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. 2023 Aug 1;8(8):765-772.
doi: 10.1001/jamacardio.2023.1749.

Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial

Hongwu Chen  1 , Chengzong Li  2 , Bing Han  3 , Fangyi Xiao  4 , Fu Yi  5 , Youquan Wei  6 , Chenyang Jiang  7 , Cao Zou  8 , Linsheng Shi  9 , Wei Ma  10 , Weiming Wang  11 , Yuegang Wang  12 , Hong Du  13 , Long Chen  14 , Minglong Chen  1 ; STABLE-SR-III Investigators
Collaborators, Affiliations

Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial

Hongwu Chen et al. JAMA Cardiol. .

Abstract

Importance: The overall success rate of circumferential pulmonary vein isolation (CPVI) treatment in patients with paroxysmal atrial fibrillation (AF) remains suboptimal, especially in older patients.

Objective: To explore the incremental benefit of low-voltage-area ablation after CPVI in older patients with paroxysmal AF.

Design, setting, and participants: This randomized clinical trial was an investigator-initiated trial to compare the efficacy of additional low-voltage-area ablation beyond CPVI vs CPVI alone in older patients with paroxysmal AF. Participants were patients aged 65 to 80 years with paroxysmal AF who were referred for catheter ablation. They were enrolled in 14 tertiary hospitals in China from April 1, 2018, to August 3, 2020, and follow-up occurred through August 15, 2021.

Interventions: Patients were randomized (1:1) to undergo CPVI plus low-voltage-area ablation or CPVI alone. Low-voltage areas were defined as areas with amplitude less than 0.5 mV in more than 3 adjacent points. If low-voltage areas existed, additional substrate ablation was performed in the CPVI plus group but not the CPVI alone group.

Main outcomes and measures: The primary end point of the study was freedom from atrial tachyarrhythmia as documented by electrocardiogram during a clinical visit or lasting longer than 30 seconds during Holter recordings occurring after a single ablation procedure.

Results: Among 438 patients who were randomized (mean [SD] age, 70.5 [4.4] years; 219 men [50%]), 24 (5.5%) did not complete the blanking period and were not included for efficacy analysis. After a median follow-up of 23 months, the recurrence rate of atrial tachyarrhythmia was significantly lower in the CPVI plus group (31/209 patients, 15%) compared with the CPVI alone group (49/205, 24%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.95; P = .03). In subgroup analyses, among all patients with low-voltage area, CPVI plus substrate modification was associated with a 51% decreased risk of ATA recurrence compared with CPVI alone (HR, 0.49; 95% CI, 0.25-0.94; P = .03).

Conclusions and relevance: This study found that additional low-voltage-area ablation beyond CPVI decreased the ATA recurrence in older patients with paroxysmal AF compared with CPVI alone. Our findings merit further replication by larger trials with longer follow-up.

Trial registration: ClinicalTrials.gov Identifier: NCT03462628.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr H. Chen reported grants from the Special Foundation for Clinical Science and Technology of Jiangsu Province (BE2017754) during the conduct of the study. Dr Jiang reported lecture fees from Biosense Webster during the conduct of the study and lecture fees from Abbott, Medtronic, and Boston Scientific outside the submitted work. Dr M. Chen reported lecture fees from Biosense Webster, Abbott, Medtronic, Bayer, and Boehringer Ingelheim. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Randomization and Flow in the STABLE-SR-III Trial
CPVI plus indicates circumferential pulmonary vein isolation plus low-voltage-area modification; CPVI alone, circumferential pulmonary vein isolation; LAA, left atrial appendage; ITT, intention to treat. aFourteen centers were not required to provide screening logs during the recruitment phase. Thus, the number of patients for eligibility assessment is not available.
Figure 2.
Figure 2.. Kaplan-Meier Estimates of Freedom From Atrial Tachyarrhythmia (ATA) After a Single Procedure by Modified Intention-to-Treat Analysis
There was a significant reduction in ATA recurrence for patients in the CPVI plus group compared with the CPVI alone group (P = .03). The curves began to diverge at 1 year, coinciding with the 7-day ambulatory monitoring at 12 months. CPVI plus indicates circumferential pulmonary vein isolation plus low-voltage-area modification; CPVI alone, circumferential pulmonary vein isolation; HR, hazard ratio.
Figure 3.
Figure 3.. Kaplan-Meier Curve for Freedom From Atrial Tachyarrhythmia (ATA) After a Single Procedure Among 4 Subgroups by Modified Intention-to-Treat Analysis
Based on randomization assignment and the existence of low-voltage areas (LVAs), all patients were divided into 4 subgroups: +LVA (CPVI plus) indicates patients with LVAs who received additional ablation beyond CPVI; +LVA (CPVI alone), patients with LVAs who received CPVI alone; −LVA (CPVI plus), patients without LVAs who received additional ablation beyond CPVI; and −LVA (CPVI alone), patients without LVAs in the CPVI alone group. Patients with LVAs who received modification in the study group had a significant reduction of ATA recurrence vs those who did not in the CPVI alone group (A). The ascertainment of recurrent ATA episodes differed at 12 months vs 3 or 6 months. CPVI plus indicates circumferential pulmonary vein isolation plus LVA modification; CPVI alone, circumferential pulmonary vein isolation; HR, hazard ratio.
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Comment in

References

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