Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

Gilbert H L Tang¹, Syed Zaid², Neal S Kleiman², Sachin S Goel², Shinichi Fukuhara³, Mateo Marin-Cuartas⁴, Philipp Kiefer⁴, Mohamed Abdel-Wahab⁴, Ole De Backer⁵, Lars Søndergaard⁵, Shekhar Saha⁶, Christian Hagl⁷, Moritz Wyler von Ballmoos², Oliver Bhadra⁸, Lenard Conradi⁸, Kendra J Grubb⁹, Emily Shih¹⁰, J Michael DiMaio¹⁰, Molly Szerlip¹⁰, Keti Vitanova¹¹, Hendrik Ruge¹¹, Axel Unbehaun¹², Jorg Kempfert¹², Luigi Pirelli¹³, Chad A Kliger¹³, Nicholas Van Mieghem¹⁴, Thijmen W Hokken¹⁴, Rik Adrichem¹⁴, Thomas Modine¹⁵, Silvia Corona¹⁵, Lin Wang¹⁶, George Petrossian¹⁶, Newell Robinson¹⁶, David Meier¹⁷, John G Webb¹⁷, Anson Cheung¹⁷, Basel Ramlawi¹⁸, Howard C Herrmann¹⁹, Nimesh D Desai¹⁹, Martin Andreas²⁰, Markus Mach²⁰, Ron Waksman²¹, Christian C Schults²¹, Hasan Ahmad²², Joshua B Goldberg²², Arnar Geirsson²³, John K Forrest²³, Paolo Denti²⁴, Igor Belluschi²⁴, Walid Ben-Ali²⁵, Anita W Asgar²⁵, Maurizio Taramasso²⁶, Joshua D Rovin²⁷, Marco Di Eusanio²⁸, Andrea Colli²⁹, Tsuyoshi Kaneko³⁰, Tamim N Nazif³¹, Martin B Leon³¹, Vinayak N Bapat³², Michael J Mack¹⁰, Michael J Reardon², Janarthanan Sathananthan³³

Affiliations

¹ Mount Sinai Health System, New York, New York, USA. Electronic address: gilbert.tang@mountsinai.org.
² Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, USA.
³ University of Michigan, Ann Arbor, Michigan, USA.
⁴ Leipzig Heart Center, Leipzig, Germany.
⁵ The Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
⁶ German Centre for Cardiovascular Research (DZHK), Munich Heart Alliance, Munich, Germany.
⁷ Ludwig Maximillian University of Munich, Munich, Germany.
⁸ University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁹ Emory University, Atlanta, Georgia, USA.
¹⁰ Baylor Scott and White Health, Heart Hospital Plano, Plano, Texas, USA.
¹¹ German Heart Center Munich, Munich, Germany.
¹² German Heart Center Berlin, Berlin, Germany.
¹³ Lenox Hill Hospital, New York, New York, USA.
¹⁴ Eramus University Medical Center, Rotterdam, the Netherlands.
¹⁵ UMCV Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.
¹⁶ St. Francis Hospital, Roslyn, New York, USA.
¹⁷ St. Paul's Hospital, Vancouver, British Columbia, Canada.
¹⁸ Lankanau Heart Institute at Main Line Health, Philadelphia, Pennsylvania, USA.
¹⁹ University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁰ Medical University of Vienna, Vienna, Austria.
²¹ MedStar Washington Hospital Center, Washington, DC, USA.
²² Westchester Medical Center, Valhalla, New York, USA.
²³ Yale University, New Haven, Connecticut, USA.
²⁴ San Raffaele University Hospital, Milan, Italy.
²⁵ Montreal Heart Institute, Montreal, Quebec, Canada.
²⁶ HerzZentrum Hirslanden Zürich, Zurich, Switzerland.
²⁷ Morton Plant Hospital, Clearwater, Florida, USA.
²⁸ Lancisi Cardiovascular Center, Ancona, Italy.
²⁹ University of Pisa, Pisa, Italy.
³⁰ Washington University School of Medicine, St. Louis, Missouri, USA.
³¹ Columbia University Irving Medical Center, New York, New York, USA.
³² Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
³³ St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: https://twitter.com/J_Sathananthan.

PMID: 37100556
DOI: 10.1016/j.jcin.2023.01.376

Free article

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

Gilbert H L Tang et al. JACC Cardiovasc Interv. 2023.

Free article

. 2023 Apr 24;16(8):927-941.

doi: 10.1016/j.jcin.2023.01.376.

Authors

Affiliations

¹ Mount Sinai Health System, New York, New York, USA. Electronic address: gilbert.tang@mountsinai.org.
² Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, USA.
³ University of Michigan, Ann Arbor, Michigan, USA.
⁴ Leipzig Heart Center, Leipzig, Germany.
⁵ The Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
⁶ German Centre for Cardiovascular Research (DZHK), Munich Heart Alliance, Munich, Germany.
⁷ Ludwig Maximillian University of Munich, Munich, Germany.
⁸ University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁹ Emory University, Atlanta, Georgia, USA.
¹⁰ Baylor Scott and White Health, Heart Hospital Plano, Plano, Texas, USA.
¹¹ German Heart Center Munich, Munich, Germany.
¹² German Heart Center Berlin, Berlin, Germany.
¹³ Lenox Hill Hospital, New York, New York, USA.
¹⁴ Eramus University Medical Center, Rotterdam, the Netherlands.
¹⁵ UMCV Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.
¹⁶ St. Francis Hospital, Roslyn, New York, USA.
¹⁷ St. Paul's Hospital, Vancouver, British Columbia, Canada.
¹⁸ Lankanau Heart Institute at Main Line Health, Philadelphia, Pennsylvania, USA.
¹⁹ University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁰ Medical University of Vienna, Vienna, Austria.
²¹ MedStar Washington Hospital Center, Washington, DC, USA.
²² Westchester Medical Center, Valhalla, New York, USA.
²³ Yale University, New Haven, Connecticut, USA.
²⁴ San Raffaele University Hospital, Milan, Italy.
²⁵ Montreal Heart Institute, Montreal, Quebec, Canada.
²⁶ HerzZentrum Hirslanden Zürich, Zurich, Switzerland.
²⁷ Morton Plant Hospital, Clearwater, Florida, USA.
²⁸ Lancisi Cardiovascular Center, Ancona, Italy.
²⁹ University of Pisa, Pisa, Italy.
³⁰ Washington University School of Medicine, St. Louis, Missouri, USA.
³¹ Columbia University Irving Medical Center, New York, New York, USA.
³² Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
³³ St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: https://twitter.com/J_Sathananthan.

PMID: 37100556
DOI: 10.1016/j.jcin.2023.01.376

Abstract

Background: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail.

Objectives: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown.

Methods: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year.

Results: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91).

Conclusions: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Keywords: TAVR explantation; paravalvular leak; prosthesis–patient mismatch; redo-TAVR; structural valve degeneration; surgical aortic valve replacement; transcatheter aortic valve replacement; transcatheter valve failure.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Meier is supported by the Swiss National Science Foundation (grant P2LAP3_199561). Dr Tang has been a proctor for Medtronic; a consultant for Medtronic and Abbott Structural Heart; and an advisory board member for Abbott Structural Heart and JenaValve. Dr Kleiman has been a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Fukuhara has been a consultant for Medtronic, Artiviion, and Terumo Aortic. Dr Mohamed Abdel-Wahab has been a consultant to Medtronic and Boston Scientific. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Bhadra has received travel compensation from Edwards Lifesciences. Dr Conradi has been a proctor, consultant, and speaker for Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Grubb has been a proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Dr Szerlip has been a proctor and consultant for Edwards Lifesciences, has received speaker honoraria from Boston Scientific; has served as an advisory board member for Abbott; and has served on a steering committee for Medtronic. Dr Ruge has been a proctor and consultant for Edwards Lifesciences and Abbott Medical; has received speaker honoraria from Edwards Lifesciences and Abbott Medical; and has served as an advisory board member for Abbott Medical. Dr Unbehaun has been a proctor for Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Kempfert has served as a proctor for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Pirelli has been a proctor for and has received speaker honoraria from Edwards Lifesciences; and has been a consultant for Medtronic. Dr Kliger has been a consultant and has received speaker honoraria from Edwards Lifesciences and Medtronic. Dr Van Mieghem has received research grants from Abbott, Boston Scientific Corporation, Edwards Lifesciences, Medtronic, Teleflex, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Modine has been a proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Webb has been a consultant to and received research funding from Edwards Lifesciences, Abbott, and ViVitro Labs. Dr Ramlawi has been a consultant for Boston Scientific, Medtronic, Liva Nova, and Atricure. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and W.L. Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and W.L. Gore; and has equity in Holistick Medical and Microinterventional Devices. Dr Desai has received institutional research funding and speaker fees from Terumo, W.L. Gore, and Medtronic. Dr Andreas has been a proctor and consultant and has received speaker honoraria from Edwards Lifesciences, Abbott, and Medtronic; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Mach has received institutional grants, research support, speaker honoraria, and travel compensation from Edwards Lifesciences, Symetis SA, Jena Valve, Boston Scientific, Medtronic, Abbott, and Novartis. Dr Waksman has been a consultant for Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia. and Transmural Solutions; has been an advisory board member for Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips Volcano, and Pi-Cardia; has received speaker honoraria from AstraZeneca and Chiesi; has received grant support from Biotronik, AstraZeneca, and Chiesi; and holds investments in MedAlliance and Transmural Solutions. Dr Geirsson has been an advisory board member for Medtronic. Dr Forrest has been a physician proctor, consultant, and member of advisory boards for Edwards Lifesciences and Medtronic. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant for InnovHeart. Dr Ben-Ali has received research grants from Edwards Lifesciences and Medtronic. Dr Asgar has received consulting fees from Medtronic, Edwards Lifesciences, and Abbott; and has received research funding from Abbott Vascular. Dr Taramasso has been a consultant for Abbott, Edwards Lifesciences, Boston Scientific, Medtronic, Shenqi Medical, Simulands, MTEx, Occlufit, MEDIRA, VentriMend, and Hi-D Imaging. Dr Rovin has been a consultant for Medtronic and Abbott; and has been a data and safety monitoring board member for W.L. Gore & Associates. Dr Kaneko has been a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and has been a consultant for 4C Medical. Dr Nazif has served as a consultant for or received honoraria from Edwards Lifesciences, Medtronic, Venus Medtech, and Boston Scientific. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Mack has served as coprimary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Reardon has been a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; and has been a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

Redo Aortic Valve Interventions: A Good Start Is Half the Job to Subsequent Permutations.
Tarantini G, Fabris T. Tarantini G, et al. JACC Cardiovasc Interv. 2023 Apr 24;16(8):954-957. doi: 10.1016/j.jcin.2023.03.014. JACC Cardiovasc Interv. 2023. PMID: 37100558 No abstract available.

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Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

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Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

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