title: MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results.
abstract: BACKGROUND
  Magnetic resonance imaging (MRI) can be safely performed in patients with magnetic resonance (MR)-conditional pacemaker systems but remains relatively contraindicated with non-MR-conditional pacemaker systems.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the safety of MRI without positioning restrictions in patients with an MR-conditional pacemaker and currently a non-MR-conditional Medtronic CapSureFix Novus 5076 lead(s).
  
  
  METHODS
  The study randomized 266 patients in a 2:1 ratio to the MRI group (177 patients) or to the control group (89 patients). At 9-12 weeks postimplant, the MRI group underwent MRI at 1.5 T. Primary end points were MRI-related complication-free rate and noninferiority of the MRI group compared to the control group with regard to the proportion of patients with an increase of ≤0.5 V in right atrial (RA) and right ventricular (RV) pacing capture thresholds from immediately before MRI to 1-month after MRI.
  
  
  RESULTS
  No MRI-related complications occurred in 156 MRI-scanned patients who were followed through 1-month post-MRI. Differences in the proportion of patients with ≤0.5 V pacing capture threshold changes from pre-MRI to 1-month post-MRI were minimal between the groups for RA (proportions of 100% in both groups; a P value cannot be calculated) and RV leads (proportions of 99.3% in the MRI group and 100% in the control group; noninferiority test, P < .0001). Proportions of patients with acceptable sensing amplitude changes from pre-MRI to 1-month post-MRI were also similar between the 2 groups for RA and RV leads (noninferiority test, P < .0001 and P = .0004, respectively). No arrhythmias occurred during MRI.
  
  
  CONCLUSIONS
  MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.
authors.affiliation: Electrophysiology Unit, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, India. Electronic address: jshenthar@yahoo.com.
authors.forename: Jayaprakash
authors.initials: J
authors.lastname: Shenthar
authors.affiliation: Pacemaker Center, Clinical Center of Serbia, Belgrade, Serbia.
authors.forename: Goran
authors.initials: G
authors.lastname: Milasinovic
authors.affiliation: Prince Sultan Cardiac Center, Riyadh, Saudi Arabia.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Al Fagih
authors.affiliation: Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Götte
authors.affiliation: Silicon Valley Cardiology, East Palo Alto, California.
authors.forename: Gregory
authors.initials: G
authors.lastname: Engel
authors.affiliation: Carnegie Hill Radiology, New York, New York.
authors.forename: Steven
authors.initials: S
authors.lastname: Wolff
authors.affiliation: Queen Mary Hospital, Hong Kong, China.
authors.forename: Hung-Fat
authors.initials: HF
authors.lastname: Tse
authors.affiliation: Medtronic, Inc, Minneapolis, Minnesota.
authors.forename: Julie
authors.initials: J
authors.lastname: Herr
authors.affiliation: Medtronic, Inc, Minneapolis, Minnesota.
authors.forename: John
authors.initials: J
authors.lastname: Carrithers
authors.affiliation: Medtronic, Inc, Minneapolis, Minnesota.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Cerkvenik
authors.affiliation: Department of Radiology, University of Bonn, Bonn, Germany.
authors.forename: Claas Philip
authors.initials: CP
authors.lastname: Nähle
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000379:methods; D019719:Diagnostic Equipment / Q000009:adverse effects; D004869:Equipment Safety / Q000379:methods; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D016896:Treatment Outcome