학술논문
Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.
Document Type
Academic Journal
Author
Anter E; Shamir Medical Center, Be'er Ya'Akov, Israel. eladan@shamir.gov.il.; Mansour M; Massachusetts General Hospital, Boston, MA, USA.; Nair DG; St. Bernards Medical Center & Arrhythmia Research Group, Jonesboro, AR, USA.; Sharma D; NCH Rooney Heart Institute, Naples, FL, USA.; Taigen TL; Cleveland Clinic, Cleveland, OH, USA.; Neuzil P; Na Homolce Hospital, Prague, Czechia.; Kiehl EL; Sentara, Norfolk, VA, USA.; Kautzner J; IKEM Prague, Prague, Czechia.; Osorio J; HCA Florida Miami, Miami, FL, USA.; Mountantonakis S; Northwell, New Hyde Park, NY, USA.; Natale A; Texas Cardiac Arrhythmia Institute, Austin, TX, USA.; Department of Biomedicine and Prevention, Division of Cardiology, University of Tor Vergata, Rome, Italy.; Hummel JD; Division of Cardiology, Ohio State University, Columbus, OH, USA.; Amin AK; Riverside Methodist Hospital, Upper Arlington, OH, USA.; Siddiqui UR; Florida Cardiology, Orlando, FL, USA.; Harlev D; Medtronic, Mounds View, MN, USA.; Hultz P; Medtronic, Mounds View, MN, USA.; Liu S; Medtronic, Mounds View, MN, USA.; Onal B; Medtronic, Mounds View, MN, USA.; Tarakji KG; Medtronic, Mounds View, MN, USA.; Reddy VY; Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY, USA.
Source
Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
Subject
Language
English
Abstract
Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .
(© 2024. The Author(s).)
(© 2024. The Author(s).)