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IVAC2L系统对健康和心源性休克猪进行长时间血流动力学支持的有效性和安全性

Effectiveness and Safety of a Prolonged Hemodynamic Support by the IVAC2L System in Healthy and Cardiogenic Shock Pigs.

作者信息

Delmas Clément, Porterie Jean, Jourdan Géraldine, Lezoualc'h Frank, Arnaud Romain, Brun Stéphanie, Cavalerie Hugo, Blanc Grégoire, Marcheix Bertrand, Lairez Olivier, Verwaerde Patrick, Mialet-Perez Jeanne

机构信息

Institute of Metabolic and Cardiovascular Diseases (I2MC), UMR1297, National Institute of Health and Medical Research (INSERM), University of Toulouse, Toulouse, France.

Intensive Cardiac Care Unit, Department of Cardiology, Rangueil University Hospital, Toulouse, France.

出版信息

Front Cardiovasc Med. 2022 Feb 8;9:809143. doi: 10.3389/fcvm.2022.809143. eCollection 2022.

DOI:10.3389/fcvm.2022.809143
PMID:35211526
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8861279/
Abstract

BACKGROUND

Mechanical circulatory supports are used in case of cardiogenic shock (CS) refractory to conventional therapy. Several devices can be employed, but are limited by their availability, benefit risk-ratio, and/or cost.

AIMS

To investigate the feasibility, safety, and effectiveness of a long-term support by a new available device (IVAC2L) in pigs.

METHODS

Experiments were carried out in male pigs, divided into healthy ( = 6) or ischemic CS ( = 4) groups for a median support time of 34 and 12 h, respectively. IVAC2L was implanted under fluoroscopic and TTE guidance under general anesthesia. CS was induced by surgical ligation of the left anterior descending artery. An ipsilateral lower limb reperfusion was created with the Solopath® system. Reperfusion was started after 1 h of support in healthy pigs and upon IVAC2L insertion in CS pigs. Hemodynamic and biological parameters were monitored before and during the whole period of support in each group.

RESULTS

Occurrence of an ipsilateral lower limb ischemia was systematic in healthy and CS pigs in a few minutes after IVAC2L implantation, and could be reversed by the arterial reperfusion, as demonstrated by distal transcutaneous pressure in oxygen (TcPO) and lactate normalization. IVAC2L support decreased pulmonary capillary wedge pressure (PCWP) (15.3 ± 0.3 vs. 7.5 ± 0.9 mmHg, < 0.001), increased systolic blood pressure (SBP) (70 ± 4.5 vs. 101.3 ± 3.1 mmHg, < 0.01), and cardiac output (CO) (4.0 ± 0.3 vs. 5.2 ± 0.6 l/min, < 0.05) in CS pigs; at CS onset and after 12 h of support, without effects on heart rate or pulmonary artery pressure (PAP). Non-sustained ventricular arrhythmias were frequent at implantation (50%). A non-significant hemolysis was observed under support in CS pigs. Bleedings were frequent at the insertion and/or operating sites (30%).

CONCLUSION

Long-term support by IVAC2L is feasible and associated with a significant hemodynamic improvement in a porcine model. These preclinical data open the door for a study of IVAC2L in human ischemic CS, keeping in mind the need for systematic reperfusion of the lower limb and the associated risk of bleeding.

摘要

背景

在常规治疗难治的心源性休克(CS)病例中使用机械循环支持。可以采用几种装置,但受到其可用性、获益风险比和/或成本的限制。

目的

研究一种新的可用装置(IVAC2L)对猪进行长期支持的可行性、安全性和有效性。

方法

在雄性猪身上进行实验,分为健康组(n = 6)或缺血性CS组(n = 4),中位支持时间分别为34小时和12小时。在全身麻醉下,在荧光镜和经胸超声心动图(TTE)引导下植入IVAC2L。通过手术结扎左前降支动脉诱导CS。使用Solopath®系统进行同侧下肢再灌注。健康猪在支持1小时后开始再灌注,CS猪在植入IVAC2L后开始再灌注。在每组支持的整个期间之前和期间监测血流动力学和生物学参数。

结果

在健康猪和CS猪中,IVAC2L植入后几分钟内系统性地出现同侧下肢缺血,并且如经皮氧分压(TcPO)和乳酸正常化所证明的,可通过动脉再灌注逆转。IVAC2L支持降低了CS猪的肺毛细血管楔压(PCWP)(15.3±0.3 vs. 7.5±0.9 mmHg,P<0.001),增加了收缩压(SBP)(70±4.5 vs. 101.3±3.1 mmHg,P<0.01)和心输出量(CO)(4.0±0.3 vs. 5.2±0.6 l/min,P<0.05);在CS发作时和支持12小时后,对心率或肺动脉压(PAP)无影响。植入时频繁出现非持续性室性心律失常(50%)。在CS猪支持期间观察到非显著性溶血。在插入和/或手术部位频繁出现出血(30%)。

结论

IVAC2L的长期支持是可行的,并且在猪模型中与显著的血流动力学改善相关。这些临床前数据为在人类缺血性CS中研究IVAC2L打开了大门,同时要记住需要对下肢进行系统性再灌注以及相关的出血风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/3d29523734af/fcvm-09-809143-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/5d85ba1b8e01/fcvm-09-809143-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/fcda114a302e/fcvm-09-809143-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/615dd1549a01/fcvm-09-809143-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/25a210f558c6/fcvm-09-809143-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/21be37464633/fcvm-09-809143-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/3d29523734af/fcvm-09-809143-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/5d85ba1b8e01/fcvm-09-809143-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/fcda114a302e/fcvm-09-809143-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/615dd1549a01/fcvm-09-809143-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/25a210f558c6/fcvm-09-809143-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/21be37464633/fcvm-09-809143-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8741/8861279/3d29523734af/fcvm-09-809143-g0006.jpg

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