Study concept and design: Proclemer, Lunati, Manotta, Gasparini.
Acquisition, analysis, or interpretation of data: Proclemer, Arenal, Ferrer, Hersi, Gasparini.
Drafting of the manuscript: Proclemer, Hersi, Gasparini.
Critical revision of the manuscript for important intellectual content: Proclemer, Arenal, Lunati, Ferrer, Hersi, Manotta.
Statistical analysis: Arenal.
Administrative, technical, or material support: Manotta.
Study supervision: Lunati, Ferrer, Hersi, Gasparini.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Arenal reported serving as consultant and speaker for Medtronic, Boston Scientific, and St Jude. Dr Lunati reported serving as consultant and speaker for educational presentations for Medtronic, Boston Scientific, St Jude, and Sorin. Dr Gasparini reported serving on advisory boards for Medtronic and Boston Scientific. No other disclosures were reported.
Funding/Support: The ADVANCE III Study was supported by Medtronic Inc.
Role of the Sponsor: Medtronic had a role in the design and conduct of the study; had no role in the collection of data; had a role in the management; had no role in the analysis and interpretation of the data; had a role in the preparation, review, or approval of the manuscript; and had no role in the decision to submit the manuscript for publication.
Additional Contributions: We thank Axel Kloppe, MD (Medizinische Klinik II, Kardiologie und Angiologie, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Ruhr-Universität-Bochum, Bochum, Germany), Marcin Gulaj, MD (MSWiA Hospital, Bialystok, Poland), and Maurits C. E. F. Wijfels, PhD (St Antonius Ziekenhuis Hospital, Nieuwegein, the Netherlands), for their contributions in the acquisition and interpretation of the data. We also acknowledge all the contributions made by the investigators of the enrolling centers of the ADVANCE III Trial in the acquisition of the data. None of the individuals acknowledged were compensated for their contributions.