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Heartech® 左心室分隔装置可改善心肌梗死后慢性心力衰竭患者的左心室收缩功能,在 1 年随访时观察到。

Heartech® left ventricular partitioning device improves left ventricular systolic function of patients with chronic heart failure post-myocardial infarction at 1-year follow-up.

机构信息

Department of Vascular and Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Catheter Cardiovasc Interv. 2022 Jan 1;99(1):50-56. doi: 10.1002/ccd.29489. Epub 2021 Jan 27.

DOI:10.1002/ccd.29489
PMID:33502092
Abstract

OBJECTIVES

This study presents 1-year follow-up data of echocardiographic outcomes in patients who received the Heartech® left ventricular (LV) partitioning device (LVPD) (Xinrui Medical Equipment Co. Ltd., Shanghai, China).

BACKGROUND

Our first-in-man study of the Heartech® LVPD confirmed its safety and efficacy in patients with chronic heart failure (HF) post-myocardial infarction (MI) 1 month post-implantation. This subsequent study reports the echocardiographic outcomes of these patients at 1 year of follow-up.

METHODS

Fifteen patients with HF post-MI from three cardiac intervention centers in China were successfully implanted with the Heartech® LVPD via percutaneous ventricular restoration procedures. Echocardiographic parameters-including LV systolic function, diastolic function, two-dimensional speckle-tracking analysis, and right ventricular systolic function-were obtained before device implantation and at 1 month and 1 year postoperatively.

RESULTS

There was no deterioration of LV diastolic function, specific strain parameters, or right ventricular function at 1 year. Relative to the echocardiographic parameters recorded before the procedure, the LV ejection fraction (32.47 ± 6.98% vs. 42.5 ± 7.41%; p = .001) was significantly improved at 1 year, while the LV end-diastolic volume index (106.29 ± 28.01 vs. 83.30 ± 31.71; p = .005) and end-systolic volume index were significantly reduced (72.47 ± 22.77 vs. 50.00 ± 19.70; p = .001).

CONCLUSIONS

One-year echocardiographic follow-up results confirmed that no deterioration of LV diastolic function or specific strain parameters was observed and LV systolic function was significantly improved in patients with HF post-MI who were implanted with the Heartech® LVPD.

摘要

目的

本研究介绍了接受 Heartech®左心室(LV)分区装置(LVPD)(心锐医疗设备有限公司,上海,中国)治疗的患者的 1 年超声心动图结果随访数据。

背景

我们首次在人体中进行的 Heartech®LVPD 研究证实,该装置在心肌梗死后 1 个月植入的慢性心力衰竭(HF)患者中具有安全性和有效性。随后的这项研究报告了这些患者在 1 年随访时的超声心动图结果。

方法

来自中国 3 家心脏介入中心的 15 名 HF 合并心肌梗死后患者成功通过经皮心室修复术植入了 Heartech®LVPD。在植入前和术后 1 个月及 1 年时,获得了超声心动图参数,包括 LV 收缩功能、舒张功能、二维斑点追踪分析和右心室收缩功能。

结果

在 1 年时,LV 舒张功能、特定应变参数或右心室功能没有恶化。与术前超声心动图参数相比,LV 射血分数(32.47±6.98% vs. 42.5±7.41%;p=0.001)在 1 年时显著改善,而 LV 舒张末期容积指数(106.29±28.01 vs. 83.30±31.71;p=0.005)和收缩末期容积指数显著降低(72.47±22.77 vs. 50.00±19.70;p=0.001)。

结论

1 年的超声心动图随访结果证实,植入 Heartech®LVPD 的心肌梗死后 HF 患者未观察到 LV 舒张功能或特定应变参数恶化,LV 收缩功能显著改善。

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