Salik Ur Rehman Iqbal, Thomas Kueffer, Sven Knecht, Patrick Badertscher, Jens Maurhofer, Philipp Krisai, Corinne Jufer, Gregor Thalmann, Dik Heg, Helge Servatius, Hildegard Tanner, Michael Kühne, Laurent Roten, Christian Sticherling, Tobias Reichlin
{"title":"替代疗效终点定义对阵发性心房颤动消融后报告结果的影响——来自使用连续节律监测的COMPARE-CRYO研究的见解","authors":"Salik Ur Rehman Iqbal, Thomas Kueffer, Sven Knecht, Patrick Badertscher, Jens Maurhofer, Philipp Krisai, Corinne Jufer, Gregor Thalmann, Dik Heg, Helge Servatius, Hildegard Tanner, Michael Kühne, Laurent Roten, Christian Sticherling, Tobias Reichlin","doi":"10.1016/j.hrthm.2025.09.026","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recurrence after atrial fibrillation (AF) ablation is commonly defined as any atrial arrhythmia lasting ≥30 seconds. It is unclear how alternative efficacy end point definitions would change the observed success rates and how they would relate to patients' disease burden or health care utilization metrics.</p><p><strong>Objective: </strong>This study aimed to evaluate the impact of alternative end point definitions after AF ablation based on AF-burden, duration or number of episodes using implantable cardiac monitors (ICM).</p><p><strong>Methods: </strong>This is a prespecified substudy of the COMPARE-CRYO (COMPARison of the PolarX and the Arctic Front CRYOballoon for pulmonary vein isolation) study, which enrolled patients with paroxysmal AF undergoing cryoballoon ablation. All patients underwent ICM implantation, and the blanking period was 90 days. Details were collected on timing, duration, and number of episodes, and AF-burden between 91-365 days. Outcome measures were redo ablations and AF-related hospitalizations.</p><p><strong>Results: </strong>The primary end point of any recurrence lasting ≥30 seconds occurred in 89 of 201 patients (44%). One-year success rates increased with increasing arrhythmia duration thresholds from 56% (≥30 sec) to 97% (≥24 hrs), with number of episode thresholds from 56% (≥1 episode) to 98% (≥100 episodes) and with AF-burden thresholds from 56% (AF-burden >0%) to 93% (AF-burden >2%). Rates of redo ablations and AF-related hospitalizations increased for AF-episode durations >1 hour, >6 AF-episodes, and an AF-burden >0.1%, and were highest for AF-episode durations >24 hours, >33 AF-episodes, and an AF-burden >1%.</p><p><strong>Conclusion: </strong>Alternative efficacy end point definitions have a significant impact on reported outcomes and health care utilization metrics after AF ablation. These findings are important when considering end point definitions other than the traditional 30 seconds in the design of future AF-ablation trials.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of alternative efficacy end point definitions on reported outcomes after ablation of paroxysmal atrial fibrillation - Insights from the COMPARE-CRYO study using continuous rhythm monitoring.\",\"authors\":\"Salik Ur Rehman Iqbal, Thomas Kueffer, Sven Knecht, Patrick Badertscher, Jens Maurhofer, Philipp Krisai, Corinne Jufer, Gregor Thalmann, Dik Heg, Helge Servatius, Hildegard Tanner, Michael Kühne, Laurent Roten, Christian Sticherling, Tobias Reichlin\",\"doi\":\"10.1016/j.hrthm.2025.09.026\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Recurrence after atrial fibrillation (AF) ablation is commonly defined as any atrial arrhythmia lasting ≥30 seconds. It is unclear how alternative efficacy end point definitions would change the observed success rates and how they would relate to patients' disease burden or health care utilization metrics.</p><p><strong>Objective: </strong>This study aimed to evaluate the impact of alternative end point definitions after AF ablation based on AF-burden, duration or number of episodes using implantable cardiac monitors (ICM).</p><p><strong>Methods: </strong>This is a prespecified substudy of the COMPARE-CRYO (COMPARison of the PolarX and the Arctic Front CRYOballoon for pulmonary vein isolation) study, which enrolled patients with paroxysmal AF undergoing cryoballoon ablation. All patients underwent ICM implantation, and the blanking period was 90 days. Details were collected on timing, duration, and number of episodes, and AF-burden between 91-365 days. Outcome measures were redo ablations and AF-related hospitalizations.</p><p><strong>Results: </strong>The primary end point of any recurrence lasting ≥30 seconds occurred in 89 of 201 patients (44%). One-year success rates increased with increasing arrhythmia duration thresholds from 56% (≥30 sec) to 97% (≥24 hrs), with number of episode thresholds from 56% (≥1 episode) to 98% (≥100 episodes) and with AF-burden thresholds from 56% (AF-burden >0%) to 93% (AF-burden >2%). Rates of redo ablations and AF-related hospitalizations increased for AF-episode durations >1 hour, >6 AF-episodes, and an AF-burden >0.1%, and were highest for AF-episode durations >24 hours, >33 AF-episodes, and an AF-burden >1%.</p><p><strong>Conclusion: </strong>Alternative efficacy end point definitions have a significant impact on reported outcomes and health care utilization metrics after AF ablation. These findings are important when considering end point definitions other than the traditional 30 seconds in the design of future AF-ablation trials.</p>\",\"PeriodicalId\":12886,\"journal\":{\"name\":\"Heart rhythm\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2025-09-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Heart rhythm\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.hrthm.2025.09.026\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart rhythm","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.hrthm.2025.09.026","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Impact of alternative efficacy end point definitions on reported outcomes after ablation of paroxysmal atrial fibrillation - Insights from the COMPARE-CRYO study using continuous rhythm monitoring.
Background: Recurrence after atrial fibrillation (AF) ablation is commonly defined as any atrial arrhythmia lasting ≥30 seconds. It is unclear how alternative efficacy end point definitions would change the observed success rates and how they would relate to patients' disease burden or health care utilization metrics.
Objective: This study aimed to evaluate the impact of alternative end point definitions after AF ablation based on AF-burden, duration or number of episodes using implantable cardiac monitors (ICM).
Methods: This is a prespecified substudy of the COMPARE-CRYO (COMPARison of the PolarX and the Arctic Front CRYOballoon for pulmonary vein isolation) study, which enrolled patients with paroxysmal AF undergoing cryoballoon ablation. All patients underwent ICM implantation, and the blanking period was 90 days. Details were collected on timing, duration, and number of episodes, and AF-burden between 91-365 days. Outcome measures were redo ablations and AF-related hospitalizations.
Results: The primary end point of any recurrence lasting ≥30 seconds occurred in 89 of 201 patients (44%). One-year success rates increased with increasing arrhythmia duration thresholds from 56% (≥30 sec) to 97% (≥24 hrs), with number of episode thresholds from 56% (≥1 episode) to 98% (≥100 episodes) and with AF-burden thresholds from 56% (AF-burden >0%) to 93% (AF-burden >2%). Rates of redo ablations and AF-related hospitalizations increased for AF-episode durations >1 hour, >6 AF-episodes, and an AF-burden >0.1%, and were highest for AF-episode durations >24 hours, >33 AF-episodes, and an AF-burden >1%.
Conclusion: Alternative efficacy end point definitions have a significant impact on reported outcomes and health care utilization metrics after AF ablation. These findings are important when considering end point definitions other than the traditional 30 seconds in the design of future AF-ablation trials.
期刊介绍：
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.
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