Original Title: Evalueringsrapport vedrørende endovaskulær behandling af abdominale aortaaneurismer uden ruptur

Authors' objectives: Endovascular aortic repair of abdominal aortic aneurysms (AAA), EVAR, is a minimally invasive surgical procedure used to prevent rupture. During EVAR, a stent is placed inside the aorta to "line" the vessel from within. The procedure typically involves small punctures in both groin arteries and can be performed under local anesthesia. As an alternative treatment, open surgery repair (OSR) involves a surgical incision in the abdomen to place a vascular graft, which replaces the dilated section of the aorta. The Danish Society for Vascular Surgery recommends that patients with a long expected remaining lifespan undergo OSR, while patients with a reasonable life expectancy and suitable anatomy are treated with EVAR. Patients with a short expected remaining lifespan are not recommended for surgical treatment. Evidence suggests that there are significant differences across the Danish regions in the extent to which patients are treated with EVAR versus OSR. This applicant-initiated evaluation reviews the current evidence on the use of EVAR for the treatment of patients with confirmed asymptomatic infrarenal AAA without rupture. The evaluation focuses on patients with an aneurysm measuring at least 5.5 cm in men and 5 cm in women. Additionally, the patient must have an expected remaining lifespan of at least 3 years and be eligible for surgical treatment. The evaluation includes four areas of interest: Clinical effectiveness and safety, the Patient perspective, Organizational implications, and Health Economics. The Danish Healthcare Quality Institute based their recommendation on the use of EVAR on the findings in the evaluation report.

Authors' results and conclusions: Clinical effect and safety: The clinical effectiveness and safety of EVAR is evaluated based on a systematic review of the scientific literature. The expert committee found that the effectiveness of EVAR compared to OSR is best assessed through randomized controlled trials (RCTs), which form the core of the evaluation. For certain outcomes, observational studies with moderate risk of bias supplement the RCT findings. EVAR shows a clinically relevant short-term reduction in patient mortality. Over time, its effectiveness aligns with that of OSR, although the evidence for long-term mortality remains uncertain. Confidence in these conclusions is rated as "moderate" and "low to very low", respectively, according to GRADE. No clinically relevant difference was found for the effect measure health-related quality of life between EVAR and OSR, with moderate confidence in the evidence. EVAR likely reduces length of hospital stay (GRADE: High). For myocardial infarction, EVAR may lower risk, but the confidence level is "very low." In general, no clinically relevant differences were found for the occurrence of adverse events, except for an increased risk of lower limb ischemia with EVAR. Confidence in this evidence ranges from "low" to "moderate". In addition, EVAR is associated with a clinically relevant increased risk of re-intervention compared to OSR. Overall, the expert committee concludes that EVAR is clinically equivalent to OSR in terms of effectiveness and safety. Patient perspective: The expert committee found that the current evidence does not provide clear insight into patient preferences regarding treatment with either EVAR or OSR. Overall, the evidence used to assess the patient perspective is of limited quality, with only a few exceptions. Based on the available evidence at the time of evaluation, the expert committee finds no definitive indication of a patient preference for either EVAR or OSR. It stresses that the current literature does not allow for a clear conclusion on this matter and that the patient perspective us currently underexplored. The expert committee cannot rule out the possibility of inequality in access to treatment options across Denmark. However, the exact causes of such disparities cannot be clearly defined based on existing knowledge or published studies. Organizational implications: The Organizational implications are primarily informed by interviews by the applicant. The expert committee expresses significant concern regarding the reliability of the interview statements. This skepticism stems from the applicant’s lack of transparency about how informants were recruited and the representativeness of the sample size. The committee cannot rule out the possibility that the statements are politically influenced, limiting their usefulness in the current evaluation. Currently, EVAR is offered at five out of seven departments in Denmark, indicating existing capacity and expertise. If EVAR is to be made available at all seven departments with the necessary competencies, this would require political commitment. The expert committee deems that a potential increased use of either EVAR or OSR, following recommendations from the Danish Healthcare Quality Institute, will impact the training of new surgeons and shift competencies among existing surgeons. The committee notes that potential centralization of EVAR to fewer departments could influence patient preferences and potentially lead to increased inequality and reduced accessibility for eligible patients. Health economics: The analyses include a cost-utility analysis (CUA), a cost-effectiveness analysis (CEA), and a budget impact analysis (BIA). In the base-case scenario, EVAR results in an average lifetime cost increase of DKK 36,145 per patient compared to OSR. The CUA shows a QALY (quality-adjusted life year) difference of -0.0965 for EVAR. The CEA indicates EVAR leads to an average gain of 0.2 life years per patient. Sensitivity analyses reveal that the results of the analyses are associated with substantial uncertainty, especially associated with input parameters concerning the length of hospital stay and 30-day mortality. For the CUA, the probabilistic sensitivity analysis indicates a 65% probability of OSR dominating EVAR, while the PSA for the CEA indicates a 79% probability of EVAR being more costly but more effective than OSR. The Danish Healthcare Quality Institute estimates that recommending EVAR will not lead to any significant budgetary consequences compared to current treatment costs, provided the patient population remains unchanged, and the treatment is used in accordance with current guidelines. However, the five-year budget impact analysis showed a potential savings of approximately DKK 4.8 million if EVAR were to be replaced with OSR for this patient group. Furthermore, the expert committee emphasize that a recommendation of EVAR may increase demand for CT scans, while a recommendation of increased use of OSR would strain inpatient bed capacity due to longer hospital stays.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.sundk.dk/media/u15jxcxd/anbefalingdokument-vedr-evaluering-af-evar.pdf

English language abstract: There is no English language summary available

Publication Type: Not Assigned

Country: Denmark

Organisation Name: The Danish Health Technology Council

Contact Address: Niels Jernes Vej 6a, 9220 Aalborg