Eugene H Blackstone1, Helena L Chang2, Jeevanantham Rajeswaran3, Michael K Parides2, Hemant Ishwaran4, Liang Li5, John Ehrlinger3, Annetine C Gelijns2, Alan J Moskowitz2, Michael Argenziano6, Joseph J DeRose7, Jean-Phillipe Couderc8, Dan Balda9, François Dagenais10, Michael J Mack11, Gorav Ailawadi12, Peter K Smith13, Michael A Acker14, Patrick T O'Gara15, A Marc Gillinov16. 1. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. Electronic address: blackse@ccf.org. 2. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY. 3. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 4. Department of Public Health Sciences, Division of Biostatistics, University of Miami, Miami, Fla. 5. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Tex. 6. Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, NY. 7. Department of Cardiovascular and Thoracic Surgery, Montefiore-Einstein Heart Center, Bronx, NY. 8. Heart Research Follow-Up Program, Cardiology Department, University of Rochester Medical Center, Rochester, NY. 9. Medicomp, Inc, Melbourne, Fla. 10. Department of Cardiac Surgery, Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Québec City, Québec, Canada. 11. Department of Cardiothoracic Surgery, Baylor Research Institute, Baylor Health Care System, Plano, Tex. 12. Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville, Va. 13. Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC. 14. Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pa. 15. Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, Mass. 16. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
Abstract
OBJECTIVE: To use novel statistical methods for analyzing the effect of lesion set on (long-standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS). METHODS:Two hundred sixty such patients were randomized to MVS + surgical ablation or MVS alone. Ablation was randomized between pulmonary vein isolation and biatrial maze. During 12 months postsurgery, 228 patients (88%) submitted 7949 transtelephonic monitoring (TTM) recordings, analyzed for AF, atrial flutter (AFL), or atrial tachycardia (AT). As previously reported, more ablation than MVS-alone patients were free of AF or AF/AFL at 6 and 12 months (63% vs 29%; P < .001) by 72-hour Holter monitoring, without evident difference between lesion sets (for which the trial was underpowered). RESULTS: Estimated freedom from AF/AFL/AT on any transmission trended higher after biatrial maze than pulmonary vein isolation (odds ratio, 2.31; 95% confidence interval, 0.95-5.65; P = .07) 3 to 12 months postsurgery; estimated AF/AFL/AT load (ie, proportion of TTM strips recording AF/AFL/AT) was similar (odds ratio, 0.90; 95% confidence interval, 0.57-1.43; P = .6). Within 12 months, estimated prevalence of AF/AFL/AT by TTM was 58% after MVS alone, and 36% versus 23% after pulmonary vein isolation versus biatrial maze (P < .02). CONCLUSIONS: Statistical modeling using TTM recordings after MVS in patients with (long-standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation. The discrepancy between AF/AFL/AT prevalence assessed at 2 time points by Holter monitoring versus weekly TTM suggests the need for a confirmatory trial, reassessment of definitions for failure after ablation, and validation of statistical methods for assessing atrial rhythms longitudinally.
RCT Entities:
OBJECTIVE: To use novel statistical methods for analyzing the effect of lesion set on (long-standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS). METHODS: Two hundred sixty such patients were randomized to MVS + surgical ablation or MVS alone. Ablation was randomized between pulmonary vein isolation and biatrial maze. During 12 months postsurgery, 228 patients (88%) submitted 7949 transtelephonic monitoring (TTM) recordings, analyzed for AF, atrial flutter (AFL), or atrial tachycardia (AT). As previously reported, more ablation than MVS-alone patients were free of AF or AF/AFL at 6 and 12 months (63% vs 29%; P < .001) by 72-hour Holter monitoring, without evident difference between lesion sets (for which the trial was underpowered). RESULTS: Estimated freedom from AF/AFL/AT on any transmission trended higher after biatrial maze than pulmonary vein isolation (odds ratio, 2.31; 95% confidence interval, 0.95-5.65; P = .07) 3 to 12 months postsurgery; estimated AF/AFL/AT load (ie, proportion of TTM strips recording AF/AFL/AT) was similar (odds ratio, 0.90; 95% confidence interval, 0.57-1.43; P = .6). Within 12 months, estimated prevalence of AF/AFL/AT by TTM was 58% after MVS alone, and 36% versus 23% after pulmonary vein isolation versus biatrial maze (P < .02). CONCLUSIONS: Statistical modeling using TTM recordings after MVS in patients with (long-standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation. The discrepancy between AF/AFL/AT prevalence assessed at 2 time points by Holter monitoring versus weekly TTM suggests the need for a confirmatory trial, reassessment of definitions for failure after ablation, and validation of statistical methods for assessing atrial rhythms longitudinally.
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