Abstract
Objective
A new technique has been devised to treat mitral regurgitation (MR) through the transapical route by replicating the edge-to-edge repair surgery. This system encompasses an easy-to-use leaflet clamp and a smaller-sized delivery system (14F–16F). 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 major chordae supporting the corresponding segment of the leaflet. This device was then transapically implanted on the prolapsing segment under 3D epicardial echocardiographic guidance. All of the animals were killed 30 days after the procedure to verify the proper location of the implanted devices.
Results
Cutting the major chordae induced an eccentric MR jet (MR grade: 3+, 27.8%/4+, 72.2%) in all of the animals. Every single pig was then successfully implanted with one clamp. The duration of catheterization ranged from 18 to 40 minutes. Overt MR reduction was observed following the procedure through echocardiography; residual MR was mild in 8 cases, trivial in 19 cases, and absent in 9 cases. In terms of hemodynamic parameters, the mean and maximum mitral valve pressure gradients were increased significantly (p<0.01), but these values were less than 4 mmHg in all of the cases. Autopsy demonstrated that all but one device were precisely placed to clip the prolapsing segment of the mitral valve, and there was no evidence of thrombosis, thromboembolism or impairment of the cardiac structure.
Table 1. Changes in hemodynamic parameters, cardiac size, and functional parameters after the procedure Preoperation Postoperation P value MR-maxA (mm2) 7.27±2.13 1.54±1.29 0.000 MVPG-max (mmHg) 1.95±0.47 3.66±0.62 0.000 MVPG-mean (mmHg) 0.87±0.31 1.7±0.28 0.000 LVEDD (mm) 46.08±2.85 46.44±3.53 0.239 LVESD (mm) 29.11±3.44 29.08±3.62 0.940 LVEF (%) 66.53±6.4 67.14±4.93 0.256 LAD (mm) 35.75±2.24 36.42±1.99 0.057 LAA (mm2) 12.95±2.22 12.64±1.55 0.301
Figure 1
Conclusions
Transapical implantation of the novel mitral valve repair device is effective and safe in reducing acutely induced MR in pigs; thus, suggesting that it has great potential for clinical benefit in patients with MR.
Acknowledgement/Funding
Shanghai Science and Technology Committee
First-in-Human Results of a Novel User-Friendly Transcatheter Edge-to-Edge Mitral Valve Repair Device