Clinical Usefulness of Simulation-Guided Catheter Ablation of Atrial Fibrillation: Updated Outcome of a Multicenter Prospective Randomized Study

Abstract

Background: Catheter ablation of persistent atrial fibrillation (AF) is still challenging and is characterized by a significant AF recurrence rate; however, no optimal extra-pulmonary vein lesion set is known. We previously reported the clinical feasibility of in silico simulation-guided AF catheter ablation. Methods: We randomly assigned 118 patients with persistent AF (77.8% men, age 60.8 ± 9.9 years) to the simulation-guided ablation group (53 patients) and the empirical ablation group (55 patients) based on the operators' experience. For in silico ablation, four virtual linear and one electrogram-guided lesion sets were tested on patient heart computed tomogram-based models, and the lesion set with the fastest termination time was reported to the operator in the simulation-guided ablation group. The primary outcome was freedom from atrial tachyarrhythmias lasting longer than 30 seconds after a single procedure. The duration of the follow-up was 31.5 ± 9.4 months. Findings: Virtual in silico ablation procedures were successful in 95.2% of the patients (108/118). The clinical recurrence rate was significantly lower after a simulation-guided ablation than after an empirical ablation (20.8% vs. 40.0%, log-rank p = 0.042). Simulation-guided ablation was independently associated with a better long-term rhythm outcome of persistent AF ablation (HR = 0.29 [0.12-0.69], p = 0.005). The superiority of the rhythm outcome of the simulation-guided ablation was more significant in males, non-obese patients with a less remodeled atrium (left atrial dimension <50 mm), ejection fraction ≥ 50%, and those without hypertension or diabetes (p <0.01). There were no significant differences between the groups for the total procedure time (p = 0.403), ablation time (p = 0.510), and major complication rate (p = 0.900). Interpretation: Among patients with persistent AF, the simulation-guided ablation was superior to the empirical catheter ablation regarding the rhythm outcome. Trial Registration Number: This study was registered with the ClinicalTrials.gov number NCT02171364 Funding Statement: This work was supported by a grant [HI18C0070] from the Korea Health 21 R&D Project, Ministry of Health and Welfare and a grant [NRF-2017R1A2B4003983] from the Basic Science Research Program run by the National Research Foundation of Korea (NRF), which is funded by the Ministry of Science, ICT & Future Planning (MSIP). Declaration of Interests: The authors declare that they have no conflicts of interest. Ethics Approval Statement: The study protocol adhered to the Declaration of Helsinki and was approved by the institutional review board of each participating center. Written informed consent was obtained from all patients.