Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

Uri Landes; John G. Webb; Ole De Backer; Lars Sondergaard; Mohamed Abdel-Wahab; Lisa Crusius; Won Keun Kim; Christian Hamm; Nicola Buzzatti; Matteo Montorfano; Sebastian Ludwig; Niklas Schofer; Lisa Voigtlaender; Mayra Guerrero; Abdallah El Sabbagh; Josep Rodés-Cabau; Leonardo Guimaraes; Ran Kornowski; Pablo Codner; Taishi Okuno; Thomas Pilgrim; Claudia Fiorina; Antonio Colombo; Antonio Mangieri; Helene Eltchaninoff; Luis Nombela-Franco; Maarten P.H. Van Wiechen; Nicolas M. Van Mieghem; Didier Tchétché; Wolfgang H. Schoels; Matthias Kullmer; Corrado Tamburino; Jan Malte Sinning; Baravan Al-Kassou; Gidon Y. Perlman; Haim Danenberg; Alfonso Ielasi; Chiara Fraccaro; Giuseppe Tarantini; Federico De Marco; Guy Witberg; Simon R. Redwood; John C. Lisko; Vasilis C. Babaliaros; Mika Laine; Roberto Nerla; Fausto Castriota; Ariel Finkelstein; Itamar Loewenstein; Amnon Eitan; Ronen Jaffe; Philipp Ruile; Franz J. Neumann; Nicolo Piazza; Hind Alosaimi; Horst Sievert; Kolja Sievert; Marco Russo; Martin Andreas; Matjaz Bunc; Azeem Latib; Rebecca Govdfrey; David Hildick-Smith; Janarthanan Sathananthan; Mark Hensey; Abdullah Alkhodair; Philipp Blanke; Jonathon Leipsic; David A. Wood; Tamim M. Nazif; Susheel Kodali; Martin B. Leon; Marco Barbanti

doi:10.1016/j.jacc.2020.02.051

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

Uri Landes, John G. Webb^*, Ole De Backer, Lars Sondergaard, Mohamed Abdel-Wahab, Lisa Crusius, Won Keun Kim, Christian Hamm, Nicola Buzzatti, Matteo Montorfano, Sebastian Ludwig, Niklas Schofer, Lisa Voigtlaender, Mayra Guerrero, Abdallah El Sabbagh, Josep Rodés-Cabau, Leonardo Guimaraes, Ran Kornowski, Pablo Codner, Taishi OkunoThomas Pilgrim, Claudia Fiorina, Antonio Colombo, Antonio Mangieri, Helene Eltchaninoff, Luis Nombela-Franco, Maarten P.H. Van Wiechen, Nicolas M. Van Mieghem, Didier Tchétché, Wolfgang H. Schoels, Matthias Kullmer, Corrado Tamburino, Jan Malte Sinning, Baravan Al-Kassou, Gidon Y. Perlman, Haim Danenberg, Alfonso Ielasi, Chiara Fraccaro, Giuseppe Tarantini, Federico De Marco, Guy Witberg, Simon R. Redwood, John C. Lisko, Vasilis C. Babaliaros, Mika Laine, Roberto Nerla, Fausto Castriota, Ariel Finkelstein, Itamar Loewenstein, Amnon Eitan, Ronen Jaffe, Philipp Ruile, Franz J. Neumann, Nicolo Piazza, Hind Alosaimi, Horst Sievert, Kolja Sievert, Marco Russo, Martin Andreas, Matjaz Bunc, Azeem Latib, Rebecca Govdfrey, David Hildick-Smith, Janarthanan Sathananthan, Mark Hensey, Abdullah Alkhodair, Philipp Blanke, Jonathon Leipsic, David A. Wood, Tamim M. Nazif, Susheel Kodali, Martin B. Leon, Marco Barbanti

^*Corresponding author for this work

Cardiology

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

173 Scopus citations

Abstract

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives: The authors sought to examine outcomes following redo-TAVR. Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm² and 1.51 ± 0.57 cm²; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Original language	English
Pages (from-to)	1882-1893
Number of pages	12
Journal	Journal of the American College of Cardiology
Volume	75
Issue number	16
DOIs	https://doi.org/10.1016/j.jacc.2020.02.051
State	Published - 28 Apr 2020

Funding

Funders	Funder number
CeloNova
Comed B.V.
GADA
Hangzhou Nuomao Medtech
Holistick Medical
Speakers Bureau for Edwards Lifesciences
Thubrikar Aortic Valve Inc.
ViVitro Labs
Abbott Laboratories
Medtronic
Edwards Lifesciences
GE Healthcare
Boston Scientific Corporation
Abbott Vascular
Symetis
Biotronik
MicroPort

Keywords

durability
transcatheter aortic valve replacement
transcatheter heart valve
valve-in-valve

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.jacc.2020.02.051

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Landes, U., Webb, J. G., De Backer, O., Sondergaard, L., Abdel-Wahab, M., Crusius, L., Kim, W. K., Hamm, C., Buzzatti, N., Montorfano, M., Ludwig, S., Schofer, N., Voigtlaender, L., Guerrero, M., El Sabbagh, A., Rodés-Cabau, J., Guimaraes, L., Kornowski, R., Codner, P., ... Barbanti, M. (2020). Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction. Journal of the American College of Cardiology, 75(16), 1882-1893. https://doi.org/10.1016/j.jacc.2020.02.051

@article{47236876f042442a93453adef4aad605,

title = "Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction",

abstract = "Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives: The authors sought to examine outcomes following redo-TAVR. Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.",

keywords = "durability, transcatheter aortic valve replacement, transcatheter heart valve, valve-in-valve",

author = "Uri Landes and Webb, {John G.} and {De Backer}, Ole and Lars Sondergaard and Mohamed Abdel-Wahab and Lisa Crusius and Kim, {Won Keun} and Christian Hamm and Nicola Buzzatti and Matteo Montorfano and Sebastian Ludwig and Niklas Schofer and Lisa Voigtlaender and Mayra Guerrero and {El Sabbagh}, Abdallah and Josep Rod{\'e}s-Cabau and Leonardo Guimaraes and Ran Kornowski and Pablo Codner and Taishi Okuno and Thomas Pilgrim and Claudia Fiorina and Antonio Colombo and Antonio Mangieri and Helene Eltchaninoff and Luis Nombela-Franco and {Van Wiechen}, {Maarten P.H.} and {Van Mieghem}, {Nicolas M.} and Didier Tch{\'e}tch{\'e} and Schoels, {Wolfgang H.} and Matthias Kullmer and Corrado Tamburino and Sinning, {Jan Malte} and Baravan Al-Kassou and Perlman, {Gidon Y.} and Haim Danenberg and Alfonso Ielasi and Chiara Fraccaro and Giuseppe Tarantini and {De Marco}, Federico and Guy Witberg and Redwood, {Simon R.} and Lisko, {John C.} and Babaliaros, {Vasilis C.} and Mika Laine and Roberto Nerla and Fausto Castriota and Ariel Finkelstein and Itamar Loewenstein and Amnon Eitan and Ronen Jaffe and Philipp Ruile and Neumann, {Franz J.} and Nicolo Piazza and Hind Alosaimi and Horst Sievert and Kolja Sievert and Marco Russo and Martin Andreas and Matjaz Bunc and Azeem Latib and Rebecca Govdfrey and David Hildick-Smith and Janarthanan Sathananthan and Mark Hensey and Abdullah Alkhodair and Philipp Blanke and Jonathon Leipsic and Wood, {David A.} and Nazif, {Tamim M.} and Susheel Kodali and Leon, {Martin B.} and Marco Barbanti",

note = "Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = apr,

day = "28",

doi = "10.1016/j.jacc.2020.02.051",

language = "אנגלית",

volume = "75",

pages = "1882--1893",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "16",

}

Landes, U, Webb, JG, De Backer, O, Sondergaard, L, Abdel-Wahab, M, Crusius, L, Kim, WK, Hamm, C, Buzzatti, N, Montorfano, M, Ludwig, S, Schofer, N, Voigtlaender, L, Guerrero, M, El Sabbagh, A, Rodés-Cabau, J, Guimaraes, L, Kornowski, R , Codner, P, Okuno, T, Pilgrim, T, Fiorina, C, Colombo, A, Mangieri, A, Eltchaninoff, H, Nombela-Franco, L, Van Wiechen, MPH, Van Mieghem, NM, Tchétché, D, Schoels, WH, Kullmer, M, Tamburino, C, Sinning, JM, Al-Kassou, B, Perlman, GY, Danenberg, H, Ielasi, A, Fraccaro, C, Tarantini, G, De Marco, F, Witberg, G, Redwood, SR, Lisko, JC, Babaliaros, VC, Laine, M, Nerla, R, Castriota, F, Finkelstein, A, Loewenstein, I, Eitan, A, Jaffe, R, Ruile, P, Neumann, FJ, Piazza, N, Alosaimi, H, Sievert, H, Sievert, K, Russo, M, Andreas, M, Bunc, M, Latib, A, Govdfrey, R, Hildick-Smith, D, Sathananthan, J, Hensey, M, Alkhodair, A, Blanke, P, Leipsic, J, Wood, DA, Nazif, TM, Kodali, S, Leon, MB & Barbanti, M 2020, 'Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction', Journal of the American College of Cardiology, vol. 75, no. 16, pp. 1882-1893. https://doi.org/10.1016/j.jacc.2020.02.051

TY - JOUR

T1 - Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

AU - Landes, Uri

AU - Webb, John G.

AU - De Backer, Ole

AU - Sondergaard, Lars

AU - Abdel-Wahab, Mohamed

AU - Crusius, Lisa

AU - Kim, Won Keun

AU - Hamm, Christian

AU - Buzzatti, Nicola

AU - Montorfano, Matteo

AU - Ludwig, Sebastian

AU - Schofer, Niklas

AU - Voigtlaender, Lisa

AU - Guerrero, Mayra

AU - El Sabbagh, Abdallah

AU - Rodés-Cabau, Josep

AU - Guimaraes, Leonardo

AU - Kornowski, Ran

AU - Codner, Pablo

AU - Okuno, Taishi

AU - Pilgrim, Thomas

AU - Fiorina, Claudia

AU - Colombo, Antonio

AU - Mangieri, Antonio

AU - Eltchaninoff, Helene

AU - Nombela-Franco, Luis

AU - Van Wiechen, Maarten P.H.

AU - Van Mieghem, Nicolas M.

AU - Tchétché, Didier

AU - Schoels, Wolfgang H.

AU - Kullmer, Matthias

AU - Tamburino, Corrado

AU - Sinning, Jan Malte

AU - Al-Kassou, Baravan

AU - Perlman, Gidon Y.

AU - Danenberg, Haim

AU - Ielasi, Alfonso

AU - Fraccaro, Chiara

AU - Tarantini, Giuseppe

AU - De Marco, Federico

AU - Witberg, Guy

AU - Redwood, Simon R.

AU - Lisko, John C.

AU - Babaliaros, Vasilis C.

AU - Laine, Mika

AU - Nerla, Roberto

AU - Castriota, Fausto

AU - Finkelstein, Ariel

AU - Loewenstein, Itamar

AU - Eitan, Amnon

AU - Jaffe, Ronen

AU - Ruile, Philipp

AU - Neumann, Franz J.

AU - Piazza, Nicolo

AU - Alosaimi, Hind

AU - Sievert, Horst

AU - Sievert, Kolja

AU - Russo, Marco

AU - Andreas, Martin

AU - Bunc, Matjaz

AU - Latib, Azeem

AU - Govdfrey, Rebecca

AU - Hildick-Smith, David

AU - Sathananthan, Janarthanan

AU - Hensey, Mark

AU - Alkhodair, Abdullah

AU - Blanke, Philipp

AU - Leipsic, Jonathon

AU - Wood, David A.

AU - Nazif, Tamim M.

AU - Kodali, Susheel

AU - Leon, Martin B.

AU - Barbanti, Marco

PY - 2020/4/28

Y1 - 2020/4/28

N2 - Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives: The authors sought to examine outcomes following redo-TAVR. Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

AB - Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives: The authors sought to examine outcomes following redo-TAVR. Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

KW - durability

KW - transcatheter aortic valve replacement

KW - transcatheter heart valve

KW - valve-in-valve

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U2 - 10.1016/j.jacc.2020.02.051

DO - 10.1016/j.jacc.2020.02.051

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C2 - 32327098

AN - SCOPUS:85083715296

SN - 0735-1097

VL - 75

SP - 1882

EP - 1893

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 16

ER -

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

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Keywords

UN SDGs

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