Author Contributions: Dr Smith had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Williams, Brennan, Sedrakyan, Alexander, Lopes, Dokholyan, Zhao, Michler, Thourani, Edwards, Duggirala, Gross, Marinac-Dabic, Smith.
Acquisition of data: Williams, Peterson, Brennan, Dokholyan, Zhao, Michler, Duggirala.
Analysis and interpretation of data: Williams, Peterson, Brennan, Sedrakyan, Tavris, Alexander, Lopes, Zhao, O’Brien, Thourani, Gross, Smith.
Drafting of the manuscript: Williams, Sedrakyan, Dokholyan, Zhao, Michler, Thourani, Edwards, Smith.
Critical revision of the manuscript for important intellectual content: Williams, Peterson, Brennan, Sedrakyan, Tavris, Alexander, Lopes, O’Brien, Michler, Thourani, Duggirala, Gross, Marinac-Dabic, Smith.
Statistical analysis: Peterson, Sedrakyan, Zhao, O’Brien.
Obtained funding: Gross, Marinac-Dabic, Smith.
Administrative, technical, or material support: Williams, Dokholyan, Edwards, Duggirala, Gross, Smith.
Study supervision: Brennan, Sedrakyan, Alexander, Lopes, Dokholyan, Michler, Thourani, Marinac-Dabic, Smith.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Peterson reported receiving grants from Eli Lilly, Janssen Pharmaceuticals, and Society of Thoracic Surgeons. Dr Alexander reported being a co-investigator for the Duke Core Clinical Center in the National Institutes of Health CT Surgery Network and being on the Veterans Affairs Cooperative Studies Program Protocol Review Committee. Dr Lopes reported being a consultant for and board membership of Boehringer-Ingelheim and Bristol-Myers Squibb, and receiving grants from AstraZeneca, Boehringer-Ingelheim, and Daiichi Sankyo. Dr Thourani reported receiving honoraria for lectures and being on the advisory board of Maquet Medical. Dr Smith reported receiving honoraria from Society of Thoracic Surgeons. No other authors reported any financial disclosures.
Funding/Support: This study was funded by the US Food and Drug Administration through a contract with the Society of Thoracic Surgeons. Dr Williams is supported in part by training grant T32-HL069749 from the National Institutes of Health and is a Cardiothoracic Surgical Trials Network Scholar supported by grant U01-HL088953 from the National Heart, Lung, and Blood Institute, which also supports Drs Smith, Alexander, Thourani, and Michler as investigators of the Cardiothoracic Surgical Trials Network.
Role of the Sponsor: The US Food and Drug Administration provided scientific input regarding the design of the study, the interpretation of the data, and the approval and review of the manuscript. The US Food and Drug Administration had no direct role in the conduct of the study, in the data collection, management, or performance of the final analyses.
Disclaimer: Dr Peterson, a contributing editor for JAMA, was not involved in the editorial review of or decision to publish this article.