A Novel Magnetically Levitated Intrapericardial Left Ventricular Assist System in Advanced Heart Failure—2-Year Results From a Prospective, Multi-Centre Study

This prospective, multicenter study conducted in China evaluated the two-year outcomes of the Corheart 6, a novel miniaturized magnetically levitated left ventricular assist device, in 50 adults with advanced heart failure (left ventricular ejection fraction (LVEF) less than 30 percent, cardiac index less than 2.0 L/min/m²) enrolled across 12 centers between January and July 2022. The primary endpoint was the composite survival free of disabling stroke or device replacement at two years. Results demonstrated an 86 percent event-free survival (95 percent confidence interval (CI): 73.3 percent to 94.2 percent), with 78 percent of patients remaining on device support, six percent undergoing transplantation, and two percent being explanted for recovery. Major adverse events included stroke (six percent), right heart failure (four percent), driveline infection (12 percent), and gastrointestinal bleeding (four percent). Notably, no pump thrombosis, hemolysis, or device malfunction occurred despite lower-intensity anticoagulation (median international normalized ratio (INR) 1.96). The authors conclude that the Corheart 6 demonstrates promising long-term efficacy and safety for advanced heart failure management.