Proof of Concept: Development of a Mitral Annuloplasty Ring With Crosshatch Net. Innovations (Phila) 2024;19(2):156-160
Date
03/11/2024Pubmed ID
38462836DOI
10.1177/15569845241232685Scopus ID
2-s2.0-85187415431 (requires institutional sign-in at Scopus site)Abstract
OBJECTIVE: Here we report our preclinical, proof-of-concept testing to assess the ability of a novel device to correct mitral regurgitation. The Milwaukee Heart device aims to enable any cardiac surgeon to perform high-quality mitral valve repair using a standard annuloplasty ring with a crosshatch of microporous, monofilament suture.
METHODS: Hemodynamic, echocardiographic, and videographic data were collected at baseline, following induction of mitral regurgitation, and after repair using porcine hearts in an ex vivo biosimulator model. A commercially available cardiac prosthesis assessment platform was then used to assess the hydrodynamic characteristics of the study device.
RESULTS: Porcine biosimulator pressure and flow metrics exhibited successful correction of mitral regurgitation following device implantation with similar values to baseline. Hydrodynamic results yielded pressure gradients and an effective orifice area comparable to currently approved prostheses.
CONCLUSIONS: The study device effectively reduced mitral valve regurgitation and improved hemodynamics in our preclinical model with similar biophysical metrics to currently approved devices. Future in vivo trials are needed to evaluate the efficacy, biocompatibility, and freedom from the most likely adverse events, such as device thrombosis, embolic events, and hemolysis.
Author List
Seadler BD, Joyce DL, Zelten J, Sweeney K, Wisgerhof T, Slettehaugh Z, Yuan YW, Tefft BJ, Pearson PJAuthors
Paul Joseph Pearson MD, PhD Chief, Professor in the Surgery department at Medical College of WisconsinBrandon J. Tefft PhD Assistant Professor in the Biomedical Engineering department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AnimalsDisease Models, Animal
Echocardiography
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Hemodynamics
Mitral Valve
Mitral Valve Annuloplasty
Mitral Valve Insufficiency
Proof of Concept Study
Prosthesis Design
Swine