Durability of Pulmonary Vein Isolation With the Heliostar Radiofrequency Balloon—The Prospective RABAAF Study With Protocol‐Mandated Repeat Electrophysiology Studies

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Abstract
Introduction: Pulmonary vein isolation (PVI) is the cornerstone in atrial fibrillation (AF) ablation but achieving durable PVI remains a challenge. The radiofrequency balloon (RFB) is a “single‐shot” ablation catheter for PVI that offers selective energy titration from 10 surface electrodes and 3D mapping system integration. The durability of RFB PVI has not been investigated.Methods: The objective of this study was to evaluate the durability of RFB PVI by protocol‐mandated remaps in patients with paroxysmal or persistent AF referred for AF ablation at a high‐volume center. RFB procedures were performed under conscious sedation, PVI assessed by high‐density mapping, bidirectional block confirmed after a waiting period of ≥ 20 min, and dormant conduction assessed by adenosine injections. After 4–6 months patients underwent a remap study for assessment of PVI durability by high‐density mapping and assessment of bidirectional block.Results: Forty‐five patients were enrolled, 43 completed the RFB PVI, and 35/43 (81%) completed the remap study: 26% female, 43% persistent AF, median age 65 (interquartile range: 61–69) years, median CHA2DS2‐VASc score 1 (0–2), and median left atrial volume 31 (25–42) mL/m2. Acute PVI was achieved in 99% of pulmonary veins (PVs) but focal radiofrequency touch‐up lesions were required in 31% of patients. After 5.4 (4.9–6.1) months, 71% of PVs were durably isolated, and 29% of patients had all PVs durably isolated; 86% of patients were free from documented atrial tachyarrhythmias.Conclusion: The durability of RFB PVI achieved under conscious sedation was relatively low. However, medium‐term freedom from clinical recurrent arrhythmia was favorable.Trial Registration: URL: https://www.clinicaltrials.gov. Unique Identifier: NCT06296888.
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  • Gentofte Hospital

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