Key result
Wearable 90-day Holter monitoring achieves ~81% patient acceptance and strong AI agreement after AF ablation.
Why the study?
Routine use of implantable cardiac monitors after AF ablation is limited by cost and invasiveness, and the practical utility of less invasive wearable Holter monitoring throughout the 90-day blanking period remained unclear.
Is 90-day self-managed garment-type wearable Holter monitoring feasible and does AI-estimated AF burden agree with physician-reviewed AF burden during the blanking period in patients undergoing pulsed field ablation for atrial fibrillation?
Observational (n=54)
No
Is 90-day self-managed garment-type wearable Holter monitoring feasible and does AI-estimated AF burden agree with physician-reviewed AF burden during the blanking period in patients undergoing pulsed field ablation for atrial fibrillation?
Ninety-day self-managed garment-type wearable Holter monitoring paired with AI-based AF burden estimation is a feasible, non-invasive strategy that yields substantial clinical-grade ECG data and closely matches physician review during the post-ablation blanking period.
Supports feasibility of 90-day self-managed wearable monitoring post-PFA; leaves open whether AI burden tracking improves outcomes in larger trials.
Background Early recurrence of atrial fibrillation (ERAF) after ablation has been reported to be associated with late recurrence, indicating the clinical value of rhythm monitoring during the 90-day blanking period. Although implantable cardiac monitors (ICMs) have been used for intensive recurrence monitoring, their routine use is not feasible because of cost and invasiveness. Wearable Holter monitoring is less invasive and potentially suitable for prolonged monitoring; however, its practical utility throughout the blanking period remains unclear. Purpose We aimed to evaluate the feasibility of 90-day self-managed garment-type Holter monitoring during the blanking period after AF ablation, including patient compliance, clinical-grade ECG data yield, and agreement between AI-estimated and physician-reviewed AF burden (reference standard). Methods This prospective pilot study included consecutive patients undergoing pulsed field ablation (PFA) at a single tertiary centre. As a sub-study of a prospective investigation examining the relationship between early and late recurrence after PFA, all patients were offered a self-managed Holter system for continuous use for 90 days after ablation. Feasibility endpoints were acceptance rate, completion rate, and median daily analysable ECG time (IQR). ECG recordings were labelled as AF, non-AF, or noise/missing; noise/missing segments were excluded from analysable time. AF burden was defined as AF time divided by analysable time (AF / [AF + non-AF]). AI-estimated AF burden was generated using an in-house AF detection model and compared with reference AF burden by Pearson correlation and linear regression. Results Among 54 consecutive post-PFA patients approached, 10 declined participation and 7 discontinued monitoring; 37 completed the 90-day protocol (acceptance 44/54 (81%); overall completion 37/54 (69%); completion among those who accepted 37/44 (84%)). The main reasons for declining were heat intolerance during summer and difficulty operating the system, whereas the most frequent reason for discontinuation was discomfort or itching related to the wearable electrode. Median daily analysable ECG time was 16.2 h (IQR 13.4 - 18.5 h), indicating substantial clinical-grade data yield under self-management. AI-estimated AF burden showed strong agreement with reference AF burden (Pearson r = 0.974, p <0.001). Linear regression showed AI = 0.0162 + 0.982 × reference burden (R2 = 0.949). The mean difference (AI - physician) was + 1.53 percentage points, with an error IQR of 1.09 percentage points. Conclusion Ninety-day self-managed Holter monitoring after AF ablation was feasible and provided substantial analysable ECG data. AI-estimated AF burden closely agreed with physician-reviewed burden, supporting this approach as a practical non-invasive monitoring strategy during the blanking period.Figure1Figure2
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Nakano et al. (2026) conducted an observational in Atrial fibrillation undergoing pulsed field ablation (n=54). 90-day self-managed garment-type wearable Holter monitoring with AI-estimated AF burden vs. Physician-reviewed reference AF burden was evaluated on Feasibility (acceptance rate, completion rate, median daily analysable ECG time) and agreement between AI-estimated and physician-reviewed AF burden (Pearson r 0.974; MD +1.53 percentage points, p=<0.001). Ninety-day self-managed wearable Holter monitoring after AF ablation had 81% acceptance, 69% overall completion, and strong AI-to-physician AF burden agreement (r=0.974, p<0.001).
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