Single Center Early Feasibility Outcomes Of The Accucinch® Repair System For Heart Failure And Functional Mitral Regurgitation
James H. Wudel, Steven L. Martin, Omar Nass, Hosakate Nagaraj, Denise Doolittle.
CHI Nebraska Heart Hospital, Lincoln, NE, USA.
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BACKGROUND The CorCinch FMR study is a multi-center, non-randomized, prospective Early Feasibility Study (EFS). The objective of the study is to evaluate the safety and performance of the AccuCinch® Ventricular Repair System and assess the indices of heart failure and functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk. METHODS The AccuCinch® employs a catheter-based delivery system retrograde via the femoral artery to deliver a series of anchors into the subvalvular myocardium, using a flexible cinching cable to thereby directly reduce the basal left ventricular diameter. Procedures were performed under general anesthesia using fluoroscopy and TEE guidance. Single center data from Nebraska Heart Hospital were collected on all patients for safety, echocardiographic, and clinical outcomes as well as a subset of patients receiving a later, modified implantation technique. Longer term follow-up data will also be presented as available. RESULTS All six patients underwent AccuCinch implantation procedures and there were no 30-day adverse events (AE or SAE) from this initial series. Echocardiographic follow up was performed on all over the course of six months. Of the four patients receiving the latest implantation technique, average EF improved from 33 to 46%, LVESV decreased from 104 to 67 ml, and regurgitant volume decreased from 62 to 31 ml. Average 6MWT for these patients increased from 182 to 218, while their average overall summary KCCQ quality of life scores improved by 14 points, from 46 to 60 points. CONCLUSIONS These findings provide early feasibility data supporting the concept that a percutaneously delivered, basal left ventricular implant that cinches the myocardial wall below the mitral annulus has the potential to improve LV function and reduce the severity of fMR. <!--EndFragment-->
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