Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA.
JAMA. 2011 Jan 5;305(1):43-9. doi: 10.1001/jama.2010.1915.
Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure.
To determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician specialty, and year of procedure.
DESIGN, SETTING, AND PATIENTS: Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009.
In-hospital outcomes.
Of 111,707 patients, 25,145 received non-evidence-based ICD implants (22.5%). Patients who received a non-evidence-based ICD compared with those who received an evidence-based ICD had a significantly higher risk of in-hospital death (0.57% [95% confidence interval {CI}, 0.48%-0.66%] vs 0.18% [95% CI, 0.15%-0.20%]; P <.001) and any postprocedure complication (3.23% [95% CI, 3.01%-3.45%] vs 2.41% [95% CI, 2.31%-2.51%]; P <.001). There was substantial variation in non-evidence-based ICDs by site. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20.8%; 95% CI, 20.5%-21.1%) than nonelectrophysiologists (24.8% [95% CI, 24.2%-25.3%] for nonelectrophysiologist cardiologists; 36.1% [95% CI, 34.3%-38.0%] for thoracic surgeons; and 24.9% [95% CI, 23.8%-25.9%] for other specialties) (P<.001 for all comparisons). There was no clear decrease in the rate of non-evidence-based ICDs over time (24.5% [6908/28,233] in 2006, 21.8% [7395/33,965] in 2007, 22.0% [7245/32,960] in 2008, and 21.7% [3597/16,549] in 2009; P <.001 for trend from 2006-2009 and P = .94 for trend from 2007-2009).
Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation.
实践指南不建议在心肌梗死后或冠状动脉旁路移植手术后恢复的患者以及有严重心力衰竭症状或近期心力衰竭诊断的患者中使用植入式心脏复律除颤器（ICD）进行一级预防。
确定接受非基于证据的 ICD 的患者数量、特征和院内结局，并检查这些植入物在站点、医生专业和手术年份的分布情况。
设计、地点和患者：2006 年 1 月 1 日至 2009 年 6 月 30 日期间向国家心血管数据注册-ICD 登记处提交的病例的回顾性队列研究。
院内结局。
在 111707 名患者中，25145 名患者接受了非基于证据的 ICD 植入（22.5%）。与接受基于证据的 ICD 的患者相比，接受非基于证据的 ICD 的患者院内死亡风险显著增加（0.57%[95%置信区间{CI}，0.48%-0.66%] vs 0.18%[95% CI，0.15%-0.20%]；P<0.001）和任何术后并发症（3.23%[95% CI，3.01%-3.45%] vs 2.41%[95% CI，2.31%-2.51%]；P<0.001）。各站点之间非基于证据的 ICD 存在很大差异。电生理学家（20.8%[95% CI，20.5%-21.1%]）的非基于证据的 ICD 植入率明显低于非电生理学家（非电生理学家心脏病专家为 24.8%[95% CI，24.2%-25.3%]；胸外科医生为 36.1%[95% CI，34.3%-38.0%]；其他专业为 24.9%[95% CI，23.8%-25.9%]）（所有比较均 P<.001）。随着时间的推移，非基于证据的 ICD 率并没有明显下降（2006 年为 24.5%[6908/28233]，2007 年为 21.8%[7395/33965]，2008 年为 22.0%[7245/32960]，2009 年为 21.7%[3597/16549]；2006 年至 2009 年的趋势 P<0.001，2007 年至 2009 年的趋势 P =.94）。
在该注册处接受 ICD 植入的患者中，22.5%不符合植入的基于证据的标准。
