The ADVENT trial compared Boston Scientific’s Farapulse pulsed field ablation (PFA) system to thermal ablation. In August, the company had positive 12-month results from same trial. Earlier this year, it became the second PFA system approved by the FDA to treat AFib.
According to a sub-analysis abstract presented at Heart Rhythm Society, ADVENT revealed no significant difference in one-year freedom from AA between thermal ablation and PFA. However, studies indicate that post-ablation AA burden better predicts clinical outcomes than a 30-second AA recurrence. As a result, Boston Scientific looked at the impact of post-ablation AA burden on outcomes and the effect of ablation modality.
The company said people treated with the Farapulse PFA system had a statistically superior reduction in arrhythmia burden relative to thermal ablation.
More from Boston Scientific about the ADVENT trial
In ADVENT, symptomatic drug-refractory paroxysmal AFib patients underwent PFA or thermal (radiofrequency or cryo-) ablation. In follow-up, investigators collected transtelephonic ECG monitor (TTM) recordings weekly or for symptoms. They also collected 72-hour Holter monitor readings at six and 12 months.
The study calculated post-blanking AA burden as the greater value of either the percentage of AA over total Holter duration or the percentage of weeks of TTM with AA over the total number of weeks with TTM. Investigators also looked at quality of life (QoL) at baseline and 12 months.
Of the 607-patient cohort, the sub-analysis included 97.7% of the subjects. It featured 61,841 hours of Holter recordings from 539 patients and an average of 27 weeks of TTM from 589 patients. AA burden exceeding 0.1% was associated with a significantly reduced QoL and increase in clinical interventions. Boston Scientific reports a statistically greater reduction to less than 0.1% AA burden with Farapulse compared to thermal ablation.
The evaluation of outcomes showed that patients with prior failed Class I/III antiarrhythmic drugs (AADs) had a greater reduction in AA burden with PFA compared to thermal ablation. Patients receiving only Class II/IV AADs pre-ablation had no difference in AA burden between ablation groups.
Boston Scientific’s abstract says future comparative trials should incorporate AA burden into the endpoint. It notes that, ideally, this would come with implantable continuous monitors.
