Effect of Outcome Measures on the Apparent Efficacy of Ablation for Atrial Fibrillation: Why "Success" is an Inappropriate Term.

ABSTRACT

INTRODUCTION: Different endpoint criteria, different durations of follow-up and the completeness of follow-up can dramatically affect the perceived benefits of atrial fibrillation (AF) ablation. METHODS: We defined three endpoints for recurrence of AF post ablation in a cohort of 200 patients with symptomatic AF, refractory to antiarrhythmic drugs (AADs). A 'Strict Endpoint' where patients were considered to have a recurrence with any symptomatic or documented recurrence for ≥30 seconds with no blanking period, and off their AADs, a 'Liberal Endpoint' where only documented recurrences after the blanking period, either on or off AADs were counted, and a 'Patient-defined Outcome endpoint' which was the same as the Liberal endpoint but allowed for up to two recurrences and one repeat ablation or DCCV during follow-up. We also surveyed 50 patients on the waiting list for an AF ablation and asked them key questions regarding what they would consider to be a successful result for them. RESULTS: Freedom from recurrence of atrial tachyarrhythmias (AT) at 5 years was 62% for the Strict Endpoint, 73% for the Liberal Endpoint, and 80% for the Patient-defined Outcome endpoint (p<0.001). Of the 50 patients surveyed awaiting AF ablation, 70% said they would still consider the procedure a success if it required one repeat ablation or one DCCV (p=0.004), and 76% would be accepting of one or two recurrences during follow-up (p<0.001). CONCLUSION: In this study, the majority of patients still considered AF ablation a successful treatment if they had up to two recurrences of AF, one repeat procedure or one DCCV. Furthermore, a 'Patient-defined' definition of success lead to significantly different results in this AF ablation cohort when compared to conventionally used/guideline directed measures of success.