1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation: Results From the TriValve Registry

TY - JOUR

T1 - 1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation: Results From the TriValve Registry

AU - Mehr, Michael

AU - Taramasso, Maurizio

AU - Besler, Christian

AU - Ruf, Tobias

AU - Connelly, Kim A

AU - Weber, Marcel

AU - Yzeiraj, Ermela

AU - Schiavi, Davide

AU - Mangieri, Antonio

AU - Vaskelyte, Laura

AU - Alessandrini, Hannes

AU - Deuschl, Florian

AU - Brugger, Nicolas

AU - Ahmad, Hasan

AU - Biasco, Luigi

AU - Orban, Mathias

AU - Deseive, Simon

AU - Braun, Daniel

AU - Rommel, Karl-Philipp

AU - Pozzoli, Alberto

AU - Frerker, Christian

AU - Näbauer, Michael

AU - Massberg, Steffen

AU - Pedrazzini, Giovanni

AU - Tang, Gilbert H L

AU - Windecker, Stephan

AU - Schäfer, Ulrich

AU - Kuck, Karl-Heinz

AU - Sievert, Horst

AU - Denti, Paolo

AU - Latib, Azeem

AU - Schofer, Joachim

AU - Nickenig, Georg

AU - Fam, Neil

AU - von Bardeleben, Stephan

AU - Lurz, Philipp

AU - Maisano, Francesco

AU - Hausleiter, Jörg

N1 - Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2019/8/12

Y1 - 2019/8/12

N2 - OBJECTIVES: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair.BACKGROUND: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse.METHODS: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed.RESULTS: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.CONCLUSIONS: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.

AB - OBJECTIVES: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair.BACKGROUND: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse.METHODS: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed.RESULTS: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.CONCLUSIONS: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.

KW - Aged

KW - Aged, 80 and over

KW - Cardiac Catheterization/adverse effects

KW - Compassionate Use Trials

KW - Europe

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Hemodynamics

KW - Humans

KW - Male

KW - North America

KW - Recovery of Function

KW - Registries

KW - Retrospective Studies

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

U2 - 10.1016/j.jcin.2019.04.019

DO - 10.1016/j.jcin.2019.04.019

M3 - SCORING: Journal article

C2 - 31395215

VL - 12

SP - 1451

EP - 1461

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 15

ER -