Khaled Awad1, John Griffin2, Thomas C Crawford3, S Lane Cox4, Kevin Ferrick5, Alexander Mazur6, Rafael E Pena7, Steven G Lloyd8, Justin Michalski9, Whitney Johnson9, William M Bailey10. 1. University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: kawad@uabmc.edu. 2. Chesapeake Regional Medical Center, Chesapeake, Virginia. 3. University of Michigan, Ann Arbor, Michigan. 4. Cardiology Center of Amarillo, Amarillo, Texas. 5. Montefiore Medical Center, Bronx, New York. 6. University of Iowa Hospitals and Clinics, Cardiology, Iowa City, Iowa. 7. St. Mary Medical Center, Langhorne, Pennsylvania. 8. University of Alabama at Birmingham, Birmingham, Alabama. 9. Biotronik, Inc, Lake Oswego, Oregon. 10. Louisiana Heart Rhythm Specialists and Lafayette General Medical Center, Lafayette, Louisiana.
Abstract
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE: The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. METHODS: Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. RESULTS: One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. CONCLUSION: These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE: The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. METHODS:Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. RESULTS: One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. CONCLUSION: These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.
Authors: Rainer Zbinden; Christian Wollmann; Johannes Brachmann; Jochen Michaelsen; Clemens Steinwender; Pramesh Kovoor; Sebastian Kelle; Andrew D McGavigan; Chi Keong Ching; Gemma A Figtree; Jan Schmidt; Tobias Timmel; Joachim Lotz Journal: Europace Date: 2019-11-01 Impact factor: 5.214
Authors: Wolfgang Rudolf Bauer; Dennis H Lau; Christian Wollmann; Andrew McGavigan; Jacques Mansourati; Theresa Reiter; Simone Frömer; Mark E Ladd; Harald H Quick Journal: Sci Rep Date: 2019-12-03 Impact factor: 4.379