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贾维克 2000 左心室辅助装置作为移植桥:日本机械循环辅助支持注册研究。

The Jarvik 2000 left ventricular assist device as a bridge to transplantation: Japanese Registry for Mechanically Assisted Circulatory Support.

机构信息

Department of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.

Department of Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.

出版信息

J Heart Lung Transplant. 2018 Jan;37(1):71-78. doi: 10.1016/j.healun.2017.10.016. Epub 2017 Oct 24.

DOI:10.1016/j.healun.2017.10.016
PMID:29129374
Abstract

BACKGROUND

The Jarvik 2000 ventricular assist device features a miniaturized intraventricular pump and an intermittent low-speed function that facilitates aortic valve opening. Despite its long history, little is known about the Jarvik device with regard to post-implantation outcomes.

METHODS

Prospectively collected data from 13 participating hospitals were extracted from the Japanese Registry for Mechanically Assisted Circulatory Support database to analyze mortality, morbidity and de-novo aortic regurgitation. Data on 83 patients who underwent implantation of the Jarvik 2000 were reviewed. Median support duration was 191 (maximum 758) days. All recipients underwent implantation as a bridge to transplantation.

RESULTS

Overall survival proportions at 1 and 2 years were 85.0% and 79.3%, respectively. Nine patients were in INTERMACS Level 1, and 28 patients were on mechanical circulatory support at the time of implantation. Causes of death included stroke, infection and device malfunction. Three patients had their device removed: 2 at the time of heart transplantation and 1 after recovery of the left ventricle. Common adverse events included major bleeding (27.7%), new infection (31.3%), stroke (20.5%) and device malfunction (20.5%). De-novo aortic regurgitation was observed in 17 patients, 6 of whom developed at least moderate regurgitation during follow-up.

CONCLUSIONS

Mid-term survival after Jarvik 2000 implantation was satisfactory and comparable to that reported by other national and international registries (INTERMACS and IMACS) for continuous-flow LVADs. De novo aortic regurgitation occurred despite the intermittent low-speed effect of this device, with some recipients experiencing progressive worsening of aortic regurgitation within 2 years post-implantation.

摘要

背景

Jarvik 2000 心室辅助装置具有微型化的心室内泵和间歇性低速功能,有助于主动脉瓣开放。尽管该设备历史悠久,但对于植入后的结果知之甚少。

方法

从日本机械循环支持数据库中提取了 13 家参与医院的前瞻性收集数据,以分析死亡率、发病率和新发主动脉瓣反流。对 83 名接受 Jarvik 2000 植入的患者进行了回顾性研究。中位支持时间为 191 天(最长 758 天)。所有受者均作为心脏移植的桥接进行植入。

结果

1 年和 2 年的总体生存率分别为 85.0%和 79.3%。9 名患者为 INTERMACS 级别 1,28 名患者在植入时处于机械循环支持状态。死亡原因包括中风、感染和设备故障。有 3 名患者移除了设备:2 名在心脏移植时,1 名在左心室恢复后。常见的不良事件包括大出血(27.7%)、新发感染(31.3%)、中风(20.5%)和设备故障(20.5%)。17 名患者出现新发主动脉瓣反流,其中 6 名在随访期间出现至少中度反流。

结论

Jarvik 2000 植入后的中期生存率令人满意,与其他国家和国际登记处(INTERMACS 和 IMACS)报告的连续血流左心室辅助装置的生存率相当。尽管该设备具有间歇性低速效应,但仍发生新发主动脉瓣反流,一些受者在植入后 2 年内出现主动脉瓣反流逐渐加重。

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