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Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study
AIMS: Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 stud...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10468200/ https://www.ncbi.nlm.nih.gov/pubmed/37589146 http://dx.doi.org/10.1093/europace/euad248 |
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author | Heeger, Christian-Hendrik Popescu, Sorin Stefan Inderhees, Tim Nussbickel, Noemi Eitel, Charlotte Kirstein, Bettina Phan, Huong-Lan Hatahet, Sascha Subin, Behnam Traub, Anna Große, Niels Kuck, Karl-Heinz Vogler, Julia Tilz, Roland R |
author_facet | Heeger, Christian-Hendrik Popescu, Sorin Stefan Inderhees, Tim Nussbickel, Noemi Eitel, Charlotte Kirstein, Bettina Phan, Huong-Lan Hatahet, Sascha Subin, Behnam Traub, Anna Große, Niels Kuck, Karl-Heinz Vogler, Julia Tilz, Roland R |
author_sort | Heeger, Christian-Hendrik |
collection | PubMed |
description | AIMS: Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 study aimed to assess the efficacy, safety, and 1-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advance Pro CB (AF-CB4). METHODS AND RESULTS: A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who underwent POLARx-based PVI (POLARx group) were prospectively enrolled and were compared to 102 consecutive patients previously treated with the AF-CB4 (AF-CB4 group). The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AF-CB4, P = 0.0551) years. A total of 412 (POLARx) and 404 (AF-CB4) PVs were identified. All PVs, except for one PV in the POLARx group, were successfully isolated. A significant difference regarding the mean minimal CB temperature reached using the POLARx CB (−56.1 ± 8.3°C) and AF-CB4 (−46.9 ± 10.1°C) was observed (P < 0.0001). Real-time PVI was visualized in 71% of PVs in the POLARx group and 46% of them in the AF-CB4 group (P < 0.001). The mean procedure time was comparable: 54.5 ± 17.1 min for POLARx and 59.4 ± 18.6 min for AF-CB4 (P = 0.0509). No differences were observed in terms of periprocedural complications. There were comparable rates in freedom of AF or atrial tachycardia recurrence after 12 months, beyond a 90-day long blanking period: 78.9% in the POLARx group vs. 77.2% in the AF-CB4 group (P = 0.804). CONCLUSION: The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4. |
format | Online Article Text |
id | pubmed-10468200 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-104682002023-08-31 Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study Heeger, Christian-Hendrik Popescu, Sorin Stefan Inderhees, Tim Nussbickel, Noemi Eitel, Charlotte Kirstein, Bettina Phan, Huong-Lan Hatahet, Sascha Subin, Behnam Traub, Anna Große, Niels Kuck, Karl-Heinz Vogler, Julia Tilz, Roland R Europace Clinical Research AIMS: Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 study aimed to assess the efficacy, safety, and 1-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advance Pro CB (AF-CB4). METHODS AND RESULTS: A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who underwent POLARx-based PVI (POLARx group) were prospectively enrolled and were compared to 102 consecutive patients previously treated with the AF-CB4 (AF-CB4 group). The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AF-CB4, P = 0.0551) years. A total of 412 (POLARx) and 404 (AF-CB4) PVs were identified. All PVs, except for one PV in the POLARx group, were successfully isolated. A significant difference regarding the mean minimal CB temperature reached using the POLARx CB (−56.1 ± 8.3°C) and AF-CB4 (−46.9 ± 10.1°C) was observed (P < 0.0001). Real-time PVI was visualized in 71% of PVs in the POLARx group and 46% of them in the AF-CB4 group (P < 0.001). The mean procedure time was comparable: 54.5 ± 17.1 min for POLARx and 59.4 ± 18.6 min for AF-CB4 (P = 0.0509). No differences were observed in terms of periprocedural complications. There were comparable rates in freedom of AF or atrial tachycardia recurrence after 12 months, beyond a 90-day long blanking period: 78.9% in the POLARx group vs. 77.2% in the AF-CB4 group (P = 0.804). CONCLUSION: The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4. Oxford University Press 2023-08-17 /pmc/articles/PMC10468200/ /pubmed/37589146 http://dx.doi.org/10.1093/europace/euad248 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Clinical Research Heeger, Christian-Hendrik Popescu, Sorin Stefan Inderhees, Tim Nussbickel, Noemi Eitel, Charlotte Kirstein, Bettina Phan, Huong-Lan Hatahet, Sascha Subin, Behnam Traub, Anna Große, Niels Kuck, Karl-Heinz Vogler, Julia Tilz, Roland R Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title | Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title_full | Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title_fullStr | Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title_full_unstemmed | Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title_short | Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study |
title_sort | novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ice-age-1 study |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10468200/ https://www.ncbi.nlm.nih.gov/pubmed/37589146 http://dx.doi.org/10.1093/europace/euad248 |
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