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 - 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
UR - http://www.scopus.com/inward/record.url?scp=85138367171&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85138367171&partnerID=8YFLogxK
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 -