Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International 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:
27 09 2021
Historique:
received: 17 05 2021
revised: 24 06 2021
accepted: 06 07 2021
entrez: 24 9 2021
pubmed: 25 9 2021
medline: 3 11 2021
Statut: ppublish

Résumé

The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation. Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking. Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year. From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively. The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Sections du résumé

OBJECTIVES
The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation.
BACKGROUND
Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking.
METHODS
Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year.
RESULTS
From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively.
CONCLUSIONS
The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Identifiants

pubmed: 34556271
pii: S1936-8798(21)01338-8
doi: 10.1016/j.jcin.2021.07.015
pii:
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

1978-1991

Investigateurs

Aditya Sengupta (A)
David Holzhey (D)
Thilo Noack (T)
Katherine B Harrington (KB)
Siamak Mohammadi (S)
Derek R Brinster (DR)
Marvin D Atkins (MD)
Muhanad Algadheeb (M)
Rodrigo Bagur (R)
Nimesh D Desai (ND)
Oliver D Bhadra (OD)
Lenard Conradi (L)
Christian Shults (C)
Lowell F Satler (LF)
Basel Ramlawi (B)
Newell B Robinson (NB)
Lin Wang (L)
George A Petrossian (GA)
Martin Andreas (M)
Paul Werner (P)
Andrea Garatti (A)
Flavien Vincent (F)
Eric Van Belle (E)
Francis Juthier (F)
Lionel Leroux (L)
John R Doty (JR)
Joshua B Goldberg (JB)
Hasan A Ahmad (HA)
Kashish Goel (K)
Ashish S Shah (AS)
Arnar Geirsson (A)
John K Forrest (JK)
Kendra J Grubb (KJ)
Sameer Hirji (S)
Pinak B Shah (PB)
Giuseppe Bruschi (G)
Guido Gelpi (G)
Igor Belluschi (I)
Maral Ouzounian (M)
Marc Ruel (M)
Talal Al-Atassi (T)
Joerg Kempfert (J)
Axel Unbehaun (A)
Nicholas M Van Mieghem (NM)
Thijmen W Hokken (TW)
Walid Ben Ali (W)
Reda Ibrahim (R)
Philippe Demers (P)
Alejandro Pizano (A)
Marco Di Eusanio (M)
Filippo Capestro (F)
Rodrigo Estevez-Loureiro (R)
Miguel A Pinon (MA)
Michael H Salinger (MH)
Joshua Rovin (J)
Augusto D'Onofrio (A)
Chiara Tessari (C)
Antonio Di Virgilio (A)
Maurizio Taramasso (M)
Marco Gennari (M)
Andrea Colli (A)
Brian K Whisenant (BK)
Tamim M Nazif (TM)
Neal S Kleiman (NS)
Molly Y Szerlip (MY)
Ron Waksman (R)
Isaac George (I)
Tom C Nguyen (TC)
Francesco Maisano (F)
G Michael Deeb (GM)
Joseph E Bavaria (JE)
Michael J Reardon (MJ)
Michael J Mack (MJ)
Vinayak N Bapat (VN)
William T Brinkman (WT)
J Michael DiMaio (JM)
Timothy J George (TJ)
Katherine B Harrington (KB)
Michael J Mack (MJ)
Srinivasa Potluri (S)
William H Ryan (WH)
Justin M Schaffer (JM)
Robert L Smith (RL)
John J Squiers (JJ)
Molly Szerlip (M)
Sameer Hirji (S)
Tsuyoshi Kaneko (T)
Pinak B Shah (PB)
Isaac George (I)
Tamim Nazif (T)
Hussein Rahim (H)
Kendra Grubb (K)
Marvin Atkins (M)
Sachin Goel (S)
Neal Kleiman (N)
Michael Reardon (M)
Moritz Wyler von Ballmoos (M)
John Doty (J)
Brian Whisenant (B)
Michael Salinger (M)
Lowell Satler (L)
Christian Schults (C)
Ron Waksman (R)
Susan Fisher (S)
Joshua Rovin (J)
Sophia L Alexis (SL)
Gilbert H L Tang (GHL)
Derek R Brinster (DR)
Chad A Kliger (CA)
Luigi Pirelli (L)
Bruce Rutkin (B)
Pey-Jen Yu (PJ)
George Petrossian (G)
Newell Robinson (N)
Lin Wang (L)
Michael Deeb (M)
Shinichi Fukuhara (S)
Jessica Oakley (J)
Joseph Bavaria (J)
Nimesh Desai (N)
Lisa Walsh (L)
Tom Nguyen (T)
Alejandro Pizano (A)
Basel Ramlawi (B)
Kashish Goel (K)
Ashish S Shah (AS)
Hasan Ahmad (H)
Joshua Goldberg (J)
David Spielvogel (D)
Syed Zaid (S)
John Forrest (J)
Arnar Geirsson (A)
Muhanad Algadheeb (M)
Rodrigo Bagur (R)
Michael Chu (M)
Walid Ben Ali (W)
Raymond Cartier (R)
Philippe Demers (P)
Reda Ibrahim (R)
Siamak Mohammadi (S)
Josep Rodes-Cabau (J)
Pierre Voisine (P)
Maral Ouzounian (M)
Alain-Philippe Abois (AP)
Talal Al-Atassi (T)
Munir Boodhwani (M)
Alexander Dick (A)
Christopher Glover (C)
Marino Labinaz (M)
Buu-Khanh Lam (BK)
Marc Ruel (M)
Martin Andreas (M)
Paul Werner (P)
Lionel Leroux (L)
Thomas Modine (T)
Cedric Delhaye (C)
Adeline Delsaux (A)
Tom Denimal (T)
Anaïs Gaul (A)
Francis Juthier (F)
Mohammad Koussa (M)
Thibault Pamart (T)
Eric Van Belle (E)
Flavien Vincent (F)
Joerg Kempfert (J)
Svetlana Sonnabend (S)
Axel Unbehaun (A)
Markus Krane (M)
Rudiger Lange (R)
Andrea Munsterer (A)
Keti Vitanova (K)
Michael Borger (M)
David Holzhey (D)
Philippe Kiefer (P)
Thilo Noack (T)
Christian Hagl (C)
Shekhar Saha (S)
Oliver Bhadra (O)
Len Conradi (L)
Filippo Capestro (F)
Marco Di Eusanio (M)
Antonio Di Virgilio (A)
Giuseppe Bruschi (G)
Bruno Merlanti (B)
Claudio F Russo (CF)
Guido Gelpi (G)
Claudia Romagnoni (C)
Andrea Garatti (A)
Igor Belluschi (I)
Paolo Denti (P)
Augusto D'Onofrio (A)
Chiara Tessari (C)
Andrea Colli (A)
Thijmen W Hokken (TW)
Nicholas Van Mieghem (N)
Rodrigo Estevez-Loureiro (R)
Miguel Pinnon (M)
Marco Gennari (M)
Francesco Maisano (F)
Maurizio Taramasso (M)

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Fukuhara is a consultant for Terumo Aortic. Dr Pirelli is a physician proctor for and has received speaker honoraria from Edwards Lifesciences; and is a consultant for Medtronic. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, and Terumo Aortic. Dr Rodés-Cabau has received institutional research grants from and is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Borger has reported that his hospital receives speaker honoraria and/or consulting fees on his behalf from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr Lange is a consultant for Medtronic. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for InnovHeart. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Kaneko is a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and is a consultant for 4C Medical. Dr Tang is a physician proctor for Medtronic; is a consultant for Medtronic, Abbott, and NeoChord; and is an advisory board member for Abbott and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Vinayak N Bapat (VN)

Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.

Syed Zaid (S)

Westchester Medical Center, Valhalla, New York, USA.

Shinichi Fukuhara (S)

University of Michigan, Ann Arbor, Michigan, USA.

Shekhar Saha (S)

LMU Klinikum Munich, Munich, Germany.

Keti Vitanova (K)

German Heart Center Munich, Munich, Germany.

Philipp Kiefer (P)

Leipzig Heart Center, Leipzig, Germany.

John J Squiers (JJ)

Baylor, Scott & White The Heart Hospital, Plano, Texas, USA.

Pierre Voisine (P)

Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.

Luigi Pirelli (L)

Lenox Hill Hospital, Northwell Health, New York, New York, USA.

Moritz Wyler von Ballmoos (MW)

Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, USA.

Michael W A Chu (MWA)

London Health Sciences Center, Western University, London, Ontario, Canada.

Josep Rodés-Cabau (J)

Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.

J Michael DiMaio (JM)

Baylor, Scott & White The Heart Hospital, Plano, Texas, USA.

Michael A Borger (MA)

Leipzig Heart Center, Leipzig, Germany.

Rudiger Lange (R)

German Heart Center Munich, Munich, Germany.

Christian Hagl (C)

LMU Klinikum Munich, Munich, Germany.

Paolo Denti (P)

San Raffaele University Hospital, Milan, Italy.

Thomas Modine (T)

CHU Bordeaux, Bordeaux, France.

Tsuyoshi Kaneko (T)

Brigham and Women's Hospital, Boston, Massachusetts, USA.

Gilbert H L Tang (GHL)

Mount Sinai Health System, New York, New York, USA. Electronic address: gilbert.tang@mountsinai.org.

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