The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair?
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The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair? / Taramasso, Maurizio; Hahn, Rebecca T; Alessandrini, Hannes; Latib, Azeem; Attinger-Toller, Adrian; Braun, Daniel; Brochet, Eric; Connelly, Kim A; Denti, Paolo; Deuschl, Florian; Englmaier, Andrea; Fam, Neil; Frerker, Christian; Hausleiter, Joerg; Juliard, Jean-Michel; Kaple, Ryan; Kreidel, Felix; Kuck, Karl Heinz; Kuwata, Shingo; Ancona, Marco; Malasa, Margarita; Nazif, Tamim; Nickenig, Georg; Nietlispach, Fabian; Pozzoli, Alberto; Schäfer, Ulrich; Schofer, Joachim; Schueler, Robert; Tang, Gilbert; Vahanian, Alec; Webb, John G; Yzeiraj, Ermela; Maisano, Francesco; Leon, Martin B.
In: JACC-CARDIOVASC INTE, Vol. 10, No. 19, 09.10.2017, p. 1982-1990.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - The International Multicenter TriValve Registry: Which Patients Are Undergoing Transcatheter Tricuspid Repair?
AU - Taramasso, Maurizio
AU - Hahn, Rebecca T
AU - Alessandrini, Hannes
AU - Latib, Azeem
AU - Attinger-Toller, Adrian
AU - Braun, Daniel
AU - Brochet, Eric
AU - Connelly, Kim A
AU - Denti, Paolo
AU - Deuschl, Florian
AU - Englmaier, Andrea
AU - Fam, Neil
AU - Frerker, Christian
AU - Hausleiter, Joerg
AU - Juliard, Jean-Michel
AU - Kaple, Ryan
AU - Kreidel, Felix
AU - Kuck, Karl Heinz
AU - Kuwata, Shingo
AU - Ancona, Marco
AU - Malasa, Margarita
AU - Nazif, Tamim
AU - Nickenig, Georg
AU - Nietlispach, Fabian
AU - Pozzoli, Alberto
AU - Schäfer, Ulrich
AU - Schofer, Joachim
AU - Schueler, Robert
AU - Tang, Gilbert
AU - Vahanian, Alec
AU - Webb, John G
AU - Yzeiraj, Ermela
AU - Maisano, Francesco
AU - Leon, Martin B
N1 - Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2017/10/9
Y1 - 2017/10/9
N2 - OBJECTIVES: This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.BACKGROUND: Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population.METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR.RESULTS: A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days.CONCLUSIONS: Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation.
AB - OBJECTIVES: This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.BACKGROUND: Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population.METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR.RESULTS: A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days.CONCLUSIONS: Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation.
KW - Aged
KW - Aged, 80 and over
KW - Cardiac Catheterization/adverse effects
KW - Clinical Decision-Making
KW - Female
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/adverse effects
KW - Hemodynamics
KW - Humans
KW - Male
KW - Patient Selection
KW - Postoperative Complications/etiology
KW - Prospective Studies
KW - Prosthesis Design
KW - Registries
KW - Risk Factors
KW - Severity of Illness Index
KW - Time Factors
KW - Treatment Outcome
KW - Tricuspid Valve/diagnostic imaging
KW - Tricuspid Valve Insufficiency/diagnostic imaging
KW - Ventricular Function, Right
U2 - 10.1016/j.jcin.2017.08.011
DO - 10.1016/j.jcin.2017.08.011
M3 - SCORING: Journal article
C2 - 28982563
VL - 10
SP - 1982
EP - 1990
JO - JACC-CARDIOVASC INTE
JF - JACC-CARDIOVASC INTE
SN - 1936-8798
IS - 19
ER -