Pre-clinical Experience with a Multi-Chordal Patch for Mitral Valve Repair.

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Innovation

Background:

• Surgical repair of flail mitral valve leaflets using neochordoplasty yields good results.
• Current neochordoplasty techniques are challenging for anterior and bi-leaflet repairs, being time-consuming and prone to errors.
• These challenges can lead to persistent localized flail if neochordae are placed or sized incorrectly.

Purpose of the Study:

• To report pre-clinical findings on a novel multi-chordal patch designed for mitral valve repair.
• To evaluate the feasibility and early outcomes of this new device in addressing flail mitral valve leaflets.

Main Methods:

• The multi-chordal patch was designed using human cadaver hearts and laser-cut from expanded polytetrafluoroethylene.
• Prototypes underwent testing in ex vivo human hearts (N=6) with leaflet flail.
• In vivo testing involved acute (N=6) and chronic (N=2) swine models with induced flail mitral valve leaflets.

Main Results:

• Successful repair of A2 and P2 prolapse was achieved, restoring coaptation length to 8.1±2.2mm (posterior) and 10.2±1.3mm (anterior) in ex vivo hearts.
• In vivo repairs showed only trace regurgitation.
• The patch demonstrated excellent durability, healing, and endothelialization in chronic swine models at 23 and 120 days.

Conclusions:

• A novel multi-chordal patch device offers a potentially simpler and more effective approach to mitral valve repair.
• Early pre-clinical results indicate good outcomes and device integration.
• This innovation may overcome existing challenges in repairing anterior and bi-leaflet mitral valve leaflet flail.