TY - JOUR
T1 - Biatrial maze procedure versus pulmonary vein isolation for atrial fibrillation during mitral valve surgery
T2 - New analytical approaches and end points
AU - Cardiothoracic Surgical Trials Network Investigators
AU - Blackstone, Eugene H.
AU - Chang, Helena L.
AU - Rajeswaran, Jeevanantham
AU - Parides, Michael K.
AU - Ishwaran, Hemant
AU - Li, Liang
AU - Ehrlinger, John
AU - Gelijns, Annetine C.
AU - Moskowitz, Alan J.
AU - Argenziano, Michael
AU - DeRose, Joseph J.
AU - Couderc, Jean Phillipe
AU - Balda, Dan
AU - Dagenais, François
AU - Mack, Michael J.
AU - Ailawadi, Gorav
AU - Smith, Peter K.
AU - Acker, Michael A.
AU - O'Gara, Patrick T.
AU - Gillinov, A. Marc
N1 - Funding Information:
Dr Ailawadi reports being on consultant boards for Abbott, Edwards, Medtronic, and AtriCure. Dr Smith reports receiving grants from the National Institutes of Health / CTSN ; personal fees from Abbott Vascular, Edwards LifeSciences, and St Jude; and grants from Edwards LifeSciences . Dr Gillinov reports being a consultant to AtriCure, Medtronic, Abbott, CryoLife, Edwards LifeSciences, and ClearFlow. Cleveland Clinic has right to royalties from AtriCure. All other authors have nothing to disclose with regard to commercial support.
Funding Information:
Supported by grant No. R01 HL103552 and by a cooperative agreement (No. U01 HL088942 ) with the National Heart, Lung, and Blood Institute , including funding by the National Institute of Neurological Disorders and Stroke and the Canadian Institutes of Health Research .
Publisher Copyright:
© 2018 The American Association for Thoracic Surgery
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - Cardiothoracic Surgical Trials Network
KW - ablation
KW - atrial arrhythmia
KW - postablation heart rhythm monitoring
KW - transtelephonic monitoring
UR - http://www.scopus.com/inward/record.url?scp=85058166328&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058166328&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2018.06.093
DO - 10.1016/j.jtcvs.2018.06.093
M3 - Article
C2 - 30557941
AN - SCOPUS:85058166328
SN - 0022-5223
VL - 157
SP - 234-243.e9
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 1
ER -