TY - JOUR
T1 - MRI Safety for Patients Implanted With the MRI Ready ICD System
T2 - MRI Ready Study Results
AU - MRI Ready Investigators
AU - Nazarian, S.
AU - Cantillon, Daniel J.
AU - Woodard, Pamela K.
AU - Mela, Theofanie
AU - Cline, Adam M.
AU - Strickberger, Adam S.
N1 - Funding Information:
The authors thank the MRI Ready IDE Investigators and staff for their support in the MRI Ready Clinical trial. 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.
Funding Information:
The MRI Ready IDE study was a prospective, multicenter, nonrandomized, single-arm clinical trial evaluating the safety and efficacy of an implanted single-chamber MRI Ready ICD system in patients who had undergone a pre-defined nondiagnostic MRI Ready IDE study ( NCT02787291 ). This trial was sponsored by the manufacturer, St. Jude Medical (Sylmar, California). Tenets of the Declaration of Helsinki were followed, as were all laws and regulations of the participating countries. Institutional Review Board/Ethics Committee approval and informed patient consent were obtained for all participating centers and patients.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/8
Y1 - 2019/8
N2 - Objectives: 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) (St. Jude Medical, Sylmar, California) 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.
AB - Objectives: 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) (St. Jude Medical, Sylmar, California) 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.
KW - ICD system
KW - MRI Ready IDE Study
KW - Post MRI induction testing
KW - implantable cardioverter-defibrillator
KW - magnetic resonance imaging
UR - http://www.scopus.com/inward/record.url?scp=85070417712&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2019.05.010
DO - 10.1016/j.jacep.2019.05.010
M3 - Article
C2 - 31439295
AN - SCOPUS:85070417712
SN - 2405-500X
VL - 5
SP - 935
EP - 943
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 8
ER -