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

Abstract

BackgroundThe 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.MethodsPatients 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 ± SD and were compared using paired Student’s t-test. A p < 0.05 was considered significant.ResultsThirty-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 ± 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 ± 2.1/15.0 ± 6.0, at 2nd FU 3.2 ± 2.1/14.9 ± 6.5; p = ns. RA-PTH/RV-PTH at baseline 0.68 ± 0.18/0.78 ± 0.22, at 2nd FU 0.71 ± 0.24/0.78 ± 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).ConclusionThe 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.

Preliminary findings on the safety of 1.5 and 3 Tesla magnetic resonance imaging in cardiac pacemaker patients

“…The first prospective studies looking at the safety of MRI scanning of device patients date back the early 2000s, whereas the study on pacing system specifically designed for MR conditional scanning was published in 2011 . Further studies were done in support of new MR conditional systems from other manufacturers proving safety and effectiveness of the MR conditional systems. However, current experience with newer MRI‐compatible PMs is still limited, with implant numbers for MRI‐certified devices and experience with MRI scans still low for the new 3T MRI systems …”

“…New generations of implantable pacemakers (PMs) have been designed to allow patients to safely undergo MRI provided that specific conditions are verified during the scan (MR conditional pacing systems). Since the release of the first MR conditional system, clinical studies report satisfactory results concerning safety and effectiveness of these systems in terms of device performance and patient safety . However, recent evolution of MRI system from the 1.5 Tesla(T) to the 3T technology, with stronger magnetic fields and gradients, has imposed the need to verify that existing implantable device are safe under more compelling criteria …”

“…Even though MRI scans in PM patients are performed for clinical purposes in an increasing number of subjects, studies with data reporting compliance with MR conditions of use are currently limited . INFINITE‐MRI I and II are two studies designed to provide confirmatory evidence of safety and performance of two MR conditional system (ImageReady™, Boston Scientific, St Paul, MN, USA) designed for use in the MRI environment, (Ingenio™ pulse generators/Fineline II leads, for 1.5T MRI and Accolade™ pulse generator/Ingevity leads, for 3T MRI) in patients undergoing MRI under the labeled conditions of use.…”

Not All Pacemakers Are Created Equal: MRI Conditional Pacemaker and Lead Technology

“…Scan zone restrictions exist and the license permits MRI scanning above the level of the eyes and below the level of the greater trochanters only (Fig. ) . A potential drawback to the ProMRI series is the permitted scan time duration.…”

Review of Journal of Cardiovascular Magnetic Resonance 2012

“…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 [179]. Patients with standard PM indications and Evia PM were eligible for enrollment in this single center prospective non-randomized pilot study.…”