Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices

Abstract

Purpose: To explore the safety and clinical utility of MRI in participants with non-MRI-conditional cardiac implantable electronic devices, by establishing the Patient Registry of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe).

Materials and methods: From September 2015 to June 2019, 532 participants (211 women) with a mean age of 69 years ± 14 (standard deviation) were enrolled prospectively in the PROMeNADe registry (ClinicalTrials.gov identifier: NCT03081364) and underwent a total of 608 MRI examinations (61 cardiac MRI examinations). All participants had device interrogations performed before and after each MRI. Pacemaker-dependent patients received asynchronous pacing. Patients with an implantable cardioverter defibrillator (ICD) had tachycardia therapies disabled during the MRI. An electrophysiology nurse monitored participants for any hemodynamic or rhythm abnormalities. Referring physicians were surveyed regarding the clinical utility of the MRI. Standard descriptive analyses included summary statistics with percentages and means.

Results: Cardiac devices included pacemakers (46%), ICDs (30%), cardiac resynchronization therapy (CRT) pacemakers (4%), and CRT defibrillators (17%), as well as abandoned leads (2%). Pacemaker-dependent patients comprised 27% of all MRI examinations. There were no patient- or device-related complications. Clinical utility surveys of MRI examinations were completed by 150 physicians. According to the survey responses, these MRI examinations changed the suspected diagnosis 25% of the time and changed suspected prognosis in 26% of participants, with planned medical or surgical treatment being changed 42% of the time.

Conclusion: This registry demonstrates that MRI examinations, including thoracic MRI examinations, can be performed safely in patients who have non-MRI-conditional devices, in pacemaker-dependent patients with ICDs, and in patients with abandoned leads. These MRI examinations can have a substantial impact on patient care, justifying the extensive resources used to perform them.Supplemental material is available for this article.© RSNA, 2020See also the commentary by Peshock in this issue.

Conflict of interest statement

Disclosures of Conflicts of Interest: S.K.G. disclosed no relevant relationships. L.Y. disclosed no relevant relationships. A.P.W. disclosed no relevant relationships. S.F. disclosed no relevant relationships. I.M.S. disclosed no relevant relationships.

2020 by the Radiological Society of North America, Inc.

Figures

Figure 1:

Flowchart demonstrates algorithm of patient enrollment and protocol for device evaluation and programming. BP = blood pressure, ECG = electrocardiogram, ICD = implantable cardioverter defibrillator, PVC = premature ventricular contraction, VOO/DOO = asynchronous pacing, VVI/DDI = inhibited pacing.

Figure 2:

The Patient Registry of Magnetic Resonance Imaging in Non-Approved DEvices survey form sent to referring physicians. The referring physician could select more than one option when answering the fourth question in the survey.

Figure 3:

MRI examinations in patients with non–MRI-conditional cardiac implantable electronic devices according to the referring physician by specialty.

Figure 4:

Chest radiograph, posteroanterior view, in a 64-year-old woman with history of heart transplantation, demonstrates retained portion of right ventricular pacing lead and defibrillator lead with superior vena cava coil. This patient underwent five MRI examinations as part of this registry.

Figure 5:

MRI examinations in patients with non–MRI-conditional cardiac implantable electronic devices and abandoned leads according to reason for lead abandonment. OHT = orthotopic heart transplant.

Figure 6:

Chest radiograph, posteroanterior view, in an 85-year-old woman with history of previous pacemaker that was explanted and retained right ventricular pacing lead. There is evidence of vertebroplasties at multiple levels.

Figure 7:

Chest radiograph, posteroanterior view, in a 79-year-old man with history of previous pacemaker, with abandoned right atrial and right ventricular pacing leads on the right side at time of new cardiac resynchronization therapy defibrillator implant on the left side. Arrows indicate a nodular opacity in the right midlung concerning for mass.

Figure 8:

Chest radiograph, anteroposterior view, in a 76-year-old man with history of previous abdominal cardiac resynchronization therapy defibrillator that was explanted, with retained right ventricular defibrillator lead, coronary sinus lead, and an epicardial patch.

Figure 9a:

(a-b) Description of survey responses regarding diagnostic utility and prognostic utility (a) as well as impact on treatment plans (b) for patients undergoing cardiac and noncardiac MRI examinations in the presence of nonconditional cardiac implanted electronic devices. CMR = cardiac MRI.

Figure 9b:

(a-b) Description of survey responses regarding diagnostic utility and prognostic utility (a) as well as impact on treatment plans (b) for patients undergoing cardiac and noncardiac MRI examinations in the presence of nonconditional cardiac implanted electronic devices. CMR = cardiac MRI.