Key result
Catheter ablation yields higher rates of asymptomatic AF recurrence than antiarrhythmic drugs at ~24% vs. 3%.
Why the study?
Does catheter ablation compared to antiarrhythmic drug therapy affect the correlation between symptoms and true AF episodes in patients with paroxysmal atrial fibrillation?
RCT (n=92)
Open-label
randomly broken into two groups
Yes
Does catheter ablation compared to antiarrhythmic drug therapy affect the correlation between symptoms and true AF episodes in patients with paroxysmal atrial fibrillation?
Absolute Event Rate: 23.5% vs 3%
Patient-reported symptoms correlate poorly with true AF episodes, particularly after catheter ablation, highlighting the unreliability of symptoms for evaluating treatment efficacy.
Requires rhythm monitoring post-ablation to capture silent recurrences; confirms symptom-based endpoints underestimate efficacy in AF trials and practice.
Purpose: to reveal a correlation between the symptoms and heart rhythm as well as to evaluate the incidence of symptomatic and asymptomatic paroxysmal atrial fibrillation (AF) in patients with paroxysmal AF after catheter ablation and antiarrhythmic drug therapy (AAD) through long-term observation based on data from implantable cardiac heart monitors (ICM). Materials and Methods: 92 patients with paroxysmal AF were randomly broken into two groups: 1) AF catheter ablation + ICM (Group I; n=46); 2) AAD + ICM (Group II; n=46). The data recorded by the device were matched against the symptoms diaries kept by the patients. Results: through the follow-up period (24 months), 17 (40%) patients of the catheter ablation Group and another 33 (71.8%) patients belonging to the AAD Group had AF relapse, whereas in 4 (23.5%) patients of the catheter ablation group and in 1 (3%) patients of the AAD group the paroxysms were asymptomatic. Only 30% of episodes recorded by the ICM in the AF catheter ablation + ICM Group and 78% of episodes in patients receiving AAD + ICM were found to be true AF paroxysms. Summary: the rhythm status did not match the patients’ symptoms in terms of AF, which was observed in 70% of the cases after catheter ablation and in 22% of cases in the AAD group. Asymptomatic AF was more common among the patients belonging to the catheter ablation group (23.5%) if compared to those who underwent AAD (3%). The subjective evaluation of the symptoms done by the patients regarding their arrhythmia did not reflect the true state of things related to the heart rhythm, which makes such evaluation not reliable if employed to judge the treatment efficiency.
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Simonyan et al. (2016) conducted an RCT in Paroxysmal atrial fibrillation (n=92). Catheter ablation vs. Antiarrhythmic drug therapy (AAD) was evaluated on Incidence of asymptomatic AF among patients with AF relapse. Catheter ablation resulted in a higher rate of asymptomatic atrial fibrillation relapses (23.5%) compared to antiarrhythmic drug therapy (3%), indicating that symptom-based evaluation is unreliable.
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