[NEJM最新论文]:磁悬浮心脏泵治疗心功能衰竭2年预后 | 中国病理生理学会危重病医学专业委员会
现在的位置: 首页时讯速递, 进展交流>正文
[NEJM最新论文]:磁悬浮心脏泵治疗心功能衰竭2年预后
2018年04月16日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure

Mandeep R. Mehra, Daniel J. Goldstein, Nir Uriel, et al

N Engl J Med 2018; 378:1386-1395

DOI: 10.1056/NEJMoa1800866

Abstract

BACKGROUND 背景

In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.

在本项研究的早期分析中,与机械轴承轴流式连续流量泵相比,磁悬浮离心式连续流量循环泵能够改善晚期心衰患者6个月的临床预后。

METHODS 方法

In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was −10 percentage points.

在一项随机非劣效和优效试验中,我们比较了离心式流量泵与轴流式流量泵对晚期心衰患者的恶疗效,无论支持的目的如何(心脏移植桥接治疗或目标治疗)。复合主要终点为2年时无致残性卒中(指修订Rankin评分> 3分;评分从0-6分,分值越高残疾程度越严重)生存或无再次手术更换或拔除失功设备的生存。风险差异的非劣效界值(离心式流量泵组减轴流式流量泵组)为-10个百分点。

RESULTS 结果

Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02).

总共366名患者中,190名被分至离心式流量泵组,176名被分至轴流式流量泵组。对意向治疗人群,离心式流量泵组151名患者(79.5%)及轴流式流量泵组106名患者(60.2%)发生主要终点事件(绝对差异,19.2个百分点;95%可信限下界,9.8个百分点 [非劣效比较 P < 0.001];风险比,0.46; 95% 可信区间 [CI], 0.31 to 0.69 [优效比较P < 0.001])。离心式流量泵组患者因流量泵故障导致再次手术比例少于轴流式流量泵组(3名患者 [1.6%] vs. 30名患者 [17.0%];风险比,0.08; 95% CI, 0.03 to 0.27; P<0.001)。两组患者死亡及致残性卒中比例相似,但离心式流量泵组卒中整体发生率较低 (10.1% vs. 19.2%; 风险比,0.47; 95% CI, 0.27 to 0.84, P=0.02)。

CONCLUSIONS 结论

In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)

对于晚期心衰患者,在无致残性卒中及无再次手术更换或拔除失功设备的生存方面,完全磁悬浮离心式流量泵优于机械轴承轴流式流量泵。

给我留言

您必须 [ 登录 ] 才能发表留言!

×
腾讯微博