Safety and Efficacy of the Corheart 6 Left Ventricular Assist System.

Abstract

To assess the efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) in patients with end-stage heart failure. A retrospective cohort study was conducted at Nanjing First Hospital to evaluate the clinical outcomes of patients with end-stage heart failure who underwent implantation of the Corheart 6 LVAS between March 2022 and March 2024. A total of 28 patients were enrolled. The primary endpoint was a composite of survival free from disabling stroke at 6 months post-implantation. Statistical analyses were conducted to compare pre- and post-implantation outcomes. No intraoperative or 30 day postoperative mortality occurred. Survival rates were 100% at 3 months and 89.3% at 6 months, with three deaths attributed to cerebral hemorrhage, device alarm mismanagement, and systemic amyloidosis complications. Significant improvements in cardiac function were observed. Hemolysis markers remained stable. Adverse events included hemorrhagic cerebrovascular accident (3.6%), ventricular arrhythmias (25%), pulmonary infections (35.7%), driveline exit site infection (3.6%), renal failure (requiring dialysis) (7.1%), and right heart failure (3.6%). No pump thrombosis, hemolysis or device malfunction occurred. The Corheart 6 LVAS demonstrated favorable mid-term survival and cardiac functional improvement in critically ill heart failure patients, with a manageable safety profile.