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. 2023 Mar 30;25(3):896-904.
doi: 10.1093/europace/euad017.

Pulmonary vein isolation with the radiofrequency balloon catheter: a single centre prospective study

Alvise Del Monte  1 , Alexandre Almorad  1 , Luigi Pannone  1 , Domenico Giovanni Della Rocca  1 , Antonio Bisignani  1 , Cinzia Monaco  1 , Sahar Mouram  1 , Robbert Ramak  1 , Anaïs Gauthey  1 , Ingrid Overeinder  1 , Gezim Bala  1 , Antonio Sorgente  1 , Erwin Ströker  1 , Juan Sieira  1 , Pedro Brugada  1 , Mark La Meir  2 , Gian-Battista Chierchia  1 , Carlo de Asmundis  1
Affiliations

Pulmonary vein isolation with the radiofrequency balloon catheter: a single centre prospective study

Alvise Del Monte et al. Europace. .

Abstract

Aims: The multielectrode radiofrequency balloon catheter (RFB) has been developed to achieve safe and effective pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation. This single-centre study aimed to evaluate the midterm clinical outcome and predictors of single-shot PVI with the novel RFB.

Methods and results: All consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with the RFB were prospectively included. Clinical and procedural parameters were systematically collected. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint consisted of freedom from any atrial tachyarrhythmias (ATas) lasting >30 s during the follow-up after a 3-month blanking period. Persistent single-shot PVI was defined as PVI achieved with a single RFB application without acute reconnection. A total of 104 consecutive patients (mean age 64.3 ± 11.4 years, 56.7% males) were included. 15 patients (14.4%) presented with persistent AF. The procedure time was 59.0 min with a dwell time of 20.0 min. One major complication occurred in one patient. At a mean follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. ATas occurred in 14 patients, 11/69 patients (15.9%) with paroxysmal AF and 3/13 (23.1%) with persistent AF. The best cut-offs to predict persistent single-shot PVI were impedance drop >19.2 Ω [area under the receiver operator characteristic curve (AUC) 0.74] and temperature rise >11.1° C (AUC 0.77).

Conclusion: In a large cohort of patients undergoing PVI with the RFB, the complication rate was 1%. At a mid-term follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. Specific cut-offs of impedance drop and temperature rise may be useful to predict persistent single-shot isolation.

Keywords: Atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Radiofrequency ablation; Radiofrequency balloon; Single-shot predictors.

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Conflict of interest statement

Conflict of interest: A.B. is a consultant for Biotronik. A.S. received research grants from Daiichi Sankyo and Bayer; he has received speaker fees from Menarini and Bayer. P.B. received compensation for teaching purposes from Biotronik. M.L.M. is a consultant for Atricure. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, Acutus Medical. C.d.A. receives research grants on behalf of the centre from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, Daiichi Sankyo. All remaining authors have declared no conflicts of interest.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Post-ablation voltage map of the left atrium. Voltage map of the left atrium in postero-anterior (Panel A) and antero-posterior (Panel B) views showing pulmonary vein isolation after ablation with the radiofrequency balloon catheter.
Figure 2
Figure 2
Kaplan–Meier curve of any atrial tachyarrhythmias (ATas)-free survival during the follow-up; the overall freedom from ATas was 82.9% at a mean follow-up of 10.1 ± 5.3 months.
Figure 3
Figure 3
ROC curves for univariate regression analysis of predictors of single-shot pulmonary vein isolation. Panel A: ROC curve for impedance drop (AUC = 0.74); panel B: ROC curve for temperature rise (AUC = 0.77).
See this image and copyright information in PMC

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