植入式血流动力学监测在舒张性心力衰竭患者管理中的应用：COMPASS-HF试验的亚组分析
Application of implantable hemodynamic monitoring in the management of patients with diastolic heart failure: a subgroup analysis of the COMPASS-HF trial.
作者信息
Zile Michael R, Bourge Robert C, Bennett Tom D, Stevenson Lynne Warner, Cho Yong K, Adamson Philip B, Aaron Mark F, Aranda Juan M, Abraham William T, Smart Frank W, Kueffer Fred J
机构信息
Division of Cardiology, Departmentof Medicine, Medical University of South Carolina and RHJ Department of Veterans Affairs Medical Center, Charleston, SC 29425, USA.
出版信息
J Card Fail. 2008 Dec;14(10):816-23. doi: 10.1016/j.cardfail.2008.07.235. Epub 2008 Sep 6.
BACKGROUND
Nearly half of all patients with chronic heart failure (HF) have a normal ejection fraction (EF), and abnormal diastolic function (ie, diastolic heart failure [DHF]). However, appropriate management of DHF patients remains a difficult and uncertain challenge.
METHODS AND RESULTS
The Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial was designed to evaluate whether an implantable hemodynamic monitor (IHM) was safe and effective in reducing the number of heart failure-related events (HFRE) in patients with chronic HF. The current study presents data on a prespecified and planned subgroup analysis from the COMPASS-HF trial: 70 patients with an EF > or =50% (ie, DHF). As such, this represents a subgroup analysis of the COMPASS-HF Trial. DHF patients were randomized to IHM-guided care (treatment) vs. standard care (control) for 6 months. All 70 patients received optimal medical therapy, but the hemodynamic information from the IHM was used to guide patient management only in the treatment group. The HFRE rate in DHF patients randomized to treatment was 0.58 events/6 months compared with DHF patients randomized to control, which was 0.73 events/6 months; this represented a 20% nonsignificant reduction in the overall HFRE rate in the treatment group (95% CI = -46, 56, P = .66). There was a 29% nonsignificant reduction in the relative risk of a HF hospitalization in the DHF patients randomized to treatment compared with DHF patients randomized to control (95% CI = -69, 70, P = .43).
CONCLUSIONS
The IHM was shown to be safe and was associated with a very low system-related and procedure-related complication rate in DHF patients. However, in this subgroup analysis limited to 70 DHF patients, the addition IHM-guided care did not significantly lower the rate of HFR events. The results of this subgroup analysis in DHF patients, for whom there are currently no proven, effective management strategies, will be used to design future studies defining the effects of IHM-guided care in patients with DHF.
背景
几乎一半的慢性心力衰竭（HF）患者射血分数（EF）正常，但存在舒张功能异常（即舒张性心力衰竭 [DHF]）。然而，对 DHF 患者进行恰当管理仍然是一项困难且不确定的挑战。
方法与结果
“心力衰竭晚期体征和症状患者的纪事管理”（COMPASS-HF）试验旨在评估植入式血流动力学监测器（IHM）在减少慢性 HF 患者心力衰竭相关事件（HFRE）数量方面是否安全有效。本研究展示了 COMPASS-HF 试验中一个预先设定且计划好的亚组分析数据：70 例 EF≥50% 的患者（即 DHF 患者）。因此，这代表了 COMPASS-HF 试验的一项亚组分析。DHF 患者被随机分为接受 IHM 指导的治疗组与标准治疗的对照组，为期 6 个月。所有 70 例患者均接受了最佳药物治疗，但仅在治疗组中使用来自 IHM 的血流动力学信息来指导患者管理。随机分配至治疗组的 DHF 患者的 HFRE 发生率为 0.58 次事件/6 个月，而随机分配至对照组的 DHF 患者为 0.73 次事件/6 个月；这表明治疗组的总体 HFRE 发生率有 20% 的降低，但无统计学意义（95% CI = -46, 56，P = 0.66）。与随机分配至对照组的 DHF 患者相比，随机分配至治疗组的 DHF 患者 HF 住院相对风险有 29% 的降低，但无统计学意义（95% CI = -69, 70，P = 0.43）。
结论
在 DHF 患者中，IHM 被证明是安全的，且与极低的系统相关和操作相关并发症发生率相关。然而，在这项限于 70 例 DHF 患者的亚组分析中，增加 IHM 指导的治疗并未显著降低 HF 事件发生率。对于目前尚无经证实的有效管理策略的 DHF 患者，该亚组分析结果将用于设计未来研究，以明确 IHM 指导的治疗对 DHF 患者的影响。
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