Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2010 Aug 31;56(10):766-73. doi: 10.1016/j.jacc.2010.05.025.
The purpose of the study was to define the extent and nature of cardiac resynchronization therapy (CRT) device usage outside consensus guidelines using national data.
Recent literature has shown that the application of CRT in clinical practice frequently does not adhere to evidence-based consensus guidelines. Factors underlying these practices have not been fully explored.
From the National Cardiovascular Data Registry's Implantable Cardiac-Defibrillator Registry, we defined a cohort of 45,392 cardiac resynchronization therapy-defibrillator (CRT-D) implants between January 2006 and June 2008 with a primary prevention indication. We defined "off-label" implants as those in which the ejection fraction was >35%, the New York Heart Association functional class was below III, or the QRS interval duration was <120 ms in the absence of a documented need for ventricular pacing. The relationships between patient, implanting physician, and hospital characteristics with off-label use were explored with multivariable hierarchical logistic regression models.
Overall, 23.7% of devices were placed without meeting all 3 implant criteria, most often due to New York Heart Association functional class below III (13.1% of implants) or QRS interval duration <120 ms (12.0%). Atrial fibrillation/flutter, previous percutaneous coronary intervention, and the performance of an electrophysiology study before implant were independently associated with increased odds of off-label use, whereas diabetes mellitus, increasing age, and female sex were associated with decreased odds. Physician training and insurance payer were weakly associated with the likelihood of off-label use.
Nearly 1 in 4 patients receiving CRT devices in the study time frame did not meet guideline-based indications. Given the evolving evidence base supporting the use of CRT, these practices require careful scrutiny.
本研究旨在利用国家数据定义超出共识指南的心脏再同步治疗（CRT）设备使用的范围和性质。
最近的文献表明，CRT 在临床实践中的应用经常不符合基于证据的共识指南。这些实践背后的因素尚未得到充分探讨。
我们从国家心血管数据注册的植入式心脏除颤器注册中定义了一个 45392 例心脏再同步治疗除颤器（CRT-D）植入的队列，这些患者在 2006 年 1 月至 2008 年 6 月期间具有一级预防指征。我们将“非适应证”植入定义为射血分数>35%、纽约心脏协会功能分级低于 III 级或 QRS 间隔持续时间<120ms 而无记录的心室起搏需求的患者。使用多变量分层逻辑回归模型探讨了患者、植入医师和医院特征与非适应证使用之间的关系。
总体而言，有 23.7%的设备不符合所有 3 项植入标准，最常见的原因是纽约心脏协会功能分级低于 III 级（13.1%的植入）或 QRS 间隔持续时间<120ms（12.0%）。房颤/房扑、既往经皮冠状动脉介入治疗和植入前进行电生理研究与非适应证使用的可能性增加独立相关，而糖尿病、年龄增加和女性与非适应证使用的可能性降低相关。医师培训和保险支付人与非适应证使用的可能性呈弱相关。
在研究时间范围内，近 1/4 的接受 CRT 设备治疗的患者不符合基于指南的适应证。鉴于支持 CRT 使用的循证医学证据不断发展，这些做法需要仔细审查。
