Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair: a systematic review and economic evaluation

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance. DATA SOURCES: Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus' Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016. METHODS: We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis. RESULTS: We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1% (mean follow-up of 24 months) to 23.8% (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I-III endoleaks. All-cause mortality ranged from 2.7% (mean follow-up of 24 months) to 42% (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1% of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63% probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups. LIMITATIONS: Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data. CONCLUSIONS: Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases. FUTURE WORK: Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016036475. FUNDING: The National Institute for Health Research Health Technology Assessment programme.