Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Efficacy and safety of pulmonary vein isolation using a novel radiofrequency balloon: a two centre experience
S. Bordignon1, I. My2, S. Tohoku1, A. Rillig3, S. Chen1, B. Reißmann4, L. Urbanek1, F. Ouyang5, K. R. J. Chun1, B. Schmidt1, A. Metzner3
1Medizinische Klinik III - CCB, Agaplesion Markus Krankenhaus, Frankfurt am Main; 2Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum UKE 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; 5Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Background: A novel irrigated RF balloon (RFB) for pulmonary vein isolation (PVI) was recently released in selected centres. We pooled the initial procedural data on efficacy and safety of RFB-PVI from two high volume German centres.

 

Methods: Data from consecutive RFB procedures were prospectively collected. All procedures were performed using the novel open irrigated 28 mm RFB in conjunction with an inner lumen spiral catheter (SC) and a steerable sheath with 13,5 or 14F inner diameter. A 3D electroanatomical LA map was created to guide the RFB navigation. Every application lasted 60 seconds, the electrodes facing the posterior wall were switched off after 20 seconds to increase safety. Procedural data specific for each pulmonary vein were compared. The moment of isolation was systematically recorded during the first application at each PV, as well as the total number of applications needed to achieve PVI.

 

Results: Data from 85 consecutive patients were collected (61% male, 67±11 y.o., 72% with paroxysmal AF). 335 PVs were identified (5 LCPV), and 334 could be isolated using solely the 28 mm RFB. Single shot PVI was recorded in 189/335(56%) PVs. Mean time to isolation (TTI) during a first application was overall 13±10 seconds, without significant difference among different PVs (LSPV 14±9, LIPV 12±9, RSPV 11±8, RIPV 13±10 seconds). Overall an average of 2±2 Applications per PV were delivered. Mean procedure and fluoroscopy time were 86±33 minutes and 15±7 minutes, respectively. Looking at safety, an esophageal temperature rise was recorded in 52/335(16%) PVs, particularly during ablation at the LIPV (23/80 - 29%). Safety events included 1/85(1,2%) phrenic nerve palsy, 2/85 clinical strokes (2,3%), and one cardiac tamponade (1/85-1,2%).

 

Conclusion: In this two centre initial experience the RFB showed a high efficacy allowing for a fast PVI procedure, with 56% of PVs that could be isolated at the first application. Systematic analysis of multicentric experiences out of the learning curve are needed to better define the procedural safety profile.
https://dgk.org/kongress_programme/jt2022/aV573.html