The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation

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@article{b84415b5818d47fcaed4d5eec006e14d,
title = "The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation",
abstract = "INTRODUCTION: Cryoballoon (CB) ablation for pulmonary vein isolation (PVI) 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{\texttrademark}; Boston Scientific) to a commonly used and clinically well characterized system (Arctic Front Advance Pro{\texttrademark}, AFA; Medtronic).METHODS AND RESULTS: Fifty consecutive patients with symptomatic AF, who underwent CB-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute PVI 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] s, AFA 30 [21, 43] s, p = 0.165). The POLARx 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] °C, AFA -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 freeze cycles per patient (POLARx 5 [4, 6], AFA 4.5 [4, 5], p = 0.002) were higher in the POLARx group. Two cerebral ischemic events occurred in the POLARx group, two patients in each group had phrenic nerve injury.CONCLUSION: Both systems enable effective isolation of pulmonary veins. The POLARx required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to assess long-term efficacy and safety of this technology.",
author = "Fabian Moser and Laura Rottner and Julia Moser and Ruben Schleberger and Marc Lemoine and Paula M{\"u}nkler and Leon Dinshaw and Paulus Kirchhof and Bruno Reissmann and Feifan Ouyang and Andreas Rillig and Andreas Metzner",
note = "{\textcopyright} 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.",
year = "2022",
month = jan,
doi = "10.1111/jce.15288",
language = "English",
volume = "33",
pages = "48--54",
journal = "J CARDIOVASC ELECTR",
issn = "1045-3873",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation

AU - Moser, Fabian

AU - Rottner, Laura

AU - Moser, Julia

AU - Schleberger, Ruben

AU - Lemoine, Marc

AU - Münkler, Paula

AU - Dinshaw, Leon

AU - Kirchhof, Paulus

AU - Reissmann, Bruno

AU - Ouyang, Feifan

AU - Rillig, Andreas

AU - Metzner, Andreas

N1 - © 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.

PY - 2022/1

Y1 - 2022/1

N2 - INTRODUCTION: Cryoballoon (CB) ablation for pulmonary vein isolation (PVI) 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 a commonly used and clinically well characterized system (Arctic Front Advance Pro™, AFA; Medtronic).METHODS AND RESULTS: Fifty consecutive patients with symptomatic AF, who underwent CB-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute PVI 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] s, AFA 30 [21, 43] s, p = 0.165). The POLARx 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] °C, AFA -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 freeze cycles per patient (POLARx 5 [4, 6], AFA 4.5 [4, 5], p = 0.002) were higher in the POLARx group. Two cerebral ischemic events occurred in the POLARx group, two patients in each group had phrenic nerve injury.CONCLUSION: Both systems enable effective isolation of pulmonary veins. The POLARx required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to assess long-term efficacy and safety of this technology.

AB - INTRODUCTION: Cryoballoon (CB) ablation for pulmonary vein isolation (PVI) 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 a commonly used and clinically well characterized system (Arctic Front Advance Pro™, AFA; Medtronic).METHODS AND RESULTS: Fifty consecutive patients with symptomatic AF, who underwent CB-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute PVI 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] s, AFA 30 [21, 43] s, p = 0.165). The POLARx 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] °C, AFA -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 freeze cycles per patient (POLARx 5 [4, 6], AFA 4.5 [4, 5], p = 0.002) were higher in the POLARx group. Two cerebral ischemic events occurred in the POLARx group, two patients in each group had phrenic nerve injury.CONCLUSION: Both systems enable effective isolation of pulmonary veins. The POLARx required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to assess long-term efficacy and safety of this technology.

U2 - 10.1111/jce.15288

DO - 10.1111/jce.15288

M3 - SCORING: Journal article

C2 - 34766404

VL - 33

SP - 48

EP - 54

JO - J CARDIOVASC ELECTR

JF - J CARDIOVASC ELECTR

SN - 1045-3873

IS - 1

ER -