Durability of Pulmonary Vein Isolation With the Heliostar Radiofrequency Balloon-The Prospective RABAAF Study With...

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.

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.

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.

The durability of RFB PVI achieved under conscious sedation was relatively low. However, medium-term freedom from clinical recurrent arrhythmia was favorable.

URL: https://www.

gov. Unique Identifier: NCT06296888.