Annual rupture risk of abdominal aortic aneurysm enlargement without detectable endoleak after endovascular abdominal aortic repair

Koole, Dave; Moll, Frans L.; Buth, Jacob; Hobo, Roel; Zandvoort, Herman J.A.; Bots, Michiel L.; Pasterkamp, Gérard; Herwaarden, Joost A. van

doi:10.1016/j.jvs.2011.06.095

Cited by 41 publications

(30 citation statements)

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“…Some data suggest that aneurysm growth of >8 mm, or absolute size >7 cm, defines an increased risk for rupture, although rupture can still occur in stable or shrinking aneurysms. 9 It is accepted type I and III endoleaks should be aggressively treated, but the threshold for explantation with type II or no endoleaks visualized remains to be established. 4,[10][11][12] We have used >5 mm growth without an identifiable and treatable cause as indication for explant.…”

Section: Discussionmentioning

confidence: 99%

Late graft explants in endovascular aneurysm repair

Turney

Steenberge

Lyden

et al. 2014

Journal of Vascular Surgery

109

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Section: Discussionmentioning

confidence: 99%

Late graft explants in endovascular aneurysm repair

Turney

Steenberge

Lyden

et al. 2014

Journal of Vascular Surgery

109

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“…The EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair (EUROSTAR) database has reported that rate of secondary sac rupture after EVAR is low for the first 4 years, but after this time the rate appears to increase, particularly in those with known sac expansion. 110 A previous report from the EVAR trials defined a 'cluster' of findings (type I endoleak, type III endoleak, type II endoleak with sac expansion, kinking and migration), which was associated with secondary sac rupture with 67% risk of death. 111 There has been no previous comprehensive report of very long-term follow-up of EVAR or OR beyond 10 years.…”

Section: Evar Trialmentioning

confidence: 99%

The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis

Patel

Powell

Sweeting

et al. 2018

Health Technol Assess

103

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BackgroundShort-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years.ObjectiveTo assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention.DesignTwo national, multicentre randomised controlled trials: EVAR-1 and EVAR-2.SettingPatients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004.ParticipantsMen and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding.InterventionsEVAR, OR or no intervention.Main outcome measuresThe primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness.ResultsIn EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27;p = 0.14]. At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality;p = 0.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56,p = 0.048 for total mortality; HR 5.82, 95% CI 1.64 to 20.65,p = 0.0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (p < 0.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was £3798 (95% CI £2338 to £5258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient’s lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality.LimitationsDevices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009.ConclusionsEVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign.Future workTo find easier ways to monitor sac expansion to trigger timely reintervention.Trial registrationCurrent Controlled Trials ISRCTN55703451.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and the results will be published in full inHealth Technology Assessment; Vol. 22, No. 5. See the NIHR Journals Library website for further project information.

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“…7,8 In addition, as EVAR long-term outcomes are affected by EG design, device-specific multicenter registries could better reflect the specific EG performances while avoiding any possible bias related to the use of different EG designs, configurations, and generations. [9][10][11][12] The aim of this paper was to present the 10-year outcomes of a multicenter device-specific registry, the Italian Excluder Registry (ITER), using the Gore Excluder EG.…”

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confidence: 99%