Characterizing non-standard pulsed field ablation dosing in atrial fibrillation: a FARADISE sub-analysis
L Boersma, A Dello Russo, I Garcia-Bolao, M Efremidis, N Szegedi, S Willems, H Haqqani, E Gandjbakhch, J Vijgen, P Lugenbiel, L Eckardt, J M Herzet, J Ramos Maqueda, M Johnson, G SzeplakiAbstract
Introduction
Pulsed field ablation (PFA) is a common treatment modality for the management of atrial fibrillation (AF), wherein electrical pulses induce irreversible electroporation in myocardial tissue, thereby creating durable, non-thermal lesions. The standardized workflow, which advises 8 PFA applications per pulmonary vein (PV), has established favorable safety and efficacy. In real-world clinical practice, the dosing regimen varies based on physician discretion, and dosing strategies outside of the standardized workflow have not been characterized.
Purpose
To examine the relationship between PFA applications, patient safety, and long-term outcomes.
Methods
The FARADISE registry (NCT05501873) is a prospective, real-world, standard-of-care registry enrolling AF patients clinically-indicated for a pentaspline PFA procedure. Standard workflows require eight applications per PV, targeting the left inferior pulmonary vein (LIPV), left superior pulmonary vein (LSPV), right inferior pulmonary vein (RIPV), and right superior pulmonary vein (RSPV). This analysis reports the average number of PV applications per de novo, PV isolation-only (PVI-only) patient. Patients were excluded if fewer or more than four standard workflow PVs were ablated, if they received more than 64 total PFA applications, or if less than 8 average PV applications were given. Patients were stratified into groups based on average PV PFA applications per patient: 8, >8 to 10, and >10. Safety and long-term outcomes at one year were compared across dosing cohorts. Clinical effectiveness was defined as freedom from arrhythmia recurrence, repeat procedure, or cardioversion.
Results
Among 607 patients meeting analysis criteria, 210 received an average of 8 PFA applications per PV, 223 received >8 and ≤10, and 174 received >10. Paroxysmal AF diagnosis (8: 71%, >8-10: 75%, >10: 74%, p=0.59) and female sex (8: 37%, >8-10: 34%, >10: 29%, p=0.27) were similar between groups, while age declined slightly in higher PV dosing groups (8: 65±10, >8-10: 62±10, >10: 61±11, p<0.01). Skin-to-skin procedure time increased as average PV dose increased (8: 40 [33-49] minutes, >8-10: 45 [37-60] minutes, >10: 51 [42-64] minutes, p<0.01), and serious adverse events were low across all groups (8: 1.0%, >8-10: 2.7%, >10: 0.6%, p=0.21). Clinical effectiveness trended upward as average PV dose increased (8: 74%, >8-10: 79%, >10: 83%, p=0.1) (Table 1).
Conclusions
In the real-world FARADISE registry, both guideline-based and physician-tailored dosing strategies produced favorable clinical effectiveness and few serious adverse events. These findings suggest that the pentaspline PFA catheter maintains a strong safety and effectiveness profile across dosing levels, supporting its flexibility in clinical practice.Boersma et al Figure 1