Ching Chi Keong, Chakraborty Rabindra Nath, Kler Tarlochan Singh, Pumprueg Satchana, Ngarmukos Tachapong, Chan Joseph Yat Sun, Anand Sumit, Yadav Rakesh, Sitthisook Surapun, Yim Ka Wing, Jaswal Rakesh K, Bhargava Kartikeya
National Heart Centre Singapore, Singapore.
Apollo Gleneagles Hospital, Kolkata, India.
Pacing Clin Electrophysiol. 2017 Dec;40(12):1389-1395. doi: 10.1111/pace.13232. Epub 2017 Dec 5.
Utilization of cardiac magnetic resonance imaging (cMRI) as an imaging modality in clinical practice is rapidly increasing. More evidence from randomized studies establishing clinical safety and performance of pacing systems in patients undergoing a cMRI scan is needed.
The purpose of this prospective, multicenter, randomized study was to demonstrate safety and efficacy of the Accent MRI™ conditional pacing systems (St. Jude Medical, St. Paul, MN, USA) in patients undergoing cMRI scan.
Patients (n = 283) indicated for dual-chamber pacemaker implant were randomized to either the MRI Group (MG) (n = 140) or the Control Group (CG) (n = 143) after successful device implantation of the Accent MRI™ system. Clinical evaluation and device interrogation were performed at pre- and post-MRI scan, and 1 month post-MRI for all patients. At 9-12 weeks postimplant, patients in MG underwent a nondiagnostic cMRI scan at 1.5 Tesla (T), while patients in CG underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI scan-related complications and that for efficacy was significant changes in right atrial/ventricular capture threshold and sensing amplitude between right before MRI, immediately after MRI, and 1 month post-MRI.
Results showed 100% freedom from MRI scan-related complications. There were no significant changes in device performance between pre-MRI scan and 1 month post-MRI scan time points in both study groups.
cMRI scanning with 1.5 T scanners is safe in patients implanted with the Accent MRI™ conditional pacing system and has no significant effect on the electrical parameters of the device and leads.
心脏磁共振成像（cMRI）作为一种成像方式在临床实践中的应用正在迅速增加。需要更多来自随机研究的证据来确定在接受cMRI扫描的患者中起搏系统的临床安全性和性能。
这项前瞻性、多中心、随机研究的目的是证明Accent MRI™条件起搏系统（美国明尼苏达州圣保罗市圣犹达医疗公司）在接受cMRI扫描的患者中的安全性和有效性。
在成功植入Accent MRI™系统后，将拟植入双腔起搏器的患者（n = 283）随机分为MRI组（MG）（n = 140）或对照组（CG）（n = 143）。对所有患者在MRI扫描前、扫描后以及MRI扫描后1个月进行临床评估和设备问询。植入后9 - 12周，MG组患者在1.5特斯拉（T）下进行非诊断性cMRI扫描，而CG组患者进行两次设备问询和临床评估，中间间隔45分钟。安全终点是无MRI扫描相关并发症，疗效终点是MRI扫描前、扫描后即刻以及MRI扫描后1个月之间右心房/心室捕获阈值和感知幅度的显著变化。
结果显示无MRI扫描相关并发症。两个研究组在MRI扫描前和MRI扫描后1个月的时间点之间，设备性能均无显著变化。
对于植入Accent MRI™条件起搏系统的患者，使用1.5T扫描仪进行cMRI扫描是安全的，并且对设备和导线的电参数没有显著影响。
