Key result
LSI-guided PVI yields ~96% 12-month arrhythmia freedom in observational cohort.
Why the study?
The study was designed to capture best practices using Lesion Index-guided catheter ablation to treat paroxysmal atrial fibrillation subjects in a real-world setting.
Does LSI-guided pulmonary vein isolation prevent atrial fibrillation recurrence in adults with paroxysmal atrial fibrillation?
Observational (n=143)
Yes
Does LSI-guided pulmonary vein isolation prevent atrial fibrillation recurrence in adults with paroxysmal atrial fibrillation?
LSI-guided ablation for paroxysmal atrial fibrillation demonstrated high acute isolation success and a very low 12-month recurrence rate across different global workflows.
Answers are grounded in this paper and cite their sources.
May support LSI-guided PVI workflows in paroxysmal AF; leaves open randomized confirmation of efficacy.
Background: Pulmonary vein isolation (PVI) ablation is a standard therapy for paroxysmal atrial fibrillation (PAF). Lesion Index (LSI) is a metric to guide radiofrequency (RF) ablation using the TactiCath Ablation Catheter, Sensor Enabled with the EnSite Cardiac Mapping System (Abbott). Objective: This study (NCT-03906461) was designed to capture best practices using LSI-guided catheter ablation to treat PAF subjects in a real-world setting. Methods: This prospective single-arm observational study enrolled 143 PAF subjects in the United States, Europe, and Japan undergoing de novo PVI with RF ablation. PVI lesions were assigned to 10 anatomically defined segments. Mean LSIs achieved for all lesions were analyzed. Follow-up was conducted between 3-6 months and 12 months after the procedure. Results: Pulmonary veins were isolated in all subjects. The mean achieved LSI was 4.9, with lower values in Europe (4.4) and Japan (4.5) than the United States (5.5). First-pass success, defined as no gaps requiring touch-up ablation after 20 minutes post isolation, was achieved in 76.2% of subjects. Use of high LSI (≥5) resulted in shorter procedure, RF, and fluoroscopy times and fewer touch-up ablations compared to low LSI (<5). At 12 months, 99.3% of subjects were free from procedure- or device-related serious adverse events and 95.7% (112/117) (35.0% on antiarrhythmic drugs) were free from recurrence and/or a repeat ablation procedure for atrial fibrillation / atrial flutter / atrial tachycardia. Conclusion: LSI-guided ablation strategies proved safe and effective despite differences in LSI workflows. Use of high LSI values resulted in shorter procedure, RF, and fluoroscopy times and fewer touch-up ablations compared to low LSI.
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Prasad et al. (2022) conducted an observational in Paroxysmal atrial fibrillation (n=143). Lesion Index (LSI)-guided pulmonary vein isolation was evaluated on Summary of LSI values achieved for RF lesion formation in different anatomical regions of the left atrium around the pulmonary veins. LSI-guided pulmonary vein isolation resulted in a mean achieved LSI of 4.9 across all regions, with 95.7% of subjects free from recurrence at 12 months.
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