Key result
Transapical implantation of the ValveClamp device effectively reduced acutely induced mitral regurgitation in a porcine model, with precise device placement and no evidence of mitral stenosis at 30 days.
Why the study?
A new transapical mitral regurgitation device with an easy-to-use leaflet clamp and a smaller delivery system was developed, prompting evaluation of its effectiveness in a porcine model.
Does the ValveClamp device reduce mitral regurgitation in a porcine model of acute MR?
Does the ValveClamp device reduce mitral regurgitation in a porcine model of acute MR?
The novel ValveClamp device effectively and safely reduced acute mitral regurgitation in a porcine model, suggesting potential for human transcatheter edge-to-edge repair.
Supports feasibility in acute porcine MR; hypothesis-generating for human transcatheter translation.
BACKGROUND: A new technique has been developed for treating mitral regurgitation (MR) via a transapical approach, which encompasses an easy-to-use leaflet clamp and a smaller-sized delivery system (14F-16F). OBJECTIVES: We aimed to evaluate the effectiveness of this device in a porcine model of acute MR. METHODS: Acute MR was induced in 36 anesthetized porcine subjects by severing the chordae supporting the corresponding segment of the leaflet. The ValveClamp system was then transapically implanted on the prolapsing segment under epicardial echocardiographic guidance. Echocardiographic assessments were performed before and after the transapical interventions. All of the animals were killed 30 days after the procedure to verify the proper location of the implanted devices. RESULTS: Epicardial echocardiography revealed severe MR (n = 26) or moderate to severe MR (n = 10) in the pig model of acute MR. Overt MR reduction was observed following the procedure through echocardiography; residual MR was absent in 10 cases, mild in 17 cases, and moderate in 9 cases. There was no evidence of mitral stenosis at the end of the procedure in terms of mitral valve area and mitral valve pressure gradient. Autopsy demonstrated that all ValveClamp devices were precisely placed to clamp the prolapsing segment of the mitral valve. CONCLUSIONS: Transapical implantation of the ValveClamp device under epicardial echocardiographic guidance was effective and safe in reducing acutely induced MR in this pig model. It is potentially applicable as a novel user-friendly transcatheter edge-to-edge mitral valve repair device for the treatment of MR in humans.
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Ge et al. (2020) studied Acute mitral regurgitation (n=36). ValveClamp system was evaluated on Mitral regurgitation reduction and proper location of implanted devices. Transapical implantation of the ValveClamp device effectively reduced acutely induced mitral regurgitation in a porcine model, with precise device placement and no evidence of mitral stenosis at 30 days.
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