This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Permanent atrial fibrillation
Age ≥ 65 years
Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
New York Heart Association (NYHA) functional class II- IV
Asymptomatic atrial fibrillation
Life expectancy to < 12 months.
Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
Mechanical tricuspid valve replacement
Parallel
Pacemaker implantation with Left bundle branch area pacing (LBBAP)
Procedure/SurgeryLeft bundle branch pacing is a novel pacing modality that can bypass the pathological or disease-vulnerable region in the cardiac conduction system, to provide physiological pacing modality for patients. The procedure involves the implantation of a permanent pacemaker with a pacing lead positioned at the left bundle branch area to achieve physiological conduction system pacing. LBBAP-Pacemaker device and leads should be implanted according to the physician's standard practice.
Atrioventricular node ablation (AVNA)
Procedure/SurgeryAtrioventricular node ablation uses heat energy, called radiofrequency energy, to destroy the area between the upper and lower heart chambers. This area is called the atrioventricular node.
Pharmacologic therapy optimized for Atrial Fibrillation management
DrugPharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide, propafenone, dronedarone, amiodarone) along with anticoagulation therapy (e.g., apixaban) as per current clinical guidelines (e.g., ESC 2024 or ACC/AHA/HRS 2023) in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation. Treatment is tailored based on patient tolerance and clinical efficacy.
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
Change in NT-proBNP concentration (pg/ml) at 12, and 24 months
Change in health-related quality of life measured by 36-item short form survey (SF-36) questionnaire at 6, 12, 24 months
The SF-36 is a 36-item questionnaire that measures health-related quality of life across eight domains, including physical functioning, bodily pain, and mental health. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Change in health-related quality of life measured by EuroQol 5-Dimension Questionnaire (EQ-5D) at 6, 12, 24 months
The EuroQol 5-Dimension Questionnaire (EQ-5D) evaluates health-related quality of life using a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are derived as an index value (range: -0.594 to 1) The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'
Change in left ventricular ejection fraction (LV-EF, %) at 6, 12, and 24 months
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