Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02087-y
Novel radiofrequency ablation balloon for pulmonary vein isolation: procedural efficacy and predictors of single-shot isolation
I. My1, M. Butt1, L. Rottner2, R. Schleberger3, F. Moser2, M. Lemoine3, J. Moser3, J. Obergassel2, J. Wenzel1, P. Kirchhof2, B. Reißmann4, F. Ouyang2, A. Rillig3, A. Metzner3
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Hamburg; 2Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 4Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Background and purpose 
A compliant multi-electrode radiofrequency balloon catheter (RFB) was recently introduced for pulmonary vein isolation (PVI). The aim of the study is to evaluate this novel system in a prospective ablation registry. 

Methods 
In this observational study consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) undergoing RFB-based PVI were enrolled in a high-volume ablation center. All procedures were conducted in conjunction with a 3D-Mapping system and the procedural parameters were collected and analyzed to determine predictive values of effective single-shot PVI.

Results 
67 patients (40 male (60%); 32 (48%) patients with paroxysmal AF) were included. Baseline characteristics are as follows: mean age 66.5±11,3 years, median AF duration 0.9 years (interquartile range: 2.3), mean left ventricular ejection fraction 55±9%, median CHA2DS2VASc-Score 3±1.7. Successful PVI was obtained in 262/266 (98.4%) PVs and total number of applications was n=584 with a mean of 2.2±1.8 applications per PV. A total of 124/266 (46%) PVs were isolated after a single RFB application. Mean time to isolation (TTI) in the single-RFB application group was 11.5±8.2 sec. Single-shot RFB PVI was more frequently seen at the right inferior PV (RIPV), followed by right superior (RSPV), left inferior PV (LIPV) and left superior PV (LSPV) (40/67 (59.7%) for RIPV; 33/67 (49.3%) for RSPV; 30/65 (46.2%) for LIPV; 20/65 (30.8%) for LSPV). Left common PV (LCPV) was isolated with a single application in 1/2 (50%) LCPVs. Esophageal temperature during RF applications exceeded 39°C in 51/266 (19%) PVs, with 24/584 (4.1%) applications that needed to be stopped prematurely due excessive esophageal temperature rise (higher than 40°C). Median procedure and fluoroscopy time were 94±30 and 16.4±6 min, respectively. A statistically significant higher mean impedance drop and temperature rise in the group of PVs that were isolated after single RFB application was observed (21.9±6.3 vs. 17.5±5.4 Ohm and 10.8±4.9 vs. 8.8±4.6 °C respectively, p<0,01).

Conclusion 
RFB system-based PVI is feasible and acutely highly effective in a real-world setting. Higher impedance drop and temperature rise during RF ablation correlate with PVI after a single RFB application.
https://dgk.org/kongress_programme/ht2022/aP324.html