Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon
{"title":"射频球囊消融术：AURORA 研究的 1 年结果。","authors":"Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon","doi":"10.1007/s10840-024-01938-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.</p><p><strong>Methods: </strong>Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.</p><p><strong>Results: </strong>A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm<sup>2</sup>. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).</p><p><strong>Conclusion: </strong>RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.\",\"authors\":\"Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon\",\"doi\":\"10.1007/s10840-024-01938-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.</p><p><strong>Methods: </strong>Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.</p><p><strong>Results: </strong>A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm<sup>2</sup>. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).</p><p><strong>Conclusion: </strong>RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.</p>\",\"PeriodicalId\":16202,\"journal\":{\"name\":\"Journal of Interventional Cardiac Electrophysiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Interventional Cardiac Electrophysiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10840-024-01938-0\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Interventional Cardiac Electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10840-024-01938-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.
Background: A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.
Methods: Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.
Results: A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm2. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).
Conclusion: RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.
期刊介绍：
The Journal of Interventional Cardiac Electrophysiology is an international publication devoted to fostering research in and development of interventional techniques and therapies for the management of cardiac arrhythmias. It is designed primarily to present original research studies and scholarly scientific reviews of basic and applied science and clinical research in this field. The Journal will adopt a multidisciplinary approach to link physical, experimental, and clinical sciences as applied to the development of and practice in interventional electrophysiology. The Journal will examine techniques ranging from molecular, chemical and pharmacologic therapies to device and ablation technology. Accordingly, original research in clinical, epidemiologic and basic science arenas will be considered for publication. Applied engineering or physical science studies pertaining to interventional electrophysiology will be encouraged. The Journal is committed to providing comprehensive and detailed treatment of major interventional therapies and innovative techniques in a structured and clinically relevant manner. It is directed at clinical practitioners and investigators in the rapidly growing field of interventional electrophysiology. The editorial staff and board reflect this bias and include noted international experts in this area with a wealth of expertise in basic and clinical investigation. Peer review of all submissions, conflict of interest guidelines and periodic editorial board review of all Journal policies have been established.
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