Women and atrial fibrillation: artificial intelligence-guided catheter ablation is associated with a higher freedom from any arrhythmia versus pulmonary vein isolation in women (TAILORED-AF trial)

Abstract Background/Introduction Atrial fibrillation (AF) affects women and men differently, in particular when considering clinical presentation and quality of life. Despite having generally more symptoms, women are less likely to undergo AF ablation and have a higher rate of AF recurrence after undergoing ablation. Particularly, extra-PV ablation approaches have not proven advantageous versus pulmonary vein isolation (PVI) alone in women. The TAILORED-AF randomised clinical trial (NCT04702451) demonstrated a reduced rate of AF recurrence after a de novo catheter ablation targeting artificial intelligence (AI)-guided spatiotemporal dispersion in addition to PVI. Purpose To investigate whether an AI-guided, spatiotemporal based-ablation approach is superior to PVI in women with persistent AF. Methods TAILORED-AF randomised patients to an AI-guided tailored ablation or PVI-only. We compared outcomes and dispersion characteristics between female and male patients. Results From the 370 patients treated in the TAILORED-AF trial, 77 (21%) were female. Women were significantly older (72±7 vs 65±12 years, p<0.001) and had a higher CHA2DS2-VASc score (3 [2-4] vs 2 [1-3], p<0.001). There was a larger percentage of women with a body mass index over 30kg/m2 (53% vs 40%, p=0.04), and a smaller percentage with diabetes or vascular disease (9 vs 19%, p=0.02 and 8% vs 17%, p=0.02, respectively). No difference was observed in AF duration (6±7 vs 6±5 months, p=0.31) and in left ventricular ejection fraction (55±10% vs 55±10%, p=0.81). Procedure and radiofrequency times and AF termination rates were not different between women and men (179±76 min vs 178±55, p=0.53, 45±21 min vs 41±16 min, p=0.29 and 64% vs 66%, p=0.84, respectively). There was no sex-related differences in complications following a Tailored ablation. Analyses of spatiotemporal dispersion location collected with electroanatomic mapping showed no sex-related differences in dispersion extent in the left atrium (LA) (13.7% in women vs 14.4% in men, p=0.88) or the right atrium (RA) (0.27% in women vs 0.82% in men, p=0.09). By contrast, the percentage of low voltage surface area in AF (<0.2mV) was significantly higher in women in the LA (30.7% [21.2-39.7] vs 18.0% [10.7-30.8], p<0.01). As expected based on previous reports, less women were free from AF or AF/atrial tachycardia (AT) after one procedure compared to men in the Tailored arm (74% vs 91% in men, log-rank p<0.001 and 56% vs 61% in men, log-rank p=0.04, respectively). Importantly, the rates of 12-month freedom from AF and AF/AT after a single procedure were significantly higher post-Tailored ablation compared to PVI only (74% vs 57%, log-rank p=0.01 and 56% vs 46%, log-rank p<0.01, respectively). Conclusion(s) Tailored ablation leads to a higher rate of freedom from any atrial arrhythmia after a single procedure in women.12-month follow-up outcomes