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从实验室到临床:左心室辅助装置设计的改进能否减轻不良事件并提高生存率?

From bench to bedside: Can the improvements in left ventricular assist device design mitigate adverse events and increase survival?

作者信息

Tarzia Vincenzo, Di Giammarco Gabriele, Di Mauro Michele, Bortolussi Giacomo, Maccherini Massimo, Tursi Vincenzo, Maiani Massimo, Bernazzali Sonia, Marinelli Daniele, Foschi Massimiliano, Buratto Edward, Bejko Jonida, Gregori Dario, Scuri Silvia, Livi Ugolino, Sani Guido, Bottio Tomaso, Gerosa Gino

机构信息

Cardiac Surgery, University of Padova, Padova, Italy.

Cardiac Surgery, University of Chieti, Chieti, Italy.

出版信息

J Thorac Cardiovasc Surg. 2016 Jan;151(1):213-7. doi: 10.1016/j.jtcvs.2015.09.107. Epub 2015 Oct 3.

DOI:10.1016/j.jtcvs.2015.09.107
PMID:26548997
Abstract

OBJECTIVE

In vitro tests demonstrated that the new cone-bearing configuration of the Jarvik 2000 (Jarvik Heart Inc, New York, NY) left ventricular assist device exhibits better hydraulic efficiency than the previous pin-bearing design. We investigated the long-term outcomes of patients who received the Jarvik 2000 left ventricular assist device, depending on bearing design.

METHODS

A retrospective review of prospectively collected data from 18 centers included in the Italian Registry was performed. From May 2008 to September 2013, 99 patients with end-stage heart failure were enrolled. Patients were divided into 2 groups according to their Jarvik 2000 suspending mechanism: Group pin included patients with pin bearings (May 2008 to June 2010), and group cone included patients with newer cone bearings (July 2010 to September 2013). The 2 groups did not differ significantly in terms of baseline characteristics.

RESULTS

A total of 30 of 39 patients (group pin) and 46 of 60 patients (group cone) were discharged. During follow-up, 6 patients underwent transplantation, and in 1 patient the left ventricular assist device was explanted. The cumulative incidence competing risk of the entire cohort for noncardiovascular-related death was 28% (20%-40%); the cumulative incidence competing risk for cardiovascular-related death was 56% (42%-73%): 71% in group pin versus 26% in group cone (P = .034). The multivariate analyses confirmed that the pin-bearing design was a risk factor for cardiovascular death, along with Interagency Registry for Mechanically Assisted Circulatory Support class. Right ventricular failures and ischemic and hemorrhagic strokes were significantly higher in group pin.

CONCLUSIONS

Patients with the new pump configuration showed a better freedom from cardiovascular death and lower incidence of fatal stroke and right ventricular failure. Further studies are needed to prove the favorable impact of pump-enhanced fluid dynamics on long-term results.

摘要

目的

体外测试表明,Jarvik 2000型(纽约州Jarvik心脏公司)左心室辅助装置的新型锥形轴承配置比先前的销形轴承设计具有更高的水力效率。我们根据轴承设计,对接受Jarvik 2000左心室辅助装置的患者的长期结局进行了调查。

方法

对意大利注册中心纳入的18个中心前瞻性收集的数据进行回顾性分析。2008年5月至2013年9月,纳入99例终末期心力衰竭患者。根据Jarvik 2000的悬吊机制将患者分为2组:销形轴承组包括采用销形轴承的患者(2008年5月至2010年6月),锥形轴承组包括采用新型锥形轴承的患者(2010年7月至2013年9月)。两组在基线特征方面无显著差异。

结果

销形轴承组39例患者中有30例、锥形轴承组60例患者中有46例出院。随访期间,6例患者接受了移植,1例患者的左心室辅助装置被取出。整个队列非心血管相关死亡的累积竞争风险发生率为28%(20%-40%);心血管相关死亡的累积竞争风险发生率为56%(42%-73%):销形轴承组为71%,锥形轴承组为26%(P = 0.034)。多因素分析证实,销形轴承设计是心血管死亡的危险因素,与机构间机械辅助循环支持分级相同。销形轴承组右心室衰竭、缺血性和出血性卒中的发生率显著更高。

结论

采用新型泵配置的患者心血管死亡风险更低,致命性卒中和右心室衰竭的发生率更低。需要进一步研究来证明泵增强的流体动力学对长期结果的有利影响。

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