Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry
PURPOSE: Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Adv...
Published in: | Journal of Interventional Cardiac Electrophysiology |
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ftpubmed:oai:pubmedcentral.nih.gov:9470593 2023-05-15T15:12:16+02:00 Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry Kimura, Masaomi Kobori, Atsushi Nitta, Junichi Hirao, Kenzo Shizuta, Satoshi Kurita, Takashi Okishige, Kaoru Kumagai, Koichiro Koyama, Junjiro Hiroshima, Kenichi Inaba, Osamu Goya, Masahiko Yamauchi, Yasuteru Kueffer, Fred J. Becker, Daniel Okumura, Ken 2022-02-04 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9470593/ http://www.ncbi.nlm.nih.gov/pubmed/35119586 https://doi.org/10.1007/s10840-022-01132-0 en eng Springer US http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9470593/ http://www.ncbi.nlm.nih.gov/pubmed/35119586 http://dx.doi.org/10.1007/s10840-022-01132-0 © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . CC-BY J Interv Card Electrophysiol Article Text 2022 ftpubmed https://doi.org/10.1007/s10840-022-01132-0 2022-09-18T00:50:41Z PURPOSE: Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Advance) in Japan. METHODS: Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) were treated at 10 Japanese hospitals. Efficacy was evaluated by freedom from a ≥ 30-s recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT), AF-related symptoms, and quality of life using the EQ-5D-3L questionnaire. The safety endpoint was serious device- and procedure-related adverse events. RESULTS: The study included 352 patients with PAF (65 ± 10 years of age, 36% female, 36% without prior failure of AAD). Mean duration since first diagnosis of AF was 3.0 ± 5.5 years. Serious device- and procedure-related adverse event rate was 2.6% (95% CI: 1.2–4.8%). Freedom from AF/AFL/AT was 88.5% (95% CI: 84.7–91.4%) at 12 months and 86.7% (95% CI: 81.1–90.8%) at 24 months. The number of patients with ≥ 1 AF symptom was significantly decreased from 88% at enrollment to 22% (p < 0.01) at 12-month follow-up. General quality of life using EQ-5D did not improve significantly after 12 months in the summary score. However, in the visual analog scale score, there was improvement (5.8 ± 18.4; p < 0.01). CONCLUSIONS: This study demonstrates that cryoablation used for PVI is a safe and effective treatment in real-world use for patients with PAF in Japan. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10840-022-01132-0. Text Arctic PubMed Central (PMC) Arctic Journal of Interventional Cardiac Electrophysiology 64 3 695 703 |
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Article Kimura, Masaomi Kobori, Atsushi Nitta, Junichi Hirao, Kenzo Shizuta, Satoshi Kurita, Takashi Okishige, Kaoru Kumagai, Koichiro Koyama, Junjiro Hiroshima, Kenichi Inaba, Osamu Goya, Masahiko Yamauchi, Yasuteru Kueffer, Fred J. Becker, Daniel Okumura, Ken Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
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PURPOSE: Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Advance) in Japan. METHODS: Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) were treated at 10 Japanese hospitals. Efficacy was evaluated by freedom from a ≥ 30-s recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT), AF-related symptoms, and quality of life using the EQ-5D-3L questionnaire. The safety endpoint was serious device- and procedure-related adverse events. RESULTS: The study included 352 patients with PAF (65 ± 10 years of age, 36% female, 36% without prior failure of AAD). Mean duration since first diagnosis of AF was 3.0 ± 5.5 years. Serious device- and procedure-related adverse event rate was 2.6% (95% CI: 1.2–4.8%). Freedom from AF/AFL/AT was 88.5% (95% CI: 84.7–91.4%) at 12 months and 86.7% (95% CI: 81.1–90.8%) at 24 months. The number of patients with ≥ 1 AF symptom was significantly decreased from 88% at enrollment to 22% (p < 0.01) at 12-month follow-up. General quality of life using EQ-5D did not improve significantly after 12 months in the summary score. However, in the visual analog scale score, there was improvement (5.8 ± 18.4; p < 0.01). CONCLUSIONS: This study demonstrates that cryoablation used for PVI is a safe and effective treatment in real-world use for patients with PAF in Japan. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10840-022-01132-0. |
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Kimura, Masaomi Kobori, Atsushi Nitta, Junichi Hirao, Kenzo Shizuta, Satoshi Kurita, Takashi Okishige, Kaoru Kumagai, Koichiro Koyama, Junjiro Hiroshima, Kenichi Inaba, Osamu Goya, Masahiko Yamauchi, Yasuteru Kueffer, Fred J. Becker, Daniel Okumura, Ken |
author_facet |
Kimura, Masaomi Kobori, Atsushi Nitta, Junichi Hirao, Kenzo Shizuta, Satoshi Kurita, Takashi Okishige, Kaoru Kumagai, Koichiro Koyama, Junjiro Hiroshima, Kenichi Inaba, Osamu Goya, Masahiko Yamauchi, Yasuteru Kueffer, Fred J. Becker, Daniel Okumura, Ken |
author_sort |
Kimura, Masaomi |
title |
Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
title_short |
Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
title_full |
Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
title_fullStr |
Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
title_full_unstemmed |
Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry |
title_sort |
cryoballoon ablation for paroxysmal atrial fibrillation in japan: 2-year safety and efficacy results from the cryo af global registry |
publisher |
Springer US |
publishDate |
2022 |
url |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9470593/ http://www.ncbi.nlm.nih.gov/pubmed/35119586 https://doi.org/10.1007/s10840-022-01132-0 |
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Arctic |
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Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
J Interv Card Electrophysiol |
op_relation |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9470593/ http://www.ncbi.nlm.nih.gov/pubmed/35119586 http://dx.doi.org/10.1007/s10840-022-01132-0 |
op_rights |
© The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
op_rightsnorm |
CC-BY |
op_doi |
https://doi.org/10.1007/s10840-022-01132-0 |
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Journal of Interventional Cardiac Electrophysiology |
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