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    Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial

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    Author
    Gammie, J.S.
    Bartus, K.
    Gackowski, A.
    Date
    2018
    Journal
    Journal of the American College of Cardiology
    Publisher
    Elsevier USA
    Type
    Article
    
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    See at
    https://dx.doi.org/10.1016/j.jacc.2017.10.062
    Abstract
    Background: Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality. Objectives: This study evaluated safety and performance of a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart. Methods: In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with a mitral valve repair system (MVRS) via small left thoracotomy. The primary (30-day) endpoint was successful implantation of cords with MR reduction to moderate or less. Results: The primary endpoint was met in 27 of 30 patients (90%). Three patients required conversion to open mitral surgery. There were no deaths, strokes, or permanent pacemaker implantations. At 1 month, MR was mild or less in 89% (24 of 27) and was moderate in 11% (3 of 27). At 6 months, MR was mild or less in 85 % (22 of 26), moderate in 8% (2 of 26), and severe in 8% (2 of 26). Favorable cardiac remodeling at 6 months included decreases in end-diastolic (161 ± 36 ml to 122 ± 30 ml; p < 0.001) and left atrial volumes (106 ± 36 ml to 69 ± 24 ml; p < 0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 mm to 28.2 ± 5.1 mm; p < 0.001 as did the mitral annular area (10.0 ± 2.7 cm2 vs. 6.9 ± 2.0 cm2; p < 0.0001). Conclusions: MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device’s safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870). Copyright 2018 American College of Cardiology Foundation
    Keyword
    echocardiography
    mitral valve
    regurgitation
    surgery
    valvuloplasty
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85038404919&doi=10.1016%2fj.jacc.2017.10.062&partnerID=40&md5=1083da851b6b87a3522655b76097df81; http://hdl.handle.net/10713/9743
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.jacc.2017.10.062
    Scopus Count
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    UMB Open Access Articles 2018

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