Monocenter feasibility study of the MRI compatibility of the Evia pacemaker in combination with Safio S pacemaker leadReport as inadecuate




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Journal of Cardiovascular Magnetic Resonance

, 14:67

First Online: 25 September 2012Received: 15 March 2012Accepted: 17 August 2012

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 1 FU, after 1 month 2 FU and 3 months 3 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 2 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 2 FU AS-VS at baseline 3.2 ± 2.1-15.0 ± 6.0, at 2 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 2 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.

KeywordsPacemaker Magnetic resonance Adverse events Follow-up Remote monitoring AbbreviationsAEAdverse event

CABGCoronar artery bypass grafting

CEEuropean conformity

DRDual chamber rate responsive

ECGElectrocardiogram

FrFrench

FUFollow-up

IEGMIntracardiac electrogram

KgKilogramms

MRMagnetic resonance

MRIMagnetic resonance imaging

MsMilliseconds

mVMillivolts

PMPacemakers

PTHPacing threshold

RFRadio frequency

RARight atrial

RVRight ventricular

RVOTRight ventricular outflow tract

SADESystem related serious adverse device effect

SARSpecific absorption rate

SDStandard deviation

SRSingle chamber rate responsive

VVolts

VPVentricular pacing

VTVentricular tachycardia

WWatts.

Electronic supplementary materialThe online version of this article doi:10.1186-1532-429X-14-67 contains supplementary material, which is available to authorized users.

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Author: Christian G Wollmann - Erich Steiner - Paul Vock - Bonaventure Ndikung - Harald Mayr

Source: https://link.springer.com/article/10.1186/1532-429X-14-67







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