Bastian Dirk, Ebrahim Iftikhar O, Chen Ju-Yi, Chen Mien-Cheng, Huang Dejia, Huang Jin-Long, Kuznetsov Vadim A, Maus Bärbel, Naik Ajay M, Verhees Koen J P, Fagih Ahmed R Al
Klinikum Fürth, Fürth, Germany.
Netcare Unitas Hospital, Pretoria, South Africa.
Pacing Clin Electrophysiol. 2018 Jun 13. doi: 10.1111/pace.13410.
Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs).
In this prospective, multicenter, observational, multinational study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (Medtronic plc, Minneapolis, MN, USA; either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy -defibrillators, and 5.1% cardiac resynchronization therapy -pacemakers, from 117 hospitals in 23 countries across four geographical regions between 2012 and 2016.
For all device types, in all regions, there were fewer females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women, and older patients were less likely to receive a magnetic resonance imaging-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF.
We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials. We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations.
目前，全球有几个地区在医疗器械试验中的代表性仍然不足。全景2研究旨在评估心脏植入式电子设备（CIED）患者临床实践模式的当代地区差异。
在这项前瞻性、多中心、观察性、跨国研究中，分析了4706例接受美敦力CIED（美敦力公司，明尼阿波利斯，明尼苏达州，美国；包括初次植入设备、更换或升级）患者的基线和植入数据，其中包括：54%为植入式脉冲发生器（IPG），20.3%为植入式心脏除颤器（ICD），15%为心脏再同步治疗除颤器，5.1%为心脏再同步治疗起搏器，这些数据来自2012年至2016年期间四个地理区域23个国家的117家医院。
对于所有设备类型，在所有地区，纳入的女性均少于男性，且女性患缺血性心肌病的可能性较小。所有设备类型的植入手术持续时间在不同地区存在显著差异。来自新兴国家的受试者、女性和老年患者接受磁共振成像兼容设备的可能性较小。不同地区之间的除颤测试存在显著差异。欧洲患者的房颤（AF）发生率最高，植入的单腔IPG数量最少。对中风病史的评估表明，一般栓塞风险与中风的相关性比与房颤的相关性更强。
我们提供了来自几个地区接受美敦力CIED患者的全面描述性数据，其中一些地区在随机对照试验中研究较少。我们发现患者特征存在显著差异。一些医疗决策似乎受到社会经济因素的影响。长期随访数据将有助于评估这些差异是否需要调整对结果的预期。
