Left atrial ablation using the dual-energy, lattice-tip catheter in the SAFE-Ablation Registry: How to avoid...

The dual-energy, lattice-tip catheter delivers either pulsed field ablation (PFA) or radiofrequency (RF) ablation (RFA) to treat atrial fibrillation. In both first-in-human and United States Food and Drug Administration pivotal trials, in which the catheter delivered both PFA and RFA, the system proved to be effective and safe-including no strokes. However, pivotal trials often do not reflect real-world clinical practice, such as the inclusion of patients with significant comorbidities and atrial scarring-factors that could promote procedure-related stroke.

This study aimed to study the neurovascular safety of lattice-tip ablation of atrial arrhythmias in an unselected "real-world" population.

The Stroke AFter LatticE-Tip Ablation (SAFE-Ablation) registry is a single-center retrospective registry of consecutive patients undergoing left atrial ablation using the lattice-tip catheter. There were 2 sequential timeframes: Period-1 (using "default" PFA and RFA power settings) and Period-2 (preferential left atrial PFA or decreased RFA [RFA_{LA-Attenuated}] settings: target temperature [68°C] and current limit [∼65%]).

Catheter ablation was performed in 507 patients-both de novo and redo-ablation (54.4%). During Period-1 (n = 294), 4 patients (1.4%) developed procedure-related stroke-all when using PFA+RFA_LA (n = 164) vs PFA-only (n = 130) (2.4% vs 0%, P = .073). During Period-2, 213 procedures were performed using PFA-only (n = 136) or PFA+RFA_{LA-Attenuated} (n = 77)-all without stroke. Combining cohorts, stroke was significantly more likely to occur in patients receiving PFA+RFA_LA using default RF settings compared with patients receiving PFA-only or PFA+RFA_{LA-Attenuated} (2.4% vs 0%; P = .004).

During left-sided RFA with the lattice-tip catheter, use of the default settings is associated with procedure-related stroke. Ablation is safest when employing PFA-only or RFA using attenuated energy settings.