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Mitra-patch: An Expanded Poly-tetrafluoro Ethylene (eptfe) Patch Design To Simplify Mitral Valve Prolapse Repairs
Muralidhar Padala1, Weiwei Shi1, Bryant McIver1, Jakob Vinten-Johansen1, Robert WM Frater2, Surendra K. Chawla3.
1Emory University, Atlanta, GA, USA, 2Albert Einstein College of Medicine, New York, NY, USA, 3St. Francis Hospital, Hartford, CT, USA.

OBJECTIVE: Mitral neochordoplasty requires significant expertise in valve repair, to determine the optimal placement of chordae and neochordal length. We report a novel and simple ePTFE patch design (Mitra-Patch) with a muscle portion, a leaflet portion and multiple neochordae (Fig A) that simplifies implantation without complicated sizing algorithms.
METHODS: The Mitra-Patch is laser cut from a radial reinforced ePTFE tube. Each patch consists of a web of four chordae, with proximal leaflet segments and a single papillary muscle attachment segment. Correction of cusp prolapse and regurgitation was tested in ex-vivo porcine hearts (N=6, 3 anterior and 3 posterior), then in five acute swine, with A2 prolapse from marginal chordal transection and in two chronic swine followed to 3 weeks and 4 months. The muscle portion of the device was sutured first to the papillary head with a special holder(Fig B), followed by attachment to the leaflet edge using the length of the reference chord, which is the height of the stretched opposite leaflet chord. Echocardiographic imaging was performed at monthly intervals, with gross necropsy and detailed histopathological analysis.
RESULTS: Leaflet prolapse and regurgitation were repaired in all the ex-vivo hearts as shown in Fig C1-3, with coaptation length restored from 0mm before repair to 8.1±2.2mm after posterior leaflet repair and to 10.2 ±1.3 mm after anterior leaflet repair. In the animals, regurgitation reduced from severe to trace(Fig D1-3), that sustained over the follow-up period and without diastolic obstruction. Completed endothelialization was observed at 4 months by histopathology and surface electron microscopy (FigE).The patch was intact without evidence of stretch, degeneration, thrombus or fibrous tissue incorporation, and excellent endothelialization (Fig F1), healing between the patch-leaflet (Fig F2) and patch-muscle with Dacron pledget (Fig F3)was clearly evident .
CONCLUSIONS: The Mitra-Patch can effectively correct regurgitation in a swine model of leaflet prolapse. A one-time implantation of the papillary muscle segment followed by attachment to both the leaflets at the prolapsing segment simplifies the repair.

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