Charles J Davidson1, D Scott Lim2, Robert L Smith3, Susheel K Kodali4, Robert M Kipperman5, Mackram F Eleid6, Mark Reisman7, Brian Whisenant8, Jyothy Puthumana9, Sandra Abramson10, Dale Fowler2, Paul Grayburn3, Rebecca T Hahn4, Konstantinos Koulogiannis5, Sorin V Pislaru6, Todd Zwink7, Michael Minder8, Abdellaziz Dahou11, Shekhar H Deo12, Prashanthi Vandrangi12, Florian Deuschl12, Ted E Feldman12, William A Gray10. 1. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. Electronic address: cdavidson@nm.org. 2. Department of Medicine, University of Virginia Health System Hospital, Charlottesville, Virginia, USA. 3. Department of Cardiothoracic Surgery, The Heart Hospital Baylor, Texas, USA. 4. Department of Medicine, Columbia University Medical Center, New York, New York, USA. 5. Department of Cardiovascular Surgery, Morristown Medical Center, Morristown, New Jersey, USA. 6. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. 7. Department of Medicine, University of Washington, Seattle, Washington, USA. 8. Division of Cardiovascular Diseases, Intermountain Healthcare, Salt Lake City, Utah, USA. 9. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. 10. Division of Cardiology, Main Line Health, Lankenau Medical Center, Wynnewood, Pennsylvania, USA. 11. Cardiovascular Research Foundation, New York, New York, USA. 12. Edwards Lifesciences, Irvine, California, USA.
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).
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).
Authors: Anna Sannino; Federica Ilardi; Rebecca T Hahn; Patrizio Lancellotti; Philipp Lurz; Robert L Smith; Giovanni Esposito; Paul A Grayburn Journal: Front Cardiovasc Med Date: 2022-07-11
Authors: Alberto Alperi; Marcel Almendárez; Rut Álvarez; Cesar Moris; Victor Leon; Iria Silva; Daniel Hernández-Vaquero; Isaac Pascual; Pablo Avanzas Journal: Front Cardiovasc Med Date: 2022-09-14