Selection, technique, and follow-up: keys to success in EVAR
Authors: Isabelle Van Herzeele, Frank Vermassen
Journal: The Lancet (2016)

Short-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of elective abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost within a few years.1The EVAR trial participantsComparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial.Lancet. 2004; 364: 843-848Summary Full Text Full Text PDF PubMed Scopus (1633) Google Scholar, 2Prinssen M Verhoeven EL Buth J et al.A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.N Engl J Med. 2004; 351: 1607-1618Crossref PubMed Scopus (1663) Google Scholar, 3Lederle FA Freischlag JA Kyriakides TC et al.Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.JAMA. 2009; 302: 1535-1542Crossref PubMed Scopus (860) Google Scholar The long-term survival benefit of EVAR remains unclear.4Lal BK Zhou W Kyriakides T et al.Predictors and outcomes of endoleaks in the Veterans Affairs Open Versus Endovascular Repair (OVER) trial of abdominal aortic aneurysms.J Vasc Surg. 2015; 62: 1394-1404Summary Full Text Full Text PDF PubMed Scopus (88) Google Scholar The randomised controlled EVAR trial 1 was initiated in 1999, and the EVAR trial participants and authors are to be congratulated for their persistence to obtain these long-term data in this aneurysm population suitable for both open repair and EVAR.1The EVAR trial participantsComparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial.Lancet. 2004; 364: 843-848Summary Full Text Full Text PDF PubMed Scopus (1633) Google Scholar In Rajesh Patel and colleagues' EVAR trial 15Patel R Sweeting MJ Powell JT Greenhalgh JM for the EVAR trial investigatorsEndovascular 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.Lancet. 2016; (published online Oct 12.)http://dx.doi.org/10.1016/S0140-6736(16)31135-7Summary Full Text Full Text PDF Scopus (599) Google Scholar reported in The Lancet, over a mean of 12·7 years' follow-up (max 15·8 years), they show no significant difference between the randomly assigned groups in total mortality (9·3 deaths per 100 person-years in the EVAR group vs 8·9 deaths per 100 person-years in the open-repair group) or aneurysm-related mortality (1·1 deaths per 100 person-years in the EVAR group vs 0·9 deaths per 100 person-years in the open-repair group). An early and significant survival benefit was noted in the EVAR group at 6 months after randomisation (adjusted hazard ratios 0·61, 95% CI 0·37–1·02 for total mortality; and 0·47, 0·23–0·93, p=0·031 for aneurysm-related mortality), and only after 8 years did open repair have a significantly lower mortality (1·25, 1·00–1·56, p=0·05 for total mortality; and 5·82, 1·64–20·65, p=0·006 for aneurysm-related mortality). The increased aneurysm-related mortality beyond 8 years was mainly attributable to secondary aneurysm sac rupture post-EVAR. Overall, aneurysm re-intervention rates were higher in the EVAR than in the open-repair group (4·1 and 1·7 per 100 person-years; p<0·0001) with most re-interventions taking place within 4 years of the initial treatment.5Patel R Sweeting MJ Powell JT Greenhalgh JM for the EVAR trial investigatorsEndovascular 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.Lancet. 2016; (published online Oct 12.)http://dx.doi.org/10.1016/S0140-6736(16)31135-7Summary Full Text Full Text PDF Scopus (599) Google Scholar In this trial, patients were treated more than 12 years ago and, fortunately, medical and endovascular management have since progressed. Case selection, device choice,6Verzini F Isemia G DeRango P et al.Abdominal aortic endografting beyond the trials: a 15-year single-center experience comparing newer to older generation stent-grafts.J Endovasc Ther. 2014; 21: 439-447Crossref PubMed Scopus (58) Google Scholar and planning with technical skills by use of simulation,7Desender L Van Herzeele I Lachat ML et al.on behalf of the PAVLOV Study GroupPatient-specific rehearsal prior to EVAR: influence on technical and non-technical operative performance. a randomized controlled trial.Ann Surg. 2016; (published online July 15.)https://doi.org/10.1097/SLA.0000000000001871Crossref PubMed Scopus (36) Google Scholar imaging modalities with decreased radiation, best practices in medical treatment, and surveillance programmes in centralised aortic units have all improved the overall management of aortic aneurysmal disease.8Sobocinski J Chenorhokian H Maurel B et al.The benefits of EVAR planning using a 3D workstation.Eur J Vasc Endovasc Surg. 2013; 46: 418-423Summary Full Text Full Text PDF PubMed Scopus (40) Google Scholar Although the EVAR trial 1 will always be a landmark trial, the long-term findings with only 57% of patients being alive at the end of follow-up should be interpreted with caution because of the following limitations. The data collection from 10–15 years risks bias since it was done both retrospectively and prospectively, and relies on data from NHS records for procedures at the time of patient discharge (Hospital Episode Statistics) and trial-based data. The benefit was that patients lost to follow-up were retrieved and that re-interventions after open repair, such as incisional hernia repair, not collected before 2009, could be included in a retrospective manner. Follow-up for mortality (the primary outcome) was unchanged between 1999 and 2015. In 1999, the mean age at randomisation for the EVAR trial 1 was 74 years, indicating that patients were a high-risk group for malignancy based on age rather than radiation exposure. The difference in total malignancy deaths at 15 years is small (126 in the EVAR group vs 123 in the open-repair group) and in fact more malignancy deaths were noted in the open-repair group at time intervals 6 months to 4 years and at 4–8 years. Appropriate investigation and robust data are needed and any insinuation that EVAR predisposes to or increases the risk of cancer might be dangerously misleading. The long-term surveillance after aneurysm repair in the UK trial, a country known for its evidence-based medicine, was astonishingly low despite reports warning the endovascular community about the importance of lifelong follow-up.9Schanzer A Greenberg RK Hevelone N et al.Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.Circulation. 2011; 123: 2848-2855Crossref PubMed Scopus (576) Google Scholar Unfortunately, imaging data have not yet been included to explain why aneurysms excluded with second and third generation devices still rupture during long-term follow-up. Was this aneurysm growth or rupture caused by true device failures10Wyss TR Brown LC Powell JT Greenhalgh RM Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR trials.Ann Surg. 2010; 252: 805-812Crossref PubMed Scopus (6) Google Scholar (eg, fractures, migration, endoleak type I or III), or was the initial stent graft not deployed within 3 mm of the lowest renal artery? Was surveillance continued for long enough (median CT surveillance six scans [IQR 3–8] in EVAR group vs three scans [1–6] in open-repair group5Patel R Sweeting MJ Powell JT Greenhalgh JM for the EVAR trial investigatorsEndovascular 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.Lancet. 2016; (published online Oct 12.)http://dx.doi.org/10.1016/S0140-6736(16)31135-7Summary Full Text Full Text PDF Scopus (599) Google Scholar) and were serious and life-threatening complications managed appropriately by secondary interventions (such as by relining, coiling, proximal fenestrated cuff) to save the patient's life?10Wyss TR Brown LC Powell JT Greenhalgh RM Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR trials.Ann Surg. 2010; 252: 805-812Crossref PubMed Scopus (6) Google Scholar Local investigators in this trial by Patel and colleagues5Patel R Sweeting MJ Powell JT Greenhalgh JM for the EVAR trial investigatorsEndovascular 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.Lancet. 2016; (published online Oct 12.)http://dx.doi.org/10.1016/S0140-6736(16)31135-7Summary Full Text Full Text PDF Scopus (599) Google Scholar were at liberty to treat patients to their best knowledge, but some complications that are now known to cause aneurysm rupture were not treated.11Wyss TR Dick F Brown LC Greenhalgh RM The influence of thrombus, calcification, angulation, and tortuosity of attachment sites on the time to the first graft-related complication after endovascular aneurysms repair.J Vasc Surg. 2011; 54: 965-971Summary Full Text Full Text PDF PubMed Scopus (104) Google Scholar EVAR has gained enormous popularity worldwide with a lower initial operative mortality than open repair. Secondary ruptures after EVAR account for the long-term increase in aneurysm-related mortality. These findings, confirmed by 15 years of follow-up data from the EVAR 1 trial,5Patel R Sweeting MJ Powell JT Greenhalgh JM for the EVAR trial investigatorsEndovascular 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.Lancet. 2016; (published online Oct 12.)http://dx.doi.org/10.1016/S0140-6736(16)31135-7Summary Full Text Full Text PDF Scopus (599) Google Scholar should alert physicians managing abdominal aortic aneurysms and might have implications for case selection, patients' treatment choices, and continuous surveillance after EVAR. These results also show that long-term follow-up of surgical innovations is crucial.12McCulloch P Altman DG Campbell WB et al.No surgical innovation without evaluation: the IDEAL recommendations.Lancet. 2009; 374: 1105-1112Summary Full Text Full Text PDF PubMed Scopus (1190) Google Scholar IVH is an adviser for Medtronic Academia and Silk Road Medical, has received research grants from Medtronic Academia and W L Gore & Associates, and has a research grant from Simbionix, which is unrelated to the topic of this Comment. FV is a consultant for Medtronic, W L Gore & Associates, Cook Inc, and Bloomingdale. Medtronic, W L Gore & Associates, Cook Inc, and Bloomingdale have been involved in training workshops for EVAR procedures and registries using later generation stent grafts. 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 trialEVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and re-intervention if necessary. Full-Text PDF Open Access