Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective M onocenter I CD- M agnetic resonance I maging feasibility study (MIMI)

Background The aim of this study was to evaluate the safety and efficacy of the Lumax 740 super( registered ) Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI. Materials and Methods Between November 2013 and April 2014, eighteen patients (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740 super( registered ) ICD system for at least 6 weeks before an MRI were enrolled into this single-center feasibility study. The local ethics committee approved the study before patients gave written informed consent. Patients underwent defined MRI 1.5T of the brain and lower lumbar spine with three safety follow-up evaluations obtained during the 3-month study period. Data were analyzed descriptively. Study endpoints were the absence of either MRI and pacing system related serious adverse device effects (SADE), or of a ventricular pacing threshold increase >0.5V, or of an R-wave amplitude attenuation