Eur J Cardiothorac Surg. 2026 Jan 9:ezag014. doi: 10.1093/ejcts/ezag014. Online ahead of print.
ABSTRACT
OBJECTIVES: Left Ventricular Assist Devices have become an important therapy for advanced heart failure. We present 2-year results of the prospective, multicentre clinical trial in China, showing long-term efficacy and safety of a novel miniaturized magnetically levitated, continuous-flow left ventricular assist system.
METHODS: Patients were adults with a left ventricular ejection fraction <30% and a cardiac index < 2.0 L/min/m2 without inotropic, or dependence on continuous intravenous inotropes. Clinical data, including survival status, laboratory parameters, adverse events, and functional status, were collected at baseline and at 3, 6, 12, and 24 months and analysed. The primary end-point was the composite of survival at 2 years (on device support, transplant, or recovery), free of disabling stroke or device replacement.
RESULTS: A total of 50 patients were enrolled in 12 centres between January 2022 and July 2022. At the 2-year follow-up, 39 patients (78%) remained on device support, 3 patients (6%) received heart transplants, and 1 patient (2%) had the device explanted due to cardiac recovery. The 2-year event-free survival was 86% (95% Confidence Interval [CI]: 73.3% - 94.2%). Major adverse events included right heart failure (n = 2, 4%), stroke (n = 3, 6%), driveline infection (n = 6, 12%), and gastrointestinal bleeding (n = 2, 4%). No haemolysis or device malfunction occurred.
CONCLUSIONS: This study demonstrates promising long-term effectiveness and safety of the Corheart 6 left ventricular assist system for circulatory support in patients with advanced heart failure.ClinicalTrials.gov: NCT05353816.
PMID:41512307 | DOI:10.1093/ejcts/ezag014