评估使用磁共振兼容起搏器和植入式心脏复律除颤器系统的患者进行磁共振成像检查的可及性：Really ProMRI研究设计
Assessing access to MRI of patients with magnetic resonance-conditional pacemaker and implantable cardioverter defibrillator systems: the Really ProMRI study design.
作者信息
Maglia Giampiero, Curnis Antonio, Brieda Marco, Anaclerio Matteo, Caccavo Vincenzo, Bonfanti Paolo, Melissano Donato, Caravati Fabrizio, Giovene Lisa, Gargaro Alessio
机构信息
aCardiology - Coronary Care Unit, Pugliese-Ciaccio Hospital, Catanzaro bElectrophysiology department, Spedali Civili, P.le Spedali Civili 1, Brescia cDepartment of Cardiology, S. Maria D.A. Hospital, Via Montereale 24, Pordenone dCardiology Department, A.O.U. Pol. Universitario di Bari, Piazza G. Cesare 11, eCardiology Department, Ente Ecclesiastico Miulli General Regional Hospital, SP 127 Acquaviva-Santeramo km 4, Acquaviva delle Fonti, Bari fDepartment of Cardiology II, Circolo e Fondazione Macchi Hospital, V.le Borri 57, Varese gCardiology Department, P.O. F. Ferrari, Via F. Ferrari, Casarano (Le) hDepartment of Cardiology I, Circolo e Fondazione Macchi Hospital, V.le Borri 57, Varese iClinical Office, Biotronik Italia S.p.a., V.le delle Industrie 11, Vimodrone (MI), Italy.
出版信息
J Cardiovasc Med (Hagerstown). 2015 Oct;16(10):715-20. doi: 10.2459/JCM.0000000000000186.
BACKGROUND
Despite the fact that magnetic resonance (MR)-conditional pacemaker and lead systems have been introduced more than 5 years ago, it is still not clear whether they have actually facilitated the access of pacemaker patients to this important diagnostic tool. Factors limiting MR scans in daily practice in patients with MR-conditional cardiac implantable electronic device (CIED) systems may be related to organizational, cultural and sometimes legal aspects. The Really ProMRI registry is an ongoing survey designed to assess the annual rate of MR examinations in patients with MR-conditional implants, with either pacemakers or implantable cardioverter defibrillators, and to detect the main factors limiting MRI.
METHODS
The primary endpoint of the Really ProMRI registry is to assess the current access to MRI of patients with MR-conditional pacemaker or implantable cardioverter defibrillator systems during normal practice. Data in the literature reported a 17% annual incidence of medical conditions requiring MRI in CIED patients. The Really ProMRI registry has been designed to detect 4.5% absolute difference with an 80% statistical power, by recruiting 600 patients already implanted with MR-conditional CIED implant. Patients will be followed up for 1 year, during which they will be asked to refer any prescription, execution or denial of an MR examination by patient questionnaires and original source documents.
CONCLUSION
The ongoing Really ProMRI registry will assess the actual rate of and factors limiting the access to MRI for patients with MR-conditional CIEDs.
背景
尽管磁共振（MR）兼容起搏器和导线系统在5年多以前就已问世，但目前仍不清楚它们是否真正方便了起搏器患者使用这一重要的诊断工具。在日常实践中，限制植入MR兼容心脏植入式电子设备（CIED）系统的患者进行MR扫描的因素可能与组织、文化以及有时与法律方面有关。Really ProMRI注册研究是一项正在进行的调查，旨在评估植入MR兼容设备（起搏器或植入式心律转复除颤器）的患者每年进行MR检查的比例，并找出限制MRI检查的主要因素。
方法
Really ProMRI注册研究的主要终点是评估在正常实践中，植入MR兼容起搏器或植入式心律转复除颤器系统的患者目前接受MRI检查的情况。文献数据显示，CIED患者中每年有17%的人患有需要进行MRI检查的疾病。Really ProMRI注册研究旨在通过招募600名已植入MR兼容CIED的患者，以80%的统计效能检测出4.5%的绝对差异。患者将接受为期1年的随访，在此期间，将通过患者问卷和原始资料文件询问他们是否有任何关于MR检查的处方、检查执行情况或检查被拒情况。
结论
正在进行的Really ProMRI注册研究将评估植入MR兼容CIED的患者进行MRI检查的实际比例以及限制检查的因素。
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