Bailey William M, Rosenthal Lawrence, Fananapazir Lameh, Gleva Marye, Mazur Alexander, Rinaldi C A, Kypta Alexander, Merkely Béla, Woodard Pamela K
Louisiana Heart Rhythm Specialists and Lafayette General Medical Center, Lafayette, Louisiana.
University of Massachusetts Medical School, Amherst, Massachusetts.
Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.
Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI).
The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions.
The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI 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 (SADEs) 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.
Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively.
The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions.
长期以来，永久性心脏起搏器一直被视为磁共振成像（MRI）的禁忌证。
ProMRI/ProMRI AFFIRM研究是一项多中心、前瞻性、单臂、非随机研究，旨在评估百多力ProMRI起搏器系统在特定MRI条件下的临床安全性。
设计相同的ProMRI研究（在美国）和ProMRI AFFIRM研究（在美国以外地区）纳入了272例基线起搏指标稳定的患者，这些患者植入了Entovis或Evia起搏器（DR-T或SR-T）以及Setrox或Safio 53厘米或60厘米的导线。在入组时、MRI扫描前和扫描后以及MRI扫描后1个月和3个月进行设备问询。终点指标为：（1）MRI扫描后1个月内无MRI及起搏系统相关的严重不良设备效应（SADEs）；（2）心房和心室MRI诱发的起搏阈值升高（>0.5V）未出现；（3）MRI扫描后1个月时P波和R波幅度衰减未超过（<50%），或P波<1.5mV，或R波<5.0mV。
226例患者完成了MRI及MRI扫描后1个月的随访。未发生与植入系统和MRI检查相关的不良事件，SADEs发生率为零（229/229，P<.001）。心房和心室起搏阈值未升高的比例分别为99.0%（189/191，P=.003）和100%（217/217，P<.001）。P波和R波幅度未衰减的比例分别为99.4%（167/168，P<.001）和99.5%（193/194，P<.001）。
ProMRI/ProMRI AFFIRM研究结果表明，ProMRI起搏器系统在接受头部和下腰部MRI检查的患者中具有临床安全性和有效性。
