Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

The established and the challenger: a direct comparison of current Cryoballoon technologies for pulmonary vein isolation
F. Moser1, L. Rottner1, J. Moser1, R. Schleberger1, M. Lemoine1, P. Münkler1, L. Dinshaw1, P. Kirchhof1, B. Reissmann1, F. Ouyang1, A. Rillig1, A. Metzner1
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Introduction: 

Cryoballoon ablation for pulmonary vein isolation is an effective treatment of atrial fibrillation (AF). Recently, a novel cryoablation system was introduced. The aim of the study was to compare the safety, efficacy and biophysical characteristics of a novel cryoablation system (POLARx®, Boston Scientific) to technology commonly used and clinically well characterized system (Arctic Front Advance Pro®, AFA, Medtronic).

Methods and Results: 

Fifty consecutive patients with symptomatic AF, who underwent cryoballoon-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute pulmonary vein isolation was achieved in 99.8% (POLARx 99.5%, AFA 100%, p=1.00). Time to isolation (TTI) was comparable in both groups (POLARx 35 [27,48] sec, AFA 30 [21,43] sec, p=0.165). The POLARx system showed a lower balloon temperature at TTI (POLARx -44 [-50,-36] °C, AFA -31 [-38,-21] °C, p<0.001) and lower nadir temperature (POLARx -60 [-65,-55] °CAFA -48 [-54,-45] °C, p<0.001). Procedure time (POLARx 80 [60, 105] min, AFA 62 [42, 80] min, p<0.001), fluoroscopy time (POLARx 17 [13, 22] min, AFA 11 [7, 16] min, p<0.001) and freezing cycles per patient (POLARx 5.6 [4, 6], AFA 4.7 [4, 5], p=0.002) were higher in the POLARx group. 

Conclusion: 

Both systems enable effective isolation of the pulmonary veins. The new POLARx system required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to further assess long-term efficacy and safety of this novel technology.


https://dgk.org/kongress_programme/ht2021/P433.htm