Background Cardiovascular implantable electronic devices (CIEDs) have historically restricted the use of magnetic resonance imaging (MRI) due to the potential clinical and configurational risks associated with electromagnetic interference. In this study, the authors investigated the impact of MRI on the functional integrity of non‐conditional CIEDs and their clinical correlates. Methods In this prospective, observational single‐center study, we enrolled patients undergoing MRI over a 5‐year period. Prior to assessing the impact of MRI on CIEDs, we performed interrogations in sequential duplication to assess the intrinsic variability of devices. Subsequently, we performed interrogations immediately after MRI, and monitored changes in device parameters and clinical events. Results We completed 492 MRI studies, 58% in patients with permanent pacemakers (PPMs) and 42% with implantable cardioverter defibrillators (ICDs). Subsequent MRI exposures occurred in 15% encounters. Accounting for intrinsic variability in CIED leads, there were no significant changes in RA, RV, or LV parameters after MRI, regardless of the region imaged (thoracic vs. non‐thoracic), type of CIED (PPMs vs. ICDs) and among those with serial MRIs. When ranked for % change pre‐ to post‐MRI, the majority of RA, RV, and LV metrics for thresholds, sensing, and impedance conformed to ≤20% change from baseline. No significant clinical adverse cardiac events or effect on device microcircuitry occurred during the study. Conclusion Incorporating a novel reproducibility tactic, there were neither clinically meaningful device parameter changes nor adverse clinical events during or following MRIs, suggesting the effects of MRI on non‐conditional CIED integrity are far less than previously perceived.
Objective: To evaluate feasibility of MRI in patients with non-pacemaker (PM)/Implantable cardioverter defibrillator (ICD) metallic devices and abandoned leads. Background: Relative safety of MRI performed using specified protocol has been established in MR non-conditional PM/ICDs. With limited safety data, many non-PM/ICD metallic devices and abandoned leads continue to be a contraindication for MRI. Methods: We retrospectively analyzed consecutive patients with extra-cardiac devices, non-programmable cardiac devices, and abandoned leads, who underwent MRI (GE 1.5 Tesla, WI) at a single tertiary care center over a span of 13 years. Scan protocol was designed to maintain specific absorption rate (SAR) < 4.0 W/kg and scan time < 60 minutes. Results: The cohort comprised 127 MRI exams representing 94 patients, with 13 patients having two or more scans. The devices consisted of: 23 vagal nerve stimulators (VNS), 22 implantable loop recorders, 16 spinal stimulators, 5 peripheral nerve stimulators, 3 bladder stimulators, 2 deep brain stimulators, 1 gastric stimulator, 1 bone stimulator, 1 WATCHMAN device, 22 abandoned PM/lCD leads and 1 VNS lead. There was no immediate (peri-MRI exam) morbidity or mortality. Patients did not report any discomfort, palpitations, heating, or sensation of device migration during the exam. Local follow-up data was available in 65% (100% for thoracic imaging) with a mean of 190 ± 475 days (median 13 days). No device malfunction was reported during follow-up. Conclusions: With appropriate precautions, MRI is feasible in patients with extracardiac devices, nonprogrammable cardiac devices, and abandoned leads.
Introduction: Over the last decade substantial efforts have been aimed at improving acceptability of pacemakers and ICDs in the MRI. Many labs have evaluated the construction, safety, efficacy, reproducibility and more recently, clinical impact value in such legacy devices. In parallel, there has been extensive effort by major vendors to develop safe MRI compatible devices. To date, there remains few reasons for hesitation in universal use of any PM/ICD in the MRI bore. However, mixing vendor leads and generators remains a major hurdle limiting MRI usage. Hypothesis: Mixed leads and generators has no distinct safety signal from common devices; whether CIED or non-CIED. Methods: We undertook a retrospective DB analysis to determine safety signals in those pts possessing mixed vendor leads and devices. Comparisons of impedance, amplitude, threshold and battery voltage and patient safety etc. were performed. Results: Pts from 5/2010 to 5/2022, representing 1739 pts with CIED (81%) and non-CIED (19%) underwent an MRI in a dedicated CMR Lab. The majority of the mixed cohort were obtained from the non-CIED population (>98%), not having need for generator replacement. Accordingly, 11% of these underwent an MRI to include: 73% neurologic, 8% orthopedic and 19% cardiac indications. In comparison of safety signals between standard and mixed lead/generator implants, there were no differences in any implant parameters either pre-MRI study or post-interrogation (p=NS). Similarly, there were no peri-MRI pt events or reported in the 30d and 180d post-MRI scan (p=NS). Importantly, especially for EP considerations, there were no added complications to interrogations. Moreover, utilizing a similar approach to manipulation of MRI parameters for maximum safety intrinsic to dependent/non-dependent PM status was employed regardless of lead/generator configuration yielding no complications. Conclusions: Employing a similar approach to MRI scanning in those pts with mixed vendor lead/generator configurations yielded no difference in a multitude of safety, interrogation, devices and efficacy parameters. This reassurance suggests, despite inherent incompatibility concerns between vendors while in the magnetic field, no such fears are truly warranted.
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