Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

A direct comparison between POLARx- versus Arctic Front Advance-guided pulmonary vein isolation
D. Guckel1, P. Lucas1, K. Isgandarova1, M. El Hamriti1, L. Bergau1, T. Fink1, V. Sciacca1, G. Imnadze1, M. Braun1, M. Khalaph1, G. Nölker2, C. Sohns1, P. Sommer1
1Klinik für Elektrophysiologie/Rhythmologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 2Innere Klinik II / Kardiologie, Christliches Klinikum Unna (CKU), Unna;

Background
Cryoballoon (CB)-guided pulmonary vein isolation (PVI) is an established treatment for atrial fibrillation (AF). Recently, a novel cryoballoon device (POLARx, Boston Scientific) for PVI was designed.

Objectives
The aim of this study was to compare the efficacy, safety, characteristics and outcome data of the novel CB ablation system with the established one (Arctic Front Advance Pro, AFA, Medtronic).

Methods
A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 consecutive patients (65.0±11.6, 31% female) undergoing ablation with the POLARx were compared to a cohort of 531 consecutive patients (63.0±27.9, 25% female) treated with AFA. Follow-up examinations were scheduled after 3 and 6 months.

Results

Acute PVI was achieved in all patients (n=596, 100%). Total procedure duration (POLARx, 113.3±23.2 min, AFA, 100.9±21.3 min; p<0.001) and fluoroscopy time (POLARx, 10.5±5.9 min, AFA, 4.8±3.6 min; p<0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx, -57.7±0.9 °C, AFA, -45.1±2.6 °C; p<0.001). One major complication requiring intervention occurred in the POLARx (2%) and three (1%) in the AFA group. AF-recurrence rates were significantly higher in the AFA group compared to POLARx treated patients (POLARx, n=20, 31%; AFA, n=208, 39%; p=0.049*). While there were no significant group differences in recurrence rate at the 3 months follow up (POLARx, n=15, 23%; AFA, n=94, 18%; p=0.072), AFA patients showed a significantly higher recurrence rate at the 6 months follow-up (AFA, n=177, 33%; POLARx, n=11, 17%; p=0.004*).

Conclusion
Both balloon-guided ablation systems are comparably safe and effective for acute PVI. AF ablation utilizing the POLARx system is associated with longer procedure duration and fluoroscopy times, significantly lower nadir temperatures and significantly higher mid-term AF-free survival rates. Long-term data and assessment of lesion formation are warranted.


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