Author Contributions: Ms Haas 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: Maron, Spirito, Link, Daubert, Estes, Favale.
Acquisition of data: Maron, Spirito, Shen, Haas, Formisano, Link, Epstein, Almquist, Daubert, Lawrenz, Boriani, Estes, Favale, Piccininno, Winters, Santini, Betocchi, Arribas, Sherrid, Buja, Semsarian.
Analysis and interpretation of data: Maron, Spirito, Shen, Haas, Daubert, Estes, Piccininno, Semsarian, Bruzzi.
Drafting of the manuscript: Maron, Spirito, Haas, Link, Estes, Winters, Sherrid, Bruzzi.
Critical revision of the manuscript for important intellectual content: Maron, Spirito, Shen, Formisano, Link, Epstein, Almquist, Daubert, Lawrenz, Boriani, Estes, Favale, Piccininno, Winters, Santini, Betocchi, Arribas, Buja, Bruzzi.
Statistical analysis: Haas, Buja, Semsarian, Bruzzi.
Obtained funding: Maron, Spirito.
Administrative, technical, or material support: Maron, Haas, Almquist, Boriani, Winters, Semsarian.
Study supervision: Maron, Spirito, Shen, Link, Epstein, Lawrenz, Boriani, Estes, Betocchi, Sherrid.
Financial Disclosures: Dr Epstein reported serving as a consultant for and having equity holdings in Medtronic. Dr Daubert reported receiving research grants from Biotronik, Boston Scientific/Guidant, Medtronic, and St Jude Medical; receiving speakers fees or honoraria from Boston Scientific/Guidant, Medtronic, and St Jude Medical; and serving as an advisor to Boston Scientific/Guidant and St Jude Medical. No other disclosures were reported.
Funding/Support: This study was funded in part by a grant from Medtronic Inc, which manufactures implantable cardioverter-defibrillators.
Role of the Sponsor: Medtronic Inc provided only support for investigator professional time but had no role in the design and conduct of the study; the collection, analysis, or interpretation of data; or the preparation, review, or approval of the manuscript. Statistical analysis was provided by Paolo Bruzzi, MD, PhD, and his staff, who have no connection with Medtronic Inc.
Participating Centers and Investigators: Minneapolis Heart Institute Foundation, Minneapolis, Minnesota (B.J. Maron, A.K. Almquist, R.G. Hauser); Ente Ospedaliero Ospedale Galliera, Genoa, Italy (P. Spirito, F. Formisano, D. Molini, M. Piccininno); Mayo Clinic, Rochester, Minnesota (W-K Shen, R.F. Rea); New England Medical Center, Boston, Massachusetts (M.S. Link, N.A.M. Estes III); University of Alabama at Birmingham Hospital (A.E. Epstein); University of Rochester Medical Center, Rochester, New York (J.P. Daubert); Universitá di Bologna, Bologna, Italy (G. Boriani, C. Rapezzi); Royal Prince Alfred Hospital and Centenary Institute, Sydney, Australia (C. Semsarian, J. Ingles); Universitá Federico II, Naples, Italy (S. Betocchi); St Luke’s-Roosevelt Hospital Center, New York, New York (M.V. Sherrid, F. Ehlert); University of Padua, Padua, Italy (G. Buja, D. Corrado); Universitá degli Studi di Bari, Bari, Italy (S. Favale, F. Nacci); Children's Hospital of New York–University Hospitals of Columbia and Cornell, New York, New York (R.H. Pass); Genesis Medical Center, Davenport, Iowa (M.C. Giudici); Morristown Memorial Hospital, Morristown, New Jersey (S.L. Winters); UCLA Medical Center, Los Angeles, California (K. Shannon); New York Presbyterian Hospital–Cornell University, New York, New York (B. Lerman); University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (L. Ganz); Hospital 12 Octubre, Madrid, Spain (F. Arribas, M. López Gil); Cedars-Sinai Medical Center, Los Angeles, California (R.J. Siegel); Ospedale S. Filippo Neri, Rome, Italy (M. Santini, R. Ricci, C. Pignalberi); Hospital La Paz, Madrid, Spain (J.L. Merino, R. Peinado); Ospedale S. Camillo, Rome, Italy (F. Laurenzi); Ospedale Niguarda-Cá Granda, Milan, Italy (M. Lunati, M. Paolucci); Hospital Virgen de la Arrixaca, Murica, Spain (A.G. Alberola); Hospital Gregorio Marañón, Madrid, Spain (A. Arenal Maiz); Sheba Medical Center, Tel Hashomer, Israel (M. Glikson, D.M. Luria); Ospedale degli Infermi, Torino, Italy (S. Bongioanni, M.R. Conte); Ospedale Civile, Asti, Italy (R. Massa, M. Bocchiardo); Ospedale Lancisi, Ancona, Italy (F. Capestro, A. Capestro); Ospedale Maggiore della Caritá, Novara, Italy (E. Occhetta); Ospedale S. Raffaele, Milan, Italy (P. Mazzone); Academic Teaching Hospital of University of Muenster, Bielefeld, Germany (T. Lawrenz, H. Kuhn); Ospedale San Gerardo, Monza, Italy (A. Vincenti); Ospedale S. Orsola, Brescia, Italy (A. Marchetti, C. Rusconi); Ospedale Civile di Lavagna, Lavagna, Italy (D. Oddone, M. Brignole); Ospedale di Lucca, Lucca, Italy (M. Masini); Centro Cardiologico Monzino, Milan, Italy (P. Della Bella, C. Carbucicchio); Baylor College of Medicine, Houston, Texas (H-T Shih); Azienda Ospedaliero S. Maria della Misericordia, Udine, Italy (A. Proclemer); Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (P. Bruzzi, L. Boni).
Additional Contributions: Francesco Zanella (Ospedali Galiera, Genoa, Italy) provided database formatting and Luca Boni, PhD (National Institute for Cancer Research, Genoa, Italy), provided statistical consultation and assistance. Neither Mr Zanella nor Dr Boni received compensation for their contributions. As always, we thank Michel Mirowski, MD, and Morton M. Mower, MD, for their pioneering work in conceptualizing and creating the implantable cardioverter-defibrillator for patients with life-threatening cardiac disease.