TY - JOUR
T1 - Designing comparative effectiveness trials of surgical ablation for atrial fibrillation
T2 - Experience of the Cardiothoracic Surgical Trials Network
AU - Gillinov, A. Marc
AU - Argenziano, Michael
AU - Blackstone, Eugene H.
AU - Iribarne, Alexander
AU - Derose, Joseph J.
AU - Ailawadi, Gorav
AU - Russo, Mark J.
AU - Ascheim, Deborah D.
AU - Parides, Michael K.
AU - Rodriguez, Evelio
AU - Bouchard, Denis
AU - Taddei-Peters, Wendy C.
AU - Geller, Nancy L.
AU - Acker, Michael A.
AU - Gelijns, Annetine C.
N1 - Funding Information:
This article describes a comparative effectiveness randomized trial of surgical ablation with LAA closure versus LAA closure alone in patients with persistent and long-standing persistent AF undergoing MVS. This trial has been designed and is conducted within the Cardiothoracic Surgical Clinical Trials Network (CTSN), which is supported by the National Heart, Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the Canadian Institutes for Health Research ( Appendix 1 ). Nested within this trial is a further randomized comparison of 2 different lesions sets. This article addresses trial design challenges, including how best to characterize the target population, operationalize freedom from AF as a primary end point, account for the effects of antiarrhythmic drugs, and measure and analyze secondary end points, such as postoperative AF load. This article concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area.
Funding Information:
Supported by the National Heart, Lung and Blood Institute, the Canadian Institute of Health Research, and the National Institute of Neurological Diseases and Stroke.
PY - 2011/8
Y1 - 2011/8
N2 - Objective: Since the introduction of the cut-and-sew Cox maze procedure for atrial fibrillation, there has been substantial innovation in techniques for ablation. Use of alternative energy sources for ablation simplified the procedure and has resulted in dramatic increase in the number of patients with atrial fibrillation treated by surgical ablation. Despite its increasingly widespread adoption, there is lack of rigorous clinical evidence to establish this procedure as an effective clinical therapy. Methods: This article describes a comparative effectiveness randomized trial, supported by the Cardiothoracic Surgical Clinical Trials Network, of surgical ablation with left atrial appendage closure versus left atrial appendage closure alone in patients with persistent and long-standing persistent atrial fibrillation undergoing mitral valve surgery. Nested within this trial is a further randomized comparison of 2 different lesions sets: pulmonary vein isolation and the full maze lesion set. Results: This article addresses trial design challenges, including how best to characterize the target population, operationalize freedom from atrial fibrillation as a primary end point, account for the impact of antiarrhythmic drugs, and measure and analyze secondary end points, such as postoperative atrial fibrillation load. Conclusions: This article concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area.
AB - Objective: Since the introduction of the cut-and-sew Cox maze procedure for atrial fibrillation, there has been substantial innovation in techniques for ablation. Use of alternative energy sources for ablation simplified the procedure and has resulted in dramatic increase in the number of patients with atrial fibrillation treated by surgical ablation. Despite its increasingly widespread adoption, there is lack of rigorous clinical evidence to establish this procedure as an effective clinical therapy. Methods: This article describes a comparative effectiveness randomized trial, supported by the Cardiothoracic Surgical Clinical Trials Network, of surgical ablation with left atrial appendage closure versus left atrial appendage closure alone in patients with persistent and long-standing persistent atrial fibrillation undergoing mitral valve surgery. Nested within this trial is a further randomized comparison of 2 different lesions sets: pulmonary vein isolation and the full maze lesion set. Results: This article addresses trial design challenges, including how best to characterize the target population, operationalize freedom from atrial fibrillation as a primary end point, account for the impact of antiarrhythmic drugs, and measure and analyze secondary end points, such as postoperative atrial fibrillation load. Conclusions: This article concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area.
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U2 - 10.1016/j.jtcvs.2011.04.010
DO - 10.1016/j.jtcvs.2011.04.010
M3 - Article
C2 - 21616507
AN - SCOPUS:79960407748
SN - 0022-5223
VL - 142
SP - 257-264.e2
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 2
ER -