Clinical evaluation of the CorCap cardiac support device in patients with dilated cardiomyopathy
Clinical evaluation of the CorCap cardiac support device in patients with dilated cardiomyopathy
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DOI：
10.1016/j.athoracsur.2007.03.095
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发表时间：
2007-10-01
影响因子：
4.6
通讯作者：
Kubo, Spencer H.
中科院分区：
文献类型：
--
作者：
Mann, Douglas L.;Acker, Michael A.;Kubo, Spencer H.
背景左心室（LV）重构与心力衰竭的不良结局相关。CorCap心脏支持装置（CSD; Acorn Cardiovascular，Inc，圣保罗，MN）是减弱LV重构的可植入装置。Acorn试验评估了CSD在300名心力衰竭患者中的安全性和有效性。需要二尖瓣手术的患者（n = 193）被随机分配至单纯二尖瓣手术或二尖瓣手术加CSD。不需要二尖瓣手术的患者（n = 107）随机接受药物治疗或药物治疗加CSD。主要终点是基于患者生命状态的变化、心力衰竭恶化时是否需要进行主要心脏手术以及纽约心脏协会（NYHA）分级的变化的临床复合终点。主要终点的比例优势比支持CSD治疗（1.73置信区间[CI]：1.07 - 2.79; p = 0.024）。CSD治疗患者接受的心脏手术显著（p = 0.01）减少，表明心力衰竭恶化，纽约心脏协会分级改善（p = 0.049）。两组之间的生存率无显著差异（p = 0.85）。CSD治疗导致LV舒张末期（p = 0.009）和收缩末期容积（p = 0.017）降低，LV球形指数增加（p = 0.026），明尼苏达心力衰竭生活量表评分（p = 0.04）和简明36问卷（p = 0.015）改善。没有证据表明治疗组和对照组之间的严重不良事件存在显著差异（p = 0.43）。Acorn试验的结果支持这一假设，即CSD预防左心室重构对心力衰竭的不良自然史有有利影响。
Background. Left ventricular (LV) remodeling is related to adverse outcomes in heart failure. The CorCap Cardiac Support Device (CSD; Acorn Cardiovascular, Inc, St. Paul, MN) is an implantable device that attenuates LV remodeling.Methods. The Acorn trial assessed the safety and efficacy of the CSD in 300 heart failure patients. Patients needing mitral surgery (n = 193) were randomized to mitral surgery alone or mitral surgery plus CSD. Patients who did not need mitral surgery ( n = 107) were randomized to medical therapy or medical therapy plus CSD. The primary endpoint was a clinical composite based on changes in patient vital status, the need for major cardiac procedures for worsening heart failure, and a change in New York Heart Association (NYHA) class.Results. The proportional odds ratio for the primary endpoint favored treatment with the CSD (1.73 confidence interval [CI]: 1.07 to 2.79; p = 0.024). The CSD-treated patients received significantly ( p = 0.01) fewer cardiac procedures indicative of worsening heart failure and had an improvement in New York Heart Association class ( p = 0.049). There was no significant difference in survival between groups ( p = 0.85). Treatment with the CSD led to a decrease in LV end-diastolic ( p = 0.009) and end-systolic volumes ( p = 0.017), an increase in the LV sphericity index ( p = 0.026), an improvement in the Minnesota Living with Heart Failure score ( p = 0.04), and the Short Form-36 Questionnaire ( p = 0.015). There was no evidence for a significant difference ( p = 0.43) in serious adverse events between the treatment and control groups.Conclusions. The results of the Acorn trial support the hypothesis that preventing LV remodeling with a CSD favorably impacts the untoward natural history of heart failure.