Dual-energy lattice-tip ablation system for atrial fibrillation: acute results from the Affera Global Registry

Abstract Introduction Atrial fibrillation (AF) is the most common arrythmia and catheter ablation is a well-established treatment to restore and maintain normal sinus rhythm. The all-in-one mapping and ablation, dual energy (pulsed field (PF) and radiofrequency (RF)), wide-footprint, lattice-tip catheter received CE mark approval to treat atrial arrythmias using European clinical data. Purpose The objective of this analysis was to assess initial real-world acute effectiveness and safety results in AF patients treated with the dual energy 9-mm lattice-tip catheter. Methods De novo and repeat AF patients undergoing a catheter ablation procedure in the Affera Global Registry were included and divided in sub-cohorts for analysis: pulmonary vein isolation (PVI-only), PVI plus linear lesions (PVI+), or only linear lesions (non-PVI only). Patients were enrolled in 5 centers between December 2023 and February 2025. Procedural characteristics, acute success (electrical isolation of all targeted pulmonary veins and block across linear lesions using PF or RF ablation), and acute safety (serious adverse events ≤7 days post-procedure) were evaluated. Results The study population of 119 patients were 66±11 years old, 29.4% female, 79.0% persistent AF, 21.0% paroxysmal AF, 77.3% on Class I-IV AADs at baseline, and 47.1% were redo procedures after a prior AF ablation. PVI-only (n=9), PVI+ (n=74), and non-PVI only (n=36) sub-cohorts experienced a mean total procedure time of 74±28, 86±32, and 88±43 minutes, respectively. More time was spent on pre-ablation mapping in the non-PVI only sub-cohort (22±21 min), compared to PVI-only (10±6 min) and PVI+ (12±9 min). Total number of energy applications was 87±38, 98±35, and 54±23 in the PVI-only, PVI+, and non-PVI only sub-cohorts, respectively. Patients were treated predominantly with PF energy, with each group receiving only 9 (0, 52), 5 (0, 39), and 11 (0, 59) (mean (min, max)) RF applications, respectively, per patient. Acute PVI success was achieved in all 301 targeted veins (100%), with 98.0% being isolated on the first pass. Most patients in the study cohort received linear lesions (92.5%). In this cohort, 46 cavotricuspid isthmus lines, 75 mitral lines, 62 posterior wall isolations, 80 left atrial roof lines and 103 other ablations were performed. Acute success (documented by conduction block) was achieved in all 366 targeted linear lesions (100%). There were no primary safety events, including no reports of neurological events, clinical coronary spasm, hemolysis-induced kidney injury, or phrenic nerve injury. Conclusion In this first real-world analysis of AF patients, PVI and linear ablation lesions can be safely and effectively performed with high rate of acute success rate using the 9-mm lattice-tip mapping and dual energy system with predominant use of PF.