升级为心脏再同步化治疗的发生率、预测因素和手术结果：RAFT 升级子研究。
Incidence, predictors, and procedural results of upgrade to resynchronization therapy: the RAFT upgrade substudy.
机构信息
From the Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada (V.E., J.J., M.S.); Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada (D.H.B., E.Y., G.W., A.S.L.T.); Division of Cardiology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada (J.L.S.); Division of Cardiology, Victoria Cardiac Arrhythmia Trials, Victoria, BC, Canada (L.D.S.); Division of Cardiology, Quebec Heart and Lung Institute, Quebec City, QC, Canada (F.P.); Division of Cardiology, London Health Sciences Centre, London, ON, Canada (R.Y., A.S.L.T.); Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada (E.C.); Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montreal, QC, Canada (V.E., T.K.); Division of Cardiology, St. Mary's General Hospital, Kitchener, ON, Canada (C.R.); Division of Cardiology, Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Division of Cardiology, Montreal Heart Institute, Montreal, QC, Canada (B.T.); Division of Cardiology, Libin Cardiovascular Institute of Alberta, Calgary, AB, Canada (D.V.E.); Division of Cardiology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada (B.C.); Division of Cardiology, Kingston General Hospital, Kingston, ON, Canada (C.S.S.); and Division of Cardiology, Southlake Regional Health Centre, Newmarket, ON, Canada (Z.W.).
出版信息
Circ Arrhythm Electrophysiol. 2015 Feb;8(1):152-8. doi: 10.1161/CIRCEP.114.001997. Epub 2014 Nov 23.
BACKGROUND
The resynchronization-defibrillation for ambulatory heart failure trial (RAFT) study demonstrated that adding cardiac resynchronization therapy (CRT) in selected patients requiring de novo implantable cardiac defibrillators (ICD) reduced mortality as compared with ICD therapy alone, despite an increase in procedure-related adverse events. Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade.
METHODS AND RESULTS
Participating RAFT centers provided data regarding de novo CRT-D (CRT with ICD) implant, upgrade to CRT-D during RAFT (study upgrade), and upgrade within 6 months after presentation of study results (substudy). Substudy centers enrolled 1346 (74.9%) patients in RAFT, including 644 de novo, 80 study upgrade, and 60 substudy CRT attempts. The success rate (initial plus repeat attempts) was 95.2% for de novo versus 96.3% for study upgrade and 90.0% for substudy CRT attempts (P=0.402). Acute complications occurred among 26.2% of de novo versus 18.8% of study upgrade and 3.4% of substudy CRT implantation attempts (P<0.001). The most common complication was left ventricular lead dislodgement. The principal reasons for not yet attempting upgrade in the substudy were patient preference (31.9%), New York Heart Association Class I (17.0%), and a QRS<150 ms (13.1%).
CONCLUSIONS
Among a broad group of implant physicians, CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant. Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials.
背景
在需要植入式心脏除颤器（ICD）的患者中，与单独的 ICD 治疗相比，心脏再同步治疗（CRT）的加入降低了死亡率，这是再同步除颤器的心力衰竭试验（RAFT）研究证明的，尽管与程序相关的不良事件有所增加。缺乏关于具有 ICD 治疗且需要 CRT 升级的患者的管理数据。
方法和结果
参与 RAFT 中心提供了关于 ICD 治疗患者的 CRT-D（带 ICD 的 CRT）植入、RAFT 期间升级到 CRT-D（研究升级）以及研究结果公布后 6 个月内升级（亚研究）的数据。亚研究中心共纳入 1346 例 RAFT 患者（74.9%），包括 644 例初次 CRT-D、80 例研究升级和 60 例亚研究 CRT 尝试。初次和重复尝试的成功率（初始加重复尝试）为 95.2%，与研究升级相比为 96.3%，与亚研究 CRT 尝试相比为 90.0%（P=0.402）。初次 CRT-D 发生急性并发症的患者占 26.2%，研究升级为 18.8%，亚研究 CRT 植入尝试为 3.4%（P<0.001）。最常见的并发症是左心室导联脱位。亚研究中尚未尝试升级的主要原因是患者的偏好（31.9%）、纽约心脏协会心功能分级 I 级（17.0%）和 QRS<150 ms（13.1%）。
结论
在一组广泛的植入医师中，对有 ICD 在位的患者进行 CRT 升级，与初次 CRT 植入相比，植入成功率没有差异，急性并发症发生率降低。升级决策受到 RAFT 研究和其他试验亚组分析中获益预测因素的影响。
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