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Randomized trial ofpacemaker and leadsystem for safescanning at 1.5 Tesla John GimbelDavid BelloMatthias Schmitt2013 год

Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla
статья из журнала

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Аннотация: BACKGROUND Magnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system.Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk.The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI.OBJECTIVE To confirm the safety and effectiveness of a pacemaker system designed for safe whole body MRI without MRI scan positioning restrictions.METHODS Primary eligibility criteria included standard dualchamber pacing indications.Patients (n ¼ 263) were randomized in a 2:1 ratio to undergo 16 chest and head scans at 1.5 T between 9 and 12 weeks postimplant (n ¼ 177) or to not undergo MRI (n ¼ 86) post-implant.Evaluation of the pacemaker system occurred immediately before, during (monitoring), and after MRI, 1-week post-MRI, and 1-month post-MRI, and similarly for controls.Primary end points measured the MRI-related complication-free rate for safety and compared pacing capture threshold between MRI and control subjects for effectiveness.RESULTS There were no MRI-related complications during or after MRI in subjects undergoing MRI (n ¼ 148).Differences in pacing capture threshold values from pre-MRI to 1-month post-MRI were minimal and similar between the MRI and control groups.CONCLUSIONS This randomized trial demonstrates that the Advisa MRI pulse generator and CapSureFix MRI 5086MRI lead system is safe and effective in the 1.5 T MRI environment without positioning restrictions for MRI scans or limitations of body parts scanned.
Год издания: 2013
Авторы: John Gimbel, David Bello, Matthias Schmitt, Béla Merkely, Juerg Schwitter, David L. Hayes, Torsten Sommer, Edward J. Schloss, Yanping Chang, Sarah Willey, Emanuel Kanal
Издательство: Elsevier BV
Источник: Heart Rhythm
Ключевые слова: Advanced MRI Techniques and Applications, Cardiac pacing and defibrillation studies, Cardiac Imaging and Diagnostics
Другие ссылки: Heart Rhythm (HTML)
Semmelweis University Repository (Semmelweis University) (PDF)
Semmelweis University Repository (Semmelweis University) (HTML)
PubMed (HTML)