MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results.

OBJECTIVES: A prospective, multicenter study was performed to assess the safety and efficacy of the Durata and Optisure HV leads and the Ellipse VR implantable cardioverter-defibrillator (ICD) (St. Jude Medical, Sylmar, California) in a 1.5-T magnetic resonance imaging (MRI) environment. The primary safety objective was >90% freedom from MRI scan-related complications. The primary efficacy objectives were absence of change in capture threshold and absence of decrease of sensing amplitude from pre-MRI examination to 1 month after MRI. BACKGROUND: MRI scanning of patients has been shown to be safe in patients with magnetic resonance-conditional implantable cardioverter-defibrillators (ICD) systems. METHODS: Patients with a previously implanted magnetic resonance-conditional system underwent a nondiagnostic MRI scan. After the scan, a questionnaire was given to investigators and patients who returned for 1-month follow-up examination. A subset of patients underwent ventricular tachyarrhythmia or ventricular fibrillation (VT/VF) induction testing after the MRI to evaluate defibrillation function. RESULTS: There were 220 patients (81% male; 62.1 ± 11.2 years of age) enrolled who received an MRI scans from 29 centers. All primary safety and efficacy endpoints were met (p < 0.0001). No significant detection delays were found in 34 patients who had VT/VF episodes after the MRI scan was performed. Most physicians reported easy and acceptable programming and ease of MRI scheduling. CONCLUSIONS: The MRI Ready MRI-conditional ICD system is safe, and electrical performance was not affected in patients receiving a 1.5-T whole-body MRI scan. Investigators reported favorable collaboration between cardiologists and radiologists in the MRI Ready IDE clinical trial. (A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study [MRI Ready IDE]; NCT02787291).

Patients with an ICD can safely resume work in industrial facilities following simple screening for electromagnetic interference.

Patients with ICDs are commonly advised to quit industrial jobs because of concerns that strong electromagnetic fields operating in the industrial environment might interfere with ICD functions. This study was done to assess interactions between industrial equipment and ICDs, and to devise a simple low risk screening protocol. We studied 18 patients carrying nine different ICD models who were met at their workplace by a clinical technician and were asked to walk through their workplace and perform typical duties while sensing status was monitored by listening to the ICD's beeper. All devices were interrogated at the completion of testing. At follow-up, patients were contacted by phone and were asked about employment status and history of ICD discharges or syncope. One hundred eighty-four contacts with 114 types of industrial equipment in 13 different industrial facilities (including 31 contacts with arc welding machines) were monitored. Interference with ICD's function occurred in only one contact (0.5%), when ICD therapy was temporarily suspended while a worker was attaching a huge electromagnet to a crane. At follow-up 46.0 +/- 6.0 months after testing, 7 patients (41%) are still holding the same job, 7 have retired because of reasons unrelated to their ICD, and 3 patients were transferred to a nonindustrial job. None of the patients had either an ICD shock or syncope during work. The use of a simple screening procedure can safely identify sources of electromagnetic interference that may affect ICD operation, and can predict long-term safety of working in an industrial workplace for ICD patients.