TY - JOUR
T1 - 1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
AU - Cardioband TR EFS Investigators
AU - Gray, William A.
AU - Abramson, Sandra V.
AU - Lim, Scott
AU - Fowler, Dale
AU - Smith, Robert L.
AU - Grayburn, Paul A.
AU - Kodali, Susheel K.
AU - Hahn, Rebecca T.
AU - Kipperman, Robert M.
AU - Koulogiannis, Konstantinos P.
AU - Eleid, Mackram F.
AU - Pislaru, Sorin V.
AU - Whisenant, Brian K.
AU - McCabe, James M.
AU - Liu, Jin
AU - Dahou, Abdellaziz
AU - Puthumana, Jyothy J.
AU - Davidson, Charles J.
AU - Feldman, Ted
AU - Gilmore, Suzanne Y.
AU - Krzmarzick, Ann
AU - Gerik, Laura
AU - Wang, Vanessa
AU - Cao, Annie
N1 - Funding Information:
This study was funded by Edwards Lifesciences. Dr Gray consults for Edwards Lifesciences. Dr Lim has received institutional research grants with Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Venus Medtech and WL Gore. Dr Smith has received institutional grant support and serves as a speaker for Edwards Lifesciences, Abbott, and Artivion; is on the advisory board for Edwards Lifesciences; and is a speaker for Medtronic. Dr Grayburn has received research grants from Abbott, Edwards Lifesciences, Medtronic, Gore, Neochord, and Cardiovalve; and serves as a consultant/advisory board for Abbott, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Kodali has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, JenaValve, and Abbott Vascular; has received honoraria from Admedus, TriFlo, and Dura Biotech; and is on the advisory board and received equity from MicroInterventional Devices, Dura Biotech, Supira, Adona Medical, Thubrikar Aortic Valve, Inc, and TriFlo. Dr Hahn has received fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has stock options with Navigate and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she receives no direct industry compensation. Dr Whisenant consults for Edwards Lifesciences. Dr McCabe consults for Edwards Lifesciences, Medtronic, Boston Scientific, and Cardiovascular Systems, Inc. Dr Puthumana is on the Speakers Bureau for Abbott Structural. Dr Davidson has received research grant funding and is a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022 American College of Cardiology Foundation
PY - 2022/10/10
Y1 - 2022/10/10
N2 - Background: Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. Objectives: The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). Methods: Patients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. Results: The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. Conclusions: One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.
AB - Background: Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. Objectives: The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). Methods: Patients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. Results: The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. Conclusions: One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.
KW - Cardioband
KW - annular reduction
KW - functional tricuspid regurgitation
KW - transcatheter tricuspid valve interventions
KW - tricuspid regurgitation
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U2 - 10.1016/j.jcin.2022.07.006
DO - 10.1016/j.jcin.2022.07.006
M3 - Article
C2 - 36202561
AN - SCOPUS:85138367171
SN - 1936-8798
VL - 15
SP - 1921
EP - 1932
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 19
ER -