Short- to medium-term safety and efficacy of the implantable Corheart 6 left ventricular assist system in patients with end-stage heart failure
- VernacularTitle:国产磁悬浮左心室辅助装置治疗终末期心力衰竭短中期有效性和安全性
- Author:
Zhibing QIU
1
;
Xiaochun SONG
2
;
Liangpeng LI
1
;
Hongwei SHI
3
;
Liqiong XIAO
1
;
Yunzhang WU
1
;
Xiaosong RONG
4
;
Jidan FAN
5
;
Liang WEI
6
;
Xin CHEN
1
Author Information
1. Department of Thoracic and Cardiovascular Surgery, Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing First Hospital, Nanjing, 210006, P. R. China
2. Department of Critical Care Medicine, Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing First Hospital, Nanjing, 210006, P. R. China
3. Department of Anesthesiology, Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing First Hospital, Nanjing, 210006, P. R. China
4. Department of Cardiovascular Surgery, Wuxi People s Hospital, Wuxi, 214023, Jiangsu, P. R. China
5. Department of Cardiovascular Surgery, Taizhou People s Hospital, Taizhou, 225300, Jiangsu, P. R. China
6. Department of Cardiothoracic Surgery, Huaian Hospital Affiliated to Yangzhou University, Huaian, 223001, Jiangsu, P. R. China
- Publication Type:Journal Article
- Keywords:
Left ventricular assist device;
end-stage heart failure;
efficacy;
safety
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2025;32(05):639-645
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of the Corheart 6 left ventricular assist system in patients with end-stage heart failure. Methods A retrospective study was conducted on patients with end-stage heart failure who were treated with Corheart 6 left ventricular assist system from March 2022 to June 2024 in 4 hospitals in Jiangsu Province. The efficacy of the device was evaluated by comparing changes in clinical indicators at preoperative, discharge, 3-month postoperative, and 6-month postoperative timepoints, including the New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), and left ventricular end-diastolic diameter (LVEDD). The safety of the device was assessed by analyzing the intraoperative position and orientation of the blood pump inlet cannula, as well as the incidence of adverse events. Results In this study, 39 patients were collected, including 34 males and 5 females with a mean age of (56.4±12.5) years, ranging from 20 to 75 years. There was no operative death. There was no death in postoperative 3 months with a survival rate of 100.0%. There were 3 deaths in 6 months postoperatively, with a survival rate of 92.3%. All patients had a preoperative NYHA cardiac function classification of class Ⅳ. The NYHA cardiac function class of the patients improved (P<0.05) at discharge, 3 and 6 months after surgery when compared to the preoperative period. LVEF was significantly higher at 3 months after surgery than that during the preoperative period (P<0.05). LVEDD was significantly smaller at discharge, 3 and 6 months after surgery than that during the preoperative period (P<0.05). The safety evaluation's findings demonstrated that all 39 patients' intraoperative blood pump inlet tubes were oriented correctly, the artificial blood vessel suture sites were appropriate, there were no instances of device malfunction or pump thrombosis, or instances of bleeding or hemolysis, and the rate of the remaining adverse events was low. Conclusion With a low rate of adverse events and an excellent safety profile, the Corheart 6 left ventricular assist system can efficiently enhance cardiac function in patients with end-stage heart failure. It also has considerable clinical uses.
