Comparative safety of radiofrequency versus pulsed field ablation for atrial fibrillation in a high-volume US medical center
E G Ferro, M Reynolds, D Villarreal, J Nelson, J Yoon, S Vu, A Nallaparaju, A Locke, T Maher, S Yang, P Tung, R W Yeh, A L D'avila, J Waks, D B KramerAbstract
Background
Pulsed field ablation (PFA) has demonstrated comparable efficacy to radiofrequency ablation (RFA) in the treatment of atrial fibrillation (AF), with enhanced safety due to its cardiac selectivity. More recently, however, market recalls of some PFA catheters have raised concerns about the cerebrovascular safety of PFA.
Purpose
To compare the incidence of 30-day complications following PFA versus RFA for AF, focusing on strokes and transient ischemic attacks (TIAs).
Methods
We analyzed a prospective registry from a high-volume U.S. academic center including all consecutive AF ablations from 2022 to 2025. All procedural complications were recorded. Strokes/TIAs were adjudicated by three independent neurologists blinded to treatment assignment. Inverse probability of treatment weighting (IPTW) was applied to balance clinical differences between the PFA and RFA groups, and propensity scores were used to compare stroke/TIA rates at 30 days (primary endpoint). Secondary endpoints included other non-fatal complications at 30 days, and stroke/TIA rates at 7 days.
Results
Between January 2022 and July 2025, we identified 1,504 PFA and 2,062 RFA cases performed by 12 operators. Patients in both arms had mean age of 67 years, 31% were female, and with comparable comorbidity profiles (45% paroxysmal and 50% persistent AF; mean CHA2DS2-VASc 2.4 with 7% prior stroke/TIA; mean HAS-BLED 1.5). Compared to RFA procedures, patients received PFA earlier in their disease course, as evidenced by lower use of antiarrhythmic medications (75%PFA vs 81%RFA, p<.001) and cardioversions (40%PFA vs 32%RFA, p<.001). PFA procedures had shorter left atrial dwell time (1.8 vs 2.4 hours, p<.001); PVI-only was performed in 18.8%PFA and 46%RFA cases (p<.001) while PVI/posterior wall isolation in 57%PFA and 25.5%RFA (p<.001), with similar amounts of additional lesions in both groups (e.g. mitral lines in ~20% cases). Overall, 9 patients (0.20%) experienced stroke/TIA events at 30 days, which were all confirmed by MRI or fundoscopy: 7 (0.47%) after PFA and 2 (0.10%) after RFA (unadjusted risk difference 0.37%, 95%CI –0.00 to 0.74; p=0.05). After IPTW adjustment, groups were well balanced and PFA remained associated with significantly higher stroke/TIA rates at both 7-days (0.43%PFA vs 0.05%RFA; 95%CI 0.04-0.72%; p=0.03) and 30-days (0.51%PFA vs 0.10%RFA; 95%CI 0.02-0.79%; p=0.03). No atrioesophageal fistulas were observed. The adjusted rates of other complications like phrenic nerve injury (0%PFA vs 0.15%RFA, p=0.34), coronary vasospasm (0%PFA vs 0.05%RFA, p=0.60) and pericardial tamponade (0.07%PFA vs 0.24%RFA, p=0.34) were similar in both arms.
Conclusion
PFA procedures were associated with a significantly higher risk of stroke/TIA within 30 days compared to RFA in this high-volume single center experience. Further studies are needed to confirm these findings, define mechanisms, and optimize procedural protocols to mitigate the cerebrovascular risk.Central IllustrationTemporal Trend in Stroke/TIA Events