TY - JOUR
T1 - 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation
AU - Nickenig, Georg
AU - Weber, Marcel
AU - Schueler, Robert
AU - Hausleiter, Jörg
AU - Näbauer, Michael
AU - von Bardeleben, Ralph S.
AU - Sotiriou, Efthymios
AU - Schäfer, Ulrich
AU - Deuschl, Florian
AU - Kuck, Karl Heinz
AU - Kreidel, Felix
AU - Juliard, Jean Michel
AU - Brochet, Eric
AU - Latib, Azeem
AU - Agricola, Eustachio
AU - Baldus, Stephan
AU - Friedrichs, Kai
AU - Vandrangi, Prashanthi
AU - Verta, Patrick
AU - Hahn, Rebecca T.
AU - Maisano, Francesco
N1 - Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/4/23
Y1 - 2019/4/23
N2 - Background: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. Objectives: The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. Methods: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. Results: Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm 2 vs. 0.4 cm 2 ; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). Conclusions: Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results.
AB - Background: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. Objectives: The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. Methods: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. Results: Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm 2 vs. 0.4 cm 2 ; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). Conclusions: Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results.
KW - TRI-REPAIR
KW - annular reduction
KW - tricuspid regurgitation
KW - tricuspid repair
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U2 - 10.1016/j.jacc.2019.01.062
DO - 10.1016/j.jacc.2019.01.062
M3 - Article
C2 - 30999993
AN - SCOPUS:85063960012
SN - 0735-1097
VL - 73
SP - 1905
EP - 1915
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 15
ER -