%0 Journal Article
%T Monocenter feasibility study of the MRI compatibility of the Evia pacemaker in combination with Safio S pacemaker lead
%A Wollmann Christian G
%A Steiner Erich
%A Vock Paul
%A Ndikung Bonaventure
%J Journal of Cardiovascular Magnetic Resonance
%D 2012
%I BioMed Central
%R 10.1186/1532-429x-14-67
%X 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 (1st FU), after 1 month (2nd FU) and 3 months (3rd 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 mean ¡À SD and were compared using paired Student¡¯s 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 73 ¡À 12 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 3.2 ¡À 2.1/15.0 ¡À 6.0, at 2nd FU 3.2 ¡À 2.1/14.9 ¡À 6.5; p = ns. RA-PTH/RV-PTH at baseline 0.68 ¡À 0.18/0.78 ¡À 0.22, at 2nd FU 0.71 ¡À 0.24/0.78 ¡À 0.22; 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.
%K Pacemaker
%K Magnetic resonance
%K Adverse events
%K Follow-up
%K Remote monitoring
%U http://www.jcmr-online.com/content/14/1/67