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Clinical Trial
. 2019 Dec;12(12):e007541.
doi: 10.1161/CIRCEP.119.007541. Epub 2019 Dec 12.

Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE)

Vivek Y Reddy  1   2 , Richard Schilling  3 , Massimo Grimaldi  4 , Rodney Horton  5 , Andrea Natale  5 , Stefania Riva  6 , Claudio Tondo  6 , Karl-Heinz Kuck  7 , Petr Neuzil  2 , Kendra McInnis  8 , Moe Bishara  8 , Baohui Zhang  8 , Assaf Govari  8 , Ahmed Abdelaal  8 , Moussa Mansour  9
Affiliations
Clinical Trial

Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE)

Vivek Y Reddy et al. Circ Arrhythm Electrophysiol. 2019 Dec.

Abstract

Background: Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to over-ablation of thin and under-ablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study.

Methods: Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes-up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients.

Results: At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152/152), 79.6% with a single application. Electrical reconnection occurred in only 7/150 PVs (4.7%) on adenosine/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10/39 (25.6%) patients.

Conclusions: The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: ISRCTN 11764506.

Keywords: atrial fibrillation; catheter ablation; esophagus; multielectrodes; pulmonary veins.

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