Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective Monocenter XXXX -Magnetic resonance Imaging feasibility study (MIMI).

@entity737 @entity1
BACKGROUND: The aim of this study was to evaluate the safety and efficacy of the Lumax 740(  ) @entity737 ( @entity737 ) system in @entity1 undergoing a defined 1.5 Tesla (T) MRI. MATERIALS AND METHODS: Between November 2013 and April 2014, eighteen @entity1 (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740(  ) @entity737 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 @entity1 gave written informed consent. @entity1 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   <   50%, or of an R-wave amplitude   <   5.0 mV at 1-month follow-up. The assessment of safety and efficacy was supported by recording of all adverse events, changes in pacing threshold, R-wave sensing, pacing impedances and in battery status. RESULTS: Sixteen @entity1 completed the MRI and the follow-up period. As no SADE occurred, the SADE free rate was 100%. Freedom from ventricular pacing threshold increase was 100% (16/16; 95%CI: 82.9%; 100.0%). There were no significant differences between baseline and follow-up measurements of sensing amplitudes (-0.58        2.07 mV, P   =   0.239, -0.41        1.04 mV, P   =   0.133, and -0.25        1.36 mV, P   =   0.724, for immediately after, 1 month and 3 months after MRI scan, respectively) and pacing thresholds (-0.047        0.18   V, P   =   0.317, -0.019        0.11   V, P   =   0.490, and 0.075        0.19   V, P   =   0.070, for immediately after, 1 month and 3 months after MRI scan, respectively). Lead impedances after the MRI scan were significantly lower as compared with baseline values (-22.8        21.69   , P   =   0.001, -21.62        39.71   , P   =   0.040, and -33.68        57.73   , P   =   0.018, for immediately after, 1 month and 3 months after MRI scan, respectively). CONCLUSION: MRI scans in @entity1 with MRI conditional @entity737 system (Lumax 740(  ) ) are feasible and can be performed safely under defined conditions in a hospital setting.J. Magn. Reson. Imaging 2015. J. MAGN. RESON. IMAGING 2016;43:574-584.
