In the first U.S. Food and Drug Administration (FDA) approved early feasibility study (EFS) of the Cardioband tricuspid system, 30 patients with severe tricuspid regurgitation (TR) underwent successful direct transcatheter annular reduction with 93% procedural success, 100% survival and significant reductions in TR which translated to improvements in quality of life and functional status at 30 days, according to results released Monday.
Significant TR is associated with increased morbidity and mortality. Unfortunately, there are limited therapeutic options for isolated TR. The Cardioband tricuspid valve reconstruction system (Edwards Lifesciences, Irvine, California) is a direct annular reduction therapy delivered transfemorally. The TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) trial demonstrated favorable 6-month outcomes. Recently, the Cardioband received CE mark approval for the treatment of TR in Europe.
Charles J. Davidson, MD, of the Northwestern University Feinberg School of Medicine, Chicago, and co-investigators, reported results from the Cardioband TR EFS in a manuscript published in the Jan. 11 issue of JACC: Cardiovascular Interventions.
Included were 30 patients with severe or worse TR who then underwent direct tricuspid annular reduction using the Cardioband. The authors examined procedural success and inpatient mortality. They also examined 30-day TR grade, New York Heart Association functional class (NYHA-FC) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Patients had a mean age of 77 years, and 80% were women. Procedural success was accomplished in 93% of patients, with 100% survival at 30 days. At 30 days, the septolateral tricuspid annular diameter was reduced by 13% (p<0.001) with 85% of patients seeing at least a 1 grade improvement in TF grade from baseline. This translated to 75% of patients having NYHA-FC I or II symptoms at 30 days (p<0.001) and improvement of KCCQ scores by 16 points (p<0.001) from baseline.
Michael Nabauer, MD, and Mathias Orban, MD, of Ludwig Maximilian University of Munich, wrote an accompanying editorial to the study. They acknowledged that this study is an important step for the transcatheter treatment of TR. However, despite the study demonstrating echocardiographic improvements in TR and subjective improvement in symptoms, Nabauer and Orban are quick to point out that TR is very sensitive to preload changes and notoriously difficult to accurately quantify.
The editorialists advocated for more objective measures of device success, such as cardiac output and right-sided hemodynamics. They went on to make the argument that valve replacement has several advantages to repair, but time will tell which will emerge. They concluded by stating that the elimination of TR will set the stage for a better understanding of how the right ventricle recovers by providing a means to unloading central venous and right ventricular congestion.
Davidson CJ, Lim DS, Smith RL, et al. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv 2021;14:41–50.
Nabauer M, Orban M. 2021;14:51–3.
Image Credit: Edwards Lifesciences