Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure - The COMPASS-HF study
Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure - The COMPASS-HF study
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DOI：
10.1016/j.jacc.2007.10.061
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发表时间：
2008-03-18
影响因子：
24
通讯作者：
Stevenson, Lynne Warner
中科院分区：
文献类型：
--
作者：
Bourge, Robert C.;Abraham, William T.;Stevenson, Lynne Warner
目的本研究的目的是确定使用连续心内压力监测的心力衰竭（HF）管理策略是否可以降低HF发病率。背景HF患者可能会经历频繁的失代偿，尽管进行了强化治疗和随访，但仍需要住院治疗。（Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure）研究是一项前瞻性、多中心、随机、单盲、在274名接受植入式连续血流动力学监测仪的纽约心脏协会功能分级III或IV级HF患者中进行的平行对照试验。将患者随机分配至Chronicle（Medtronic Inc.，Minneapolis，Minnesota）（n = 134）或对照组（n = 140）。所有患者均接受最佳药物治疗，但仅Chronicle组使用监护仪的血流动力学信息指导患者管理。主要终点包括无系统相关并发症，无压力传感器故障，和降低HF相关事件的发生率结果在277例接受植入术的患者中，只有8%的患者符合2个安全性终点，没有压力传感器故障和系统相关并发症（除4例并发症外，其余均成功解决）。未达到主要疗效终点，因为Chronicle组所有HF相关事件的发生率与对照组相比无显著性差异（p = 0.33）。一项回顾性分析的时间，以第一次HF住院治疗的相对风险降低了36%（p = 0.03）的HF相关的住院在Chroniclegroup.Conclusions植入式连续血流动力学监测引导下的护理相比，最佳的医疗管理并没有显着减少总HF相关事件。需要进行更多的试验来确定植入式连续血流动力学监测引导护理在晚期HF患者中的临床受益。
Objectives The purpose of this study was to determine whether a heart failure (HF) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity.Background Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up.Methods The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study was a prospective, multicenter, randomized, single-blind, parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor. Patients were randomized to a Chronicle (Medtronic Inc., Minneapolis, Minnesota) (n = 134) or control (n = 140) group. All patients received optimal medical therapy, but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group. Primary end points included freedom from system-related complications, freedom from pressure-sensor failure, and reduction in the rate of HF-related events (hospitalizations and emergency or urgent care visits requiring intravenous therapy).Results The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8% of the 277 patients who underwent implantation (all but 4 complications were successfully resolved). The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21% lower rate of all HF-related events compared with the control group (p = 0.33). A retrospective analysis of the time to first HF hospitalization showed a 36% reduction (p = 0.03) in the relative risk of a HF-related hospitalization in the Chronicle group.Conclusions The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management. Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF.