Background: The growing population of patients with active implantable medical devices (AIMDs) presents challenges for MRI access. Safety concerns regarding device malfunction and patient risk, demand standardized management strategies.
Purpose: To evaluate the safety and feasibility of a structured multidisciplinary safety protocol for 1.5T MRI in AIMD carriers.
Study type: Retrospective.
Population: 514 consecutive patients with AIMDs (cardiac implantable electronic devices (CIEDs) (n = 347), auditory implants (n = 85), neurostimulators (n = 61), and drug delivery systems (n = 21)) scheduled for clinical MRI (head (34.3%), spine (19.0%), prostate (10.5%), abdomen/pelvis (9.5%), knee (8.6%), heart (3.8%), and other sites (14.3%)) between 2019 and 2025.
Field strength/sequence: MRI was performed on 1.5T scanners using predefined protocols, with automatic compliance to device-specific SAR limits through the Philips ScanWise Implant software.
Assessment: The safety protocol included device verification, MRI-mode programming, compliance with manufacturer safety conditions, physiologic monitoring, and post-MRI device interrogation. MRI completion rates, exclusion frequencies, and adverse events were recorded, and exclusion proportions were compared across AIMD categories.
Statistical tests: Descriptive statistics.
Results: Of 514 patients, 50 (9.7%) with MR-unsafe, MR-nonconditional, or artifact-prone devices were not scanned: MR-unsafe (n = 23), MR-nonconditional (n = 22), or anticipated severe artifacts (n = 3). Four hundred and sixty-four (90.3%) patients successfully completed diagnostic MRI. Two brain examinations were terminated early due to implant-site pain. No device resets, malfunctions, or significant changes in sensing/pacing thresholds occurred. Internal magnet displacement was observed in three (3.5%) auditory implants, with two requiring surgical repositioning. Exclusion rates varied by device type, ranging from 11% to 14% for CIEDs to 29% for specific neurostimulators.
Data conclusion: A structured, multidisciplinary protocol enables safe MRI in the majority of patients with MR-conditional AIMDs. Standardized pre-MRI screening and management support safe implementation, and improve MRI accessibility for this growing and complex patient population.
Level of evidence: 4:
Technical efficacy stage: 5.