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find Author "WU Yunzhang" 1 results
  • Short - to medium-term safety and efficacy of the implantable Corheart 6 left ventricular assist system in patients with end-stage heart failure

    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 advanced 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 effectiveness and safety of the Corheart 6 left ventricular assist system were evaluated by comparing the changes in the patients' preoperative, discharge, 3-month postoperative, and 6-month postoperative indices. Effectiveness indicators included the New York Heart Association (NYHA) cardiac function class, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD). The safety indicators included the position and orientation of the intraoperative blood pump inlet tube and the frequency 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 (P<0.05) at 3 months after surgery than that during the preoperative period. LVEDD was significantly lower (P<0.05) at discharge, 3 and 6 months after surgery than that during the preoperative period. 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, there were no 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.

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