Key result
An endovascular strategy for suspected ruptured abdominal aortic aneurysms yielded similar 1-year all-cause mortality to open repair (41.1% vs 45.1%), with lower costs and higher quality of life.
Why the study?
Does an endovascular strategy reduce mortality or improve quality of life compared with open repair in patients suspected to have a ruptured abdominal aortic aneurysm?
Does an endovascular strategy reduce mortality or improve quality of life compared with open repair in patients suspected to have a ruptured abdominal aortic aneurysm?
Absolute Event Rate: 41.1% vs 45.1%
An endovascular strategy for suspected ruptured abdominal aortic aneurysms provides equivalent 1-year mortality to open repair, but with shorter hospital stays, improved quality of life, and lower costs.
This editorial refers to ‘Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial’†, by IMPROVE Trial Investigators, on page 2061 There has been considerable debate regarding the role of endovascular repair to treat ruptured abdominal aortic aneurysms.1–3 Meta-analysis of cohort data demonstrated some encouraging short-term survival benefits compared with open repair, but these studies were influenced by selection and publication bias.4–6 The Immediate Management of Patients with Rupture: Open Versus Endovascular repair (IMPROVE) randomized trial was designed to provide a robust comparison of the two treatment strategies.7 The trial was constructed to be inclusive and to consider whether availability of an endovascular service would improve the outcome of all patients with rupture, not just those with anatomy suitable for endovascular aneurysm repair (EVAR). The authors should be congratulated on the pragmatic design and the conduct of the multicentre study, which provides as close a reflection of clinical reality as possible. The trial included all patients suspected to have a ruptured aneurysm and was large enough to include an intention to treat analysis of 316 patients having endovascular strategy and 295 patients in the open repair group. The design of the trial was not a simple comparison of endovascular with open repair for ruptured aneurysms. Patients were randomized on the clinical suspicion of a ruptured aneurysm, prior to computed tomography (CT) imaging. This meant some patients were randomized that did not have a ruptured aneurysm, and the suitability of the aneurysm for endovascular repair was not assessed. The endovascular strategy group therefore comprised patients treated endovascularly (who had aneurysms suitable for endovascular repair) and patients who had open repair for aneurysms that were not suitable for endovascular repair. Endovascular repair was started in only 58% of the endovascular strategy group. The endovascular strategy group was then compared with the open surgical repair group, which contained crossovers to endovascular treatment, often due to poor fitness for surgery. This clearly muddies the waters for the purist expecting a simple endovascular vs. open repair comparison. In fact the overall mortality for patients receiving endovascular repair was 25% as compared with 38% for those who received open repair, but this did not translate into a lower mortality for patients randomized to the endovascular strategy group. The trial, however, is designed to investigate real-life practice and this means that the results can be applicable to many centres and are likely to influence future guidelines. Centres were selected to participate in the trial if they performed at least 20 elective endovascular aneurysm repairs per year, with a minimum of five emergency endovascular cases. There were some tantalizing findings from the 30-day results of the IMPROVE trial.8 Women were shown to benefit more from endovascular repair compared with open repair. The reason for this is that women have a much worse mortality for open repair compared with men (57% vs. 32%), whereas the results for endovascular repair are similar between genders (37% vs. 35%). Endovascular repair was also shown to be better for the most seriously ill and for older patients. This presumably is related to the fact that endovascular repair is a much less invasive procedure compared with open surgery and is therefore tolerated in these frail individuals with less physiological reserve. Patients having a local anaesthetic for the procedure seemed to have a better outcome than those undergoing a general anaesthetic. The use of local anaesthetic for elective as well as emergency endovascular repair is not yet widely adopted and deserves further investigation. The management of patients with ruptured aneurysms using permissive hypotension has previously been suggested as being beneficial; however, the IMPROVE trial showed that letting the blood pressure go lower than 70 mmHg was associated with an increased mortality. The 1-year data are important because the 30-day data could be heavily influenced by the quality of modern intensive and hospital care.9,10 At 1 year there was no difference in all-cause mortality between the two groups (41.1% for endovascular compared with 45.1% for open repair).7 Almost half the deaths occurred within 24 h and the majority occurred within 30 days. There was no difference in aneurysm-related mortality (33.9% for endovascular compared with 39.3% for open repair). As with the 30-day data, there was some evidence that the endovascular strategy was more beneficial in women than in men. There was a low rate of re-intervention in both groups. Patients in the endovascular strategy group had a shorter length of stay (17 days) compared with those in the open repair group (26 days), and significantly more were discharged home. Patients reported higher quality of life scores in the endovascular strategy compared with the open repair group. The endovascular strategy was shown to be more cost-effective despite a range of devices, operating theatre staff, and additional intervention costs. This is important and has implications for how the budget for vascular services in healthcare systems is planned. The observation that the operative mortality in the open repair group was lower than anticipated demonstrates that the trial centres offered above standard care. This trial supports the referral of patients to care providers that offer endovascular repair of ruptured abdominal aortic aneurysms in anatomically suitable patients. Aortic morphology has been shown to be an important determinant of outcome, and in future patients with a short aneurysm neck length may be treated with off-the-shelf branched and fenestrated endovascular devices.11 It is important that trainees and staff acquire the necessary skills, with appropriate infrastructure in place, to offer endovascular management 24 h per day, 7 days a week. Hospitals should develop algorithms to streamline care and to ensure the best outcomes are achieved (Figure 1). What is most important to patients is a fast discharge home with a good post-operative quality of life. In conclusion, the IMPROVE trial investigators have convincingly shown that an endovascular strategy is associated with lower cost, higher quality of life, and equivalent mortality to open surgical repair at 1 year. These findings support the provision of emergency endovascular repair as a standard procedure for ruptured abdominal aortic aneurysms. The 3-year data are eagerly awaited. Streamlined care and swift management begins with rapid emergency transfer to a certified emergency care centre followed by diagnostic imaging. Diagnostic CT images may be shared with the surgical/interventional team in another hospital or directly fed into the hybrid theatre for optimal care e.g. an EVAR first strategy if anatomy allows. Conflict of interest: none declared.
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Clough et al. (2015) conducted an editorial in ruptured abdominal aortic aneurysms (n=611). Endovascular strategy vs. Open repair was evaluated on all-cause mortality. An endovascular strategy for suspected ruptured abdominal aortic aneurysms yielded similar 1-year all-cause mortality to open repair (41.1% vs 45.1%), with lower costs and higher quality of life.
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