Calculating when elective abdominal aortic aneurysm repair improves survival for individual patients: development of the Aneurysm Repair Decision Aid and economic evaluation.

BACKGROUND: Abdominal aortic aneurysm (AAA) repair aims to prevent premature death from AAA rupture. Elective repair is currently recommended when AAA diameter reaches 5.5 cm (men) and 5.0 cm (women). Applying population-based indications may not be appropriate for individual patient decisions, as the optimal indication is likely to differ between patients based on age and comorbidities.
OBJECTIVE: To develop an Aneurysm Repair Decision Aid (ARDA) to indicate when elective AAA repair optimises survival for individual patients and to assess the cost-effectiveness and associated uncertainty of elective repair at the aneurysm diameter recommended by the ARDA compared with current practice. DATA SOURCES: The UK Vascular Governance North West and National Vascular Database provided individual patient data to develop predictive models for perioperative mortality and survival. Data from published literature were used to model AAA growth and risk of rupture. The cost-effectiveness analysis used data from published literature and from local and national databases.
METHODS: A combination of systematic review methods and clinical registries were used to provide data to populate models and inform the structure of the ARDA. Discrete event simulation (DES) was used to model the patient journey from diagnosis to death and synthesised data were used to estimate patient outcomes and costs for elective repair at alternative aneurysm diameters. Eight patient clinical scenarios (vignettes) were used as exemplars. The DES structure was validated by clinical and statistical experts. The economic evaluation estimated costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) from the NHS, social care provider and patient perspective over a lifetime horizon. Cost-effectiveness acceptability analyses and probabilistic sensitivity analyses explored uncertainty in the data and the value for money of ARDA-based decisions. The ARDA outcome measures include perioperative mortality risk, annual risk of rupture, 1-, 5- and 10-year survival, postoperative long-term survival, median life expectancy and predicted time to current threshold for aneurysm repair. The primary economic measure was the ICER using the QALY as the measure of health benefit.
RESULTS: The analysis demonstrated it is feasible to build and run a complex clinical decision aid using DES. The model results support current guidelines for most vignettes but suggest that earlier repair may be effective in younger, fitter patients and ongoing surveillance may be effective in elderly patients with comorbidities. The model adds information to support decisions for patients with aneurysms outside current indications. The economic evaluation suggests that using the ARDA compared with current guidelines could be cost-effective but there is a high level of uncertainty. LIMITATIONS: Lack of high-quality long-term data to populate all sections of the model meant that there is high uncertainty about the long-term clinical and economic consequences of repair. Modelling assumptions were necessary and the developed survival models require external validation.
CONCLUSIONS: The ARDA provides detailed information on the potential consequences of AAA repair or a decision not to repair that may be helpful to vascular surgeons and their patients in reaching informed decisions. Further research is required to reduce uncertainty about key data, including reintervention following AAA repair, and assess the acceptability and feasibility of the ARDA for use in routine clinical practice. FUNDING: The National Institute for Health Research Health Technology Assessment programme.