Lb-456089-4 influence of atrial arrhythmia burden on quality of life in patients undergoing pulsed field ablation: a sub-study of the pulsed af trial

Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds following pulsed field ablation (PFA) in patients with atrial fibrillation (AF) has recently been reported in the PULSED AF pivotal trial (NCT04198701). AA burden has shown better association with clinically meaningful endpoints. Paroxysmal and persistent AF patients underwent 24-hour Holters at 6 and 12 months, and weekly and symptomatic trans-telephonic monitoring (TTM) to assess AA recurrence. All transmissions were adjudicated by an independent core laboratory. For this analysis, AA burden past the 3-month blanking period was calculated as the greater value of either 1) percentage of AA on total Holter time, or 2) percentage of weeks with at least one TTM with AA out of all weeks with at least one TTM. AFEQT QoL assessments were performed at baseline and 12 months. A total of 12,264 hours of Holter recordings in 277 patients (average 44.3 hours per patient), along with an average of 29.9 weeks with at least one TTM transmission for 273 patients were available. Overall, 69.4% of paroxysmal and 62.2% of persistent patients demonstrated zero AA burden and 87.1% of paroxysmal and 81.8% of persistent patients demonstrated AA burden <10%, as shown (Figure). The median burden for patients with any AA was 7.1% in the paroxysmal and 8.7% in the persistent cohort. A larger 12-month improvement in the AFEQT QoL score was observed in patients who had zero AA burden vs. those who had any AA burden in the paroxysmal cohort (32.1 vs. 23.1 point improvement, p=0.03) versus the persistent cohort (30.5 vs. 26.8 point improvement, p=0.32). Only paroxysmal patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. Clinically meaningful QoL improvements were seen in persistent patients at all thresholds of AA burden (Table). PFA procedures resulted in zero burden in 69.4% of paroxysmal and 62.2% of persistent AF patients, and median burden in the subset of patients with AA was low (<9%). In paroxysmal AF patients, a threshold of <10% burden led to clinically meaningful improvements in QoL. In contrast, patients entering the trial with persistent AF experienced meaningful QoL improvements irrespective of burden. The relation between healthcare utilization and AA recurrence, density and burden in both cohorts will also be provided at the time of presentation.Tabled 1Paroxysmal AFPersistent AFMean improvement in AFEQT quality of life score from baseline to 12 monthsNo AA32.1 (n=101)P=0.0330.5 (n=85)P=0.32Any AA23.1 (n=43)26.8 (n=52)AA burden = 0%32.1 (n=101)P=0.0330.5 (n=85)P=0.84AA burden 0.01-10%28.2 (n=26)28.5 (n=26)AA burden 10-40%14.7 (n=13)20.7 (n=15)AA burden >40%17.4 (n=4)31.3 (n=11) Open table in a new tab