van Dijk Vincent F, Delnoy Peter Paul H M, Smit Jaap Jan J, Ramdat Misier R Anand, Elvan Arif, van Es H Wouter, Rensing Benno J W M, Raciti Giovanni, Boersma Lucas V A
St Antonius Hospital, Nieuwegein, the Netherlands.
Isala Klinieken, Zwolle, the Netherlands.
J Cardiovasc Electrophysiol. 2017 Jul;28(7):806-810. doi: 10.1111/jce.13231. Epub 2017 Jun 8.
Modern pacemakers are designed to allow patients to undergo magnetic resonance imaging (MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3T MRI.
Two prospective, nonrandomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters, and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1.5T and 3T MRI, respectively. Device measurements were done within 1 hour before and after the scan and at 1 month follow-up. Thirty-two subjects underwent MRI visit (17 subjects with 1.5T MRI and 15 subjects with 3T MRI). There were no unanticipated adverse effects related to the pacemaker. Device measurements taken pre- and post-MRI scan did not show any clinical relevant change that could indicate an effect of the MRI on the device or at the lead-tissue interface (RV threshold change: 0.01 ± 0.13 V, P = 0.60; RA threshold change: 0.01 ± 0.11 V, P = 0.53; R wave change: -0.44 ± 1.73 mV, P = 0.36; R wave change: 0.12 ± 1.67 mV, P = 0.73), with data confirmed at 1-month follow-up visit.
The study documented safety of the pacing system in the 1.5T and 3T MRI environment by showing no adverse events related to device or MRI scan. Additional data are required to cover the more complex scenarios involving different diagnostic needs, conditions of use, clinical conditions, and new emerging technologies.
现代起搏器的设计目的是让患者在一系列特定条件下接受磁共振成像（MRI）检查。本研究的目的是为一种新型起搏系统（ImageReady™，波士顿科学公司）在接受1.5T和3T MRI检查的患者中的安全性和性能提供确证性证据。
设计了两项前瞻性、非随机、单臂研究，分别为植入该系统的受试者在进行临床非必需的1.5T和3T MRI检查时，提供MRI对设备功能、导线参数和患者状况无影响的确证性数据。在扫描前1小时内、扫描后以及随访1个月时进行设备测量。32名受试者接受了MRI检查（17名受试者接受1.5T MRI检查，15名受试者接受3T MRI检查）。未出现与起搏器相关的意外不良事件。MRI扫描前后进行的设备测量未显示任何临床相关变化，表明MRI对设备或导线-组织界面没有影响（右心室阈值变化：0.01±0.13 V，P = 0.60；右心房阈值变化：0.01±0.11 V，P = 0.53；R波变化：-0.44±1.73 mV，P = 0.36；R波变化：0.12±1.67 mV，P = 0.73），1个月随访时的数据证实了这一点。
该研究通过显示无与设备或MRI扫描相关的不良事件，证明了起搏系统在1.5T和3T MRI环境中的安全性。需要更多数据来涵盖涉及不同诊断需求、使用条件、临床状况和新兴技术的更复杂情况。
