Author + information
- Received December 10, 2018
- Revision received May 9, 2019
- Accepted May 13, 2019
- Published online June 26, 2019.
- Saman Nazarian, MD, PhDa,∗ (, )
- Daniel J. Cantillon, MDb,
- Pamela K. Woodard, MDc,
- Theofanie Mela, MDd,
- Adam M. Cline, MD, MSce,
- Adam S. Strickberger, MDf,
- on behalf of the MRI Ready Investigators
- aCardiac Physiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PennsylvaniaCardiac Physiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
- bHeart and Vascular Institute, Cleveland Clinic FoundationHeart and Vascular Institute, Cleveland Clinic Foundation
- cMallinckrodt Institute of Radiology, Washington University School of MedicineMallinckrodt Institute of Radiology, Washington University School of Medicine
- dCardiac Arrhythmia Service, Harvard Medical SchoolCardiac Arrhythmia Service, Harvard Medical School
- eCardiac Arrhythmias and Heart Failure, Abbott LaboratoriesCardiac Arrhythmias and Heart Failure, Abbott Laboratories
- fArrhythmia, Inova Medical Group, VirginiaArrhythmia, Inova Medical Group, Virginia
- ↵∗Address for correspondence:
Dr. Saman Nazarian, Cardiac Electrophysiology, The University of Pennsylvania Perelman School of Medicine, 3400 Spruce Street, Founders Pavillion 9118, Philadelphia, Pennsylvania 19104.
Objective A prospective, multicenter study was performed to assess the safety and efficacy of the Durata and Optisure HV leads and the Ellipse VR implantable cardioverter-defibrillator (ICD) in a 1.5-T magnetic resonance imaging (MRI) environment. The primary safety objective was >90% freedom from MRI scan-related complications. The primary efficacy objectives were absence of change in capture threshold and absence of decrease of sensing amplitude from pre-MRI examination to 1 month after MRI.
Background MRI scanning of patients has been shown to be safe in patients with magnetic resonance-conditional implantable cardioverter-defibrillators (ICD) systems.
Methods Patients with a previously implanted magnetic resonance-conditional system underwent a nondiagnostic MRI scan. After the scan, a questionnaire was given to investigators and patients who returned for 1-month follow-up examination. A subset of patients underwent ventricular tachyarrhythmia or ventricular fibrillation (VT/VF) induction testing after the MRI to evaluate defibrillation function.
Results There were 220 patients (81% male; 62.1 ± 11.2 years of age) enrolled who received an MRI scans from 29 centers. All primary safety and efficacy endpoints were met (p < 0.0001). No significant detection delays were found in 34 patients who had VT/VF episodes after the MRI scan was performed. Most physicians reported easy and acceptable programming and ease of MRI scheduling.
Conclusions The MRI Ready MRI-conditional ICD system is safe, and electrical performance was not affected in patients receiving a 1.5-T whole-body MRI scan. Investigators reported favorable collaboration between cardiologists and radiologists in the MRI Ready IDE clinical trial. (A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study [MRI Ready IDE]; NCT02787291)
- implantable cardioverter-defibrillator
- ICD system
- magnetic resonance imaging
- MRI Ready IDE Study
- Post MRI induction testing
Sponsor: This study was supported by St. Jude Medical (now Abbott Laboratories). Dr. Nazarian is a consultant for Biosense Webster, CardioSolv, Siemens, and ImriCor; and has received research grant support from the U.S. National Institutes of Health/National Heart, Lung, Blood Institute. Dr. Cantillon is a consultant for Abbott Laboratories and Boston Scientific. Dr. Woodard has received research support from U.S. National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Mela consults for and receives honoraria from Medtronic, Biotronik, and Abbott Laboratories. Dr. Cline is an employee of Abbott Laboratories. Dr. Strickberger consults for and receives honoraria from Abbott Laboratories. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received December 10, 2018.
- Revision received May 9, 2019.
- Accepted May 13, 2019.
- 2019 American College of Cardiology Foundation
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