Abstract 11884: MRI and ICDs or Pacemakers After Magnsafe
Introduction: The MagnaSafe registry was a prospective study that examined cardiac implantable electronic devices (CIED) parameter changes when exposed to non-thoracic MRI scanning. This registry data showed that MRI scans in patients with a CIED can be performed safely. Ongoing real-word data that encompasses newer CIED technologies are required to further understand outcomes of non-MRI conditional CIED parameters after exposure to 1.5 Tesla extra-thoracic MRI. These data are especially pertinent as the REPLACE trial showed a 4% (without leads) and 15% (with leads) risk of major complications with upgrade to a MRI conditional device.
Methods: We prospectively examined 152 patients with either a pacemaker or ICD who underwent MR imaging between 2-12-2014 date and 3-15-2016 dates using a General Electric 1.5 Tesla model Optima MR450w scanner. Ambient temperature was set at 19° C. Pacing modes during MRI were 0D0 for intrinsic rates >40 and D00 for rates ≤40. All patients were cleared prior to scan by both Radiology and Cardiology per our in-house developed standard protocol with pre- and post-MRI CIED interrogation. Primary outcomes were death, generator or lead failure. Secondary outcomes were a battery voltage loss of >0.04 V, decrease in P wave voltage of >50% and R wave voltage of >25%, a threshold increase of >0.5 V, and an impedance change of >50 Ω.
Results: 181 scans were performed in 50(28%) patients with pacemakers and 131(72%) patients with ICDs. A summary of vendor and device type is listed. No patients experienced a primary or secondary outcome, regardless of whether the device was MRI-conditional. By design, each patients underwent a post MRI device interrogation there were no parameter changes seen or device complications.
Conclusions: Real-world ongoing device surveillance at Intermountain Medical Center using the MagnaSafe registry approach and endpoint to demonstrate that 1.5 Tesla extra-thoracic MRI scanning is safe in patients with all forms of CIED, regardless of whether the device was MRI conditional.. This data extend to newer Bi-V technologies and lead designs as well as subcutaneous ICDs. This data continue to support that clinically-indicated MRI tests need not be withheld in patients with CIEDs.
Author Disclosures: S. Mason: None. A. Tonkin: None. J.S. Osborn: None. J. Ethington: None. J.L. Anderson: None. R. Dhar: None. T.J. Bunch: None. D.L. Lappé: None. V.T. Le: None. K.U. Knowlton: None.
- © 2016 by American Heart Association, Inc.