Department of Vascular and Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Catheter Cardiovasc Interv. 2022 Jan 1;99(1):50-56. doi: 10.1002/ccd.29489. Epub 2021 Jan 27.
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).
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.
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.
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).
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.
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。
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。
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。
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)。
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。