1. MRI Safety for Patients Implanted With the MRI Ready ICD System
- Author
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Mri Ready Investigators, Pamela K. Woodard, Adam S. Strickberger, Daniel J. Cantillon, Saman Nazarian, Adam M. Cline, and Theofanie Mela
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,Ventricular Tachyarrhythmias ,Defibrillation ,business.industry ,medicine.medical_treatment ,Magnetic resonance imaging ,030204 cardiovascular system & hematology ,Implantable cardioverter-defibrillator ,medicine.disease ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Multicenter study ,Ventricular fibrillation ,medicine ,In patient ,030212 general & internal medicine ,Radiology ,business - Abstract
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 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)
- Published
- 2019