Safety of magnetic resonance imaging in patients with cardiac implantable electronic devices with generator and lead(s) brand mismatch

Abstract

Magnetic resonance imaging (MRI) is a valuable imaging modality for the assessment of both cardiac and non‐cardiac structures. With a growing population of patients with cardiovascular implantable electronic devices (CIEDs), 50%–75% of these patients will need an MRI. MRI‐conditional CIEDs have demonstrated safety of MRI scanning with such devices, yet non‐conditional devices such as hybrid CIEDs which have generator and lead brand mismatch may pose a safety risk. In this retrospective study, we examined the outcomes of patients with hybrid CIEDs undergoing MRI compared to those patients with non‐hybrid CIEDs. A total of 349 patients were included, of which 24 patients (7%) had hybrid CIEDs. The primary endpoint was the safety of MRI for patients with hybrid CIEDs as compared to those with non‐hybrid devices, measured by the rate of adverse events, including death, lead or generator failure needing immediate replacement, loss of capture, new onset arrhythmia, or power‐on reset. Secondary endpoints consisted of pre‐ and post‐MRI changes of decreased P‐wave or R‐wave sensing by ≥50%, changes in pacing lead impedance by ≥50 ohms, increase in pacing thresholds by ≥ 0.5 V at 0.4 ms, and decreasing battery voltage of ≥ 0.04 V. The primary endpoint of any adverse reaction was present in 1 (4.2%) patient with a hybrid device, and consistent of atrial tachyarrhythmia, and in 10 (3.1%) patients with a non‐hybrid device, and consisted of self‐limited atrial and non‐sustained ventricular arrhythmias; this was not statistically significant. No significant differences were found in the secondary endpoints. This study demonstrates that MRI in patients with hybrid CIEDs does not result in increased patient risk or significant device changes when compared to those patients who underwent MRI with non‐hybrid CIEDs.

SCMR expert consensus statement for cardiovascular magnetic resonance of patients with a cardiac implantable electronic device

“…The CIED system as a whole, even if individual components are classified as MR-conditional, may fall outside of labeling if the patients have mismatched CIED-lead vendors. As shown in Table 1 , a combined prospective/retrospective study with 246 generator models, 210 lead models and 638 unique generator-lead combinations published by Bhuva et al reported no increased risk of MRI in patients with mismatched device-lead vendors compared to those with matched vendors [35] ; this study was consistent with a smaller previous study [36] . While these two initial studies are encouraging, it should be noted that they do not cover all potential combinations/permutations of such mismatches.…”

Cardiac Magnetic Resonance Imaging for the Diagnosis of Infective Endocarditis in the COVID-19 Era

“…26 , 27 , 28 For limitations related to CIEDs, recent studies demonstrate that CMR in non-MRI-conditional systems, including those with hybrid configurations, is feasible and safe without clinically meaningful device parameter changes or adverse events. 29 , 30 Though, abandoned leads remain a challenge. 31 , 32 , 33 , 34 Recent advances in wideband LGE protocols, for both segmented and single-shot sequences, have demonstrated efficacy in accurately reducing device-related artifact, particularly with transvenous ICDs and cardiac resynchronization therapy devices.…”