Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study

Alexandre Almorad; Alvise Del Monte; Domenico Giovanni Della Rocca; Luigi Pannone; Robbert Ramak; Ingrid Overeinder; Gezim Bala; Erwin Ströker; Juan Sieira; Aurélie Dubois; Antonio Sorgente; Milad El Haddad; Saverio Iacopino; Serge Boveda; Carlo de Asmundis; Gian-Battista Chierchia

doi:10.1093/europace/euad252

Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study

Europace. 2023 Aug 2;25(9):euad252. doi: 10.1093/europace/euad252.

Authors

Alexandre Almorad¹, Alvise Del Monte¹, Domenico Giovanni Della Rocca¹, Luigi Pannone¹, Robbert Ramak¹, Ingrid Overeinder¹, Gezim Bala¹, Erwin Ströker¹, Juan Sieira¹, Aurélie Dubois¹, Antonio Sorgente¹, Milad El Haddad², Saverio Iacopino³, Serge Boveda⁴, Carlo de Asmundis¹, Gian-Battista Chierchia¹

Affiliations

¹ Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Laarbeeklaan 101, 1090 Brussels, Belgium.
² Independent Researcher, Helsinki, Finland.
³ Arrhythmology Department, Maria Cecilia Hospital SPA, Cotignola, Italy.
⁴ Département de Rythmologie, Clinique Pasteur, 45 avenue de Lombez, BP 27617, 31076 Toulouse Cedex 3, France.

Abstract

Aims: Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF).

Methods and results: This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80-77.12) vs. 77.0 (35.13-122.71) min (P < 0.001)], dwell time [19.59 (14.41-30.24) vs. 27.03 (17.11-57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days.

Conclusions: The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times.

Keywords: Cryoballoon; Pulmonary vein isolation; Radiofrequency balloon.

Publication types

Multicenter Study

MeSH terms

Atrial Appendage*
Atrial Fibrillation*
Esophageal Fistula*
Humans
Prospective Studies
Pulmonary Veins*