William M Bailey1, Alexander Mazur2, Craig McCotter3, Pamela K Woodard4, Lawrence Rosenthal5, Whitney Johnson6, Theofanie Mela7. 1. Louisiana Heart Rhythm Specialists and Lafayette General Medical Center, Lafayette, Louisiana. Electronic address: wbailey@heartrhythmmd.com. 2. University of Iowa Hospitals and Clinics, Iowa City, Iowa. 3. Upstate Cardiology, Greenville, South Carolina. 4. Washington University School of Medicine, St. Louis, Missouri. 5. University of Massachusetts Medical School, Worcester, Massachusetts. 6. Biotronik Inc, Lake Oswego, Oregon. 7. Massachusetts General Hospital, Boston, Massachusetts.
Abstract
BACKGROUND: Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE: The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI. METHODS: The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s). Device interrogation was performed at enrollment, pre- and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects through 1 month post-MRI; (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V); and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. RESULTS: In total, 216 patients completed the MRI and 1-month post-MRI follow-up. One adverse event possibly related to the implanted system and the MRI procedure occurred, resulting in a serious adverse device effect-free rate of 99.6% (220/221; P < .0001. Freedom from atrial and ventricular pacing threshold increase was 100% (194/194, P < .001) and 100% (206/206, P < .001) respectively. Freedom from P- and R-wave amplitude attenuation was 98.2% (167/170, P < .001) and 100% (188/188, P < .001) respectively. CONCLUSION: The results of the ProMRI Phase B study demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac MRI conditions.
BACKGROUND: Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE: The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI. METHODS: The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s). Device interrogation was performed at enrollment, pre- and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects through 1 month post-MRI; (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V); and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. RESULTS: In total, 216 patients completed the MRI and 1-month post-MRI follow-up. One adverse event possibly related to the implanted system and the MRI procedure occurred, resulting in a serious adverse device effect-free rate of 99.6% (220/221; P < .0001. Freedom from atrial and ventricular pacing threshold increase was 100% (194/194, P < .001) and 100% (206/206, P < .001) respectively. Freedom from P- and R-wave amplitude attenuation was 98.2% (167/170, P < .001) and 100% (188/188, P < .001) respectively. CONCLUSION: The results of the ProMRI Phase B study demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac MRI conditions.
Authors: Rainer Zbinden; Christian Wollmann; Johannes Brachmann; Jochen Michaelsen; Clemens Steinwender; Pramesh Kovoor; Sebastian Kelle; Andrew D McGavigan; Chi Keong Ching; Gemma A Figtree; Jan Schmidt; Tobias Timmel; Joachim Lotz Journal: Europace Date: 2019-11-01 Impact factor: 5.214
Authors: Wolfgang Rudolf Bauer; Dennis H Lau; Christian Wollmann; Andrew McGavigan; Jacques Mansourati; Theresa Reiter; Simone Frömer; Mark E Ladd; Harald H Quick Journal: Sci Rep Date: 2019-12-03 Impact factor: 4.379
Authors: Thuy D Nguyen; Sarah A Sandberg; Amir K Durrani; Kevin W Mitchell; Matthew D Keith; Marye J Gleva; Pamela K Woodard Journal: Heart Rhythm O2 Date: 2020-12-18