Pulmonary Vein Isolation Using the Visually Guided Laser Balloon
Is a visually-guided laser balloon (VGLB) as safe and effective as conventional radiofrequency ablation when used for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF)?
The subjects of this study were 353 patients (mean age 60 years) with paroxysmal AF who underwent PVI. The patients were randomly assigned to the use of a VGLB (n = 178) or a conventional irrigated radiofrequency ablation catheter. The primary efficacy endpoint was freedom from a treatment failure after a 90-day blanking period. Treatment failure was defined as failure to isolate all PVs, symptomatic AF, atrial tachycardia or flutter, use of antiarrhythmic drug therapy, or an additional ablation procedure. The study was designed to demonstrate noninferiority.
The primary endpoint was met in a similar proportion of patients in the VGLB and control groups (61.1% and 61.7%, respectively). Phrenic nerve injury was more common in the VGLB group (3.5% vs. 0.6%), whereas the risk of PV stenosis was lower in the VGLB group (0% vs. 2.9%).
The authors concluded that the VGLB is noninferior to radiofrequency ablation in regards to safety and efficacy when used for PVI.
Although noninferior to standard radiofrequency ablation, it is not clear that the VGLB offers any advantages, particularly if a force-sensing catheter is used. Furthermore, in the SUPIR study, the senior author of this study recently reported that 91% of PVs were still isolated 3-4 months after PVI using a second-generation cryoballoon catheter. Although PV mapping was not routinely repeated 3-4 months post-ablation in the present study, the modest clinical efficacy (61%) suggests that the durability of PVI is lower with the VGLB than with the cryoballoon catheter.
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