Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions

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• 作者：William M. Bailey ; MD ; FHRS^* ; ^{wbailey@heartrhythmmd.com" class="auth_mail" title="E-mail the corresponding author} ; Alexander Mazur ; MD^&dagger ; ; Craig McCotter ; MD^&Dagger ; ; Pamela K. Woodard ; MD^§ ; ; Lawrence Rosenthal ; MD^¶ ; ; Whitney Johnson ; MS^‖ ; Theofanie Mela ; MD^# ; for the ProMRI Study Investigators
• 关键词：CI ; confidence interval ; FDA ; Food and Drug Administration ; MR ; magnetic resonance ; MRI ; magnetic resonance imaging ; SADE ; serious adverse device effect ; SAR ; whole-body specific absorption rate
• 刊名：Heart Rhythm
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：13
• 期：2
• 页码：464-471
• 全文大小：356 K

文摘

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.