Abstract
BACKGROUND: Reshaping the dilated left ventricle using a surgically implanted papillary muscle sling has been shown to provide long-term improvement in cardiac function compared to annuloplasty alone in patients with systolic heart failure. A papillary muscle sling which can be implanted via a transcatheter approach has the potential to make this treatment more widely available to patients. METHODS: The Vsling transcatheter papillary muscle sling device was evaluated in a chronic animal model (sacrificed at 30 and 90 days), in a simulator, and in a human cadaver. RESULTS: The Vsling device was successfully implanted in 10 pigs, 6 simulator procedures, and 1 human cadaver. Procedure complexity and device usability were rated as reasonable or better by 6 interventional cardiologists. Gross and histological analysis in chronic pigs through 90 days demonstrated near-complete endothelial coverage with mild inflammation and small hematoma formation but without adverse tissue reactions, thrombi, or embolization. CONCLUSIONS: Preliminary feasibility and safety of the Vsling implant and implantation procedure have been demonstrated. Human trials are planned to begin in the summer of 2022.