TY - JOUR
T1 - Outcomes After Current Transcatheter Tricuspid Valve Intervention
T2 - Mid-Term Results From the International TriValve Registry
AU - Taramasso, Maurizio
AU - Alessandrini, Hannes
AU - Latib, Azeem
AU - Asami, Masahiko
AU - Attinger-Toller, Adrian
AU - Biasco, Luigi
AU - Braun, Daniel
AU - Brochet, Eric
AU - Connelly, Kim A.
AU - Denti, Paolo
AU - Deuschl, Florian
AU - Englmeier, Andrea
AU - Fam, Neil
AU - Frerker, Christian
AU - Hausleiter, Jörg
AU - Himbert, Dominique
AU - Ho, Edwin
AU - Juliard, Jean Michel
AU - Kaple, Ryan
AU - Kreidel, Felix
AU - Kuck, Karl Heinz
AU - Ancona, Marco
AU - Lauten, Alexander
AU - Lurz, Philipp
AU - Mehr, Michael
AU - Nazif, Tamin
AU - Nickening, Georg
AU - Pedrazzini, Giovanni
AU - Pozzoli, Alberto
AU - Praz, Fabien
AU - Puri, Rishi
AU - Rodés-Cabau, Josep
AU - Schäfer, Ulrich
AU - Schofer, Joachim
AU - Sievert, Horst
AU - Sievert, Kolja
AU - Tang, Gilbert H.L.
AU - Tanner, Felix C.
AU - Vahanian, Alec
AU - Webb, John G.
AU - Windecker, Stephan
AU - Yzeiray, Ermela
AU - Zuber, Michel
AU - Maisano, Francesco
AU - Leon, Martin B.
AU - Hahn, Rebecca T.
N1 - Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/1/28
Y1 - 2019/1/28
N2 - Objectives: A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. Background: TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). Methods: The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. Results: A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm 2 ). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. Conclusions: TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.
AB - Objectives: A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. Background: TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). Methods: The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. Results: A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm 2 ). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. Conclusions: TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.
KW - transcatheter tricuspid valve intervention
KW - tricuspid regurgitation
KW - tricuspid valve
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U2 - 10.1016/j.jcin.2018.10.022
DO - 10.1016/j.jcin.2018.10.022
M3 - Article
C2 - 30594510
AN - SCOPUS:85060345385
SN - 1936-8798
VL - 12
SP - 155
EP - 165
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 2
ER -