ABSTRACT
OBJECTIVES: This global, multicenter, prospective study, initiated to meet U.S. Food and Drug Administration condition-of-approval requirements, evaluated the safety and efficacy of the Medtronic magnetic resonance imaging (MRI)-conditional pacing system when used in an MRI environment in routine clinical practice. The primary endpoint was MRI-related complications. The secondary endpoint was the cumulative change in pacing capture threshold (PCT) for patients undergoing multiple MRI scans. BACKGROUND: Large-scale, real-world evaluation of MRI in patients implanted with an MRI-conditional pacing system remains limited, with few published data for patients who undergo multiple MRI scans. METHODS: Patients were enrolled and followed up prospectively from the time of implantation. Evaluation of the pacemaker function was performed before and after MRI. The MRI-related complication-free rate was evaluated. Changes in electrical performance after each scan and cumulative changes over multiple scans were analyzed. RESULTS: In 81 centers, 2,629 patients were implanted with a complete SureScan pacing system (41.8% women, age 70.2 ± 12.5 years). A total of 526 patients (28.5%) received 872 clinically indicated MRI scans, including 58 thoracic scans. No MRI-related complications occurred during or after MRI, meeting the primary objective. Six (1%) MRI-related observations (atrial fibrillation, PCT increase, and chest symptoms) were reported. A total of 171 patients (32.5%) underwent 2 or more scans with no cumulative increase in PCT. CONCLUSIONS: This report constitutes the largest longitudinal MRI experience in patients implanted with an MRI-conditional pacing system. Results support the safety profile of the SureScan system and demonstrate for the first time that patients may safely undergo multiple MRI scans. (SureScan Post-Approval Study; NCT01299675).
Subject(s)
Cardiac Pacing, Artificial/methods , Magnetic Resonance Imaging/adverse effects , Pacemaker, Artificial/adverse effects , Aged , Aged, 80 and over , Atrial Fibrillation/complications , Atrial Fibrillation/therapy , Canada , Cardiac Pacing, Artificial/statistics & numerical data , Equipment Design , Equipment Safety , Female , Follow-Up Studies , Humans , India , Magnetic Resonance Imaging/methods , Male , Middle Aged , Prospective Studies , United States , United States Food and Drug AdministrationABSTRACT
With a burgeoning population, increases in life expectancy, and expanding indications, the number of patients with cardiac devices such as pacemakers and implantable cardioverter defibrillators continues to increase each year. A majority of these patients will develop an indication for magnetic resonance imaging (MRI) in their lifetime. MRIs have established themselves as one of the most powerful imaging tools for a variety of conditions. However, given the historic safety concerns, many physicians are reluctant to use MRIs in this patient population. In this paper, we discuss the potential adverse effects of MRIs in patients with cardiac devices, review key studies that have addressed strategies to limit adverse effects, and provide our cardiovascular MRI laboratory's protocol for imaging patients with implanted cardiac devices.