Endovascular treatment for ruptured abdominal aortic aneurysm
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BACKGROUND: An abdominal aortic aneurysm (AAA) (pathological enlargement of the aorta) can develop in both men and women as they grow older. It is most commonly seen in men over the age of 65 years. Progressive aneurysm enlargement can lead to rupture and massive internal bleeding, a fatal event unless timely repair can be achieved. Despite improvements in perioperative care, mortality remains high (approximately 50%) after conventional open surgical repair. A newer minimally invasive technique, endovascular aneurysm repair (EVAR), has been shown to reduce early morbidity and mortality as compared to conventional open surgery for planned AAA repair. Emergency endovascular aneurysm repair (eEVAR) has been used successfully to treat ruptured abdominal aortic aneurysm (RAAA), proving that it is feasible in selected patients. However, it is not yet known if eEVAR will lead to significant improvements in outcomes for these patients or indeed if it can replace conventional open repair as the preferred treatment for this lethal condition. OBJECTIVES: To assess the advantages and disadvantages of emergency endovascular aneurysm repair (eEVAR) in comparison with conventional open surgical repair for the treatment of ruptured abdominal aortic aneurysm (RAAA). This will be determined by the effect on short-term mortality, major complication rates, aneurysm exclusion, and late complications when compared with the effects in patients who have had conventional open repair of RAAA. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched February 2014) and CENTRAL (2014, Issue 2). Reference lists of relevant publications were also checked. SELECTION CRITERIA: Randomised controlled trials in which patients with a clinically or radiologically diagnosed RAAA were randomly allocated to eEVAR or conventional open surgical repair. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for eligibility by at least two review authors. Data extraction and quality assessment were also completed independently by two review authors. Disagreements were resolved through discussion. Meta-analysis was performed using fixed-effect models with odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous data and mean differences with 95% CIs for continuous data. MAIN RESULTS: Three randomised controlled trials were included in this review. A total of 761 patients with a clinical or radiological diagnosis of RAAA were randomised to receive either eEVAR or open surgical repair. Overall risk of bias was low but one study did not adequately report random sequence generation, putting it at risk of selection bias, two studies did not report on outcomes identified in their protocol, indicating reporting bias, and one study was underpowered. There was no clear evidence to support a difference between the two interventions on 30-day (or in-hospital) mortality, OR of 0.91 (95% CI 0.67 to 1.22; P = 0.52). The 30-day complications included myocardial infarction, stroke, composite cardiac complications, renal complications, severe bowel ischaemia, spinal cord ischaemia, re-operation, amputation, and respiratory failure. Individual complication outcomes were reported in only one or two studies and therefore no robust conclusion can currently be drawn. For complication outcomes that did include at least two studies in the meta-analysis there was no clear evidence to support a difference between eEVAR and open repair. Six-month outcomes were evaluated in only a single study, which included mortality and re-operation, with no clear evidence of a difference between the interventions and no overall association. Cost per patient was only evaluated in a single study and therefore no overall associations can currently be derived. AUTHORS' CONCLUSIONS: The conclusions of this review are currently limited by the paucity of data. From the data available there is no difference in the outcomes evaluated in this review between eEVAR and open repair, specifically 30-day mortality. Not enough information was provided for complications in order to make a well informed conclusion at this time. Long-term data are lacking for both survival and late complications. More high quality, randomised controlled trials comparing eEVAR and open repair for the treatment of RAAA are needed in order to better understand if one method is superior to the other, or if there is no difference between the methods on relevant outcomes.
