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Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

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 .

SUBMITTER: Anter E

PROVIDER: S-EPMC11333282 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Anter Elad E Mansour Moussa M Nair Devi G DG Sharma Dinesh D Taigen Tyler L TL Neuzil Petr P Kiehl Erich L EL Kautzner Josef J Osorio Jose J Mountantonakis Stavros S Natale Andrea A Hummel John D JD Amin Anish K AK Siddiqui Usman R UR Harlev Doron D Hultz Paul P Liu Shufeng S Onal Birce B Tarakji Khaldoun G KG Reddy Vivek Y VY

Nature medicine 20240517 8

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 patie ...[more]

PMID: 38760584

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Project description:Background and objectiveTreatment for atrial fibrillation (AF) has evolved significantly, with pulmonary vein isolation (PVI) becoming an established treatment. However, the outcomes following catheter ablation for persistent AF remain unsatisfactory. Hybrid catheter-surgical ablation has emerged as a therapeutic approach for persistent AF, combining the strengths of both interventions. The purpose of this narrative review is to comprehensively examine the current state of knowledge regarding hybrid ablation for AF.MethodsA thorough PubMed search using the terms "hybrid ablation", "atrial fibrillation", "catheter ablation", and "guideline on cardiology" within the timeframe of 1980 to 2024 resulted in 138,969 articles. Consensus on the selected articles was reached through a series of structured meetings and discussions.Key content and findingsPVI has demonstrated higher sinus rhythm maintenance rates, especially for paroxysmal AF. However, the efficacy is not as high for persistent AF. Additional ablation strategies, such as linear ablation, complex fractionated atrial electrogram ablation, low voltage zone ablation as well as posterior wall isolation, lack consistent evidence of effectiveness. Hybrid ablation, involving collaboration between cardiac surgeons and electrophysiologists, presents a promising alternative for hard-to-treat AF. Recent studies report favorable outcomes of hybrid ablation, with atrial arrhythmia-free rates ranging from 53.5% to 76%, surpassing those of catheter ablation alone, which might result from better lesion durability or intervention for non-PV foci and left atrial appendage excision or closure during hybrid ablation. The rate of complications associated with hybrid ablation is higher than catheter ablation alone.ConclusionsWhile favorable outcomes of hybrid ablation for persistent AF have been reported, it is not recommended for all AF patients due to its invasiveness compared to catheter ablation. Additionally, some patients with persistent AF maintain sinus rhythm with catheter ablation alone. More clinical data are needed to determine which patients are suitable candidates for hybrid ablation.

Dataset Information

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Publications

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Similar Datasets

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