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


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
12 08 2019
Historique:
received: 18 12 2018
revised: 01 04 2019
accepted: 12 04 2019
entrez: 10 8 2019
pubmed: 10 8 2019
medline: 29 7 2020
Statut: ppublish

Résumé

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. 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. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 31395215
pii: S1936-8798(19)30934-3
doi: 10.1016/j.jcin.2019.04.019
pii:
doi:

Types de publication

Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1451-1461

Subventions

Organisme : CIHR
Pays : Canada

Commentaires et corrections

Type : CommentIn

Informations de copyright

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

Auteurs

Michael Mehr (M)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Maurizio Taramasso (M)

Department of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland.

Christian Besler (C)

Leipzig Heart Center, University of Leipzig, Leipzig, Germany.

Tobias Ruf (T)

Mainz University Hospital, University of Mainz, Mainz, Germany.

Kim A Connelly (KA)

Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Marcel Weber (M)

Bonn University Hospital, University of Bonn, Bonn, Germany.

Ermela Yzeiraj (E)

Albertinen Heart Center, Hamburg, Germany.

Davide Schiavi (D)

San Raffaele University Hospital, Milan, Italy.

Antonio Mangieri (A)

San Raffaele University Hospital, Milan, Italy.

Laura Vaskelyte (L)

CardioVascular Center, Frankfurt, Germany.

Hannes Alessandrini (H)

Asklepios Klinik St. Georg, Hamburg, Germany.

Florian Deuschl (F)

University Heart Center Hamburg, University of Hamburg, Hamburg, Germany.

Nicolas Brugger (N)

Inselspital, University of Bern, Bern, Switzerland.

Hasan Ahmad (H)

Westchester Medical Center, Valhalla, New York.

Luigi Biasco (L)

CardioCentro Ticino, Lugano, Switzerland.

Mathias Orban (M)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Simon Deseive (S)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Daniel Braun (D)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Karl-Philipp Rommel (KP)

Leipzig Heart Center, University of Leipzig, Leipzig, Germany.

Alberto Pozzoli (A)

Department of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland.

Christian Frerker (C)

Asklepios Klinik St. Georg, Hamburg, Germany.

Michael Näbauer (M)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Steffen Massberg (S)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.

Giovanni Pedrazzini (G)

CardioCentro Ticino, Lugano, Switzerland.

Gilbert H L Tang (GHL)

Westchester Medical Center, Valhalla, New York; Mount Sinai Medical Center, New York, New York.

Stephan Windecker (S)

Inselspital, University of Bern, Bern, Switzerland.

Ulrich Schäfer (U)

University Heart Center Hamburg, University of Hamburg, Hamburg, Germany.

Karl-Heinz Kuck (KH)

Asklepios Klinik St. Georg, Hamburg, Germany.

Horst Sievert (H)

CardioVascular Center, Frankfurt, Germany.

Paolo Denti (P)

San Raffaele University Hospital, Milan, Italy.

Azeem Latib (A)

San Raffaele University Hospital, Milan, Italy.

Joachim Schofer (J)

Albertinen Heart Center, Hamburg, Germany.

Georg Nickenig (G)

Bonn University Hospital, University of Bonn, Bonn, Germany.

Neil Fam (N)

Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Stephan von Bardeleben (S)

Mainz University Hospital, University of Mainz, Mainz, Germany.

Philipp Lurz (P)

Leipzig Heart Center, University of Leipzig, Leipzig, Germany.

Francesco Maisano (F)

Department of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland.

Jörg Hausleiter (J)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: joerg.hausleiter@med.uni-muenchen.de.

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