Key result
Protocol A cuts transseptal puncture time by ~5 minutes vs. Protocol B in zero-fluoroscopy AF ablation.
Why the study?
Two ICE-guided transseptal puncture strategies are used for zero-fluoroscopy AF ablation, but their efficiency, safety, and learning curves had not been directly compared.
Does an ICE-guided sheath pull-back strategy (Protocol A) reduce transseptal puncture time compared to a mapping catheter-guided strategy (Protocol B) in patients undergoing zero-fluoroscopy AF ablation?
RCT (n=43)
Open-label
1:1 ratio using REDCap system, block size of six
No
Does an ICE-guided sheath pull-back strategy (Protocol A) reduce transseptal puncture time compared to a mapping catheter-guided strategy (Protocol B) in patients undergoing zero-fluoroscopy AF ablation?
Absolute Event Rate: 14.6% vs 20%
p-value: p=0.027
Both ICE-guided transseptal puncture strategies are safe and effective for zero-fluoroscopy AF ablation, with the sheath pull-back method offering greater early procedural efficiency.
ICE sheath pull-back shortens transseptal time in zero-fluoroscopy AF ablation; extends RCT evidence for efficient ICE optimization without safety trade-offs.
Background Transseptal puncture (TSP) is a critical step in left atrial (LA) access for atrial fibrillation (AF) ablation. Intracardiac echocardiography (ICE) combined with electroanatomical mapping now enables zero‐fluoroscopy TSP in experienced practice. Two ICE‐guided TSP strategies are used in contemporary clinical settings; however, their efficiency, safety, and learning curves have not been directly compared. Methods This prospective randomized controlled trial was conducted at National Taiwan University Hospital between February 2023 and April 2024. Patients undergoing first‐time AF ablation were randomized to two TSP strategies: Protocol A advanced the transseptal sheath from the superior vena cava to the fossa ovalis under ICE guidance, whereas Protocol B used a mapping catheter to identify the fossa and guide sheath positioning. Procedural duration, TSP metrics, and learning curve were assessed. Patients were followed for periprocedural complications and AF recurrence for one year. Results Forty‐three patients were enrolled (mean age 63.2 ± 9.8 years, 72.1% male). Zero fluoroscopy was achieved in all procedures, with no complications or crossover. Protocol A demonstrated shorter initial TSP times than Protocol B (8.5 ± 3.7 vs. 12.0 ± 5.4 min, p = 0.018). Protocol B exhibited a steeper learning curve, achieving comparable efficiency after approximately 10 cases. Both strategies achieved successful LA access and 100% pulmonary vein isolation, with no differences in complication rates or one‐year AF recurrence. Conclusions Both ICE‐guided strategies are safe and effective for zero‐fluoroscopy TSP. Protocol A offers greater early efficiency, whereas Protocol B demonstrates rapid adaptability, supporting practical positioning of these complementary strategies in radiation‐free AF ablation.
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Chen et al. (2026) conducted an RCT in Atrial fibrillation (first-time ablation) (n=43). Protocol A (ICE-guided pull-back approach) vs. Protocol B (mapping catheter-guided approach) was evaluated on Total transseptal puncture time (p=0.027). Protocol A demonstrated a significantly shorter total transseptal puncture time compared to Protocol B (14.6 vs 20.0 minutes, p=0.027) during zero-fluoroscopy atrial fibrillation ablation.
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