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)
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
- Klíčová slova
- atrial fibrillation, catheter ablation, esophagus, multielectrodes, pulmonary veins,
- MeSH
- akční potenciály MeSH
- časové faktory MeSH
- design vybavení MeSH
- fibrilace síní diagnóza patofyziologie chirurgie MeSH
- katetrizační ablace škodlivé účinky přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace etiologie MeSH
- prospektivní studie MeSH
- recidiva MeSH
- senioři MeSH
- srdeční frekvence * MeSH
- srdeční katetrizace škodlivé účinky přístrojové vybavení MeSH
- srdeční katétry * MeSH
- venae pulmonales patofyziologie chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
- Spojené státy americké 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
Citace poskytuje Crossref.org
