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

Treatment of atrial fibrillation by a novel compliant cryo-balloon ablation system - what’s different?
K. Weinmann1, K. Rietzler1, C. Pflieger1, D. Aktolga1, C. Bothner1, A. Pott1, W. Rottbauer1, T. Dahme1
1Klinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm;

Background:
Cryo-balloon pulmonary vein (PV) isolation is an established anatomical single-shot procedure for the treatment of atrial fibrillation (AF). We compared a novel compliant to a non-compliant cryo-balloon system.

Methods:
We prospectively enrolled 100 consecutive AF patients and treated them with either a compliant (POLARx™, Boston Scientific) or a non-compliant (Arctic Front Advance Pro™, Medtronic) cryo-balloon system. Main difference of these two ablations systems is their handling characteristic, whereas the non-compliant cryo-balloon system is more rigid than the novel cryo-balloon ablation system. In this study we analyzed the procedural differences of the two ablation systems. 

Results:
Patients were 67.0
±11.6 years old, 47% (47 patients) were female. Comparison of baseline characteristics regarding cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, CHADS-VASc score) and left atrial diameter showed no difference between groups. Eventhough the average nadir cryo-balloon temperature at every single PV was lower with the compliant system compared to the non-compliant cryo-balloon (-55.2±4.1 °C vs. -65.1±4.7 °C; p<0.001), the non-compliant cryo-balloon system showed a better occlusion for the right superior PV (RSPV) (3.9±0.2 vs. 3.8±0.4; p=0.036) leading to a higher rate of isolation with the first freeze (“one shot isolation”) (non-compliant system 56% vs. compliant system 44%; p=0.01) and lower number of ablations at the RSPV (1.3±0.4 vs. 1.6±1.0; p=0.05)

Real time observation of PV isolation was not different between both balloon types (non-compliant 76% vs. compliant 71%; p=0.366), likewise the time to isolation (TTI) was also not different between the non-compliant and the compliant cryo-balloon system (LSPV: 56.6±35.9 s vs. 48.2±17.6 s, p=0.218; LIPV: 36.3±14.4 s vs. 38.3±14.0 s, p=0.559; RSPV: 41.7±29.7 s vs. 43.8±18.2 s, p=0.704; RIPV: 48.6±28.2 s vs. 45.1±16.2 s, p=0.508). 

Evaluation of procedural characteristics revealed a significantly longer procedure duration (67.3±21.4 vs. 80.6±28.4 min, p=0.01) and concomitant longer fluoroscopy time (12.1±4.6 vs. 15.6±7.3 min, p=0.005) in the group of the compliant cryo-balloon system.

Conclusion:
The novel compliant cryo-balloon system achieved similar procedural characteristics in comparison to the established non-compliant cryo-balloon. Mostly due to its more rigid handling, the non-compliant cryo-balloon system achieved advantageous ablation results at the RSPV. Whereas the compliant cryo-balloon showed lower nadir temperatures with higher rates in phrenic nerve palsy. 


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