Why the study?
Single-shot catheters developed to improve PVI efficiency have lacked integration into 3D-mapping technology, prompting evaluation of a novel fully 3D-mapping-integrated radiofrequency balloon catheter.
Is pulmonary vein isolation with a novel fully 3D-mapping-integrated multi-electrode radiofrequency balloon catheter safe and effective in patients with atrial fibrillation?
Is pulmonary vein isolation with a novel fully 3D-mapping-integrated multi-electrode radiofrequency balloon catheter safe and effective in patients with atrial fibrillation?
A novel fully 3D-mapping-integrated radiofrequency balloon catheter for pulmonary vein isolation appears safe and effective, yielding an 81.8% recurrence-free survival at 12 months.
Supports feasibility of the novel catheter for PVI in AF; leaves open confirmation versus standard methods in randomized trials.
Pulmonary vein isolation (PVI), as the cornerstone of atrial fibrillation (AF) ablation, has emerged a widely used therapy for patients suffering from AF. To improve PVI efficiency, single-shot catheters (SSCs) have been developed. Regrettably, SSCs are not integrated into 3D-mapping technology. In that regard, a novel radiofrequency balloon catheter (RFBC, Heliostar, Biosense Webster) with full integration into 3D-mapping technology has been developed. The aim of this study was to assess operative and follow-up outcomes of the RFBC in AF patients. In this monocentric prospective registry, patients with a first-time PVI using the RFBC were included. Follow-up visits were scheduled 3, 6, 12 and 24 months after ablation and in case of symptoms. A total of 171 patients (36.8% female) were included, with a mean age of 68.5 ± 10.2 years. Among them, 63 patients (36.8%) presented with persistent AF. Notably, no major periprocedural complications were observed. The mean follow-up period was 287 ± 157 days. In the Kaplan-Meier analysis, the estimated recurrence-free survival after 12 months was 81.8%. Based on our data, PVI with the fully 3D-mapping-integrated RFBC seems to be safe and effective and to have a favorable 12-month outcome in patients with paroxysmal and persistent AF.
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Teumer et al. (2023) studied this question.
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