Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy-defibrillators incorporating quadripolar left ventricular leads

Abstract

Background: Magnetic resonance imaging (MRI) scanning of magnetic resonance (MR)-conditional cardiac implantable cardioverter-defibrillators (ICDs) can be performed safely following specific protocols. MRI safety with cardiac resynchronization therapy-defibrillators (CRT-Ds) incorporating quadripolar left ventricular (LV) leads is less clear.

Objective: The purpose of this study was to evaluate the safety and effectiveness of ICDs and CRT-D systems with quadripolar LV leads after an MRI scan.

Methods: The ENABLE MRI Study included 230 subjects implanted with a Boston Scientific ImageReady ICD (n = 39) or CRT-D (n = 191) incorporating quadripolar LV leads undergoing nondiagnostic 1.5-T MRI scans (lumbar and thoracic spine imaging) a minimum of 6 weeks postimplant. Pacing capture thresholds (PCTs), sensing amplitudes (SAs), and impedances were measured before and 1 month post-MRI using the same programmed LV pacing vectors. The ability to sense/treat ventricular fibrillation (VF) was assessed in a subset of patients.

Results: A total of 159 patients completed a protocol-required MRI scan (MRI Protection Mode turned on) with no scan-related complications. All right ventricular (RV) and left LV PCT and SA effectiveness endpoints were met: RV PCT 99% (145/146 patients), LV PCT 100% (120/120), RV SA 99% (145/146), and LV SA 98% (116/118). In no instances did MRI result in a change in pacing vector or lead revision. All episodes of VF were appropriately sensed and treated.

Conclusion: This first evaluation of predominantly CRT-D systems with quadripolar LV leads undergoing 1.5-T MRI confirmed that scanning was safe with no significant changes in RV/LV PCT, SA, programmed vectors, and VF treatment, thus suggesting that MRI in patients having a device with quadripolar leads can be performed without negative impact on CRT delivery.

Trial registration: ClinicalTrials.gov NCT02652481.

Keywords: Cardiac resynchronization therapy; Implantable cardioverter-defibrillator; Magnetic resonance imaging; Quadripolar lead; Ventricular fibrillation.