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: Iñaki Imaz, Sonia García-Pérez, Jesús González-Enríquez, Javiera Valdés, Andrés Fernández-Ramos, Carmen Bouza, Antonio Sarría-Santamera
We searched for studies that could provide us with information on the harms produced by the interventions that result from the implementation of an abdominal aortic aneurysm (AAA) screening programme, which are mainly the ultrasound diagnostic test and the surgical interventions to repair a detected AAA. We found large observational studies that describe the long-term consequences of the surgical repair of non-ruptured AAA. These studies describe large series of data that show what happens to subjects who undergo AAA repair without symptoms of rupture.
The harms include a short term (in-hospital and 30 days after surgery) overall mortality of between 1.15% and 4.8%, and a cumulative overall long-term mortality rate of 36% after 5 years of follow up. It has been reported that, after 8 years of follow up, of the deaths among patients who had an intact AAA repaired by endovascular aneurysm repair (EVAR), 24% were procedure-related and the rest (76%) were not related to surgical repair of the aneurysm.
Complications after intact AAA repairs are also frequent. After 4 years of follow-up, the rates of rupture were 1.8% after EVAR and 0.5% after open aneurysm repair (OAR); and the rate of AAA related interventions was 9% after EVAR and 1.7% after OAR, with 4 years of follow-up. Age, gender, preoperative morbidity, smoking and aneurysm size are relevant risk factors that predict outcomes in the elective AAA repairs that follow the detection of an AAA suitable for repair.
Ultrasonographic scanning is a highly accurate screening method for AAA. Close to 100% sensitivity and specificity values have been reported. The available information about harms indicates no relevant safety issues regarding the accuracy of the test used for AAA screening.
Inconsistent results have been found regarding psychological effects of an AAA screening programme. An appropriate design for measurement of changes in quality of life for participants versus not participants was not identified. Therefore, it is not possible to determine whether screening for AAA affects the health related quality of life among participants.
Relevant factors that can influence the safety profile of the AAA screening performance are hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery. The implementation of an AAA screening programme can increase the burden on local vascular surgical services by increasing the rate of elective repairs, but the need to operate on emergency ruptures can be reduced.
The implementation of an abdominal aortic aneurysm (AAA) screening programme can cause harm to the screened subjects due to the expected increase in the number of detected AAAs (increase of incidence) and consequently in the number of surgical interventions to repair intact or non-ruptured AAAs suitable for repair. We have searched for information on AAA screening programme effects including psychological effects, on the impact of organisational issues on the screening effects and on the validity of the diagnostic tests. A search was focused on the effects produced by the interventions that come from the implementation of an AAA screening programme, which are mainly the surgical interventions to repair a detected AAA. The detection of an intact AAA may lead to a high risk surgical intervention to repair it. These interventions, carried out by EVAR (endovascular aneurysm repair) or OAR (open aneurysm repair), can cause serious harms in terms of mortality, morbidity and psychological effects. Some subjects may suffer early harms, even though the natural history of their AAA would not cause clinical problems during their lifetime.
The objective of this domain has been to describe the most important harms that derive for implement an AAA screening programme according to the available literature. We have considered that this information should come not only from articles that describe the performance of a screening programme but also from articles describing the surgical interventions to repair non-ruptured, elective, eligible, asymptomatic or intact AAAs. These terms are used as synonyms in the literature.
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. |
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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 | |
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C0001 | Patient safety | What kind of harms can use of the technology cause to the patient; what are the incidence, severity and duration of harms? | yes | What harms can Screening for AAA cause to the screened subjects and what are the characteristics of the harms? |
C0005 | Patient safety | Are there susceptible patient groups that are more likely to be harmed through use of the technology? | yes | Are there susceptible participant groups that are more likely to be harmed through use of the technology? |
C0006 | Patient safety | What are the consequences of false positive, false negative and incidental findings brought about using the technology to the patients from the viewpoint of patient safety? | yes | What are the consequences of false positive, false negative and incidental findings brought about using Screening for AAA from the viewpoint of safety? |
C0029 | Patient safety | Does the existence of harms influence tolerability or acceptability of the technology? | yes | Does the existence of harms influence tolerability or acceptability of Abdominal Aorta Aneurysm Screening? |
C0007 | Patient safety | What are the special features in using (applying/interpreting/maintaining) the technology that may increase the risk of harmful events? | yes | What are the special features in using (applying/interpreting/maintaining) Screening for AAA that may increase safety risks? |
C0002 | Patient safety | What is the dose relatedness of the harms to patients? | no | This screening programme doesn't include different doses of intervention. The effects of diferent kind of Screening programmes will be assessed in the COO60 element of this domain. |
C0003 | Patient safety | What is the timing of onset of harms to patients: immediate, early or late? | no | A precise description of harms, including their timing, will be included in the COOO1 element within this domain. |
C0004 | Patient safety | Is the incidence of the harms to patients likely to change over time? | no | Changes over time dependant on the experience or learning curve performing the Screening Programme (i.e.: surgical interventions, diagnostic test, organizational issues) will be included in the C0007 element within this domain. |
C0008 | Patient safety | What is the safety of the technology in comparison to alternative technologies used for the same purpose? | no | Considering that mortality is the most relevant indicator to answer this question and that a comparison of mortality between screening and no screening is going to be provided in the “Clinical Effectiveness” domain (EFF1, EFF2, EFF3, EFF4, EFF24 questions), we consider this question already included in other Assessment Elements. |
C0060 | Safety risk management | How does the safety profile of the technology vary between different generations, approved versions or products? | yes | How does the safety profile of the technology vary between different kind of Screening programmes? |
C0061 | Safety risk management | Is there evidence that harms increase or decrease in different organizational settings? | yes | Is there evidence that harms increase or decrease in different organizational settings? |
C0062 | Safety risk management | How can one reduce safety risks for patients (including technology-, user-, and patient-dependent aspects)? | yes | How can one reduce safety risks for screened subjects? |
C0063 | Safety risk management | How can one reduce safety risks for professionals (including technology-, user-, and patient-dependent aspects)? | no | The introduction of a new health-care programme can affect organizations, including the health of their professionals. Those effects depend on the balance between new resources / new requirements allocated to the organization and how the organizations implement them. We have judged this issue irrelevant because it can be dealt with in a more coherent manner within the organizational domain. |
C0064 | Safety risk management | How can one reduce safety risks for environment (including technology-, user-, and patient-dependent aspects)? | no | The procedures included in this screening programme don't cause relevant environmental risks. |
C0020 | Occupational safety | What kind of occupational harms can occur when using the technology? | no | The introduction of a new health-care programme can affect organizations, including the health of their professionals. Those effects depend on the balance between new resources / new requirements allocated to the organization and how the organizations implement them. We have judged this issue irrelevant because it can be dealt with in a more coherent manner within the organizational domain. |
C0040 | Environmental safety | What kind of risks for public and environment may occur when using the technology? | no | The procedures included in this screening programme don't cause relevant risks for public or environmental. Anyway, a precise description of harms will be included in the COOO1 element within this domain. |
Information sources and selection criteria
In addition to the general bibliographic searches that were done for the whole project (Core HTA), four specific searches on Medline using OVID and Embase were also performed. The searches were limited to articles published after the year 1999. All the searches were done in June 2011.
The first search sought articles about harms and risks of AAA screening, including psychological aspects and test validity. Inclusion criteria:
The second search focused on effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair. Inclusion criteria:
The third search sought clinical trials and systematic reviews about health related effects of AAA screening. Inclusion criteria:
The fourth search sought articles about the relationship between outcomes of AAA repair and characteristics of the health centre, surgeon and surgery team. Inclusion criteria:
We retrieved also information from the general bibliographic searches that were done for the whole project (Core HTA for AAA Screening), and from other searches on the Cochrane and INAHTA databases, and from the references of the retrieved articles.
After reading the abstracts a list of 126 non-duplicated studies was available. The full texts of all of these articles were read and 52 of them were selected based on the inclusion criteria. The flow chart of the literature screening and selection process is shown in the figure {SAF Figure 1}.
The template for study characteristics table (16 November 2011 version) that is proposed in the online tools was used to extract data from the articles. Individual tables of the included articles are available upon request.
Detailed methodology of the literature search, selection process and data extraction is available in {Appendix SAF-1}.
Important harms of the implementation of an AAA screening programme derive from the expected increase in the number of detected AAAs (increase of incidence) and consequently in the number of surgical interventions to repair intact or non-ruptured AAAs suitable for repair. The surgical repair of an AAA, by EVAR or OAR, is a high-risk intervention. There are serious consequences, in terms of mortality, morbidity and psychological effects, for those in whom an AAA has been detected, which are mainly measured by quality of life (QoL) scales.
OVERALL MORTALITY
The European Society for Vascular Surgery reported data from 27,635 intact AAA surgical interventions performed in 386 hospitals in ten countries of Europe and Oceania between 2003 and 2007{1}. Most interventions were OAR (18,471), though EVAR accounted for 7,578, and the rest were unspecified. The mean age of patients was 72.1 years, and 13.5% of the patients were women. The overall mortality rate, which included in-hospital mortality or 30-day mortality, was 2.83%. The overall mortality rate for OAR was 3.5%, and for EVAR 1.15%.
Schermerhorn et al. reported data from 45,660 Medicare beneficiaries undergoing elective AAA repair in the USA during the 2001–2004 period, for whom the overall 30-day mortality was 1.2% with EVAR and 4.8% with OAR {2}. The probability of survival after 5 years was around 64% in this latter study {2}, being similar between EVAR and OAR.
RELATED MORTALITY
Among 5612 patients with intact AAA repaired by EVAR between June 1996 and February 2004, 589 had died within 8 years of follow-up and 24% of those deaths were procedure-related (141 patients) {3}. Of the 141 procedure-related deaths, 88 (14.9% of the 589 total deaths) were within the 30 days after surgery, 28 (4.8% of the 589 total deaths) due to AAA-rupture and 25 due to graft infection (4.2% of the 589 total deaths). The non procedure-related deaths were caused by cancer (117 patients, 19.9%), other cardiovascular problems (27%), pulmonary problems (6.5%), renal problems (1.5%), multi-organ failure (1.4%), unknown reasons (10.7%) and other reasons (9.2%). (According to the Committee for Standardized Reporting Practices in Vascular Surgery {4}, all deaths within 30 days after the surgical intervention were considered procedure-related deaths. The definition of “mortality related to AAA repair” varies so it must be borne in mind that published figures on procedure-related mortality could be inaccurate.)
MORBIDITY
The Medicare database reported highly frequent complications from 45,660 elective AAA repairs performed by EVAR and OAR {2}, which are detailed in {SAF-2}. This Medicare database reported, after 4 years follow-up, rupture rates of 1.8% and 0.5%, respectively, after EVAR and OAR respectively. The re-intervention rates were 9% after EVAR and 1.7% after OAR.
QUALITY OF LIFE
Inconsistent results have been found regarding the psychological effects of an AAA screening programme. An appropriate design for measuring changes in QoL for participants versus non-participants has not been identified. Therefore, it is not possible to determine whether screening for AAA affects the health-related QoL among participants. However, other information can be highlighted from the literature related to QoL.
The Viborg trial, which measured QoL using the Screen QL scale, found significantly lower scores for those invited to an AAA screening when they compared scores before versus after the scan {5}. However, the Gloucestershire screening programme reported a statistically significant fall in anxiety levels between before and 1 month after screening {6}.
A cross-sectional case-control study within the West Australia trial compared QoL before and after screening only for those who attended screening. They found increased self-perceived general health from before to after screening {7}.
The MASS trial found higher anxiety scores, no difference in depression scores, and lower scores on the SF-36 mental and physical scales at 6 weeks post-screening for those who had an AAA compared with those who had a negative screening{8}. However, other studies found that poorer self-assessed health among those who have compared with those who do not have an aneurysm could be more predictive of an aneurysm rather than a consequence of an AAA screening programme {9}.
The ADAM trial found QoL benefits for early repair using OAR compared with surveillance for small AAAs {10}.
SEXUAL DYSFUNCTION
The ADAM trial compared immediate elective repair with surveillance for small AAAs {10}. In the elective immediate OAR group more patients became impotent compared with the surveillance group.
More information about quality of life effects can be found in result card RC-SOC5.
Importance: Critical
Transferability: Completely
The most important harms related to an AAA screening programme derive from the surgical interventions to repair intact or non-ruptured AAAs. Across the studies, the most relevant risk factors that predict outcomes in elective non-ruptured AAA repairs were: gender, age, preoperative morbidity, smoking and aneurysm size.
GENDER
There is no clear evidence about the effect of gender on the safety profile of the AAA screening. Chong et al. found higher long-term survival among women after open AAA repair (hazard ratio [HR] =0.72, 95% confidence interval [CI] 0.55-0.93) {11}. The UK Small Aneurysm Trial, which included 40 to 55 mm AAAs, did not find significant differences in death hazard between men and women {12}. In an observational study of 220,403 AAA patient-discharges in the USA, women had higher odds of both presenting with rupture and of in-hospital mortality compared with men, for both intact and ruptured AAA repairs {13}. A systematic review that evaluated outcomes of 2387 EVARs, reported in 39 articles, found a significantly higher risk of complications after surgery among women {14}.
Women appear more likely to suffer AAA rupture at smaller aortic diameters than males. AAAs of equal diameter represented a greater proportional dilatation in females than in males in an observational study of elective AAA repairs. This led to the authors to recommend a smaller aneurysm diameter threshold of 52 mm for repair in females rather than the 55 mm threshold commonly used in males {15}.
AGE
Increasing age is an important adverse determinant of mortality for intact AAA repair. The 2008 Report of the European Society for Vascular Surgery, which reported data from 27,635 intact AAA surgical interventions {1}, found a 1% mortality rate for patients between 51 and 55 years and nearly 5.2% mortality rate for those patients between 81 and 85 years old. Other studies have confirmed this {11,16,17}.
SMOKING
The multivariate analysis of 1020 open non-rupture AAA repairs with a mean follow-up of 57.6 months found that smoking increased general morbidity in open AAA repairs (odds ratio [OR]=2.15, 95% CI 1.03-4.46){11}. The UK Small Aneurysm Trial found that current smokers had a higher death risk than former smokers {12}.
OTHER FACTORS
Long-term mortality after open AAA repair was associated with the presence of coronary artery disease (HR= 1.36, 95% CI 1.08-1.72), chronic obstructive pulmonary disease (HR 1.59, 95%CI 1.21-2.09), chronic renal failure (HR 2.87, 95% CI 1.90-4.33), and congestive cardiac failure (HR=2.52, 95%CI 1.78-3.57) after a mean of 57.6 months of follow-up {11}. The same study found that preoperative renal failure increased postoperative renal decline and that increasing size of aneurysm increased peri-operative and long term mortality.
The UK Small Aneurysm Trial found significant increases in mortality rates after intact AAA repair with older age, larger diameter of the aneurysm (higher hazard for those with 49 to55 mm versus both 40 to44 mm and 45 to48 mm), lower ankle brachial-pressure index, and worse lung function (lower FEV1 [forced expiratory volume in 1 second]) {12}.
Egorova et al. developed a model to define high risk patients when they are treated with elective EVAR of AAA. The model analysed the 30-day mortality of the 44,360 elective EVAR in USA. The regression model ordered the significant factors from the highest to the lowest predicted mortality as follows: renal failure with dialysis (highest score), clinically significant lower extremity ischemia, age > 85 years, liver disease, congestive heart failure, renal failure without dialysis, 80-84 years age, female, neurological disorders, chronic pulmonary disease, surgeon experience in EVAR less than three procedures, hospital annual volume in EVAR less than seven procedures and 75-79 years age {18}.
Importance: Critical
Transferability: Completely
Evidence about the consequences of false positive, false negative and incidental findings of using AAA screening from a safety perspective are scarce in the literature. However, the available data indicate that the magnitude of the estimates would be low. An evaluation of the screening programme of Huntingdon (UK) found no false negatives when comparing ultrasound results with further ruptures. They also found no false positives when comparing ultrasound with computed tomography. They reported ultrasound sensitivity of 100% for detecting AAAs of 4.5 cm or more, specificity of 100% for AAAs of up to 3.0 cm, and therefore 100% for both positive and negative predictive values {19}.
Lindholt JS et al. {20} estimated accuracy from the inter-observer values. Their estimated sensitivity, specificity and predictive values of a positive test for AAA in the distal part of the infrarenal aorta were 98.9%, 99.8% and 97. 0%, respectively. The sensitivity, specificity and predictive value of a positive test for AAA in the proximal part of the infrarenal aorta were estimated at 87.4%, 99.9%, and 94.7%.
Based on the previous figures we calculated false positive and false negative rates (ratio of false positives to non-cases and ratio of false negatives to cases respectively). The false positive and false negative rates of AAA in the distal part of the infrarenal aorta using ultrasonography were 0.0013 and 0.0107 respectively {20}. The false positive and false negative rates of AAA in the proximal part of the infrarenal aorta found using ultrasonography were 0.0006 and 0.1260 respectively {20}. The incidence of false-positive scans is small and of little clinical consequence as they are likely to be detected on surveillance rescanning or confirmatory computed tomography (CT) scan. A false negative finding would result in same outcomes as those occurring in subjects for whom screening was not performed.
Ultrasound has high accuracy values when used as the first diagnostic test in AAA screening programmes; however some difficulties with visualising the aorta may occur in some cases (1.2% in the MASS trial){8}. The MASS trial, which performed the screen in non-routine clinics using portable ultrasound machines, had 1.2% non-valid ultrasound tests. Therefore, it is advisable for some cases to be re-scanned in a hospital setting by experienced sonographers.
The AAA screening clinical trials have not reported incidental discoveries of other pathologies. According to the clinical trials the frequency of incidental discovery of other pathologies in screening programmes for AAA would be low.
Importance: Critical
Transferability: Completely
There is scarce information on the impact of harms on acceptability or tolerability of AAA screening. However, some factors have been identified that influence AAA screening uptake. Three randomised clinical trials evaluating the efficacy of screening for AAA reported that increasing age is negatively associated with the rate of screening attendance {31-33}. Lindholt et al. {32} found from the “Viborg trial” that the age ranges 68-70 (OR 0.82, 95% CI 0.69-0.97) and 71-73 (OR 0.59, 95% CI 0.50-0.70) had significant lower attendance rates compared with the age range 65-67, when adjusting for all other predictors. This is consistent with results from the “Chichester trial” {33} and the “Western Australia Trial” {31}. Compliances in the “Chichester trial” were 80%, 76%, 74%, and 66% for ages 65, 66-70, 71-75, and 76-80 years, respectively. Moreover, compliance figures for women were 73%, 69%, 66%, 58% for the same age ranges {33}. Lindholt et al. showed that attendance rates were above average among people with chronic pulmonary and cardiovascular conditions (OR 1.40, 95% CI 1.12-1.77) compared with healthy individuals {32}. People with mobility-disabling diseases showed low rates of attendance compared with healthy individuals, although this was not statistically significant {32}.
There is also scarce information about the determinants of uptake for other screening programmes {34}. A systematic review found only one study that measured the impact of information about benefit and risks on screening uptake. The study, a randomised controlled trial that measured women’s uptake of Down’s syndrome screening, found no increase in uptake when women received additional clinical information in different forms (detailed leaflet, audiovisual) {35}.
A recent systematic review of barriers to colorectal cancer screening uptake in participants over 65 years of age found that unpleasantness, discomfort, and perceived risks associated with performing the tests were the most commonly reported barriers related to screening tests{36}. This would not apply to the AAA screening, however, because in AAA screening the perceived risk associated with the diagnostic test is low.
Additional information of factors affecting AAA screening uptake is included in the result cards RC-SOC8 and RC-SOC9.
Importance: Optional
Transferability: Partially
INTRA- OR INTER-OBSERVER VARIATION
Beales et al. systematically reviewed studies on intra- or inter-observer variations in ultrasound measurements {21}. The acceptable level of observer variation between aortic diameter measurements was suggested to be 5 mm. From the nine studies evaluated, five o presented coefficients lower that this limit. The most relevant factors they found that could affect reproducibility were: observer´s experience level, patient´s obesity and bowel gas, aortic diameter, and whether the machine was modern.
Singh et al. assessed the agreement between ultrasound and computed tomography measurements of normal and aneurysmatic aorta and the common iliac artery diameter {22}. After evaluating 3686 measurement pairs from 555 patients, they found considerable disagreement between the two techniques. Ultrasound underestimated aortic diameter in measurements of normal sized aortas (<30 mm) as compared with CT, whereas the opposite was true for aneurysmal aortas.
Singh et al. examined in an additional study the intra and inter-observer variability of CT measurements in 59 individuals. The authors found that approximately 95% of the CT measurements of the maximal infrarenal aortic diameter of the abdominal aorta could be performed with accuracy within the limit of 4 mm. The intra-observer variability for both planes was less than inter-observer variability, was increased with increasing vessel diameter, and was influenced by the experience level of the radiologist.
VOLUME–OUTCOME RELATIONSHIP
A systematic review that examined both open and endovascular repair of intact AAA found that hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery were all significant and highly associated with mortality {23}. Regarding hospital volume, a meta-analysis of 421,229 elective AAA repairs resulted in a pooled OR of mortality for high-volume institutions (≥43 OAR per annum) of 0.66 (95% CI: 0.65-0.67) as compared with low-volume institutions (<43 OAR per annum) {24}.
A meta-analysis evaluating 115,273 AAA repairs found that repairs by high-volume surgeons resulted in a decreased mortality compared with those by low-volume surgeons (pooled OR: 0.56; 95% CI 0.54-0.57), suggesting a threshold of 13 AAAs surgical repairs per year {25}. Surgeon volume had more effect than did hospital volume in a study of 5972 OARs after adjusting for other patient and hospital characteristics {26}. However, neither surgeon nor hospital volumes were found to have a significant influence on mortality after EVARs {26}.
Surgeon specialty, which implies subspecialty training and board certification, was also identified as influencing outcomes in AAA repair {27-29}. Operations performed by vascular specialist surgeons were associated with significant reductions in mortality compared with those done by general surgeons.
INCREASED BURDEN ON SURGICAL SERVICES
There is evidence that AAA screening causes an increased burden on local vascular surgical services; however its consequence on health outcomes has not been assessed. Among the 67,770 men recruited in the MASS trial, and after 10 years of follow-up, 552 elective operations took place in the invited group (n=33,883) and 226 in the control group (n=33,887). Sixty-two men underwent emergency surgery in the invited group compared with141 in the control group. These data show that the rate of elective repairs doubles with the advent of screening, and emergency ruptures are reduced by half {30}.
Importance: Important
Transferability: Partially
Specific evidence that determines the influence of the type of AAA screening on safety were not identified. However, attendance rate could influence the outcomes of AAA screening. More information on the differences between AAA screening programmes depending on attendance rate is available in the result cards RC-CUR23 and RC-ORG5.
Hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery has been found highly associated with mortality when an AAA is detected and repaired {37}, which makes advisable that both, open and endovascular repair of intact AAA be performed by high volume hospitals and high volume surgeons. More information regarding volume-outcome relationship is in the result card RC-SAF4.
Importance: Optional
Transferability: Partially
Hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery have all been found to be highly associated with mortality when an AAA is detected and repaired {37}, which makes it advisable that both open and endovascular repair of intact AAA should be performed by high-volume hospitals and high-volume surgeons.
Attendance rate is another relevant factor associated with AAA screening outcomes. More information on differences in attendance rates between AAA screening programmes is available in result cards RC-CUR23 and RC-ORG5.
More information about the volume-outcome relationship is available in result card RC-SAF4.
Importance: Optional
Transferability: Partially
Hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery have all been found to be highly associated with mortality when an AAA is detected and repaired, which makes it advisable that both, open and endovascular repair of intact AAAs should be performed by high volume hospitals and high volume surgeons. More information about the volume—outcome relationship is in result card RC-SAF4.
Recommendations for quality assurance that are provided in the “Organisational Aspects” domain are applicable to this question (RC-ORG3 and RC-ORG15). A summary of the recommendations applicable to the safety of an AAA screening programme are the following.
Quality of screening should be guaranteed by applying several criteria – appropriate training of staff, standardised calibration of equipment, monitoring screening outcome and performance (AAA related morbidity and mortality). All monitoring processes should be carried out using information technology (identification and collation of screening cohort; management of administration, screening and referral process; recording of AAA surgery and outcomes).
Human resources for AAA screening should include: clinical staff (director/clinical lead, ultrasound clinician, consultants in vascular units), screening staff (ultrasound screening technicians, clinical skills trainer, nurse practitioner), management/administration/technical staff (coordinator, clerical officer, medical physicist, IT lead), governance (strategic health authorities, primary care trusts, primary care providers, local screening programme, diagnostic and treatment services).
Importance: Important
Transferability: Partially
The rationale for the screening is that early detection and treatment of asymptomatic AAA should extend life or improve quality of life compared with treatment at the time of symptomatic clinical diagnosis. However, the safety domain is focused on a description of the harms but not on the estimation of the effect of population-based AAA screening. To estimate the effect of the screening a comparison against a similar population must be done. This has not been the objective of our investigation given that the effectiveness domain covers those objectives.
Important sources of information for this domain have been large observational studies that describe what happens to patients who undergo the proposed intervention following screening within the programme. We have identified serious consequences for intact AAA repair in terms of mortality and morbidity and psychological effects.
Adverse events are variably and sometimes poor reported in randomised controlled trials {38,39}. We have identified real-world data from large observational studies describing the effect of the surgical repair of intact AAAs. We have found this information useful for estimating what might happen in a hypothetic situation if a screening programme was implemented in a European scenario. The implementation of an AAA screening programme in Europe would result in a high number of high-risk surgical interventions done in different kinds of healthcare systems, in different hospitals with different surgeons and to different patients.
The evidence table template for extracting data proposed in the online tool has been used. However, we found this template more oriented to clinical trials than observational studies. We did not find the assessment criteria proposed in that template completely applicable for our set of studies. The variability between methods and designs among our selected studies made it difficult to apply a systematic system for grading the evidence.
Appendix SAF-1 Safety domain specific search.
The following searches have been performed:
1. FIRST SEARCH
Search about harms and risks of AAA screening, including psychological aspects.
2. SECOND SEARCH
Search about effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair.
3. THIRD SEARCH
Search of clinical trials and systematic reviews about health related effects of AAA screening
4. FOURTH SEARCH
Search about the relation between Health Centre’s, surgeon’s and surgery team characteristics and risks and benefits of AAA repair.
The flow chart on the literature screen and selection process is included in the domain methodology section {SAF Figure 1}.
The first Medline search retrieved 144 references, 15 of them were selected after abstract screening and deletion of duplicates. The first Embase search retrieved 116 references, 4 of them were selected after abstract screening and deletion of duplicates.
The second Medline search retrieved 67 references, 40 of them were selected after abstract screening and deletion of duplicates. The second Embase search retrieved 22 references, 14 of them were selected after abstract screening and deletion of duplicates.
The third Medline search retrieved 88 references, 26 of them were selected after abstract screening and deletion of duplicates. The third Embase search retrieved 93 references, 3 of them were selected after abstract screening and deletion of duplicates.
The fourth Medline search retrieved 131 references, 28 of them were selected after abstract screening and deletion of duplicates. The fourth Embase search retrieved 40 references, 2 of them were selected after abstract screening and deletion of duplicates.
More references were retrieved and selected from other sources of information through searches on Cochrane, INAHTA databases, references from the articles retrieved and others sources.
After merging all of these sources of information a list of 126 non-duplicated studies was available. The full texts of all of these articles were read by investigators of the domain, namely JGE, SGP, II, CA and CB. After reading all these articles 52 were selected because they met the inclusion criteria. The template for study characteristics table (version Nov 16 2011) that is proposed in the online tools was used to extract data from the articles. Individual tables of the articles are available upon request.
Search about harms and risks of AAA screening, including psychological aspects and test validity.
Inclusion criteria:
Name of the database or link/reference to other source: MEDLINE via OVID
Search string or search terms:
Date of search 15/06/2011
Name and affiliation of person who performed the search: Javiera Valdés. AETS ISCIII.
Number of references retrieved: 144
Abstract screen:
Number included 15
Name of the database or link/reference to other source: EMBASE
Search string or search terms
Date of search 23/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 116
Abstract screen:
Number included 4
Total selection for the first search after deletion of duplicates: 19 studies
Search about effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair.
Inclusion criteria:
Name of the database or link/reference to other source MEDLINE via OVID.
Search string or search terms
Date of search 23/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 67
Abstract screen:
Number included 40
Name of the database or link/reference to other source EMBASE
Search string or search terms
Date of search 23/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 22
Abstract screen:
Number included 14
Total selection for the second search after deletion of duplicates: 54 studies
Search of clinical trials and systematic reviews about health related effects of AAA screening
Inclusion criteria:
Clinical trials or systematic review studies about:
Name of the database or link/reference to other source : MEDLINE via OVID
Search string or search terms
Date of search 13/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 88
Abstract screen:
Number included 26
Name of the database or link/reference to other source: EMBASE
Search string or search terms
Date of search 13/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 93
Abstract screen:
Number included 3
Total selection for the third search after deletion of duplicates: 29
Search about the relation between Health Centre’s, surgeon’s and surgery team characteristics and risks and benefits of AAA repair.
Inclusion criteria:
-
Name of the database or link/reference to other source MEDLINE via OVID
Search string or search terms
Date of search 23/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 131
Abstract screen:
Number included 28
Name of the database or link/reference to other source EMBASE
Search string or search terms
Date of search 23/06/2011
Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.
Number of references retrieved: 40
Abstract screen:
Number included 2
Total selection for the third search after deletion of duplicates: 30
LIST OF INCLUDED ARTICLES:
(1) Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA et al. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet 2002; 360(9345):1531-1539.
(2) Ashton HA, Gao L, Kim LG, Druce PS, Thompson SG, Scott RA et al. Fifteen-year follow-up of a randomized clinical trial of ultrasonographic screening for abdominal aortic aneurysms. Br J Surg 2007; 94(6):696-701.
(3) Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. Br J Surg 2011; 98(11):1517-1525.
(4) Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg 2011; 53(5):1167-1173.
(5) Brady AR, Fowkes FG, Greenhalgh RM, Powell JT, Ruckley CV, Thompson SG. Risk factors for postoperative death following elective surgical repair of abdominal aortic aneurysm: results from the UK Small Aneurysm Trial. On behalf of the UK Small Aneurysm Trial participants. Br J Surg 2000; 87(6):742-749.
(6) Chong T, Nguyen L, Owens CD, Conte MS, Belkin M. Suprarenal aortic cross-clamp position: a reappraisal of its effects on outcomes for open abdominal aortic aneurysm repair. J Vasc Surg 2009; 49(4):873-880.
(7) Coselli JS, Bozinovski J, LeMaire SA, Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg 2007; 83(2):S862-S864.
(8) Couto E, Duffy SW, Ashton HA, Walker NM, Myles JP, Scott RA et al. Probabilities of progression of aortic aneurysms: estimates and implications for screening policy. J Med Screen 2002; 9(1):40-42.
(9) Dimick JB, Stanley JC, Axelrod DA, Kazmers A,Henke PK, Jacobs LA et al. Variation in death rate after abdominal aortic aneurysmectomy in theUnited States: impact of hospital volume, gender, and age. Ann Surg 2002; 235(4):579-585.
(10) Dimick JB, Cowan JA, Jr., Stanley JC, Henke PK, Pronovost PJ, Upchurch GR, Jr. Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the United States. J Vasc Surg 2003; 38(4):739-744.
(11) Dimick JB, Upchurch GR, Jr. Endovascular technology, hospital volume, and mortality with abdominal aortic aneurysm surgery. J Vasc Surg 2008; 47(6):1150-1154.
(12) Egorova N, Giacovelli J, Gelijns A, Greco G, Moskowitz A, McKinsey J et al. Defining high-risk patients for endovascular aneurysm repair. J Vasc Surg 2009; 50(6):1271-1279.
(13) Holt PJ, Poloniecki JD, Hofman D, Hinchliffe RJ, Loftus IM, Thompson MM et al. Re-interventions, readmissions and discharge destination: modern metrics for the assessment of the quality of care. Eur J Vasc Endovasc Surg 2010; 39(1):49-54.
(14) Holt PJE. Meta-analysis and systematic review of the relationship between volume and outcome in abdominal aortic aneurysm surgery. Br J Surg 2007; 94(4):395-403.
(15) Jamrozik K, Norman PE, Spencer CA, Parsons RW, Tuohy R, Lawrence-Brown MM et al. Screening for abdominal aortic aneurysm: lessons from a population-based study. Med J Aust 2000; 173(7):345-350.
(16) Jetty P, Hebert P, van Walraven C. Long-term outcomes and resource utilization of endovascular versus open repair of abdominal aortic aneurysms inOntario. J Vasc Surg 2010; 51(3):577-583.
(17) Jibawi A, Hanafy M, Guy A. Is there a minimum caseload that achieves acceptable operative mortality in abdominal aortic aneurysm operations? Eur J Vasc Endovasc Surg 2006; 32(3):273-276.
(18) Jim J, Rubin BG, Geraghty PJ, Criado FJ,Sanchez LA.Outcome of endovascular repair of small and large abdominal aortic aneurysms. Ann Vasc Surg 2011; 25(3):306-314.
(19) Kibbe MR, Matsumura JS, Excluder I. The Gore Excluder US multi-center trial: analysis of adverse events at 2 years. Semin Vasc Surg 2003; 16(2):144-150.
(20) Kim LG, Scott RA, Thompson SG, Collin J, Morris GE, Sutton GL et al. Implications of screening for abdominal aortic aneurysms on surgical workload. Br J Surg 2005; 92(2):171-176.
(21) Kim LG, RA PS, Ashton HA, Thompson SG, Multicentre Aneurysm Screening Study Group., Kim LG et al. A sustained mortality benefit from screening for abdominal aortic aneurysm.[Erratum appears in Ann Intern Med. 2007 Aug 7;147(3):216]. Ann Intern Med 2007; 146(10):699-706.
(22) Laheij RJ, van Marrewijk CJ, Buth J,Harris PL, EUROSTAR c. The influence of team experience on outcomes of endovascular stenting of abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2002; 24(2):128-133.
(23) Lederle FA, Johnson GR, Wilson SE, Acher CW, Ballard DJ, Littooy FN et al. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. J Vasc Surg 2003; 38(4):745-752.
(24) Lederle FA, Kane RL, MacDonald R, Wilt TJ. Systematic review: repair of unruptured abdominal aortic aneurysm. Ann Intern Med 2007; 146(10):735-741.
(25) Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT, Jr., Matsumura JS, Kohler TR et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009; 302(14):1535-1542.
(26) Lee WA, Carter JW, Upchurch G, Seeger JM, Huber TS. Perioperative outcomes after open and endovascular repair of intact abdominal aortic aneurysms in theUnited Statesduring 2001. Journal of Vascular Surgery 39[3], 491-496. 1-3-2004.
(27) Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aortic aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. J Public Health Med 1998; 20(2):211-217.
(28) Lindholt JS, Vammen S, Juul S, Henneberg EW, Fasting H. The validity of ultrasonographic scanning as screening method for abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 1999; 17(6):472-475.
(29) Lindholt JS, Vammen S, Fasting H, Henneberg EW. Psychological consequences of screening for abdominal aortic aneurysm and conservative treatment of small abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2000; 20(1):79-83.
(30) Lovegrove REJ. A meta-analysis of 21,178 patients undergoing open or endovascular repair of abdominal aortic aneurysm. The British journal of surgery 2008; 95(6):677-684.
(31) Lucarotti ME, Heather BP, Shaw E, Poskitt KR. Psychological morbidity associated with abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg 1997; 14(6):499-501.
(32) Maher MMM. Abdominal aortic aneurysms: Elective endovascular repair versus conventional surgery - Evaluation with evidence-based medicine techniques. Radiology 2003; 228(3):647-658.
(33) Marteau TM, Kim LG, Upton J, Thompson SG, Scott AP, Marteau TM et al. Poorer self assessed health in a prospective study of men with screen detected abdominal aortic aneurysm: a predictor or a consequence of screening outcome? J Epidemiol Community Health 2004; 58(12):1042-1046.
(34) McPhee J, Eslami MH, Arous EJ, Messina LM, Schanzer A. Endovascular treatment of ruptured abdominal aortic aneurysms in theUnited States(2001-2006): a significant survival benefit over open repair is independently associated with increased institutional volume. J Vasc Surg 2009; 49(4):817-826.
(35) McPhee JT, Robinson WP, III, Eslami MH, Arous EJ, Messina LM, Schanzer A et al. Surgeon case volume, not institution case volume, is the primary determinant of in-hospital mortality after elective open abdominal aortic aneurysm repair. J Vasc Surg 2011; 53(3):591-599.
(36) McPhee JT, Hill JS, Eslami MH. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004. J Vasc Surg 2007; 45(5):891-899.
(37) Nowygrod R, Egorova N, Greco G, Anderson P, Gelijns A, Moskowitz A et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg 2006; 43(2):205-216.
(38) Polo-De Santos M, Luengo-Matos S, Munoz-Navarro B, Saz-Parkinson Z. Results from the monitoring use programme for endovascular repair of abdominal aortic aneurysms in Spain. Int Angiol 2009; 28(3):181-191.
(39) Prinssen M, Buskens E, Nolthenius RP, van Sterkenburg SM, Teijink JA, Blankensteijn JD. Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial. J Endovasc Ther 2004; 11(6):613-620.
(40) Schermerhorn ML, O'Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med 2008; 358(5):464-474.
(41) Scott RA, Wilson NM, Ashton HA, Kay DN. Influence of screening on the incidence of ruptured abdominal aortic aneurysm: 5-year results of a randomized controlled study. Br J Surg 1995; 82(8):1066-1070.
(42) Scott RA, Vardulaki KA, Walker NM, Day NE, Duffy SW, Ashton HA et al. The long-term benefits of a single scan for abdominal aortic aneurysm (AAA) at age 65. Eur J Vasc Endovasc Surg 2001; 21(6):535-540.
(43) Scott RA,BridgewaterSG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg 2002; 89(3):283-285.
(44) Spencer CA,NormanPE, Jamrozik K, Tuohy R, Lawrence-Brown M, Spencer CA et al. Is screening for abdominal aortic aneurysm bad for your health and well-being? ANZ J Surg 2004; 74(12):1069-1075.
(45) TheUKSmall Aneurysm Trial Participants. Long-Term Outcomes of Immediate Repair Compared with Surveillance of Small Abdominal Aortic Aneurysms. N Engl J Med 2002; 346(19):1445-1452.
(46) Thomas SM, Beard JD,IrelandM, Ayers S, Vascular Society ofGreat BritainandIreland, British Society of Interventional Radiology. et al. Results from the prospective registry of endovascular treatment of abdominal aortic aneurysms (RETA): mid term results to five years. Eur J Vasc Endovasc Surg 2005; 29(6):563-570.
(47) Thompson SG, Ashton HA, Gao L, Scott RA, Multicentre Aneurysm Screening Study Group., Thompson SG et al. Screening men for abdominal aortic aneurysm: 10 year mortality and cost effectiveness results from the randomised Multicentre Aneurysm Screening Study. BMJ 2009; 338:b2307.
(48) Tu JV,AustinPC, Johnston KW, Tu JV, Austin PC, Johnston KW. The influence of surgical specialty training on the outcomes of elective abdominal aortic aneurysm surgery. J Vasc Surg 2001; 33(3):447-452.
(49) van Marrewijk CJ, Leurs LJ, Vallabhaneni SR,Harris PL, Buth J, Laheij RJ et al. Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? J Endovasc Ther 2005; 12(4):417-429.
(50) Vardulaki KA, Walker NM, Couto E, Day NE, Thompson SG, Ashton HA et al. Late results concerning feasibility and compliance from a randomized trial of ultrasonographic screening for abdominal aortic aneurysm. Br J Surg 2002; 89(7):861-864.
(51) Walschot LHB. Outcome after endovascular abdominal aortic aneurysm repair: A meta-analysis. J Endovasc Ther 2002; 9(1):82-89.
(52) Wilmink AB, Forshaw M, Quick CR, Hubbard CS, Day NE, Wilmink ABM et al. Accuracy of serial screening for abdominal aortic aneurysms by ultrasound. J Med Screen 2002; 9(3):125-127.
LIST OF EXCLUDED ARTICLES:
(1)Abbruzzese TA, Kwolek CJ, Brewster DC, Chung TK, Kang J, Conrad MF et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis. J Vasc Surg 2008; 48(1):19-28.
(2)Abularrage CJ, Sheridan MJ, Mukherjee D, Abularrage CJ, Sheridan MJ, Mukherjee D. Endovascular versus "fast-track'' abdominal aortic aneurysm repair. Vasc Endovascular Surg 2005; 39(3):229-236.
(3)Alonso-Perez M, Segura RJ, Sanchez J, Sicard G, Barreiro A, Garcia M et al. Factors increasing the mortality rate for patients with ruptured abdominal aortic aneurysms. Ann Vasc Surg 2001; 15(6):601-607.
(4)Becker GJ, Kovacs M, Mathison MN, Katzen BT, Benenati JF, Zemel G et al. Risk stratification and outcomes of transluminal endografting for abdominal aortic aneurysm: 7-year experience and long-term follow-up. J Vasc Interv Radiol 2001; 12(9):1033-1046.
(5)Becquemin JP, Allaire E, Desgranges P, Kobeiter H, Becquemin JP, Allaire E et al. Delayed complications following EVAR. Tech Vasc Interv Radiol 2005; 8(1):30-40.
(6)Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med 2005; 352(23):2398-2405.
(7)Bosch JLK. Abdominal aortic aneurysms: Cost-effectiveness of elective endovascular and open surgical repair. Radiology 2002; 225(2):337-344.
(8)Bown MJS. A meta-analysis of 50 years of ruptured abdominal aortic aneurysm repair. Br J Surg 2002; 89(6):714-730.
(9)Buth J, Laheij RJ, Buth J, Laheij RJ. Early complications and endoleaks after endovascular abdominal aortic aneurysm repair: report of a multicenter study. J Vasc Surg 2000; 31(1 Pt1):134-146.
(10) Cau JR. Total Laparoscopic Aortic Repair for Occlusive and Aneurysmal Disease: First 95 Cases. Eur J Vasc Endovasc Surg 2006; 31(6):567-574.
(11) Chaikof EL, Chaikof EL. Caring for patients with an abdominal aortic aneurysm: data, knowledge, and wisdom. J Vasc Surg 2009; 50(4 Suppl):S1.
(12) Cho JS, Kim JY, Rhee RY, Gupta N, Marone LK, Dillavou ED et al. Contemporary results of open repair of ruptured abdominal aorto-iliac aneurysms: effect of surgeon volume on mortality. J Vasc Surg 2008; 48(1):10-17.
(13) Cuypers PW, Gardien M, Buth J, Charbon J, Peels CH, Hop W et al. Cardiac response and complications during endovascular repair of abdominal aortic aneurysms: a concurrent comparison with open surgery. J Vasc Surg 2001; 33(2):353-360.
(14) Davenport DL, O'Keeffe SD, Minion DJ, Sorial EE, Endean ED, Xenos ES et al. Thirty-day NSQIP database outcomes of open versus endoluminal repair of ruptured abdominal aortic aneurysms. J Vasc Surg 2010; 51(2):305-309.
(15) De Rango PC. Outcome after Endografting in Small and Large Abdominal Aortic Aneurysms: A Metanalysis. Eur J Vasc Endovasc Surg 2008; 35(2):162-172.
(16) Dzieciuchowicz L, Majewski W, Slowinski M, Krasinski Z, Jawien AA, Bieda K et al. Improved outcome after rupture of abdominal aortic aneurysm over an 18-year period. Ann Vasc Surg 2008; 22(1):25-29.
(17) Eckstein HH, Bockler D, Flessenkamper I, Schmitz-Rixen T, Debus S, Lang W et al. Ultrasonographic screening for the detection of abdominal aortic aneurysms. Dtsch 2009; 106(41):657-663.
(18) Enzler MA, van Marrewijk CJ, Buth J, Harris PL, Enzler MA, van Marrewijk CJ et al. [Endovascular therapy of aneurysms of the abdominal aorta: report of 4,291 patients of the Eurostar Register]. [German]. Vasa 2002; 31(3):167-172.
(19) Fassiadis NR. Is screening of abdominal aortic aneurysm effective in a general practice setting? International Angiology 2005;24(2):185-8.
(20) Flu WJ, van Kuijk JP, Merks EJ, Kuiper R, Verhagen HJ, Bosch JG et al. Screening for abdominal aortic aneurysms using a dedicated portable ultrasound system: early results. Eur J Echocardiogr 2009; 10(5):602-606.
(21) Forbes TL, DeRose G, Kribs SW, Harris KA, Forbes TL, DeRose G et al. Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair. J Vasc Surg 2004; 39(1):102-108.
(22) Forbes TL, DeRose G, Lawlor DK, Harris KA, Forbes TL, DeRose G et al. The association between a surgeon's learning curve with endovascular aortic aneurysm repair and previous institutional experience. Vasc Endovascular Surg 2007; 41(1):14-18.
(23) Giles KA, Hamdan AD, Pomposelli FB, Wyers MC, Dahlberg SE, Schermerhorn ML et al. Population-based outcomes following endovascular and open repair of ruptured abdominal aortic aneurysms. J Endovasc Ther 2009; 16(5):554-564.
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(26) Harris PL, Vallabhaneni SR, Desgranges P, Becquemin JP, van Marrewijk C, Laheij RJ et al. Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience. European Collaborators on Stent/graft techniques for aortic aneurysm repair. J Vasc Surg 2000; 32(4):739-749.
(27) HobbsS.Claridge. Strategies to improve the effectiveness of abdominal aortic aneurysm screening programmes. J Med Screen 2004; 11(2):93-96.
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(31) Jordan WD, Jr., Moore WM, Jr., Melton JG, Brown OW, Carpenter JP, Endologix I, et al. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg 2009 Nov;50(5):979-86.
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(33) Lawrence-Brown MM, Norman PE, Jamrozik K, Semmens JB,DonnellyNJ, Spencer C et al. Initial results of ultrasound screening for aneurysm of the abdominal aorta inWestern Australia: relevance for endoluminal treatment of aneurysm disease. Cardiovasc Surg 2001; 9(3):234-240.
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(35) Lee ES, Pickett E, Hedayati N, Dawson DL, Pevec WC, Lee ES et al. Implementation of an aortic screening program in clinical practice: implications for the Screen For Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act. J Vasc Surg 2009; 49(5):1107-1111.
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(46) Matsumoto AH. What Randomized Controlled Trials Tell Us About Endovascular Repair of Abdominal Aortic Aneurysms. Journal of Vascular and Interventional Radiology 2008; 19(6 SUPPL.):S18-S21.
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(49) Muszbek NT. Systematic Review of Utilities in Abdominal Aortic Aneurysm. Eur J Vasc Endovasc Surg 2008; 36(3):283-289.
(50) Nordon IMH. Modern Treatment of Juxtarenal Abdominal Aortic Aneurysms with Fenestrated Endografting and Open Repair - A Systematic Review. Eur J Vasc Endovasc Surg 2009; 38(1):35-41.
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(65) Stolberg HO. Treatment of abdominal aortic aneurysms: review with evidence-based methods. Radiology 2003; 228(3):614-616.
(66) Subramanian K, Woodburn KR, Travis SJ, Hancock J, Subramanian K, Woodburn KR et al. Secondary interventions following endovascular repair of abdominal aortic aneurysm. Diagn Interv Radiol 2006; 12(2):99-104.
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Appendix SAF-2. Table on complications from intact abdominal aortic aneurysm repairs
Table. Medicare reported complications data from 45,660 intact abdominal aortic aneurysm repairs performed by EVAR (endovascular aneurysm repair) and OAR (open aneurysm repair)*. With author’s permission.
EVAR (N=22,830) |
OAR (N=22,830) | |
Medical Complications (% of patients) | ||
Myocardial infarction |
7 |
9.4 |
Pneumonia |
9.3 |
17.4 |
Acute renal failure |
5.5 |
10.9 |
Renal failure requiring dialysis |
0.4 |
0.5 |
Deep-vein thrombosis or pulmonary embolism |
1.1 |
1.7 |
Surgical complications (% of patients) | ||
Conversion to open repair |
1.6 |
- |
Acute mesenteric ischemia |
1.0 |
2.1 |
Reintervention for bleeding |
0.8 |
1.2 |
Tracheostomy |
0.2 |
1.5 |
Thrombectomy |
0.4 |
0.2 |
Embolectomy |
1.3 |
1.7 |
Repair of infected graft of graft-enteric fistula |
0.01 |
0.09 |
Major amputation |
0.04 |
0.13 |
Complications related to laparatomy | ||
Lysis of adhesions without resection |
0.1 |
1.2 |
Bowel resection |
0.6 |
1.3 |
Ileus of bowel obstruction without resection of lysis of adhesions |
5.1 |
16.7 |
Mean length of hospital stay (nº of days) |
3.4 + 4.7 |
9.3 + 8.1 |
Discharge home (% of survivors) |
94.5 |
81.6 |