Guidance
Rationale and impact
- Identifying asymptomatic abdominal aortic aneurysms
- Identifying symptomatic or ruptured abdominal aortic aneurysms
- Imaging technique
- Providing information to people with a diagnosed AAA
- Reducing the risk of rupture
- Monitoring the risk of rupture
- Emergency transfer to regional vascular services
- Supporting people during transfer
- Predicting surgical outcomes in unruptured aneurysms
- Predicting surgical outcomes for ruptured aneurysms
- Improving surgical outcomes
- Repairing unruptured aneurysms
- Anaesthesia and analgesia during unruptured aneurysm repair
- Repairing ruptured aneurysms
- Anaesthesia and analgesia during ruptured aneurysm repair
- Abdominal compartment syndrome
- Monitoring for complications after endovascular aneurysm repair
- Managing endoleaks after endovascular aneurysm repair
Rationale and impact
Identifying asymptomatic abdominal aortic aneurysms
Why the committee made the recommendations
Recommendations 1.1.1 to 1.1.6
The committee were mindful that the NHS abdominal aortic aneurysm (AAA) screening programme does not cover men under 65 or women of any age. This means some men and all women who are at risk of AAA are not currently screened. The recommendations highlight these groups and specify risk factors significantly associated with AAA that could be used to help with opportunistic screening.
There are also men who have no risk factors for AAA and were not seen by the screening programme when they turned 65. As their risk of AAA is low, the committee only recommended informing them about the NHS AAA screening programme and how it works. Men can then self-refer if they feel screening is right for them. Evidence from cross-sectional studies also found that people of Hispanic, African-American and Asian family origin were individually less likely than people of European family origin to have an AAA, so the committee wished to raise awareness of this.
Aortic ultrasound is recommended because it is the standard technique used in clinical practice and in the screening programme. It has high diagnostic accuracy, and is associated with lower costs and fewer side effects than CT. People with an AAA diameter of 5.5 cm or larger (inner-to-inner maximum anterior-posterior aortic diameter on ultrasound) need to be seen by a regional vascular service within 2 weeks because their aneurysm is at higher risk of rupture. The committee recommended that people with aneurysms less than 5.5 cm in diameter are seen within 12 weeks of diagnosis because this is the timeframe set by the NHS AAA screening programme.
How the recommendations might affect practice
The recommendations outlining key risk factors will increase the number of people being screened and improve AAA diagnosis. The recommendations should also promote equal access to healthcare, because they provide guidance on when a potential AAA should be investigated in women, who are currently not covered by the NHS AAA screening programme.
Using aortic ultrasound to detect AAAs is good practice. The recommendations ensure that the time within which people with newly-identified aneurysms are seen by regional vascular services is proportional to the risk of rupture. These timings match the timeframe the NHS AAA screening programme uses for people they assess.
Identifying symptomatic or ruptured abdominal aortic aneurysms
Why the committee made the recommendations
Recommendations 1.1.7 to 1.1.9
Based on their own experience, the committee highlighted the most important signs and symptoms of ruptured AAAs, because:
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non-specialists commonly fail to diagnose them
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improved diagnosis should increase the chance of survival
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urgent discussion of a suspected ruptured AAA with a regional vascular service will improve the chances of appropriate treatment and survival.
Aortic ultrasound is the standard technique for detecting the presence of AAA in a person with a suspected ruptured aneurysm. A ruptured AAA is a surgical emergency, and bedside ultrasound is the quickest reliable method to confirm the presence of an AAA. An immediate discussion with the regional vascular unit ensures appropriate management is started as soon as possible. The committee recognised that the sensitivity of aortic ultrasound is not 100% and several factors can make it difficult to visualise the aorta. Since AAA rupture is a life-threatening surgical emergency, they agreed that it would be safest to discuss any non-diagnostic ultrasound findings with the regional vascular unit.
How the recommendations might affect practice
There is variation in awareness of AAA among non-specialists. Implementing the recommendations should reduce this variation and increase the chance of ruptured AAA being diagnosed earlier.
Using bedside aortic ultrasound to detect AAAs is common practice. Preventing delays to repair through immediate discussions with a regional vascular unit should improve outcomes for people with ruptured AAAs.
Imaging technique
Why the committee made the recommendations
Recommendations 1.1.10 to 1.1.12
The committee agreed that it was important to take consistent measurements of aneurysm size throughout the NHS, so that results are comparable. The NHS AAA screening programme specifies inner-to-inner maximum anterior-posterior aortic diameter on ultrasound, and the committee agreed this would be the most appropriate measurement on which to base practice across the whole NHS.
The committee recommended thin-slice contrast-enhanced arterial-phase CT angiography for imaging in people being evaluated for elective repair, because it is widely recognised as the gold standard technique for assessing aneurysm anatomy before repair. For suspected ruptured AAAs, CT angiography should also be considered. However, the committee recognised that some people will need immediate transfer for repair without waiting for a CT scan.
No evidence was found demonstrating whether or not post-processing techniques affected postoperative outcomes for people having elective or emergency AAA repair. As post-processing techniques are an established part of clinical practice, the committee agreed not to make recommendations in this area.
How the recommendations might affect practice
Implementing a consistent measurement method to be used across the NHS (and that matches the method used in the NHS AAA screening programme) will improve the reproducibility of results, improving surveillance for individuals with AAA and the ability to analyse data at the population level.
Thin-slice contrast-enhanced arterial-phase CT angiography is widely used for imaging in people being evaluated for AAA repair, so this recommendation is unlikely to make a major difference to current practice. The recommended timings reflect current standards within the NHS AAA screening programme.
As post-processing techniques are established in practice, a lack of recommendations on these will not have an impact.
Providing information to people with a diagnosed AAA
Why the committee made the recommendations
Recommendations 1.1.13 to 1.1.15
The committee agreed some consensus recommendations on what information should be provided to people who have been diagnosed with an AAA. In particular, the recommendations cover information for people who are not being considered for repair, either because their AAA is too small (data from the NHS screening programme show that the risk of rupture for an AAA below 5.5 cm is only 0.4% per year) or because their medical comorbidities mean the risks of repair outweigh the benefits. It is important to avoid making people anxious about not being offered repair, but also to avoid giving the impression that AAA repair is always beneficial if the aneurysm meets the criteria for treatment (see recommendation 1.5.1). Explaining how the decision to repair is made (based on the person's health at that particular time) and the uncertainties around this will help people to better understand the options available.
The committee emphasised that clinicians should ensure that people understand their options and the balance of risks they face. They noted that several clinic visits, including opinions from specialists such as anaesthetists, geriatricians, and cardiologists, are likely to be needed.
Reducing the risk of rupture
Why the committee made the recommendations
Recommendations 1.2.1 and 1.2.2
The committee focused on modifiable risk factors that could influence the management of people with known AAAs. There was some evidence that high blood pressure increases the chance of AAA growth and rupture, and the committee knew from their own experience that people with an AAA do not always receive appropriate management for high blood pressure. There is also evidence that smoking increases the risk of AAA rupture. As a result, the committee referred to the NICE guidelines on these topics.
The committee agreed that there was not enough high-quality evidence to make clinical recommendations on non-surgical interventions for slowing aneurysm growth and reducing the risk of rupture. In light of this, they made recommendations for research on 2 drug interventions that might reduce aneurysm growth and rupture risk.
How the recommendations might affect practice
The NICE guidelines on hypertension and stop smoking services cover current practice, so organisations are unlikely to need to change practice.
Non-surgical interventions for small AAAs are not usually used outside of clinical trials, so a lack of recommendations will have little impact on practice.
Monitoring the risk of rupture
Why the committee made the recommendations
Recommendations 1.2.3 and 1.2.4
The committee recommended ultrasound surveillance because ultrasound is current practice and no evidence was found for other imaging techniques. They recommended that monitoring frequency should be in line with the NHS AAA screening programme to ensure consistency across the whole NHS. The screening programme surveillance intervals are based on evidence on risk of rupture, depending on the size of the AAA. This means that people with larger aneurysms are monitored more frequently, offering the best balance between benefits and costs.
The committee are aware that the NHS AAA screening programme may change the surveillance intervals it uses in the future. If this happens, the committee agreed that regional vascular services should change to match the new intervals, to ensure that they continue to provide care based on best practice.
How the recommendations might affect practice
Changing monitoring intervals to reflect those used in the NHS AAA screening programme will maintain a consistent standard across the NHS, and ensure that the most effective imaging intervals are used.
Emergency transfer to regional vascular services
Why the committee made the recommendations
Recommendations 1.3.1 to 1.3.5
There was no evidence on symptoms, signs or risk assessment tools for deciding whether people with ruptured aneurysms are likely to survive transfer to a regional vascular service. Based on their own experience, the committee highlighted specific circumstances (cardiac arrest and persistent loss of consciousness) in which people are unlikely to survive transfer and subsequent aortic repair. This will help reduce the number of people being given ineffective and invasive treatment at the end of life.
The committee referred to the NICE guideline on care of dying adults in the last days of life to ensure that appropriate and compassionate care is given to people with a ruptured AAA when the decision has been made not to operate.
There was also no evidence on how quickly people with ruptured AAA should be transferred to regional vascular units. In the absence of evidence, the committee adapted recommendations from the NICE guideline on service delivery for major trauma. They agreed, based on their experience of emergency transfer, that the timing specified for people with major trauma was appropriate for people with ruptured AAA and manageable for referring units.
How the recommendations might affect practice
The recommendations on assessing people for transfer will raise awareness among emergency staff, but will have little resource impact on clinical practice. The recommendations on transfer speed will improve practice by minimising variation in transfer times across the NHS. The timeframe recommended is the same as for major trauma, and the committee agreed that this is a reasonably similar situation.
The NICE guideline on care of dying adults cover current practice, so organisations are unlikely to need to change practice.
Supporting people during transfer
Why the committee made the recommendation
As there was no evidence specific to the use of permissive hypotension during transfer of people with ruptured or symptomatic AAA, the committee agreed that a consensus recommendation was needed in this important clinical area. As a result the committee adapted recommendations from the NICE guideline on assessment and initial management for major trauma.
How the recommendation might affect practice
The recommendation will reduce the likelihood of inappropriate fluid administration during transfer of people with ruptured AAA. This, in turn, will improve the outcomes of endovascular aneurysm repair and open surgical repair procedures. The recommendation is in line with NICE recommendations on fluid administration for other major trauma, and the committee agreed that this was appropriate for ruptured AAA.
Predicting surgical outcomes in unruptured aneurysms
Why the committee made the recommendations
Recommendations 1.4.1 and 1.4.3
There was limited evidence that cardiopulmonary exercise testing can help predict outcomes following endovascular aneurysm repair (EVAR) and open surgical repair. While the evidence was limited, the committee agreed that cardiopulmonary exercise testing could have a useful role in shared decision-making between healthcare professionals and patients when the benefits and harms of surgery are uncertain.
There are other tests for assessing people before surgery, but there was no evidence available for them. One study found that higher estimated glomerular filtration rate (eGFR) was associated with improved outcomes after elective EVAR, but it did not give clear eGFR thresholds that could be used in decision-making. In the absence of evidence, the committee referred to the NICE guideline on routine preoperative tests for elective surgery. Some of the studies reviewed for that guideline focused on people having elective AAA repair.
The evidence highlighted that none of the risk assessment tools had a high enough predictive accuracy at predicting postoperative outcomes. The specific tools listed are the ones for which evidence was available. This evidence led the committee to conclude that these tools would not improve decision-making and could potentially lead to inappropriate decisions about patient management. They agreed that this could lead to harm, and therefore advised that risk assessment tools should not be used.
How the recommendations might affect practice
The use of cardiopulmonary exercise testing will have limited impact on practice as it is only recommended in situations where it will help in shared decision-making.
Risk assessment tools are not widely used outside the context of research on AAA. Therefore, the recommendations will have little impact on practice.
Predicting surgical outcomes for ruptured aneurysms
Why the committee made the recommendations
Recommendations 1.4.4 and 1.4.5
There is evidence that some risk factors and risk assessment tools are associated with poor postoperative outcomes. However, it is not clear how any particular factor or combination of factors could be used to decide if aneurysm repair is suitable for a person with a ruptured AAA. The committee emphasised that there is a potential for harm if clinicians base their decision to repair solely on risk assessment tools and scores, because some people would be inappropriately offered or denied repair.
How the recommendations might affect practice
The recommendations will have a beneficial impact, by ensuring decisions about care are not made based on inappropriate factors or tools. This, in turn, should prevent inappropriate decisions being made about whether or not to offer repair.
Improving surgical outcomes
Why the committee made the recommendations
Recommendations 1.4.6 to 1.4.9
The committee made a recommendation on cardiovascular disease because it is common in people with AAA and it is best practice to reduce the risk of problems in people who have it. The other NICE guidelines that are referenced include recommendations to help reduce this risk.
The evidence showed that giving beta blockers just before surgery is not beneficial, and may be harmful by lowering low blood pressure and heart rate. The committee noted that some people with AAA may need to take beta blockers for other conditions (such as atrial fibrillation). As a result, they recommended against routine use before AAA repair, rather than recommending against beta blockers altogether.
Remote ischaemic preconditioning was not recommended because there was evidence that it does not improve outcomes and that it can cause problems such as an irregular heartbeat.
The committee recommended further research because there was not enough evidence to make recommendations on prehabilitation (including exercise programmes before surgery), or on any interventions after AAA repair.
How the recommendations might affect practice
Providing support to reduce the risk of problems from cardiovascular disease is already current practice. In addition, beta blockers and routine ischaemic preconditioning are not currently in routine use before AAA repair, so these recommendations should have a minimal impact on practice.
Repairing unruptured aneurysms
Why NICE made the recommendations
Recommendations 1.5.1 to 1.5.7
When to consider repair
A number of factors should be considered before treating asymptomatic aneurysms, one of which is size.
It is standard practice to repair large aneurysms (over 5.5 cm in diameter on ultrasound, measured using an anterior-posterior diameter inner-to-inner), and to monitor smaller aneurysms (less than 4 cm in diameter) until they become larger. Repair is sometimes offered for aneurysms below 5.5 cm if they are growing rapidly, or if they are symptomatic. However, data from the NHS screening programme show that, for aneurysms below 5.5 cm, the risk of rupture remains very low (0.4% per year). It is clear from the evidence that there is no benefit to repairing aneurysms that are below 5.5 cm, asymptomatic and not growing rapidly. Based on this evidence, we highlighted factors that would help healthcare professionals decide when to repair aneurysms.
Given the risks and other disadvantages of AAA repair, conservative management is sometimes a better option. Because of this, healthcare professionals need to explain the balance of benefits and risks to people with AAAs, so they can make an informed decision.
Open surgical repair, standard endovascular aneurysm repair or conservative management
The evidence showed that, compared with open surgical repair for people with an unruptured infrarenal abdominal aortic aneurysm, elective EVAR has medium- and long-term harms that outweigh its short-term benefits. EVAR is associated with fewer perioperative deaths, and less time in hospital in general (and critical care in particular). But it also has worse long-term survival than open surgical repair, and more long-term complications, leading to further procedures.
Even when taking the short-term benefits of EVAR into account, all plausible cost-effectiveness estimates show that EVAR either:
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has higher net costs and lower net benefits than open surgical repair or
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is substantially above the range NICE normally considers to be a cost-effective use of NHS resources.
There is a small group of people who have abdominal copathology or other considerations that mean open surgical repair is unsuitable. Examples of copathologies include people who have internal scar-tissue from previous abdominal surgery (a so-called hostile abdomen), people who have a single, fused kidney that is wrapped around the aorta ('horseshoe kidney'), and people who have a stoma. Although there was no evidence on this population, EVAR is a potential option for these people, as the risks of open surgical repair may be much higher for them. This recommendation should not be used to extend EVAR to people who could reasonably have open surgical repair.
Open surgical repair is contraindicated for some people with an unruptured AAA because of anaesthetic risks and/or medical comorbidities. For these people, the risk of their AAA rupturing if no repair is attempted has to be balanced against:
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the perioperative risks and long-term complications of EVAR
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the uncertainty around whether they will benefit from EVAR
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the large costs of EVAR.
With all this in mind, it is clear that practice needs to be rebalanced. Conservative management is a better option than EVAR for many people. However, NICE also acknowledged stakeholder comments highlighting the importance of individualised care. For some people, EVAR may be appropriate. Clinicians should discuss the risks of EVAR and conservative management with people with AAAs, taking into account the uncertainty that EVAR will provide a benefit.
People who are not offered repair may be anxious about having an AAA but not receiving treatment for it. However, a better explanation of the risks they face, in the context of their other life-limiting comorbidities, can help with anxiety. To help with this, the committee made consensus recommendations (see recommendations 1.1.13 to 1.1.14) on the information to cover when discussing repair with people who have an AAA.
Complex endovascular aneurysm repair
The evidence for complex EVAR was limited in quantity and quality. However, complex EVAR grafts and procedures are much more expensive than standard EVAR, so the difference in cost between EVAR and open surgical repair is likely to be even greater than for infrarenal AAAs. In addition, using standard EVAR stent grafts for complex AAA usually violates the manufacturer's 'instructions for use'.
Although there is currently no evidence that complex EVAR has better outcomes than open surgical repair, people with complex AAAs have higher perioperative mortality rates than people with infrarenal AAAs. Because of this, an increased perioperative survival benefit may be more important for them, and may justify the use of complex EVAR. This would differentiate complex EVAR from standard EVAR, which clearly does not provide enough short-term benefits to outweigh the worse long-term outcomes or the increased cost (when compared with open surgical repair).
Open surgical repair is contraindicated for some people with an unruptured AAA because of anaesthetic risks and/or medical comorbidities. For these people, the risk of their AAA rupturing if no repair is attempted has to be balanced against:
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the perioperative risks and long-term complications of complex EVAR
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the uncertainty around whether they will benefit from complex EVAR
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the large costs of complex EVAR.
With all this in mind, it is clear that conservative management is a better option than complex EVAR for many people. However, NICE also acknowledged stakeholder comments highlighting the importance of individualised care. For some people, complex EVAR may be appropriate. Clinicians should discuss the risks of complex EVAR and conservative management with people with AAAs, taking into account the uncertainty that complex EVAR will provide a benefit.
As with standard EVAR, NICE acknowledged that in the face of the evidence reviewed, practice needs to be rebalanced towards open surgical repair in this scenario as well. But, because of the limited evidence for complex EVAR and the importance of individualised care, NICE concluded that it is important for clinicians and people with AAA to discuss the uncertainties and weigh up the risks and benefits of repair, in order to make an informed decision.
More evidence on this procedure would be helpful, and NICE has made a recommendation for research comparing complex EVAR with open surgical repair.
EVAR and complex EVAR for specific subgroups of people
For each of the recommendations, NICE considered whether there were any specific groups that would benefit from standard or complex EVAR for unruptured AAAs. We explored groups defined by age, sex, AAA diameter and life expectancy, but it was not possible with the current evidence to identify any specific groups in which the benefits would outweigh the harm and costs.
Other evidence sources
The key randomised controlled trials (RCTs) in this area are relatively old. NICE looked at more recent observational evidence, to see if changes in surgical and endovascular techniques and technology have led to different outcomes. The observational studies are at high risk of bias, but their findings are broadly in line with the RCTs. They show that, while outcomes from EVAR have improved over the last 15 years, outcomes from open surgical repair have also improved by roughly the same amount. This means the difference in outcomes between the two has remained fairly constant.
Registries like the National Vascular Registry can provide a useful snapshot of current practice, and the analyses that informed NICE's decision-making made use of data from them. However, they are not designed to evaluate the comparative benefits and harms of different surgical approaches, such as EVAR and open surgical repair. Therefore, they cannot be considered a reasonable alternative to RCT data. In addition, an analysis using the registry data showed that EVAR still did not provide greater long-term benefits than open surgical repair, and that it still has higher net costs.
Implementation challenges
NICE acknowledged the need to rebalance practice towards open repair and identified the possible implementation challenges.
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Possible increased perioperative mortality with open surgical repair: Improvements in practice since the RCTs were published have led to better standards for open surgical repair and EVAR alike. In addition, the NHS AAA screening programme means that AAAs are more likely to be diagnosed earlier than in the past, so people can have repair when they are younger and healthier. For these reasons, open surgical repair of unruptured AAAs can be provided with a low incidence of morbidity and mortality.
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The risk that vascular units will have trouble meeting an increased demand for open surgical repair: All vascular surgeons should be competent to perform open surgical repair of AAAs, and the Intercollegiate Surgical Curriculum Programme's Vascular surgery curriculum puts more emphasis on open surgical repair than on EVAR. This means that future surgeons should be well prepared to provide open surgical repair with a low incidence of morbidity and mortality.
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Potential shortage of beds in the NHS: As people who have open surgical repair spend more time in hospital immediately after the procedure, there may be a small, short-term increase in waiting times for AAA repair. However, an analysis comparing waiting times showed that open surgical repair would still provide greater benefit than EVAR for a lower cost even with a substantial increase in waiting times for open surgical repair.
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The possibility that reducing the number of EVAR procedures performed for unruptured aneurysms will make it difficult to provide EVAR for ruptured aneurysms: There are a number of ways this implementation issue might be addressed:
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vascular services could be centralised further (for example by establishing aortic units)
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in line with the recommendations, EVAR can be offered in certain situations.
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Goal-directed therapy
The evidence did not show any benefit from goal-directed therapy for people having repair of an unruptured AAA. Goal-directed therapy covers a broad range of different haemodynamic monitoring and management practices, some of which are routinely performed during major surgery. The committee recognised that it was not possible to specify which practices should or should not be performed and agreed that drafting recommendations would be too prescriptive.
How the recommendations might affect practice
The recommendation on when to repair unruptured aneurysms is unlikely to impact on current clinical practice because it reflects what is already being done within the NHS. Data from the NHS AAA screening programme indicate that the risk of rupture for AAAs that are smaller than 5.5 cm is very low.
The recommendations on EVAR could have a large impact on practice and will also affect the timing and type of information about treatment options given to patients. In light of the evidence reviewed, practice needs to be rebalanced towards open surgical repair for infrarenal aneurysms. The recommendations will minimise harm by reducing long-term mortality and the need for re-intervention as a result of the problems with EVAR. The reduction in EVAR, and so EVAR-related re-interventions, will result in significant cost savings for the NHS.
A lack of recommendations on goal-directed therapy will not impact on practice. Basic haemodynamic management is routinely performed during most surgical procedures, but goal-directed therapy is not widely adopted during AAA surgery.
Anaesthesia and analgesia during unruptured aneurysm repair
Why the committee made the recommendation
The committee noted that there was some evidence that adding an epidural to general anaesthesia reduced the need for further analgesia for people having open surgical repair of an unruptured AAA. This was consistent with their own clinical experience of better pain control and reduced postoperative respiratory complications with an epidural. Adding an epidural is fairly widespread in current practice, and the committee agreed that it should be recommended as an option.
No evidence was found on anaesthesia and analgesia for people undergoing EVAR for unruptured AAA. The committee agreed that no recommendations were needed in this area because they had recommended that EVAR should not be used to treat unruptured infrarenal abdominal aortic aneurysm, except in clinical trials or for people for whom open surgical repair is unsuitable because of abdominal copathology.
How the recommendations might affect practice
The use of an epidural in addition to general anaesthesia for people having open surgical repair of an unruptured AAA is already fairly widespread in current practice. Therefore the overall impact of the recommendation is likely to be small, although it may reduce existing variation.
Repairing ruptured aneurysms
Why the committee made the recommendations
Recommendations 1.6.1 to 1.6.3
Which technique to use
The evidence showed that, compared with open surgical repair, a strategy that uses EVAR (where anatomically possible) to repair ruptured infrarenal abdominal aortic aneurysm provides a reasonable balance of benefits and costs.
As the average cost-effectiveness results for EVAR were favourable, the committee discussed whether they should recommend EVAR whenever it is possible. They decided not to, for 2 reasons.
Firstly, there is uncertainty in the evidence for EVAR from the IMPROVE trial. People who had EVAR for a ruptured AAA in this trial were followed up for at most 7 years. People who had EVAR for an unruptured AAA in the EVAR-1 trial were followed up for 15 years, and the committee noted that these data indicate that EVAR leads to increasingly worse survival when compared with open surgical repair, because follow-up duration increases (see why NICE made the recommendations on repairing unruptured aneurysms). The medium-term survival data from the IMPROVE trial give some indication that a similar long-term pattern may develop in trials of ruptured AAA, with the survival curves converging as follow-up gets longer. Therefore, it is possible that longer-term data would show EVAR to be worse than open surgical repair for people with ruptured AAA as well.
Secondly, there was evidence that the balance of benefits and costs for EVAR varies between different groups of people with ruptured AAAs. In particular, most women have better short-term survival after EVAR, whereas the evidence favours open surgical repair for younger men. Therefore, the committee recommended that either EVAR or open surgical repair can be considered, and provided detail on the groups for which each approach is likely to be best.
Complex EVAR is only recommended within the context of an RCT because there is currently no evidence to support it as an option for people with ruptured complex AAA. Open surgical repair of these aneurysms is recommended as the only approach that should be used in people for whom emergency repair is suitable until the safety and effectiveness of complex EVAR has been established in this setting.
Tranexamic acid
No evidence on the use of tranexamic acid in people with a ruptured AAA was identified. The committee was aware that tranexamic acid is included in some major haemorrhage protocols and some patients, without major trauma, may receive it before undergoing surgery. In the committee's experience, tranexamic acid is not routinely used in people with a ruptured AAA, so it agreed to recommend research on tranexamic acid for preventing and treating excessive blood loss during EVAR or open surgical repair.
Goal-directed therapy
There was no evidence on goal-directed therapy for people having repair of a ruptured aneurysm. Goal-directed therapy covers a broad range of different haemodynamic monitoring and management practices; some of which are routinely performed during major surgery. The committee recognised that it was not possible to specify which practices should or should not be performed and agreed that drafting recommendations would be too prescriptive.
How the recommendations might affect practice
The recommendations will have little impact on current practice, as both standard EVAR and open surgical repair are currently offered to people with ruptured infrarenal AAAs. In relation to complex EVAR, the recommendation not to use it outside of RCTs will limit the use of a technically complex and expensive procedure in people for whom open surgery is a safe and suitable option.
Because the guideline recommends that fewer EVAR procedures should be performed for unruptured aneurysms (see the section on repairing unruptured aneurysms), surgical teams may have less opportunity to develop the skills they need to provide EVAR in emergency cases. The committee were mindful of this issue, but were convinced by the evidence showing that, overall, people with AAAs would be worse off if EVAR procedures were performed for unruptured aneurysms just to maintain EVAR expertise. Elective EVAR will still be available in certain circumstances and centralisation of aortic services may maintain expertise. However, neither training nor service models were in the scope of this guideline, so the committee did not review any evidence and were unable to make any specific recommendations in these areas.
A lack of recommendations on goal-directed therapy will not impact on practice. Basic haemodynamic management is routinely performed during most surgical procedures, but goal-directed therapy is not widely adopted during AAA surgery.
A lack of recommendations on tranexamic acid will have little impact on practice. Tranexamic acid is used in varying degrees across the NHS, but it is not standard practice for people with ruptured or symptomatic AAAs who are being transferred before surgery.
Anaesthesia and analgesia during ruptured aneurysm repair
Why the committee made the recommendation
No evidence was identified on the optimal use of anaesthesia and analgesia in people having open surgical repair or EVAR of a ruptured AAA. The committee agreed, based on their knowledge and experience, that general anaesthesia alone is widely accepted as best practice for open surgical repair, so did not make a recommendation on this. The committee made a recommendation on the use of local infiltrative anaesthesia alone in people having EVAR for ruptured AAA because it was considered that increased awareness of this option was needed.
How the recommendation might affect practice
The committee agreed that the potential impact of this recommendation on practice is unclear, because it is difficult to predict the proportion of people for whom EVAR under local infiltrative anaesthesia might be an option. The main aim of this recommendation is to raise awareness of this option.
Abdominal compartment syndrome
Why the committee made the recommendations
Recommendations 1.6.5 and 1.6.6
There was no evidence relating to preventing or managing abdominal compartment syndrome in people who are having AAA repair. The committee agreed it was important to raise awareness of this potentially life-threatening condition, and made recommendations to highlight that it can occur after both endovascular aneurysm repair and open surgical repair.
How the recommendations might affect practice
The recommendations will ensure that clinicians are aware of abdominal compartment syndrome in people who have undergone repair of ruptured AAA. This may result in better postoperative assessment and management.
Monitoring for complications after endovascular aneurysm repair
Why the committee made the recommendations
Recommendations 1.7.1 to 1.7.5
Imaging surveillance is needed after EVAR, because there is a risk that people will develop complications from the procedure or need another operation. These risks are lower after open surgical repair, so surveillance is not standard practice and in this case the committee did not recommend it.
The committee noted that the frequency of EVAR surveillance is highly variable in practice. In the absence of evidence on how often imaging should be done, the committee agreed a recommendation to tailor surveillance to the perceived risk of complications. This should focus attention and resources on the people at greatest risk, and help to identify complications earlier.
In practice, identifying complications after EVAR usually involves sequential imaging, with ultrasound frequently used as the first-line test and other imaging modalities used to detect specific complications. Imaging modalities may be complimentary, and the clinical significance of some imaging findings remains unclear, which makes identifying a true reference standard difficult.
Contrast-enhanced CT angiography was widely used as a gold standard in the evidence that was reviewed. However, this has led to some abnormalities that are detected on other imaging modalities, but not on CT, being defined as false positives (for that modality, rather than as false negatives for CT). This may have introduced bias, and makes it difficult to rely on CT as a reference standard.
The evidence showed that colour duplex ultrasound was highly accurate at identifying changes in sac size when compared with contrast-enhanced CT angiography. Increases in sac size are often believed to indicate an endoleak even if no leak can be seen on the ultrasound. There was little evidence on graft kinking, but the committee agreed based on their experience that colour duplex ultrasound and CT angiography were equally as effective at detecting this type of complication.
In the evidence reviewed, contrast-enhanced ultrasound was the only imaging technique that had acceptable accuracy for directly identifying endoleaks when compared with contrast-enhanced CT angiography. Importantly, other imaging techniques had unacceptably high rates of false-negative results. For this reason, the committee agreed that in situations where the definitive exclusion (or identification) of endoleak is important (for example where endoleak is suspected) either contrast-enhanced CT angiography or contrast-enhanced ultrasound should be used. Contrast-enhanced ultrasound was not recommended for assessing other complications because the evidence for its use only covered endoleaks.
The committee agreed that it is particularly important not to falsely exclude an endoleak, so the sensitivity of a diagnostic test is more important than its specificity. While colour duplex ultrasound is highly accurate at identifying changes in sac size (which may indicate an endoleak), the available evidence shows that it has suboptimal sensitivity for directly detecting type I and III endoleaks. In addition, the accuracy of ultrasound was shown to be dependent on the operator, so its accuracy may be variable in practice. This variability in diagnostic accuracy, and resultant potential for harm if an endoleak is missed, led the committee to recommend that colour duplex ultrasound alone should not be used to confirm or exclude the presence of endoleaks.
How the recommendations might affect practice
There is variation in which imaging techniques are used for surveillance. Some centres use ultrasound only, and some use contrast-enhanced CT angiography and ultrasound. Colour duplex ultrasound is widely used, but contrast-enhanced ultrasound is not. These recommendations are not likely to alter surveillance regimens substantially because many centres use imaging tests in a complementary fashion, often relying on sac size as a trigger for further investigation if necessary. Sonographers will need training in administering contrast agents if contrast-enhanced ultrasound is to be more widely adopted.
Managing endoleaks after endovascular aneurysm repair
Why the committee made the recommendations
Recommendations 1.8.1 to 1.8.3
Endoleaks following EVAR are common. They can have a negative impact on patient prognosis and long-term quality of life, and further interventions are frequently needed to repair them. In the absence of evidence, the committee made recommendations based on their experience because:
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it is good practice to repair type I and III endoleaks and some type II endoleaks
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healthcare professionals are not all aware that type II endoleaks without sac expansion can be managed conservatively
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there are circumstances when sac expansion occurs without imaging evidence of a leak site (called type V endoleak), and these situations need further investigation.
How the recommendations might affect practice
The recommendations will have minimal impact on current practice because it is common practice to intervene for type I and type III endoleaks, and type II endoleaks if there is evidence of aneurysm sac expansion.