Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside

Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy. The aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculop...

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Bibliographic Details
Published in:JACC. Cardiovascular interventions 2022-06, Vol.15 (12), p.1249-1263
Main Authors: 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, Lederman, Robert J
Format: Article
Language:English
Subjects:
Cardiac Catheterization - adverse effects
Cardiac Catheterization - methods
Heart Failure - diagnostic imaging
Heart Failure - etiology
Heart Failure - therapy
Heart Valve Prosthesis Implantation - adverse effects
Heart Valve Prosthesis Implantation - methods
Humans
Mitral Valve - diagnostic imaging
Mitral Valve - surgery
Mitral Valve Insufficiency - diagnostic imaging
Mitral Valve Insufficiency - etiology
Mitral Valve Insufficiency - surgery
Prospective Studies
Treatment Outcome
Ventricular Dysfunction, Left
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Summary:Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy. The 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. The 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. Nineteen 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. Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments.
ISSN:1936-8798
1876-7605
DOI:10.1016/j.jcin.2022.04.013