An economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation from an English NHS perspective

Abstract

Funding Acknowledgements Type of funding sources: Other. Main funding source(s): This cost-effectiveness study was funded by Medtronic Background The UK National Institute of Care Excellence (NICE) recommend the use of pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) in those who have not responded to drug treatment. Recently, three randomized controlled trials have demonstrated that as an initial rhythm control strategy, PVI with cryoballoon ablation, reduces atrial arrhythmia recurrence compared to antiarrhythmic drug (AAD) therapy in patients with symptomatic PAF. Purpose To evaluate the cost-effectiveness of first-line cryoablation versus first-line optimized AADs in an English National Health Service (NHS) setting. Methods Individual patient-level data from 703 participants with untreated PAF recruited into Cryo-FIRST, STOP AF First and EARLY-AF were used to derive equations to predict the following outcomes: rates of ablation, AF recurrence and resolution, AF-related hospital attendance, and health-related quality of life (HRQoL) utilities. Where parameters could not be sourced from the trial data, inputs were taken from the published literature or derived using clinical expert opinion. The cost-effectiveness model (CEM) was a hybrid of a decision tree with a one-year time horizon and a Markov model (three-month cycle length) with a lifetime time horizon and was developed from the perspective of the English NHS. Health benefits were expressed in quality-adjusted life years (QALYs), and all benefits and costs were discounted at 3.5% per year in line with NICE requirements. Uncertainty in the CEM inputs was explored using probabilistic sensitivity analysis. The results include an initial 12-week blanking period for all studies. Results The three-monthly rate of AF recurrence was reduced on average by 46.7% (p<0.001) in those treated with cryoablation. Similarly, the monthly rate of receiving an ablation following initial treatment was reduced by 72.8% (p<0.001) in the cryoablation arm. Furthermore, the average cryoablation patient was associated with a 4.3% (p=0.025) increase in their HRQoL. While the likelihood of failure was greater in the AAD group, in those who failed initial treatment, there was no difference in the rate of AF symptom resolution. The CEM indicates that cryoablation is more effective (+0.17 QALYs) and more costly (+£1,414) over a lifetime compared to optimized AADs. Cryoablation resulted in an Incremental Cost-Effectiveness Ratio of £8,435 with a 78.5% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY gained. Individuals in both treatment arms were predicted to receive ~1.2 ablations over a lifetime regardless of initial treatment. However, there was a 45% relative reduction in the amount of time spent in symptomatic AF states for those initially treated with cryoablation. Conclusions AF rhythm control in drug naïve patients with cryoballoon ablation is cost-effective compared to optimized AADs in an English NHS setting.