The Efficacy of Left Atrial vs Biatrial Cardioneuroablation in Patients With Vasovagal Syncope: A Randomized Clinical Trial
Abstract
BACKGROUND
Cardioneuroablation has been proposed to be effective in patients with vasovagal syncope, whereas the preferred ablation strategy is undetermined.
OBJECTIVES
This study aimed to determine the preferred ablation strategy of cardioneuroablation between the left atrial (LA) and the bilateral atrial (BiA) approach.
METHODS
This study was a prospective randomized clinical trial to compare the efficacy of 2 ablation strategies for patients with vasovagal syncope. The participants were randomly assigned to either the LA or BiA ganglion plexus ablation group in a 1:1 ratio.
RESULTS
Eighty participants (37 men [46.2%]; age 38 ±16 years) were enrolled, with 40 participants in each group. The efficacy was 87.5% in the LA group (95% CI: 76.8 to 98.2%) and 90% (95% CI: 80.7 to 99.7%) in the BiA group (P = 0.723; P for noninferiority = 0.001). Compared to the BiA group, LA group reduced the average procedure time by 13 minutes (95% CI: 6-20 minutes), the average x-ray dosage by 5.7 mGy (95% CI: 2.1-9.3 mGy), the average ablation lesions by 4 (95% CI: 2-6), and ablation time by 125 seconds (95% CI: 60-190 seconds). No significant difference was observed in presyncope recurrence rate (15% vs 10%; P = 0.498), quality of life (78.7 ± 13.6 vs 80.9 ± 10.6; P = 0.417), mean heart rate (79 ± 11 vs 77 ± 9; P = 0.391), and response to head-up tilt test (57.1% vs 62.2%; P = 0.664) between groups at 12 months.
CONCLUSIONS
The LA approach's efficacy was noninferior to the BiA approach,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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