Vivek Y Reddy1,2, Richard Schilling3, Massimo Grimaldi4, Rodney Horton5, Andrea Natale5, Stefania Riva6, Claudio Tondo6, Karl-Heinz Kuck7, Petr Neuzil2, Kendra McInnis8, Moe Bishara8, Baohui Zhang8, Assaf Govari8, Ahmed Abdelaal8, Moussa Mansour9. 1. Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R.). 2. Homolka Hospital, Prague, Czech Republic (V.Y.R., P.N.). 3. Health NHS Trust St, Bartholomew's Hospital West, London, United Kingdom (R.S.). 4. Generale Regionale F. Miulli, Bari, Italy (M.G.). 5. Texas Cardiac Arrhythmia Institute, Austin (R.H., A.N.). 6. Centro Cardiologico Monzino, Milan, Italy (S.R., C.T.). 7. Asklepios Hospital St Georg Cardiology, Hamburg, Germany (K.-H.K.). 8. Biosense Webster Inc, Irvine, CA (K.M., M.B., B.Z., A.G., A.A.). 9. Massachusetts General Hospital, Boston (M.M.).
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.
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 fibrillationpatients 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.
Authors: Shinwan Kany; Johannes Brachmann; Thorsten Lewalter; Karl-Heinz Kuck; Dietrich Andresen; Stephan Willems; Ellen Hoffmann; Lars Eckardt; Dierk Thomas; Matthias Hochadel; Jochen Senges; Andreas Metzner; Andreas Rillig Journal: Clin Res Cardiol Date: 2020-10-28 Impact factor: 5.460
Authors: Ikechukwu Ifedili; Kristina Mouksian; David Jones; Ibrahim El Masri; Mark Heckle; John Jefferies; Yehoshua C Levine Journal: Curr Cardiol Rev Date: 2022