1. Description, Feasibility, and Histological Assessment of the Vsling, a Novel Transcatheter Ventricular Repair Device
- Author
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Gregg W. Stone, MD, Horst Sievert, MD, PhD, Renu Virmani, MD, Lea Waisman Shaler, MSc, MBA, Boaz Manash, MSc, MBA, and David Neustadter, PhD
- Subjects
Heart failure ,Papillary muscle repositioning ,Papillary muscle sling ,Transcatheter ,Ventricular reshaping ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - 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.
- Published
- 2022
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