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Multicenter Study
. 2023 Nov 2;25(11):euad286.
doi: 10.1093/europace/euad286.

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience

Shohreh Honarbakhsh  1   2 , Claire A Martin  3   4 , Joao Mesquita  3 , Rahul Herlekar  3 , Richard Till  5 , Neil T Srinivasan  6 , Edward Duncan  7 , Fong Leong  8 , Rajdip Dulai  9 , Rick Veasey  9 , Sandeep Panikker  10 , John Paisey  11 , Balasubramanian Ramgopal  11 , Moloy Das  12 , Wissam Ahmed  12 , Jonathan Sahu  13 , Mark J Earley  1   14 , Malcolm C Finlay  1 , Richard J Schilling  1   14 , Ross J Hunter  1   14
Affiliations
Multicenter Study

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience

Shohreh Honarbakhsh et al. Europace. .

Abstract

Aims: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI.

Methods and results: Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively.

Conclusions: This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.

Keywords: Atrial fibrillation; Cryoablation; Novel technology; Pulmonary vein isolation.

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Conflict of interest statement

Conflict of interest: R.J.H. has received speaker fees, consultancy fees, research, and educational grants from Medtronic and Biosense Webster. R.J.H., R.J.S., and S.H. are inventors of the STAR Mapping system and Founders of Rhythm AI. S.H. is a British Heart Foundation Clinical Intermediate Fellow and receives funding from the British Heart Foundation grant. C.A.M. has received research grants and consultancy fees from Boston Scientific and speaker and travel grants from Boston Scientific and Medtronic. M.D. has received research grant and speaker fees from Boston Scientific, consulting fees from Philips, and fellowship funding from Boston Scientific and Biosense Webster. J.P. has received consultancy fees from Medtronic and Boston Scientific. R.J.S. has received speaker and travel grants from Biosense Webster and research grants from Biosense Webster. R.J.H. has received travel grants for the purposes of attending conferences from Biosense Webster. The remaining authors have declared no conflicts of interest..

Figures

Graphical Abstract
Graphical Abstract
Demonstrates the spread of temperature profiles on a per vein basis with the PolarX Cryoballoon for cryoablations with a TTI that demonstrated successful PVI.
Figure 1
Figure 1
Consort flow diagram.
Figure 2
Figure 2
Demonstrates the spread of temperature profiles on a per vein basis with the PolarX Cryoballoon for cryoablations with a time to isolation (TTI) that demonstrated successful pulmonary vein isolation (PVI).
See this image and copyright information in PMC

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