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Randomized Controlled Trial
. 2025 Jan;11(1):1-9.
doi: 10.1016/j.jacep.2024.09.017. Epub 2024 Sep 29.

Coronary Sinus Isolation for High-Burden Atrial Fibrillation: A Randomized Clinical Trial

Jonathan P Ariyaratnam  1 , Melissa E Middeldorp  2 , Anthony G Brooks  3 , Gijo Thomas  3 , Kadhim Kadhim  3 , Rajiv Mahajan  3 , Rajeev K Pathak  3 , Glenn D Young  3 , Jonathan M Kalman  4 , Prashanthan Sanders  5
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Free article
Randomized Controlled Trial

Coronary Sinus Isolation for High-Burden Atrial Fibrillation: A Randomized Clinical Trial

Jonathan P Ariyaratnam et al. JACC Clin Electrophysiol. 2025 Jan.
Free article

Abstract

Background: The coronary sinus is an arrhythmogenic structure that can initiate and maintain atrial fibrillation (AF). Coronary sinus ablation has been shown to be effective in prolonging the AF cycle length and terminating AF in patients with both paroxysmal and persistent AF who have persistent AF after pulmonary vein isolation (PVI).

Objectives: The objective of this study was to undertake a randomized controlled trial to investigate the efficacy of coronary sinus isolation (CSI) as an adjunctive ablation strategy for the treatment of high-burden AF.

Methods: Consecutive patients presenting with symptomatic long episodes of paroxysmal AF (≥48 h but ≤7 days) or persistent AF (>7 days and ≤12 months) referred for first-time ablation were enrolled. Participants were randomized to either PVI, roofline ablation, and CSI (CSI group) or PVI and roofline ablation only (non-CSI group). Participants were assessed postprocedurally via clinical follow-up and 7-day Holter monitoring at regular intervals. The primary outcome was single-procedure drug-free atrial arrhythmia-free survival at 2 years.

Results: A total of 100 participants were recruited to the study; 48 were randomized to the CSI group and 52 to the non-CSI group. Acutely successful CSI was achieved in 45 of the 48 patients in the CSI group. At 2 years follow up, 30 of 48 patients (62.5%) in the CSI group and 33 of 52 (63.4%) in the non-CSI group were free from arrhythmia recurrence. Single-procedure drug-free survival at 2 years was no different between groups (P = 0.91). Similarly, multiple procedure drug assisted survival at 5 years was not different between groups (P = 0.80). Complication rates were not significantly different between groups (P = 0.19).

Conclusions: Adjunctive CSI as part of a de novo ablation strategy does not confer any additional benefit greater than PVI and roofline for the treatment of high-burden AF.

Keywords: ablation; atrial fibrillation; coronary sinus; outcomes; randomized.

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Conflict of interest statement

Funding Support and Author Disclosures This study was supported by the National Health and Medical Research Council of Australia. Drs Kalman and Sanders are supported by Investigator Grant Fellowships from the National Health and Medical Research Council of Australia. The University of Adelaide reports receiving on behalf of Dr Mahajan lecture and/or consulting fees from Abbott, Bayer, Biotronik, Medtronic, and Pfizer. The University of Adelaide reports receiving on behalf of Dr Mahajan research funding from Abbott, Bayer, and Medtronic. Dr Sanders reports having served on the advisory board of Medtronic, Abbott Medical, Boston-Scientific, Pacemate, and CathRx. Dr Sanders reports that the University of Adelaide has received on his behalf lecture and/or consulting fees from Medtronic, Boston-Scientific, and Abbott Medical. Dr Sanders reports that the University of Adelaide has received on his behalf research funding from Medtronic, Abbott Medical, Boston Scientific, and Becton Dickenson. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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