Robert J. Lederman

BACKGROUND: Transcatheter mitral cerclage ventriculoplasty places a circumferential tensioning loop around the base of the left ventricle to reduce mitral annular dimensions and reshape ventricular geometry in patients with functional mitral regurgitation and heart failure. Early experience demonstrated reductions in mitral regurgitation and improvements in heart failure symptoms. METHODS: The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study was an investigator-initiated, prospective, multicenter study. Between 1 and 5 years, vital status, serious adverse events, routine clinical documentation, and site-reported transthoracic echocardiography findings were collected. RESULTS: Nineteen procedures were attempted in 18 participants (63% heart failure with reduced ejection fraction, 37% heart failure with preserved ejection fraction). Median age was 73 years, and 63% were female. Kaplan-Meier estimated 5-year survival was 57%. One participant underwent left ventricular assist device implantation after 2 years, and 1 participant underwent mitral transcatheter edge-to-edge repair after 3 years; none underwent heart transplantation. The study was suspended after complete heart block developed in 6 participants, including 4 requiring new cardiac implantable electronic devices. Among participants with available follow-up echocardiography, site-reported imaging demonstrated mitral regurgitation reduction and improved left ventricular ejection fraction through 5 years. Symptomatic improvement was most apparent during the first year and attenuated thereafter. CONCLUSIONS: Cerclage ventriculoplasty was associated with mitral regurgitation reduction and improved ventricular function among participants with available long-term follow-up. Symptomatic benefit was greatest during the first year and diminished thereafter, suggesting that favorable remodeling may not fully offset progression of the underlying cardiomyopathy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03929913.