From the Scripps Research Institute (R.J.R.), the La Jolla Cardiovascular Research Institute (R.J.R., P.D.S.), University of California, San Diego (U.B.-G.), and Scripps Memorial Hospital (S.L.H., G.T.T.), La Jolla, the University of California, Los Angeles, Los Angeles (N.G.B.), and Providence St. Joseph Medical Center, Burbank (R.H.M.S.) - all in California; the Department of Entomology, University of Arizona, Tucson (H.S.C.); Intermountain Medical Center, Salt Lake City (J.L.A., A.E.T.); Inova Heart and Vascular Institute, Falls Church, VA (A.A.); Allegheny General Hospital, Pittsburgh (R.W.W.B.), and Abington Memorial Hospital, Abington (J.V.F.) - both in Pennsylvania; Yale University School of Medicine, New Haven, CT (R.L.); Providence Heart Institute, Southfield, MI (C.E.M.); Oklahoma Heart Institute, Tulsa (E.T.M.); University of Mississippi Medical Center, Jackson (A.L.R.); Medical College of Wisconsin, Milwaukee (J.C.R.); Bassett Medical Center, Cooperstown (J.D.S.), and Advanced Cardiovascular Imaging, Carnegie Hill Radiology, New York (S.U., S.D.W.) - both in New York; Methodist DeBakey Heart and Vascular Center, Houston (D.J.S.); and Baptist Health, Lexington, KY (G.F.T.).
N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.
The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning).
Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings.
MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events.
In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).
长期以来，心血管植入式电子设备的存在一直是进行磁共振成像（MRI）的禁忌症。我们建立了一个前瞻性登记处，以确定在 1.5 特斯拉磁场强度下对具有起搏器或植入式心律转复除颤器（ICD）的患者进行 MRI 的相关风险，这些设备为“非 MRI 条件”（即未获得食品和药物管理局批准用于 MRI 扫描）。
该登记处的患者因临床需要在 1.5 特斯拉场强下进行非胸部 MRI。使用标准化协议在 MRI 前后对设备进行询问，并在扫描前进行适当的重新编程。主要终点是扫描期间死亡、发生器或导联故障、诱导性心律失常、捕获丢失或电重置。次要终点是设备设置的变化。
在 1000 例安装起搏器的患者和 500 例安装 ICD 的患者中进行了 MRI。在 MRI 期间未发生死亡、导联故障、捕获丢失或室性心律失常。一个 ICD 发生器在 MRI 后无法进行询问，需要立即更换；该设备在 MRI 前未按照协议进行适当编程。我们观察到 6 例自行终止的心房颤动或扑动和 6 例部分电重置。在少数情况下，导联阻抗、起搏阈值、电池电压以及 P 波和 R 波振幅的变化超过了预设阈值。重复 MRI 与不良事件的增加无关。
在这项研究中，在适当筛选并按照预设方案对设备进行重新编程的情况下，在 1.5 特斯拉下进行临床需要的非胸部 MRI 的非 MRI 条件起搏器或 ICD 患者中，没有发生设备或导联故障。（由圣犹达医疗公司等资助；MagnaSafe 临床试验。gov 编号，NCT00907361）。
