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      Editor's Choice – Re-interventions After Repair of Ruptured Abdominal Aortic Aneurysm: A Report From the IMPROVE Randomised Trial

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          Abstract

          Objective/Background

          The aim was to describe the re-interventions after endovascular and open repair of rupture, and investigate whether these were associated with aortic morphology.

          Methods

          In total, 502 patients from the IMPROVE randomised trial (ISRCTN48334791) with repair of rupture were followed-up for re-interventions for at least 3 years. Pre-operative aortic morphology was assessed in a core laboratory. Re-interventions were described by time (0–90 days, 3 months–3 years) as arterial or laparotomy related, respectively, and ranked for severity by surgeons and patients separately. Rare re-interventions to 1 year, were summarised across three ruptured abdominal aortic aneurysm trials (IMPROVE, AJAX, and ECAR) and odds ratios (OR) describing differences were pooled via meta-analysis.

          Results

          Re-interventions were most common in the first 90 days. Overall rates were 186 and 226 per 100 person years for the endovascular strategy and open repair groups, respectively ( p = .20) but between 3 months and 3 years (mid-term) the rates had slowed to 9.5 and 6.0 re-interventions per 100 person years, respectively ( p = .090) and about one third of these were for a life threatening condition. In this latter, mid-term period, 42 of 313 remaining patients (13%) required at least one re-intervention, most commonly for endoleak or other endograft complication after treatment by endovascular aneurysm repair (EVAR) (21 of 38 re-interventions), whereas distal aneurysms were the commonest reason (four of 23) for re-interventions after treatment by open repair. Arterial re-interventions within 3 years were associated with increasing common iliac artery diameter (OR 1.48, 95% confidence interval [CI] 0.13–0.93; p = .004). Amputation, rare but ranked as the worst re-intervention by patients, was less common in the first year after treatment with EVAR (OR 0.2, 95% CI 0.05–0.88) from meta-analysis of three trials.

          Conclusion

          The rate of mid-term re-interventions after rupture is high, more than double that after elective EVAR and open repair, suggesting the need for bespoke surveillance protocols. Amputations are much less common in patients treated by EVAR than in those treated by open repair.

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          Most cited references13

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          Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial.

          Short-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost after a few years. We investigated whether EVAR had a long-term survival benefit compared with open repair.
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            Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.

            The majority of infrarenal abdominal aortic aneurysm (AAA) repairs in the United States are performed with endovascular methods. Baseline aortoiliac arterial anatomic characteristics are fundamental criteria for appropriate patient selection for endovascular aortic repair (EVAR) and key determinants of long-term success. We evaluated compliance with anatomic guidelines for EVAR and the relationship between baseline aortoiliac arterial anatomy and post-EVAR AAA sac enlargement. Patients with pre-EVAR and at least 1 post-EVAR computed tomography scan were identified from the M2S, Inc. imaging database (1999 to 2008). Preoperative baseline aortoiliac anatomic characteristics were reviewed for each patient. Data relating to the specific AAA endovascular device implanted were not available. Therefore, morphological measurements were compared with the most liberal and the most conservative published anatomic guidelines as stated in each manufacturer's instructions for use. The primary study outcome was post-EVAR AAA sac enlargement (>5-mm diameter increase). In 10 228 patients undergoing EVAR, 59% had a maximum AAA diameter below the 55-mm threshold at which intervention is recommended over surveillance. Only 42% of patients had anatomy that met the most conservative definition of device instructions for use; 69% met the most liberal definition of device instructions for use. The 5-year post-EVAR rate of AAA sac enlargement was 41%. Independent predictors of AAA sac enlargement included endoleak, age ≥ 80 years, aortic neck diameter ≥ 28 mm, aortic neck angle >60°, and common iliac artery diameter >20 mm. In this multicenter observational study, compliance with EVAR device guidelines was low and post-EVAR aneurysm sac enlargement was high, raising concern for long-term risk of aneurysm rupture.
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              Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.

              Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise.
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                Author and article information

                Contributors
                Journal
                Eur J Vasc Endovasc Surg
                Eur J Vasc Endovasc Surg
                European Journal of Vascular and Endovascular Surgery
                Elsevier
                1078-5884
                1532-2165
                1 May 2018
                May 2018
                : 55
                : 5
                : 625-632
                Affiliations
                [a ]Vascular Surgery Research Group, Imperial College, London, UK
                [b ]Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
                [c ]St George's Hospital, London, UK
                [d ]Bristol Centre for Surgical Research, University of Bristol, Bristol, UK
                Author notes
                []Corresponding author. Vascular Surgery Research Group, Imperial College at Charing Cross, Fulham Palace Road, London W6 8RP, UK. j.powell@ 123456imperial.ac.uk
                [†]

                Current address: Endologix Inc., Irvine, CA, USA.

                [#]

                Current address: Department of Health Sciences, University of Leicester, Leicester, UK.

                [‡]

                See Appendix S1.

                Article
                S1078-5884(18)30065-0
                10.1016/j.ejvs.2018.01.028
                5967970
                29503083
                fa432af7-bd9d-41a4-a794-62048c2ed68d
                © 2018 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 29 November 2017
                : 29 January 2018
                Categories
                Article

                Surgery
                abdominal aortic aneurysm,morphology,re-intervention,rupture
                Surgery
                abdominal aortic aneurysm, morphology, re-intervention, rupture

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