Key result
Pulmonary vein isolation with the Heliostar radiofrequency balloon achieved durable isolation in 71% of pulmonary veins and 29% of patients at 5.4 months.
Why the study?
Achieving durable pulmonary vein isolation remains challenging in atrial fibrillation ablation, and the durability of PVI using the radiofrequency balloon catheter had not been investigated.
Does pulmonary vein isolation with the Heliostar radiofrequency balloon achieve durable isolation in patients with paroxysmal or persistent atrial fibrillation?
Cohort
No
Does pulmonary vein isolation with the Heliostar radiofrequency balloon achieve durable isolation in patients with paroxysmal or persistent atrial fibrillation?
While the Heliostar radiofrequency balloon achieved high acute success, medium-term durability of pulmonary vein isolation was relatively low (29% of patients with all PVs isolated), though clinical freedom from arrhythmia remained favorable at 86%.
Modest durable isolation rates with the Heliostar balloon should not yet change practice; leaves open its role in AF pending randomized trials.
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: . 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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Sørensen et al. (2025) conducted a cohort in Paroxysmal or persistent atrial fibrillation. Heliostar Radiofrequency Balloon was evaluated on Durable pulmonary vein isolation. Pulmonary vein isolation with the Heliostar radiofrequency balloon achieved durable isolation in 71% of pulmonary veins and 29% of patients at 5.4 months.
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