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Abstract
Next to anticoagulation, pulmonary vein isolation (PVI) is the most important interventional procedure in the treatment of atrial fibrillation (AF). Despite widespread clinical application of this therapy, patients often require multiple procedures to reach clinical success. In contrast to conventional imaging modalities, MRI allows direct visualisation of the ablation lesion. Therefore, the use of real-time MRI to guide cardiac electrophysiology procedures may increase clinical effectiveness. An essential aspect, from a decision-making point of view, is the effect on costs and the potential cost-effectiveness of new technologies. Generally, health technology assessment (HTA) studies are performed when innovations are close to clinical application. However, early stage HTA can inform users, researchers and funders about the ultimate clinical and economic potential of a future innovation. Ultimately, this can guide funding allocation. In this study, we performed an early HTA evaluate MRI-guided PVIs.
Methods We performed an economic evaluation using a decision tree with a time-horizon of 1 year. We calculated the clinical effectiveness (defined as the proportion of patients that is long-term free of AF after a single procedure) required for MRI-guided PVI to be cost-effective compared with conventional treatment.
Results Depending on the cost-effectiveness threshold (willingness to pay for one additional quality-of-life adjusted life year (QALY), interventional MRI (iMRI) guidance for PVI can be cost-effective if clinical effectiveness is 69.8% (at €80 000/QALY) and 77.1% (at €20 000/QALY), compared with 64% for fluoroscopy-guided procedures.
Conclusion Using an early HTA, we established a clinical effectiveness threshold for interventional MRI-guided PVIs that can inform a clinical implementation strategy. If crucial technologies are developed, it seems plausible that iMRI-guided PVIs will be able to reach this threshold.
- atrial fibrillation
- MRI
- quality of care and outcomes
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Footnotes
Contributors SW: conceptualisation, planning, data acquisition, analysis, writing and submission. CvL: conceptualisation, planning, data acquisition and analysis. GF: conceptualisation and technical supervision. PL: data acquisition, providing medical background and manuscript revision. JvdH: providing medical background and manuscript revision. SAJC and FvS: conceptualisation, planning, project supervision and manuscript revision.
Funding This work was conducted within the Topconsortia for Knowledge and Innovation’s - Life Sciences & Health (TKI LSH) framework and with financial support of the National Health Service, Interuniversity Cardiology Institute of the Netherlands (ICIN) – Netherlands Heart Foundation and partners of the MrI Guided RegenerAtive ThErapy (MIGRATE) consortium.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.