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Multicenter Study
. 2021 Jan 11;14(1):41-50.
doi: 10.1016/j.jcin.2020.10.017.

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes

Charles J Davidson  1 , D Scott Lim  2 , Robert L Smith  3 , Susheel K Kodali  4 , Robert M Kipperman  5 , Mackram F Eleid  6 , Mark Reisman  7 , Brian Whisenant  8 , Jyothy Puthumana  9 , Sandra Abramson  10 , Dale Fowler  2 , Paul Grayburn  3 , Rebecca T Hahn  4 , Konstantinos Koulogiannis  5 , Sorin V Pislaru  6 , Todd Zwink  7 , Michael Minder  8 , Abdellaziz Dahou  11 , Shekhar H Deo  12 , Prashanthi Vandrangi  12 , Florian Deuschl  12 , Ted E Feldman  12 , William A Gray  10 ; Cardioband TR EFS Investigators
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Free article
Multicenter Study

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes

Charles J Davidson et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).

Background: Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited.

Methods: In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee.

Results: The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001).

Conclusions: In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).

Keywords: Cardioband; reconstruction; tricuspid.

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Conflict of interest statement

Author Disclosures This work was funded by Edwards Lifesciences. Drs. Davidson, Lim, Smith, Grayburn, and Gray have received grant support or consulting fees from Edwards Lifesciences. Dr. Hahn has served as a speaker and consultant for Edwards Lifesciences and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Drs. Deo, Vandrangi, Deuschl, and Feldman are employees of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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