A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
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DOI：
10.1056/nejmoa1610426
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发表时间：
2017-02-02
影响因子：
158.5
通讯作者：
Salerno, Christopher
中科院分区：
文献类型：
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作者：
Mehra, Mandeep R.;Naka, Yoshifumi;Salerno, Christopher
背景：连续血流左心室辅助系统可提高晚期心力衰竭患者的生存率，但与泵血栓形成相关。我们研究了一种新型磁悬浮离心连续流泵的效果，该泵被设计用于避免血栓形成。方法：我们随机分配晚期心力衰竭患者接受新型离心连续流泵或市售轴向连续流泵。患者可以不考虑泵支持的预期目标（移植或终点治疗的桥梁）而入组。主要终点是无致残性卒中的生存期（以改良的Rankin评分>.3表示有致残性卒中；评分范围从0到6，分数越高表示残疾越严重）或植入后6个月无再次手术更换或移除装置的生存期。该试验对主要终点进行了非劣效性检验（非劣效性裕度，-10个百分点）。结果294例患者中，离心泵组152例，轴流泵组142例。在意向治疗人群中，离心泵组131例（86.2%）患者出现主要终点，轴流泵组109例（76.8%）患者出现主要终点（绝对差值，9.4个百分点；95%低置信区间，-2.1）
BACKGROUNDContinuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis.METHODSWe randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, -10 percentage points).RESULTSOf 294 patients, 152 were assigned to the centrifugal-flow pump group and 142 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group and in 109 (76.8%) in the axial-flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, -2.1 [P