ClinicalTrials.gov number NCT00461734.

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RFCA is a relatively safe and efficacious procedure for the therapeutic treatment of AF and typical atrial flutter. There is some randomised evidence to suggest that RFCA is superior to AADs in patients with drug-refractory paroxysmal AF in terms of freedom from arrhythmia at 12 months. RFCA appears to be cost-effective if the observed quality of life benefits are assumed to continue over a patient's lifetime. However, there remain uncertainties around longer-term effects of the intervention and the extent to which published effectiveness findings can be generalised to 'typical' UK practice. All catheter ablation procedures for the treatment of AF or atrial flutter undertaken in the UK should be recorded prospectively and centrally and measures to increase compliance in recording RFCA procedures may be needed. This would be of particular value in establishing the long-term benefits of RFCA and the true incidence and impact of any complications. Collection of appropriate quality of life data within any such registry would also be of value to future clinical and cost-effectiveness research in this area. Any planned multicentre RCTs comparing RFCA against best medical therapy for the treatment of AF and/or atrial flutter should be conducted among 'non-pioneering' centres using the techniques and equipment typically employed in UK practice and should measure relevant outcomes.

Objective: To assess the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared with antiarrhythmic drug (AAD) therapy for the treatment of atrial fibrillation (AF) from the perspective of the UK NHS. Design: Bayesian evidence synthesis and decision analytical model. Methods: A systematic review and meta-analysis was conducted and Bayesian statistical methods used to synthesise the effectiveness evidence from randomised control trials. A decision analytical model was developed to assess the costs and consequences associated with the primary outcome of the trials over a lifetime time horizon. Main outcome measure: Costs from a health service perspective and outcomes measured as quality-adjusted life years (QALYs). Results: The incremental cost-effectiveness ratio of RFCA varied between £7763 and £7910 for each additional QALY according to baseline risk of stroke, with a probability of being cost-effective from 0.98 to 0.99 for a cost-effectiveness threshold of £20 000. Results were sensitive to the duration of quality of life benefits from treatment. Conclusions: RFCA is potentially cost-effective for the treatment of paroxysmal AF in patients' predominantly refractory to AAD therapy provided the quality-of-life benefits from treatment are maintained for more than 5 years. These findings remain subject to limitations in the existing evidence regarding the nature of life benefits and the prognostic importance of restoring normal sinus rhythm conferred using RFCA.Atrial fibrillation (AF) is a common and debilitating cardiac arrhythmia. Its prevalence in the United Kingdom is rising as a result of an ageing population and an increased longevity resulting from improved medical care for chronic cardiac conditions which predispose to AF.1 A recent report estimated that approximately 1% of all NHS expenditures are the result of AF.2 The costeffective management of AF in the United Kingdom therefore represents an important consideration.Radiofrequency catheter ablation (RFCA) is an established technique for the treatment of cardiac arrhythmias, which has relatively recently been extended to allow treatment of AF. In the United Kingdom, its use for controlling AF is recommended by the National Institute for Health and Clinical Excellence (NICE) for patients who have previously failed on other management strategies.3 RFCA offers the potential to eliminate the underlying cause of AF, which other therapies fail to achieve. The primary outcome from the procedure is the restoration and maintenance of normal sinus rhythm (NSR). The sustained long-term maintenance of sinus rhythm establishes the efficacy of the intervention.RFCA results in significant upfront costs and a risk of procedural complications. However, the potential quality-of-life benefits through long-term absence of arrhythmia and any associated prognostic benefits (for example, reduced risk of stroke) may outweigh the costs when compared to longterm use of anti-arrhythmic drug (AAD) therapy and its associated adverse effects. Only one prev...