Abstract
Introduction: Interventional repair of functional mitral regurgitation (FMR) is rapidly replacing traditional surgical correction as surgery is contraindicated in most FMR patients. Current treatments reduce FMR acutely but unfavorably alter mitral valve (MV) geometry resulting in MR recurrence over time and are restricted to use in specific anatomies. We developed a new focal leaflet augmentation approach ( Fig. 1A ) that augments a single leaflet to correct FMR without the disturbing MV dynamics. Hypothesis: We hypothesize that Cardiac leaflet enhancing (CARLEN) implant can effectively correct regurgitation in different geometries seen clinically in FMR patients. Methods: CARLEN was laser cut from a thin sheet of nitinol and shape set to form a 3D structure with two arms that grasp the leaflet and a balloon like section that enables leaflet enhancement ( Fig. 1B ). A trans-septal delivery system was developed and the feasibility of deployment was tested in a swine model ( Fig. 2 ). CARLEN functionality was tested and compared to Edge-to-Edge repair (EE) in an in-vitro left heart simulator with an isolated pig MV (n=6) in different valve geometries seen in FMR patients: a) Annular dilation (AD) alone (aFMR), b) AD+asymmetric tethering (iFMR), and c) AD+symmetric tethering (dFMR). Results: CARLEN consistently and significantly decreased FMR in all geometries (aFMR: 14.79±3.11% vs 6.79±1.90%; iFMR: 20.52±2% vs 6.64±2.16%; dFMR: 21.93±7.2% vs 7.12±2.83%, p<0.05). However, significant reduction after EE was seen only in iFMR and dFMR ( Fig. 3 ). CARLEN did not perturb leaflet kinematics whereas leaflet mobility was significantly decreased after EE ( Fig. 4 ) in all geometries. Conclusion: Focal leaflet enhancement with CARLEN can effectively correct regurgitation in all clinically relevant valve geometries associated with FMR, potentially expanding the opportunity for transcatheter repair to a larger patient population.
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