Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry
Abstract Background Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF). Objectives Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a singl...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-04-01
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| Series: | Journal of Arrhythmia |
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| Online Access: | https://doi.org/10.1002/joa3.12504 |
| _version_ | 1818947733943222272 |
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| author | Kyoung Ryul Julian Chun Ken Okumura Fernando Scazzuso Young Keun On Fred J. Kueffer Kendra M. Braegelmann Surinder Kaur Khelae Fawzia Al‐Kandari Csaba Földesi the Cryo Global Registry Investigators |
| author_facet | Kyoung Ryul Julian Chun Ken Okumura Fernando Scazzuso Young Keun On Fred J. Kueffer Kendra M. Braegelmann Surinder Kaur Khelae Fawzia Al‐Kandari Csaba Földesi the Cryo Global Registry Investigators |
| author_sort | Kyoung Ryul Julian Chun |
| collection | DOAJ |
| description | Abstract Background Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF). Objectives Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry. Methods The Cryo AF Global Registry is a prospective, multi‐center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device‐ or procedure‐related adverse events over 12 month follow‐up. Results During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow‐up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device‐ and procedure‐related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%‐88.3%) in patients with PAF and 70.9% (95% CI: 64.6%‐76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first‐line PAF and PsAF was 90.0% (95% CI: 86.4%‐92.7%) and 72.9% (95% CI: 58.6%‐83.0%) at 12 months, respectively. Conclusions The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum. |
| first_indexed | 2024-12-20T08:35:36Z |
| format | Article |
| id | doaj.art-9adc890e6fde497f97b43694c26a9e0e |
| institution | Directory Open Access Journal |
| issn | 1880-4276 1883-2148 |
| language | English |
| last_indexed | 2024-12-20T08:35:36Z |
| publishDate | 2021-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Arrhythmia |
| spelling | doaj.art-9adc890e6fde497f97b43694c26a9e0e2022-12-21T19:46:35ZengWileyJournal of Arrhythmia1880-42761883-21482021-04-0137235636710.1002/joa3.12504Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global RegistryKyoung Ryul Julian Chun0Ken Okumura1Fernando Scazzuso2Young Keun On3Fred J. Kueffer4Kendra M. Braegelmann5Surinder Kaur Khelae6Fawzia Al‐Kandari7Csaba Földesi8the Cryo Global Registry InvestigatorsCardioangiologisches Centrum Bethanien Frankfurt GermanySaiseikai Kumamoto Hospital Kumamoto JapanInstitituo Cardiovascular Buenos Aires (ICBA) Buenos Aires ArgentinaDivision of Cardiology Department of Internal Medicine Heart Vascular and Stroke InstituteSamsung Medical CenterSungkyunkwan University School of Medicine Seoul Republic of KoreaMedtronic, Inc Minneapolis MN USAMedtronic, Inc Minneapolis MN USAInstitut Jantung Negara ‐ National Heart Institute Kuala Lumpur MalaysiaChest Disease Hospital KuwaitGottsegen György Országos Kardiológiai Intézet Budapest HungaryAbstract Background Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF). Objectives Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry. Methods The Cryo AF Global Registry is a prospective, multi‐center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device‐ or procedure‐related adverse events over 12 month follow‐up. Results During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow‐up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device‐ and procedure‐related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%‐88.3%) in patients with PAF and 70.9% (95% CI: 64.6%‐76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first‐line PAF and PsAF was 90.0% (95% CI: 86.4%‐92.7%) and 72.9% (95% CI: 58.6%‐83.0%) at 12 months, respectively. Conclusions The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum.https://doi.org/10.1002/joa3.12504antiarrhythmic drugatrial fibrillationcatheter ablationcryoballoonpulmonary vein isolation |
| spellingShingle | Kyoung Ryul Julian Chun Ken Okumura Fernando Scazzuso Young Keun On Fred J. Kueffer Kendra M. Braegelmann Surinder Kaur Khelae Fawzia Al‐Kandari Csaba Földesi the Cryo Global Registry Investigators Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry Journal of Arrhythmia antiarrhythmic drug atrial fibrillation catheter ablation cryoballoon pulmonary vein isolation |
| title | Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry |
| title_full | Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry |
| title_fullStr | Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry |
| title_full_unstemmed | Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry |
| title_short | Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry |
| title_sort | safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent af in a real world global setting results from the cryo af global registry |
| topic | antiarrhythmic drug atrial fibrillation catheter ablation cryoballoon pulmonary vein isolation |
| url | https://doi.org/10.1002/joa3.12504 |
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