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

Gilbert H.L. Tang; Syed Zaid; Neal S. Kleiman; Sachin S. Goel; Shinichi Fukuhara; Mateo Marin-Cuartas; Philipp Kiefer; Mohamed Abdel-Wahab; Ole De Backer; Lars Søndergaard; Shekhar Saha; Christian Hagl; Moritz Wyler von Ballmoos; Oliver Bhadra; Lenard Conradi; Kendra J. Grubb; Emily Shih; J. Michael DiMaio; Molly Szerlip; Keti Vitanova; Hendrik Ruge; Axel Unbehaun; Jorg Kempfert; Luigi Pirelli; Chad A. Kliger; Nicholas Van Mieghem; Thijmen W. Hokken; Rik Adrichem; Thomas Modine; Silvia Corona; Lin Wang; George Petrossian; Newell Robinson; David Meier; John G. Webb; Anson Cheung; Basel Ramlawi; Howard C. Herrmann; Nimesh D. Desai; Martin Andreas; Markus Mach; Ron Waksman; Christian C. Schults; Hasan Ahmad; Joshua B. Goldberg; Arnar Geirsson; John K. Forrest; Paolo Denti; Igor Belluschi; Walid Ben-Ali; Anita W. Asgar; Maurizio Taramasso; Joshua D. Rovin; Marco Di Eusanio; Andrea Colli; Tsuyoshi Kaneko; Tamim N. Nazif; Martin B. Leon; Vinayak N. Bapat; Michael J. Mack; Michael J. Reardon; Janarthanan Sathananthan

doi:10.1016/j.jcin.2023.01.376

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

Gilbert H.L. Tang, Syed Zaid, Neal S. Kleiman, Sachin S. Goel, Shinichi Fukuhara, Mateo Marin-Cuartas, Philipp Kiefer, Mohamed Abdel-Wahab, Ole De Backer, Lars Søndergaard, Shekhar Saha, Christian Hagl, Moritz Wyler von Ballmoos, Oliver Bhadra, Lenard Conradi, Kendra J. Grubb, Emily Shih, J. Michael DiMaio, Molly Szerlip, Keti VitanovaHendrik Ruge, Axel Unbehaun, Jorg Kempfert, Luigi Pirelli, Chad A. Kliger, Nicholas Van Mieghem, Thijmen W. Hokken, Rik Adrichem, Thomas Modine, Silvia Corona, Lin Wang, George Petrossian, Newell Robinson, David Meier, John G. Webb, Anson Cheung, Basel Ramlawi, Howard C. Herrmann, Nimesh D. Desai, Martin Andreas, Markus Mach, Ron Waksman, Christian C. Schults, Hasan Ahmad, Joshua B. Goldberg, Arnar Geirsson, John K. Forrest, Paolo Denti, Igor Belluschi, Walid Ben-Ali, Anita W. Asgar, Maurizio Taramasso, Joshua D. Rovin, Marco Di Eusanio, Andrea Colli, Tsuyoshi Kaneko, Tamim N. Nazif, Martin B. Leon, Vinayak N. Bapat, Michael J. Mack, Michael J. Reardon, Janarthanan Sathananthan

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

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.

Original language	English (US)
Pages (from-to)	927-941
Number of pages	15
Journal	JACC: Cardiovascular Interventions
Volume	16
Issue number	8
DOIs	https://doi.org/10.1016/j.jcin.2023.01.376
State	Published - Apr 24 2023

Keywords

paravalvular leak
prosthesis–patient mismatch
redo-TAVR
structural valve degeneration
surgical aortic valve replacement
TAVR explantation
transcatheter aortic valve replacement
transcatheter valve failure
Heart Valve Prosthesis Implantation
Humans
Heart Valve Prosthesis
Risk Factors
Transcatheter Aortic Valve Replacement/adverse effects
Treatment Outcome
Prosthesis Design
Aortic Valve Stenosis/diagnostic imaging
Registries
Aortic Valve/diagnostic imaging

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2023.01.376

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Tang, G. H. L., Zaid, S., Kleiman, N. S., Goel, S. S., Fukuhara, S., Marin-Cuartas, M., Kiefer, P., Abdel-Wahab, M., De Backer, O., Søndergaard, L., Saha, S., Hagl, C., Wyler von Ballmoos, M., Bhadra, O., Conradi, L., Grubb, K. J., Shih, E., DiMaio, J. M., Szerlip, M., ... Sathananthan, J. (2023). Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry. JACC: Cardiovascular Interventions, 16(8), 927-941. https://doi.org/10.1016/j.jcin.2023.01.376

Tang, GHL, Zaid, S, Kleiman, NS , Goel, SS, Fukuhara, S, Marin-Cuartas, M, Kiefer, P, Abdel-Wahab, M, De Backer, O, Søndergaard, L, Saha, S, Hagl, C, Wyler von Ballmoos, M, Bhadra, O, Conradi, L, Grubb, KJ, Shih, E, DiMaio, JM, Szerlip, M, Vitanova, K, Ruge, H, Unbehaun, A, Kempfert, J, Pirelli, L, Kliger, CA, Van Mieghem, N, Hokken, TW, Adrichem, R, Modine, T, Corona, S, Wang, L, Petrossian, G, Robinson, N, Meier, D, Webb, JG, Cheung, A, Ramlawi, B, Herrmann, HC, Desai, ND, Andreas, M, Mach, M, Waksman, R, Schults, CC, Ahmad, H, Goldberg, JB, Geirsson, A, Forrest, JK, Denti, P, Belluschi, I, Ben-Ali, W, Asgar, AW, Taramasso, M, Rovin, JD, Di Eusanio, M, Colli, A, Kaneko, T, Nazif, TN, Leon, MB, Bapat, VN, Mack, MJ, Reardon, MJ & Sathananthan, J 2023, 'Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry', JACC: Cardiovascular Interventions, vol. 16, no. 8, pp. 927-941. https://doi.org/10.1016/j.jcin.2023.01.376

@article{cb0df65bcf1244e9be2b129f5d5ba617,

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

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 = "paravalvular leak, prosthesis–patient mismatch, redo-TAVR, structural valve degeneration, surgical aortic valve replacement, TAVR explantation, transcatheter aortic valve replacement, transcatheter valve failure, Heart Valve Prosthesis Implantation, Humans, Heart Valve Prosthesis, Risk Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome, Prosthesis Design, Aortic Valve Stenosis/diagnostic imaging, Registries, Aortic Valve/diagnostic imaging",

author = "Tang, {Gilbert H.L.} and Syed Zaid and Kleiman, {Neal S.} and Goel, {Sachin S.} and Shinichi Fukuhara and Mateo Marin-Cuartas and Philipp Kiefer and Mohamed Abdel-Wahab and {De Backer}, Ole and Lars S{\o}ndergaard and Shekhar Saha and Christian Hagl and {Wyler von Ballmoos}, Moritz and Oliver Bhadra and Lenard Conradi and Grubb, {Kendra J.} and Emily Shih and DiMaio, {J. Michael} and Molly Szerlip and Keti Vitanova and Hendrik Ruge and Axel Unbehaun and Jorg Kempfert and Luigi Pirelli and Kliger, {Chad A.} and {Van Mieghem}, Nicholas and Hokken, {Thijmen W.} and Rik Adrichem and Thomas Modine and Silvia Corona and Lin Wang and George Petrossian and Newell Robinson and David Meier and Webb, {John G.} and Anson Cheung and Basel Ramlawi and Herrmann, {Howard C.} and Desai, {Nimesh D.} and Martin Andreas and Markus Mach and Ron Waksman and Schults, {Christian C.} and Hasan Ahmad and Goldberg, {Joshua B.} and Arnar Geirsson and Forrest, {John K.} and Paolo Denti and Igor Belluschi and Walid Ben-Ali and Asgar, {Anita W.} and Maurizio Taramasso and Rovin, {Joshua D.} and {Di Eusanio}, Marco and Andrea Colli and Tsuyoshi Kaneko and Nazif, {Tamim N.} and Leon, {Martin B.} and Bapat, {Vinayak N.} and Mack, {Michael J.} and Reardon, {Michael J.} and Janarthanan Sathananthan",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = apr,

day = "24",

doi = "10.1016/j.jcin.2023.01.376",

language = "English (US)",

volume = "16",

pages = "927--941",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "8",

}

TY - JOUR

T1 - Explant vs Redo-TAVR After Transcatheter Valve Failure

T2 - Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

AU - Tang, Gilbert H.L.

AU - Zaid, Syed

AU - Kleiman, Neal S.

AU - Goel, Sachin S.

AU - Fukuhara, Shinichi

AU - Marin-Cuartas, Mateo

AU - Kiefer, Philipp

AU - Abdel-Wahab, Mohamed

AU - De Backer, Ole

AU - Søndergaard, Lars

AU - Saha, Shekhar

AU - Hagl, Christian

AU - Wyler von Ballmoos, Moritz

AU - Bhadra, Oliver

AU - Conradi, Lenard

AU - Grubb, Kendra J.

AU - Shih, Emily

AU - DiMaio, J. Michael

AU - Szerlip, Molly

AU - Vitanova, Keti

AU - Ruge, Hendrik

AU - Unbehaun, Axel

AU - Kempfert, Jorg

AU - Pirelli, Luigi

AU - Kliger, Chad A.

AU - Van Mieghem, Nicholas

AU - Hokken, Thijmen W.

AU - Adrichem, Rik

AU - Modine, Thomas

AU - Corona, Silvia

AU - Wang, Lin

AU - Petrossian, George

AU - Robinson, Newell

AU - Meier, David

AU - Webb, John G.

AU - Cheung, Anson

AU - Ramlawi, Basel

AU - Herrmann, Howard C.

AU - Desai, Nimesh D.

AU - Andreas, Martin

AU - Mach, Markus

AU - Waksman, Ron

AU - Schults, Christian C.

AU - Ahmad, Hasan

AU - Goldberg, Joshua B.

AU - Geirsson, Arnar

AU - Forrest, John K.

AU - Denti, Paolo

AU - Belluschi, Igor

AU - Ben-Ali, Walid

AU - Asgar, Anita W.

AU - Taramasso, Maurizio

AU - Rovin, Joshua D.

AU - Di Eusanio, Marco

AU - Colli, Andrea

AU - Kaneko, Tsuyoshi

AU - Nazif, Tamim N.

AU - Leon, Martin B.

AU - Bapat, Vinayak N.

AU - Mack, Michael J.

AU - Reardon, Michael J.

AU - Sathananthan, Janarthanan

PY - 2023/4/24

Y1 - 2023/4/24

N2 - 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.

AB - 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.

KW - paravalvular leak

KW - prosthesis–patient mismatch

KW - redo-TAVR

KW - structural valve degeneration

KW - surgical aortic valve replacement

KW - TAVR explantation

KW - transcatheter aortic valve replacement

KW - transcatheter valve failure

KW - Heart Valve Prosthesis Implantation

KW - Humans

KW - Heart Valve Prosthesis

KW - Risk Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

KW - Prosthesis Design

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Registries

KW - Aortic Valve/diagnostic imaging

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U2 - 10.1016/j.jcin.2023.01.376

DO - 10.1016/j.jcin.2023.01.376

M3 - Article

C2 - 37100556

AN - SCOPUS:85152746476

SN - 1936-8798

VL - 16

SP - 927

EP - 941

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 8

ER -

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

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Keywords

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