Authors' objectives: We identified and summarised evidence that addressed the following question: What is the clinical and cost effectiveness of left atrial appendage occlusion to treat adults with atrial fibrillation and contraindications to anticoagulants?

Authors' results and conclusions: We identified a systematic review with meta-analysis of 29 non-comparative studies on the clinical follow-up of left atrial appendage occlusion (LAAO) for adults with non-valvular atrial fibrillation (AF) and contraindications to anticoagulants. The review concluded that, based on the reported incidence rate of ischaemic stroke, LAAO is potentially effective for stroke prevention in adults with AF. Eight additional non-comparative studies were identified, which reported on the rates of ischaemic stroke events after LAAO in adults with AF and contraindications to anticoagulants. However, their findings varied and should be interpreted with caution given the limitations of this type of study design, which is more prone to bias compared to experimental studies, such as randomised control trials (RCTs). Data from the Commissioning through Evaluation (CtE) registry in England provided evidence that LAAO is procedurally successful in about nine out of ten adults with AF with contraindications to oral anticoagulants. It was reported that LAAO is associated with a decreased risk of ischaemic events compared with historical epidemiological data in patients with a similar baseline risk. Five health economic analyses were included in a review of the economic literature. This included two directly applicable analyses that considered the perspective of the UK NHS and three partially applicable analyses that considered healthcare systems in other countries. All of the studies were assessed as having potentially serious limitations. A UK cost consequence analysis presented as part of the CtE study reported that LAAO in addition to medical therapy was more expensive than medical therapy alone, while another UK cost analysis reported that LAAO was cheaper than aspirin and no treatment at 10 years. German and Canadian cost-utility analyses concluded that LAAO was dominant (more effective and less costly) compared with aspirin or long-term apixaban, and dominant compared with aspirin alone, respectively. A Swedish cost-utility analysis found that LAAO was cost effective compared with no pharmacological antithrombotic treatment (no aspirin). Health Technology Wales (HTW) developed a cost-utility analysis that compared LAAO in addition to standard care with standard care with aspirin alone, from the perspective of the UK NHS. LAAO in addition to standard care was found to be more expensive and more effective than standard care alone, but the incremental cost-effectiveness ratio (ICER) of £42,302 per quality-adjusted life year (QALY) gained showed that it was not cost effective. However, it should be noted that, due to the lack of comparative evidence, the HTW cost-utility analysis shares some of the limitations of the already published cost-utility analyses, most notably the use, in the comparator arm, of predicted ischaemic stroke rates from the CHA2DS2-VASc tool.

Authors' recommendations: The evidence does not support the routine adoption of LAAO in adults with non-valvular AF who have contraindications to oral anticoagulation. There are no comparative studies of LAAO compared with standard care in adults with non-valvular AF in whom oral anticoagulation is contraindicated, although non-comparative observational studies suggest that LAAO reduces the rate of ischaemic stroke. The cost-utility analysis concludes that while LAAO in addition to standard care may be more effective than standard care with aspirin alone, it is cost incurring and not cost effective with an ICER of £42,302 per QALY.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Project Status: Completed

Year Published: 2022

URL for published report: https://healthtechnology.wales/reports-guidance/left-atrial-appendage-occlusion-in-patients-with-atrial-fibrillation/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk

Copyright: Health Technology Wales