1. Transcatheter Mitral Cerclage Ventriculoplasty From Bench to Bedside
- Author
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Rogers, Toby, Greenbaum, Adam B, Babaliaros, Vasilis C, Foerst, Jason R, Khan, Jaffar M, Bruce, Christopher G, Stine, Annette M, Satler, Lowell F, Perdoncin, Emily, Gleason, Patrick T, Lisko, John C, Tian, Xin, Miao, Rui, Sachdev, Vandana, Chen, Marcus Y, and Lederman, Robert J
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Heart Disease ,Clinical Research ,Cardiovascular ,Biomedical Imaging ,Heart Disease - Coronary Heart Disease ,Cardiac Catheterization ,Heart Failure ,Heart Valve Prosthesis Implantation ,Humans ,Mitral Valve ,Mitral Valve Insufficiency ,Prospective Studies ,Treatment Outcome ,Ventricular Dysfunction ,Left ,cardiomyopathy ,heart failure ,secondary mitral regurgitation ,transcatheter annuloplasty ,transcatheter ventriculoplasty ,ventricular repair ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
BackgroundTranscatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy.ObjectivesThe aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR.MethodsThe National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography.ResultsNineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337 days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30 days that were maintained after a median of 265 days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage.ConclusionsTranscatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments.
- Published
- 2022