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Trial and error. How to avoid commonly encountered limitations of published clinical trials.反复尝试。如何避免常见的已发表临床试验的局限性。
J Am Coll Cardiol. 2010 Feb 2;55(5):415-27. doi: 10.1016/j.jacc.2009.06.065.
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Cardiac resynchronization therapy in non-left bundle branch block morphologies.非左束支传导阻滞形态的心脏再同步治疗
Pacing Clin Electrophysiol. 2010 May;33(5):590-5. doi: 10.1111/j.1540-8159.2009.02649.x. Epub 2009 Dec 16.
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Cardiac-resynchronization therapy for the prevention of heart-failure events.心脏再同步治疗预防心力衰竭事件
N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
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The European cardiac resynchronization therapy survey.欧洲心脏再同步化治疗调查。
Eur Heart J. 2009 Oct;30(20):2450-60. doi: 10.1093/eurheartj/ehp359. Epub 2009 Aug 31.
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Upgrade and de novo cardiac resynchronization therapy: impact of paced or intrinsic QRS morphology on outcomes and survival.升级和从头心脏再同步治疗:起搏或固有 QRS 形态对结局和生存的影响。
Heart Rhythm. 2009 Oct;6(10):1439-47. doi: 10.1016/j.hrthm.2009.07.009. Epub 2009 Jul 10.
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Quality improvement: science and action.质量改进:科学与行动。
Circulation. 2009 Apr 14;119(14):1962-74. doi: 10.1161/CIRCULATIONAHA.108.768895.
7
Cardiac magnetic resonance assessment of dyssynchrony and myocardial scar predicts function class improvement following cardiac resynchronization therapy.心脏磁共振对不同步和心肌瘢痕的评估可预测心脏再同步治疗后功能分级的改善。
JACC Cardiovasc Imaging. 2008 Sep;1(5):561-8. doi: 10.1016/j.jcmg.2008.04.013.
8
Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005.2002年至2005年可植入式心律转复除颤器植入术后与死亡率及并发症相关的患者和植入医生因素
Circ Arrhythm Electrophysiol. 2008 Oct;1(4):240-9. doi: 10.1161/CIRCEP.108.777888.
9
Usefulness of baseline electrocardiographic QRS complex pattern to predict response to cardiac resynchronization.基线心电图QRS波群形态对预测心脏再同步化治疗反应的有用性。
Am J Cardiol. 2009 Jan 15;103(2):238-42. doi: 10.1016/j.amjcard.2008.08.069. Epub 2008 Nov 12.
10
Impact of advanced age on survival in patients with implantable cardioverter defibrillators.高龄对植入式心脏复律除颤器患者生存的影响。
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医疗保险患者心脏再同步治疗后束支阻滞形态和其他预后预测因素。

Bundle-branch block morphology and other predictors of outcome after cardiac resynchronization therapy in Medicare patients.

机构信息

Departments of Medicine, University of Virginia Health System, PO Box 800158, Charlottesville, VA 22901, USA.

出版信息

Circulation. 2010 Nov 16;122(20):2022-30. doi: 10.1161/CIRCULATIONAHA.110.956011. Epub 2010 Nov 1.

DOI:10.1161/CIRCULATIONAHA.110.956011
PMID:21041691
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3659803/
Abstract

BACKGROUND

Clinical trials of cardiac resynchronization therapy (CRT) have enrolled a select group of patients, with few patients in subgroups such as right bundle-branch block (RBBB). Analysis of population-based outcomes provides a method to identify real-world predictors of CRT outcomes.

METHODS AND RESULTS

Medicare Implantable Cardioverter-Defibrillator Registry (2005 to 2006) data were merged with patient outcomes data. Cox proportional-hazards models assessed death and death/heart failure hospitalization outcomes in patients with CRT and an implantable cardioverter-defibrillator (CRT-D). The 14 946 registry patients with CRT-D (median follow-up, 40 months) had 1-year, 3-year, and overall mortality rates of 12%, 32%, and 37%, respectively. New York Heart Association class IV heart failure status (1-year hazard ratio [HR], 2.23; 3-year HR, 1.98; P<0.001) and age ≥ 80 years (1-year HR, 1.74; 3-year HR, 1.75; P<0.001) were associated with increased mortality both early and late after CRT-D. RBBB (1-year HR, 1.44; 3-year HR, 1.37; P<0.001) and ischemic cardiomyopathy (1-year HR, 1.39; 3-year HR, 1.44; P<0.001) were the next strongest adjusted predictors of both early and late mortality. RBBB and ischemic cardiomyopathy together had twice the adjusted hazard for death (HR, 1.99; P<0.001) as left BBB and nonischemic cardiomyopathy. QRS duration of at least 150 ms predicted more favorable outcomes in left BBB but had no impact in RBBB. A secondary analysis showed lower hazards for CRT-D compared with standard implantable cardioverter-defibrillators in left BBB compared with RBBB.

CONCLUSIONS

In Medicare patients, RBBB, ischemic cardiomyopathy, New York Heart Association class IV status, and advanced age were powerful adjusted predictors of poor outcome after CRT-D. Real-world mortality rates 3 to 4 years after CRT-D appear higher than previously recognized.

摘要

背景

心脏再同步治疗(CRT)的临床试验纳入了一组特定的患者,亚组如右束支传导阻滞(RBBB)的患者较少。基于人群的结果分析提供了一种识别 CRT 结果的真实世界预测因素的方法。

方法和结果

将医疗保险植入式心脏复律除颤器登记(2005 年至 2006 年)数据与患者结局数据合并。Cox 比例风险模型评估了 CRT-D 患者的死亡和死亡/心力衰竭住院结局。登记的 14946 例 CRT-D 患者(中位随访时间为 40 个月)的 1 年、3 年和总死亡率分别为 12%、32%和 37%。纽约心脏协会心功能 IV 级心力衰竭状态(1 年风险比[HR],2.23;3 年 HR,1.98;P<0.001)和年龄≥80 岁(1 年 HR,1.74;3 年 HR,1.75;P<0.001)与 CRT-D 后早期和晚期死亡率增加相关。RBBB(1 年 HR,1.44;3 年 HR,1.37;P<0.001)和缺血性心肌病(1 年 HR,1.39;3 年 HR,1.44;P<0.001)是早期和晚期死亡率的下一个最强调整预测因素。RBBB 和缺血性心肌病合并后死亡的调整风险是左束支阻滞和非缺血性心肌病的两倍(HR,1.99;P<0.001)。QRS 时限至少 150 ms 预测左束支阻滞时的结果更好,但对 RBBB 无影响。二次分析显示,与 RBBB 相比,左束支阻滞时 CRT-D 的风险较低,与标准植入式心脏复律除颤器相比。

结论

在医疗保险患者中,RBBB、缺血性心肌病、纽约心脏协会心功能 IV 级状态和高龄是 CRT-D 后预后不良的强有力调整预测因素。CRT-D 后 3 至 4 年的实际死亡率似乎高于先前认识到的。