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Bipolar linear PFA shows similar safety to RFA for CTI ablation in persistent atrial fibrillation

Bipolar linear PFA shows similar safety to RFA for CTI ablation in persistent atrial fibrillation
Photo by Navy Medicine / Unsplash
Key Takeaway
Note that PFA and RFA show similar safety and CTI block rates, but non-randomized comparisons limit certainty.

This substudy RCT evaluated bipolar linear PFA (Farapoint) versus irrigated RFA in a population of 141 patients with persistent atrial fibrillation. The study design involved a randomized comparison, though the limitations section notes that comparisons were not randomized, which may affect the strength of the conclusions. Follow-up duration was not reported.

Regarding efficacy, acute CTI conduction block was similar between techniques, with RFA achieving 100% (50 of 50) and PFA achieving 98.6% (139 of 141). The p-value for this comparison was 1.00, indicating no significant difference in direction. Ablation time was significantly shorter for RFA (5 min [Q1-Q3: 4-8 min]) compared to PFA (14 min [Q1-Q3: 9-19 min]), with a p-value of 0.001.

Safety and tolerability data showed similar safety event rates between groups: RFA 2.0% versus PFA 2.1% (P = 0.96). No serious adverse events were reported. Coronary artery spasm had no clinical manifestation with PFA, though specific numbers were not reported. Discontinuations and tolerability were not reported.

Key limitations include the note that comparisons were not randomized, which is explicitly listed under study limitations. Funding or conflicts of interest were not reported. The practice relevance was not reported, and causality notes were not reported. Given these constraints, the results should be interpreted with caution regarding the generalizability and certainty of the observed benefits.

Study Details

Study typeRct
Sample sizen = 141
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: ADVANTAGE AF examined the safety and efficacy of pulsed field ablation (PFA) to treat persistent atrial fibrillation (AF). During AF ablation, typical atrial flutter (AFL) is commonly treated with cavotricuspid isthmus (CTI) ablation. OBJECTIVES: Adjunctive CTI ablation in ADVANTAGE AF was performed with radiofrequency ablation (RFA; phase 1) or bipolar linear PFA (phase 2). Here, we compared lesion characteristics, CTI ablation efficacy, and safety between the ablation modalities. METHODS: A preclinical study assessed lesion dimensions with a novel 2.0 kV bipolar linear PFA catheter. In ADVANTAGE AF, after AF ablation with a pentaspline PFA catheter, CTI ablation was performed: in phase 1 with irrigated RFA, and in phase 2 with the linear PFA catheter (Farapoint). Before PFA CTI ablation ,patients were treated with a vasopressor bolus followed by high-dose intravenous nitroglycerin. RESULTS: Preclinical assessment showed lesion depth increasing at higher field strength and plateauing after 2 applications. In ADVANTAGE AF, 50 and 141 patients received CTI ablation with RFA and PFA, respectively. Patient characteristics across the 2 cohorts were similar (RFA vs PFA). Acute CTI conduction block was similar between techniques (50 of 50 RFA [100%] vs 139 of 141 PFA [98.6%]; P = 1.00). PFA was associated with a shorter CTI ablation time (median: RFA 5 min [Q1-Q3: 4-8 min] vs 14 min [Q1-Q3: 9-19 min]; P = 0.001). RFA and PFA had similar safety event rates (RFA 2.0% vs PFA 2.1%; P = 0.96). With the use of nitroglycerin pretreatment, there was no clinical manifestation of coronary artery spasm with PFA. CONCLUSIONS: This subanalysis of ADVANTAGE AF extends the primary results by allowing comparison of bipolar linear PFA and RF ablation for CTI, integrating preclinical lesion modeling with clinical dosing, and establishing a standardized reliable coronary safety protocol. Although not randomized comparisons, these findings suggest that CTI ablation with a linear PFA catheter is associated with safety and efficacy similar to RF ablation and greater efficiency. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation [ADVANTAGE AF; NCT05443594]).
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