title: Assessing access to MRI of patients with magnetic resonance-conditional pacemaker and implantable cardioverter defibrillator systems: the Really ProMRI study design.
abstract: BACKGROUND
  Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI.
  
  
  METHODS
  The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents.
  
  
  CONCLUSIONS
  The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.
authors.affiliation: aCardiology - Coronary Care Unit, Pugliese-Ciaccio Hospital, Catanzaro bElectrophysiology department, Spedali Civili, P.le Spedali Civili 1, Brescia cDepartment of Cardiology, S. Maria D.A. Hospital, Via Montereale 24, Pordenone dCardiology Department, A.O.U. Pol. Universitario di Bari, Piazza G. Cesare 11, eCardiology Department, Ente Ecclesiastico Miulli General Regional Hospital, SP 127 Acquaviva-Santeramo km 4, Acquaviva delle Fonti, Bari fDepartment of Cardiology II, Circolo e Fondazione Macchi Hospital, V.le Borri 57, Varese gCardiology Department, P.O. F. Ferrari, Via F. Ferrari, Casarano (Le) hDepartment of Cardiology I, Circolo e Fondazione Macchi Hospital, V.le Borri 57, Varese iClinical Office, Biotronik Italia S.p.a., V.le delle Industrie 11, Vimodrone (MI), Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Maglia
authors.forename: Antonio
authors.initials: A
authors.lastname: Curnis
authors.forename: Marco
authors.initials: M
authors.lastname: Brieda
authors.forename: Matteo
authors.initials: M
authors.lastname: Anaclerio
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Caccavo
authors.forename: Paolo
authors.initials: P
authors.lastname: Bonfanti
authors.forename: Donato
authors.initials: D
authors.lastname: Melissano
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Caravati
authors.forename: Lisa
authors.initials: L
authors.lastname: Giovene
authors.forename: Alessio
authors.initials: A
authors.lastname: Gargaro
mesh_terms: D017147:Defibrillators, Implantable; D055590:Electromagnetic Phenomena; D006321:Heart / Q000503:physiopathology; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D010138:Pacemaker, Artificial; D012042:Registries; D012107:Research Design