Author Contributions: Dr Maisel 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: Shah, Maisel.
Acquisition of data: Shah, Maisel.
Analysis and interpretation of data: Shah, Maisel.
Drafting of the manuscript: Shah, Maisel.
Critical revision of the manuscript for important intellectual content: Shah, Maisel.
Statistical analysis: Maisel.
Administrative, technical, or material support: Maisel.
Study supervision: Maisel.
Financial Disclosures: None reported.
Disclaimer: Dr Maisel is a US Food and Drug Administration (FDA) consultant and chair of the FDA Circulatory System Medical Device Advisory Panel. The opinions expressed herein are the personal views of the authors and do not necessarily represent the policies, practices, positions, or opinions of the FDA.