Key result
Novel radiofrequency balloon achieves successful pulmonary vein isolation in ~99% of targeted veins.
Why the study?
A novel irrigated radiofrequency balloon for pulmonary vein isolation was released in selected centres, prompting an evaluation of its efficacy and safety.
Cohort (n=140)
Yes
The novel radiofrequency balloon is highly efficacious for fast pulmonary vein isolation, but the 8% incidence of oesophageal lesions emphasizes the need for continuous oesophageal temperature monitoring.
Answers are grounded in this paper and cite their sources.
High acute PVI success with novel RFB may aid efficiency; leaves open durability and comparative safety versus established catheters.
AIMS: A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres. METHODS AND RESULTS: Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60 s, and duration was automatically reduced to 20 s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data (<48 h) were analysed. Data from 140 patients were collected (57% male, 67 ± 11 years, 57% paroxysmal atrial fibrillation). There were 547 PVs identified, and 99.1% could be isolated using solely the RFB. Single-shot PVI was recorded in 330/547 (60%) PVs. Median time to isolation during the first application was 10 s (IQR 8-13). A total of 2.1 ± 1.8 applications per PV were delivered, with the left superior PV requiring more application compared to other PVs. Median procedure and fluoroscopy time were 77 min (61-99) and 13 min (10-17), respectively. Major safety events were recorded only in the first 25 cases at each centre and included 1/140(0.7%) cardiac tamponade, 1/140(0.7%) phrenic nerve palsy, and 2/140 strokes (1.4%). An oesophageal temperature rise was recorded in 81/547 (15%) PVs, and endoscopy detected oesophageal lesions in 7/85 (8%) patients undergoing endoscopy. CONCLUSION: The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients.
No takes yet. Share an insight, caveat, or question.
Bordignon et al. (2023) conducted a cohort in Symptomatic atrial fibrillation (n=140). Radiofrequency balloon (RFB) for pulmonary vein isolation was evaluated on Successful pulmonary vein isolation using solely the radiofrequency balloon. The novel radiofrequency balloon allowed successful pulmonary vein isolation using solely the balloon in 99.1% of targeted veins, with single-shot isolation achieved in 60% of veins.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: