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)
Language English Country United States Media print-electronic
Document type Clinical Trial, Journal Article, Multicenter Study
- Keywords
- atrial fibrillation, catheter ablation, esophagus, multielectrodes, pulmonary veins,
- MeSH
- Action Potentials MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Atrial Fibrillation diagnosis physiopathology surgery MeSH
- Catheter Ablation adverse effects instrumentation MeSH
- Middle Aged MeSH
- Humans MeSH
- Postoperative Complications etiology MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Aged MeSH
- Heart Rate * MeSH
- Cardiac Catheterization adverse effects instrumentation MeSH
- Cardiac Catheters * MeSH
- Pulmonary Veins physiopathology surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
- United States MeSH
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.
Asklepios Hospital St Georg Cardiology Hamburg Germany
Biosense Webster Inc Irvine CA
Centro Cardiologico Monzino Milan Italy
Generale Regionale F Miulli Bari Italy
Health NHS Trust St Bartholomew's Hospital West London United Kingdom
Homolka Hospital Prague Czech Republic
Icahn School of Medicine at Mount Sinai New York NY
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