Evia 起搏器联合 Safio S 起搏器导线的 MRI 兼容性的单中心可行性研究。
Monocenter feasibility study of the MRI compatibility of the Evia pacemaker in combination with Safio S pacemaker lead.
机构信息
Hospital of St, Pölten-Lilienfeld, Department of Cardiology, St, Pölten, Austria.
出版信息
J Cardiovasc Magn Reson. 2012 Sep 25;14(1):67. doi: 10.1186/1532-429X-14-67.
BACKGROUND
The purpose of this study was to evaluate the feasibility of the magnetic resonance (MR) conditional pacemaker (PM) system (Evia SR-T and DR-T with Safio S leads) under MR conditions.
METHODS
Patients with standard PM indications and Evia PM were eligible for enrollment in this single center prospective non-randomized pilot study. Patients underwent MR of the brain and lower lumbar spine at 1.5 Tesla. Atrial (RA) und ventricular (RV) lead parameters (sensing, pacing threshold [PTH], pacing impedance) were assessed immediately before (baseline follow-up [FU]) and immediately after MRI (1st FU), after 1 month (2nd FU) and 3 months (3rd FU). The effect of MR on serious adverse device effect (SADE) free-rate, on atrial and ventricular sensing (AS/VS; mV) and atrial (RA) and ventricular (RV) pacing thresholds (PTH; V/0.4 ms) were investigated between baseline and 2nd FU. Continuous variables are expressed as mean ± SD and were compared using paired Student's t-test. A p < 0.05 was considered significant.
RESULTS
Thirty-one patients were enrolled. One patient had to be excluded because of an enrollment violation. Therefore, data of 30 patients (female 12 [40%], age 73 ± 12 years, dual chamber PM 15 [50%]) were included in this analysis. No MR related SADE occurred. Lead measurements were not statistically different between the baseline FU and the 2nd FU (AS/VS at baseline 3.2 ± 2.1/15.0 ± 6.0, at 2nd FU 3.2 ± 2.1/14.9 ± 6.5; p = ns. RA-PTH/RV-PTH at baseline 0.68 ± 0.18/0.78 ± 0.22, at 2nd FU 0.71 ± 0.24/0.78 ± 0.22; p = ns). The presence of the permanent pacemakers led to MR imaging artifacts on diffusion weighted sequences of the brain, but did not affect other sequences (e.g. FLAIR and T2 weighted spin-echo images).
CONCLUSION
The use of the MR conditional Evia PM in a MR environment under predefined conditions is feasible. No MR related SADEs nor clinically relevant changes in device functions occurred.
背景
本研究旨在评估磁共振（MR）条件下起搏器（PM）系统（Evia SR-T 和 DR-T 与 Safio S 导联）的可行性。
方法
符合标准 PM 适应证且植入 Evia PM 的患者有资格参加这项单中心前瞻性非随机试点研究。患者在 1.5T 下接受脑和下腰椎磁共振检查。在进行磁共振检查前（基线随访[FU]）和检查后即刻（1 次 FU）、1 个月（2 次 FU）和 3 个月（3 次 FU）时，评估心房（RA）和心室（RV）导联的参数（感知、起搏阈值[PTH]、起搏阻抗）。比较基线和 2 次 FU 之间磁共振对严重不良器械效应（SADE）无率、心房和心室感知（AS/VS；mV）以及心房（RA）和心室（RV）起搏阈值（PTH；V/0.4 ms）的影响。连续变量用均值±标准差表示，并采用配对学生 t 检验进行比较。p<0.05 认为有统计学意义。
结果
共纳入 31 例患者。因违反纳入标准，1 例患者被排除。因此，共分析了 30 例患者的数据（女性 12 例[40%]，年龄 73±12 岁，双腔 PM 15 例[50%]）。未发生与磁共振相关的 SADE。基线 FU 和 2 次 FU 之间的导联测量值无统计学差异（AS/VS 基线时为 3.2±2.1/15.0±6.0，2 次 FU 时为 3.2±2.1/14.9±6.5；p=ns。RA-PTH/RV-PTH 基线时为 0.68±0.18/0.78±0.22，2 次 FU 时为 0.71±0.24/0.78±0.22；p=ns）。永久性起搏器的存在导致脑弥散加权序列上出现磁共振成像伪影，但不影响其他序列（如 FLAIR 和 T2 加权自旋回波图像）。
结论
在预设条件下，使用 MR 条件下的 Evia PM 在 MR 环境中是可行的。未发生与磁共振相关的 SADE 或设备功能的临床相关变化。
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