BACKGROUND: Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. OBJECTIVE: The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. METHODS: A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. RESULTS: Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. CONCLUSION: The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan.
BACKGROUND: Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. OBJECTIVE: The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. METHODS: A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. RESULTS: Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. CONCLUSION: The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan.
Authors: Daniel Kiblboeck; Christian Reiter; Juergen Kammler; Pierre Schmit; Hermann Blessberger; Joerg Kellermair; Franz Fellner; Clemens Steinwender Journal: J Cardiovasc Magn Reson Date: 2018-07-05 Impact factor: 5.364
Authors: Christoph Edlinger; Marcel Granitz; Vera Paar; Christian Jung; Alexander Pfeil; Sarah Eder; Bernhard Wernly; Jürgen Kammler; Klaus Hergan; Uta C Hoppe; Clemens Steinwender; Michael Lichtenauer; Alexander Kypta Journal: Wien Klin Wochenschr Date: 2018-05-23 Impact factor: 1.704
Authors: C Steinwender; P Lercher; C Schukro; H Blessberger; G Prenner; M Andreas; J Kraus; M Ammer; M Stühlinger Journal: J Interv Card Electrophysiol Date: 2019-12-20 Impact factor: 1.900