Johns Hopkins University
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary. Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting. This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.
Pilot studies of approximately 1500 patients, RPN #03-08-12-11 and 00051707 (manuscript submitted) demonstrated the safety of most contemporary implanted rhythm management devices in the MRI environment given appropriate precautions. When pilot studies were developed, there was a theoretical concern that there may be an increased risk associated with some device and device circumstances including: 1) PPM's or leads implanted prior to 1996; 2) ICD's implanted prior to 2000; 3) abandoned or endocardial leads; 4) leads implanted \<6 weeks; 5) ICD's where patient is pacemaker dependent. While it…
Inclusion Criteria: * Patients implanted an ICD or pacemaker who have a clinical need for MR imaging Exclusion Criteria: * Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
Perform MRI in patients with cardiac devices