diameter of an infrarenal abdominal aortic aneurysm in colour-coded mode. The red colour represents arterial blood flow.
Figure 3: Transverse diameter of an AAA
Question refers partly to RC-EFF24, RC-EFF25.
Importance: Important
Transferability: Partially
Screening for abdominal aortic aneurysm is used to identify this disease or condition in its preclinical and therefore potentially curable stage in apparently healthy people or people believing to be healthy. {1}
Question refers to RC-CUR1, RC-CUR8, RC-TEC1, RC-TEC2, RC-TEC3 and RC-EFF32.
Importance: Important
Transferability: Completely
Users of screening
AAA screening is usually done by physicians (predominantly general practitioners or medical doctors specialising in internal medicine; opportunistic screening practices) or medical technical assistants (population-based systematic screening). {22}
Necessary training
Usually, residents can be trained to perform ultrasound assessments adequately to identify high risk AAA patients. For the technical aspect of AAA screening, the grade and level of training seems to be more important than the type of medical discipline. {23}
Specificity, sensitivity and reproducibility
Variation in intraobserver repeatability and reproducibility of AAA screening by colour-coded duplex-sonography has been identified among studies, which may be in part related to the fact, that investigations were performed by investigators from different medical disciplines of varying grades and levels of training {24}. As poor reproducibility (above the level of 5 mm [which is accepted by the UK and USA AAA screening programmes]) may have negative impact on screening and surveillance, training and quality assurance are important factors of AAA screening.
Question refers partly to RC-CUR11, RC-CUR25 and RC-CUR12.
Importance: Important
Transferability: Partially
As mentioned in TEC 1 the screening process consists of different stages depending on whether a population-based systematic screening programme or various opportunistic screening practices are implemented.
Population-based systematic screening programme
For the National Health Services (NHS) AAA Screening Programme {5} in England standard operating procedures (SOP) are designed to inform and assist screening leads, strategic health authorities and other key stakeholders to establish and implement a new AAA population-based screening programme. The necessary elements of a screening programme, the screening pathway and quality assurance processes, and requirements for programmes are described. These SOPs state that the minimum population for selection of a population-based screening programme is 800,000 patients with detected AAA, which could be treated in a suitable medical centre. In the NHS AAA Screening Programme men are automatically invited by letter in the year they turn 65 years and men who are older than 65 years, and who have not previously been screened or treated for an abdominal aortic aneurysm, can opt in through self-referral direct to the screening programme (see CUR). The invitation comes from the local screening office and not from the general practitioner. {5}
In Sweden the population-based screening programme screens a defined healthy population (with defining a risk profile/an eligible population) by an invitation to a screening programme. Eligible people are invited by e-mail by the Register of Total Population managed by Statistic Sweden including age and gender. {8}
In the USA patients are eligible for population-based AAA screening if they have a family history of AAA, and/or if they are a man, age 65 to 75 years who has smoked at least 100 cigarettes in his lifetime and has never had an AAA ultrasound screening paid for by Medicare. {9}
Various opportunistic screening practices
For various opportunistic screening practices no specified population is defined for which AAA screening should be used. Usually, persons at risk are most likely adverted by assignments by their general practitioners.
Question refers partly to RC-CUR7, RC-TEC1, RC-TEC2, RC-TEC3, RC-SAF2 and RC-ORG11.
Importance: Critical
Transferability: Partially
Ultrasonic energy was first used for medical purposes (for neurological problems) in the late 1940s. The first compound contact B-mode scanner (the patient sat in a water-filled barrel with the sensor circulating around) was developed 20 years later and the first commercial hand-held transducer was released around 1965. Since then, concurrently in various countries, sonography became used more and more frequently by a range of medical disciplines. Around 1960 the Doppler effect principle was applied for the first time for cardiovascular diagnostics. Colour-coded duplex sonographic devices were launched only after 1980, when computer technology was applied to enhance sonographic pictures. Since then the image information on ultrasound machines has improved rapidly. {25, 26}
Question overlaps partly with RC-CUR17 and RC-ETH1.
Importance: Optional
Transferability: Completely
AAA may be diagnosed by a variety of methods, including physical examination (presenting as a palpable pulsatile tumour), ultrasonography, CT, MRI, angiography or radiography. CT images are three-dimensional images of the inside of the body that are generated from a large series of two-dimensional X-ray images, which are taken around a rotational axis and are especially useful for preoperative clarification of detailed anatomy and endovascular repair eligibilities. MRI, which uses the property of nuclear magnetic resonance to image nuclei of atoms inside the body and angiography, which visualises the inside of blood vessels by injecting a contrast agent into the blood vessel and imaging it using X-ray based techniques, are both more expensive than the other methods. AAA imaging by radiography is only possible in case of calcification of the aneurysm wall, which occurs in less than 50% of all AAAs {27}.
For AAA screening and determination of AAA-diameter, ultrasonography has been established as the gold standard. This technique is non-invasive, sensitive, portable and inexpensive. However, applicability may be reduced in obese people. Even if long term biological effects of diagnostic ultrasound exposure cannot be determined today {28}, most medical doctors feel that for the patient the benefits of correctly performed ultrasound outweigh the risks {29}. Nevertheless, investigations should be restricted to clearly indicated diagnostic questions. Scanning time should be held as short as possible and power should be set as low as possible, following the ALARA (As Low As Reasonably Achievable) principle {30}.
It has been proposed that population-based systematic screening programmes for AAA by ultrasonography offer a clear benefit over harm and are ethically justified as long as people are given adequate information {31}.
Ultrasonography is applicable for a wide spectrum of medical diagnostic assessments, including imaging of the heart muscle and the cardiac valves, prenatal diagnostics and gastroenterological investigations. With respect to the vascular system, colour-coded duplex sonography is applied, not only to assess potential vascular dilation, stenosis or occlusions of the carotid artery, the abdominal aortic artery and the peripheral arteries of the upper and lower extremities, but also enables detection of venous diseases, including varicosities and deep venous thrombosis. Ultrasound waves also may be used for therapeutic reasons. {32}
Question refers partly to RC-SAF4, RC-SAF7 and RC-EFF18.
Importance: Important
Transferability: Completely
Along the whole screening process, mentioned in result card TEC 1, different healthcare settings are affected.
Population-based systematic screening programme
In a population-based systematic screening programme, the testing of the people entering the programme can be undertaken in inpatient and outpatient settings. For example in the UK, ultrasound scanning for AAA is undertaken within community healthcare facilities. These are dedicated screening clinics, for example community clinics, community hospitals, mobile units or primary care facilities. Additionally, the patients themselves and general practitioners should be informed about the results of the test and whether or not referral to a vascular consultant in a hospital outpatient department or vascular centre is required (for surveillance, diagnosis and/or monitoring). The surgical treatment for AAA is undertaken in a vascular unit. {5}
In Sweden, screening is performed in imaging departments at hospitals or in separate units that specialise in ultrasonography. {8}
Various opportunistic screening practices
For various opportunistic screening practices for AAA no specified place or context is defined. Various opportunistic screening practices are usually done in the primary care setting, in most cases as an add-on investigation to other primary prevention investigations. In case of borderline positive screening results patients are usually referred to specialised units, such as a department for internal medicine with a major focus on cardiovascular diseases.
Question refers partly to RC-ORG1, RC-ORG5, RC-ORG6, RC-ORG16 and RC-ORG17.
Importance: Optional
Transferability: Partially
By definition, the size of the abdominal aorta is considered normal if it does not exceed 2.5 cm as measured by ultrasound. Enlargement of abdominal aortic diameter to 2.5 cm or more is diagnosed as “Ectasia” (2.5 cm–3 cm) and to more than 3 cm as “Aneurysm” (13). Regarding the reliability and reproducibility of inner to inner diameter (excluding the arterial wall; ITI) versus outer to outer diameter (including the arterial wall; OTO) ultrasound measurement of AAA diameter, it is assumed, that the ITI wall method is more reproducible. {22}
To assess the rupture risk of an AAA, however, more reliable parameters than diameter are peak wall stress and peak wall rupture risk. {33}
Importance: Critical
Transferability: Completely
The ultrasound device must be available in the institution or hospital where the test is carried out. In most case, packages with computers and software included are offered and installed by the companies. A printer is necessary, if printed pictures and reports are warranted. As already mentioned, the technique is applicable for a wide spectrum of medical diagnostic assessments, whereby one and the same device may be used by the different medical disciplines. Depending on the region of interest, investigators have to choose between transducers of different tissue-penetration depths. {34}
In UK, the screening equipment is purchased centrally and a technical equipment specification has been developed. The technical equipment consists of portable ultrasound machines, producing good quality black and white images, with digital recording devices from where data can easily be downloaded. The machines should be able to store and transfer data digitally. Additionally, an examination couch, wipes, a transducer and mobile computer media and devices are necessary. {5}
Question refers partly to RC-TEC11, RC-ECO1, RC-ECO2, RC-ORG7 and RC-ORG8.
Importance: Optional
Transferability: Completely
Examinations can be performed at the bedside. As the investigation has to be performed with the patient in a supine position, application of the technology requires an examination couch, if possible, adjustable for height. To use the technology the only necessary disposable item is a water-based conducting gel to facilitate the transmission of the sound waves. As the technology is non-invasive, neither needles, nor bandages or medicines are necessary. The use of paper towels may be helpful to remove conducting gel from the skin after the investigation. {34}
Question refers partly to RC-TEC10, RC-ECO1, RC-ECO2 and RC-ORG4.
Importance: Optional
Transferability: Completely
Question refers to RC-ORG10.
Importance: Unspecified
Transferability: Unspecified
Question refers to RC-ORG3, RC-ORG4 and RC-SAF9.
Importance: Unspecified
Transferability: Unspecified
Question refers to RC-SAF9, RC-ORG3 and RC-ORG4.
Importance: Unspecified
Transferability: Unspecified
Ultrasonography, based on the principle of the Doppler effect, has been established world wide as a gold standard technical device not only for screening but also for monitoring potential size progression of AAAs. This non-invasive method is highly sensitive and specific, but the display of the images is not yet internationally standardised. Further strengths of this method include safety, portability and low costs. The investigation can be carried out not only by physicians, but also by medical technical assistants, however, intensive training and experience of the investigator is highly important to keep intraobserver reproducibility as low as possible.
For the present domain, literature on screening in general and on different screening practices was readily available, however as detailed technical information on ultrasonography was scarce in databases, such as Medline, educational books and manufactories websites had to be added to the literature research. Answers to the distributed questionnaire results on the present domain were helpful and demonstrated that actual screening practices differ in the participating countries. Population-based systematic screening programmes for AAA currently exist in only a few European countries (i.e. the NHS AAA Screening Programme in the United Kingdom). In most countries, AAA screening is performed by various opportunistic screening practices in the outpatient primary care setting.
Appendix TEC-1 Result cards and related domains
Result card |
Result card question |
Related result cards |
Features of the technology | ||
B0001 (core) |
What is Screening? | |
B0001 (core) |
Are there different strategies for abdominal aortic aneurysm screening? |
Partly related to A0012, D0029 |
B0001 (core) |
Has any technical device for the detection of AAA established as internationally accepted golden standard? |
Partly related to D0029, D0030 |
B0002 (core) |
Why is abdominal aortic aneurysm screening used? |
(Partly) related to A0001, A0009, B0001, C0008, D1019, D1007 |
B0003 (core) |
What is the background of the golden standard technical device? |
Partly related to A0019, A0020, F0001 |
B0004 (core) |
Which professionals use the technology and is there a difference between the screening strategies? |
Partly related to A0013, A0014 |
B0005 (core) |
In what place and context are abdominal aortic aneurysm screening strategies intended to be used? |
(Partly) related to G0001, G0005 |
B0006 (core) |
Are there any special features relevant to the golden standard technical device for abdominal aortic aneurysm screening? |
(Partly) related to C0007, C0060, D0022 |
B0016 (core) |
To what population(s) will abdominal aortic aneurysm screening be used on? |
(Partly) related to A0007, C0005, G0009 |
B0018 (core) |
Are the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established? | |
Investments and tools required to use the technology | ||
B0007 (core) |
What material investments are needed to use the golden standard technical device for abdominal aortic aneurysm screening? |
(Partly) related to B0010, E0001, E0002, G0006 |
B0009 (core) |
What equipment and supplies are needed to use the golden standard technical device for abdominal aortic aneurysm screening? |
(Partly) related to B0009, E0001, E0002, G0004 |
B0010 (core) |
What kind of information is needed to monitor the use of the technical device for abdominal aortic aneurysm screening? |
Related to G0008 |
Training and information needed to use the technology | ||
B0012 (core) |
What kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technical device for abdominal aortic aneurysm screening? |
Related to G0003, G0004, C0062, C0063 |
B0013 (core) |
What kind of training is needed for the personnel treating or investigating patients using the technical device for abdominal aortic aneurysm screening? |
Related to G0003, G0004, C0062, C0063 |