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Published on: December 11, 2017
Development of an off bypass mitral valve repair
D L Morales1, J D Madigan, A F Choudhri
1Department of Surgery, Columbia University, College of Physicians and Surgeons, New York, NY 10032, USA. dlm@columbia.edu
The Heart Surgery Forum
|March 29, 2001
Summary
A novel mitral valve (MV) screw effectively reduced mitral regurgitation (MR) by creating durable leaflet coaptation. This innovative device shows promise for minimally invasive MV repair, with promising biocompatibility and tissue integration.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- The Bow Tie Repair (BTR) technique offers satisfactory mitral regurgitation (MR) reduction with excellent hemodynamic outcomes.
- Its simplicity supports minimally invasive approaches, necessitating innovative tools for leaflet coaptation.
Purpose of the Study:
- To evaluate the efficacy and durability of a novel mitral valve (MV) grasper and screw system for MR repair.
- To assess the device's performance in both in vitro and in vivo models.
Main Methods:
- Explanted human MVs underwent simulated hemodynamic testing with the MV grasper and screw for durability (up to 6.8 million cycles).
- In vivo testing involved nine canines, assessing leaflet coaptation, screw migration, and MR via echocardiography and histological analysis up to 12 weeks.
Main Results:
- The MV screw demonstrated no detachment or migration during extensive in vitro durability testing.
- Significant reduction in MR was observed, decreasing regurgitant flow from 72% to 34% (p=0.0025).
- In vivo, the screw achieved durable leaflet coaptation with no MR, stenosis, migration, or clot formation, showing tissue integration by 12 weeks.
Conclusions:
- The MV screw provides durable leaflet coaptation and effectively reduces MR in human MVs.
- Initial biocompatibility and tissue interaction data are promising for this novel repair technology.
- Further development of this prototype could lead to advanced off-pump mitral valve repair solutions.
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