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

Cardiovascular Medicine

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

37 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 (US)
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 - Apr 28 2020

Keywords

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

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jacc.2020.02.051

Cite this

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

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

@article{9b13d02732974998ad8e389e2dd67c23,

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 = "Funding Information: Dr. Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Dr. Kim has been a proctor for Boston Scientific and Abbott Vascular; and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Hamm has served on an Advisory Board for Medtronic. Dr. Schofer has received speaker fees from Boston Scientific; and has received travel compensation from Edwards Lifesciences, Boston Scientific, and Abbott/St. Jude Medical. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Rod{\'e}s-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; has been a consultant to Biotronik and HighLife SAS; and has received speaker fees from Boston Scientific and Biotronik. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, and Medtronic. Dr. Tamburino has served as a speaker and consultant for Medtronic; and has received speaker honoraria from Daiichi-Sankyo, Biosensor, Meril, Boheringer Ingelheim, and Balmed. Dr. Sinning : has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Danenberg has been a proctor for Medtronic; and served on a Speakers Bureau for Edwards Lifesciences. Dr. Tarantini has been a consultant to and has received lecture fees from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GADA. Dr. Redwood has been a proctor for and has received lecture fees from Edwards Lifesciences. Dr. Babaliaros has been a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Castriota has been a proctor for Medtronic and Boston Scientific. Dr. Piazza has been a consultant to Medtronic and MicroPort. Dr. H. Sievert has received study honoraria to his institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Andreas has been a proctor for Edwards Lifesciences and Abbott; and has been an Advisory Board member for Medtronic. Dr. Latib has been an Advisory Board member for Medtronic and Abbott; and has been a consultant for Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and advisory to Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Sathananthan has been a consultant to Edwards Lifesciences. Dr. Blanke has been a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circel Cardiovascular Imaging, and W. L. Gore. Dr. Leipsic has been a consultant to Circle CVI, HeartFlow, and Edwards Lifesciences; has received research grants from Edwards Lifesciences and GE Healthcare; has stock options in HeartFlow; and has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Wood has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kodali has received grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences and Admedus; and has equity in Admedus, Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve Inc. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has been an Advisory Board member for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Vinod H. Thourani, MD, served as Guest Associate Editor for this paper. Funding Information: Dr. Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Dr. Kim has been a proctor for Boston Scientific and Abbott Vascular; and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Hamm has served on an Advisory Board for Medtronic. Dr. Schofer has received speaker fees from Boston Scientific; and has received travel compensation from Edwards Lifesciences, Boston Scientific, and Abbott/St. Jude Medical. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Rod{\'e}s-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; has been a consultant to Biotronik and HighLife SAS; and has received speaker fees from Boston Scientific and Biotronik. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, and Medtronic. Dr. Tamburino has served as a speaker and consultant for Medtronic; and has received speaker honoraria from Daiichi-Sankyo, Biosensor, Meril, Boheringer Ingelheim, and Balmed. Dr. Sinning: has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Danenberg has been a proctor for Medtronic; and served on a Speakers Bureau for Edwards Lifesciences. Dr. Tarantini has been a consultant to and has received lecture fees from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GADA. Dr. Redwood has been a proctor for and has received lecture fees from Edwards Lifesciences. Dr. Babaliaros has been a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Castriota has been a proctor for Medtronic and Boston Scientific. Dr. Piazza has been a consultant to Medtronic and MicroPort. Dr. H. Sievert has received study honoraria to his institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Andreas has been a proctor for Edwards Lifesciences and Abbott; and has been an Advisory Board member for Medtronic. Dr. Latib has been an Advisory Board member for Medtronic and Abbott; and has been a consultant for Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and advisory to Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Sathananthan has been a consultant to Edwards Lifesciences. Dr. Blanke has been a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circel Cardiovascular Imaging, and W. L. Gore. Dr. Leipsic has been a consultant to Circle CVI, HeartFlow, and Edwards Lifesciences; has received research grants from Edwards Lifesciences and GE Healthcare; has stock options in HeartFlow; and has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Wood has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kodali has received grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences and Admedus; and has equity in Admedus, Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve Inc. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has been an Advisory Board member for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Vinod H. Thourani, MD, served as Guest Associate Editor for this paper. Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = apr,

day = "28",

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

language = "English (US)",

volume = "75",

pages = "1882--1893",

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

issn = "0735-1097",

publisher = "Elsevier USA",

number = "16",

}

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

N1 - Funding Information: Dr. Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Dr. Kim has been a proctor for Boston Scientific and Abbott Vascular; and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Hamm has served on an Advisory Board for Medtronic. Dr. Schofer has received speaker fees from Boston Scientific; and has received travel compensation from Edwards Lifesciences, Boston Scientific, and Abbott/St. Jude Medical. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; has been a consultant to Biotronik and HighLife SAS; and has received speaker fees from Boston Scientific and Biotronik. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, and Medtronic. Dr. Tamburino has served as a speaker and consultant for Medtronic; and has received speaker honoraria from Daiichi-Sankyo, Biosensor, Meril, Boheringer Ingelheim, and Balmed. Dr. Sinning : has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Danenberg has been a proctor for Medtronic; and served on a Speakers Bureau for Edwards Lifesciences. Dr. Tarantini has been a consultant to and has received lecture fees from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GADA. Dr. Redwood has been a proctor for and has received lecture fees from Edwards Lifesciences. Dr. Babaliaros has been a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Castriota has been a proctor for Medtronic and Boston Scientific. Dr. Piazza has been a consultant to Medtronic and MicroPort. Dr. H. Sievert has received study honoraria to his institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Andreas has been a proctor for Edwards Lifesciences and Abbott; and has been an Advisory Board member for Medtronic. Dr. Latib has been an Advisory Board member for Medtronic and Abbott; and has been a consultant for Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and advisory to Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Sathananthan has been a consultant to Edwards Lifesciences. Dr. Blanke has been a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circel Cardiovascular Imaging, and W. L. Gore. Dr. Leipsic has been a consultant to Circle CVI, HeartFlow, and Edwards Lifesciences; has received research grants from Edwards Lifesciences and GE Healthcare; has stock options in HeartFlow; and has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Wood has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kodali has received grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences and Admedus; and has equity in Admedus, Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve Inc. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has been an Advisory Board member for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Vinod H. Thourani, MD, served as Guest Associate Editor for this paper. Funding Information: Dr. Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Dr. Kim has been a proctor for Boston Scientific and Abbott Vascular; and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Hamm has served on an Advisory Board for Medtronic. Dr. Schofer has received speaker fees from Boston Scientific; and has received travel compensation from Edwards Lifesciences, Boston Scientific, and Abbott/St. Jude Medical. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; has been a consultant to Biotronik and HighLife SAS; and has received speaker fees from Boston Scientific and Biotronik. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, and Medtronic. Dr. Tamburino has served as a speaker and consultant for Medtronic; and has received speaker honoraria from Daiichi-Sankyo, Biosensor, Meril, Boheringer Ingelheim, and Balmed. Dr. Sinning: has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Danenberg has been a proctor for Medtronic; and served on a Speakers Bureau for Edwards Lifesciences. Dr. Tarantini has been a consultant to and has received lecture fees from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GADA. Dr. Redwood has been a proctor for and has received lecture fees from Edwards Lifesciences. Dr. Babaliaros has been a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Castriota has been a proctor for Medtronic and Boston Scientific. Dr. Piazza has been a consultant to Medtronic and MicroPort. Dr. H. Sievert has received study honoraria to his institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Andreas has been a proctor for Edwards Lifesciences and Abbott; and has been an Advisory Board member for Medtronic. Dr. Latib has been an Advisory Board member for Medtronic and Abbott; and has been a consultant for Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and advisory to Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Sathananthan has been a consultant to Edwards Lifesciences. Dr. Blanke has been a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circel Cardiovascular Imaging, and W. L. Gore. Dr. Leipsic has been a consultant to Circle CVI, HeartFlow, and Edwards Lifesciences; has received research grants from Edwards Lifesciences and GE Healthcare; has stock options in HeartFlow; and has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Wood has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kodali has received grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences and Admedus; and has equity in Admedus, Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve Inc. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has been an Advisory Board member for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Vinod H. Thourani, MD, served as Guest Associate Editor for this paper. Publisher Copyright: © 2020

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

UR - http://www.scopus.com/inward/record.url?scp=85083715296&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85083715296&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2020.02.051

DO - 10.1016/j.jacc.2020.02.051

M3 - Article

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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