Monocenter feasibility study of the MRI compatibility of the Evia pacemaker in combination with Safio S pacemaker lead

Background: the purpose of this study was to evaluate the feasibility of the magnetic resonance (mr) conditional pacemaker (pm) system (evia sr-t and dr-t with safio s leads) under mr conditions. methods. patients with standard pm indications and evia pm were eligible for enrollment in this single center prospective non-randomized pilot study. patients underwent mr of the brain and lower lumbar spine at 1.5 tesla. atrial (ra) und ventricular (rv) lead parameters (sensing,pacing threshold [pth],pacing impedance) were assessed immediately before (baseline follow-up [fu]) and immediately after mri (1 st fu),after 1 month (2nd fu) and 3 months (3 rd fu). the effect of mr on serious adverse device effect (sade) free-rate,on atrial and ventricular sensing (as/vs; mv) and atrial (ra) and ventricular (rv) pacing thresholds (pth; v/0.4 ms) were investigated between baseline and 2nd fu. continuous variables are expressed as meansd and were compared using paired students t-test. a p<0.05 was considered significant. results: thirty-one patients were enrolled. one patient had to be excluded because of an enrollment violation. therefore,data of 30 patients (female 12 [40%],age 7312 years,dual chamber pm 15 [50%]) were included in this analysis. no mr related sade occurred. lead measurements were not statistically different between the baseline fu and the 2nd fu (as/vs at baseline 3.22.1/15.06.0,at 2nd fu 3.22.1/14.96.5; p=ns. ra-pth/rv-pth at baseline 0.680.18/0.780.22,at 2nd fu 0.710.24/0.780.22; p=ns). the presence of the permanent pacemakers led to mr imaging artifacts on diffusion weighted sequences of the brain,but did not affect other sequences (e.g. flair and t2 weighted spin-echo images). conclusion: the use of the mr conditional evia pm in a mr environment under predefined conditions is feasible. no mr related sades nor clinically relevant changes in device functions occurred. © 2012 wollmann et al.; licensee biomed central ltd.