Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

Germán Armijo; Gilbert H L Tang; Nynke Kooistra; Alfredo Nunes Ferreira-Neto; Stefan Toggweiler; Ignacio J Amat-Santos; Lukas S Keller; Marina Urena; Hasan Ahmad; Jose Tafur Soto; Erika Muñoz-Garcia; Ander Regueiro; Geert E Leenders; Gabriela Tirado-Conte; Aditya Sengupta; Angela McInerney; Thomas Couture; Oscar Cuevas Herreros; Tania Rodriguez-Gabella; Annapoorna Kini; Mohammed Ahmed; Syed Zaid; Nieves Gonzalo; Ivan J Nuñez-Gil; Antonio J Muñoz-Garcia; Pilar Jimenez-Quevedo; Antonio Fernández-Ortiz; Dominique Himbert; Fabian Nietlispach; Pieter Stella; George D Dangas; Javier Escaned; Carlos Macaya; Josep Rodés-Cabau; Luis Nombela-Franco

doi:10.1161/CIRCINTERVENTIONS.120.009047

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

Germán Armijo, Gilbert H L Tang, Nynke Kooistra, Alfredo Nunes Ferreira-Neto, Stefan Toggweiler, Ignacio J Amat-Santos, Lukas S Keller, Marina Urena, Hasan Ahmad, Jose Tafur Soto, Erika Muñoz-Garcia, Ander Regueiro, Geert E Leenders, Gabriela Tirado-Conte, Aditya Sengupta, Angela McInerney, Thomas Couture, Oscar Cuevas Herreros, Tania Rodriguez-Gabella, Annapoorna KiniMohammed Ahmed, Syed Zaid, Nieves Gonzalo, Ivan J Nuñez-Gil, Antonio J Muñoz-Garcia, Pilar Jimenez-Quevedo, Antonio Fernández-Ortiz, Dominique Himbert, Fabian Nietlispach, Pieter Stella, George D Dangas, Javier Escaned, Carlos Macaya, Josep Rodés-Cabau, Luis Nombela-Franco

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

Abstract

BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.

METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.

RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.

CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

Original language	English
Article number	e009047
Pages (from-to)	1-9
Number of pages	9
Journal	Circulation. Cardiovascular Interventions
Volume	13
Issue number	8
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.120.009047
Publication status	Published - Aug 2020

Keywords

aortic valve stenosis
cohort studies
hemodynamics
humans
transcatheter aortic valve replacement

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10.1161/CIRCINTERVENTIONS.120.009047

Cite this

Armijo, G., Tang, G. H. L., Kooistra, N., Ferreira-Neto, A. N., Toggweiler, S., Amat-Santos, I. J., Keller, L. S., Urena, M., Ahmad, H., Tafur Soto, J., Muñoz-Garcia, E., Regueiro, A., Leenders, G. E., Tirado-Conte, G., Sengupta, A., McInerney, A., Couture, T., Cuevas Herreros, O., Rodriguez-Gabella, T., ... Nombela-Franco, L. (2020). Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry. Circulation. Cardiovascular Interventions, 13(8), 1-9. Article e009047. https://doi.org/10.1161/CIRCINTERVENTIONS.120.009047

@article{54ac3fca8c70432a8628f6a59054e770,

title = "Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry",

abstract = "BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.",

keywords = "aortic valve stenosis, cohort studies, hemodynamics, humans, transcatheter aortic valve replacement",

author = "Germ{\'a}n Armijo and Tang, {Gilbert H L} and Nynke Kooistra and Ferreira-Neto, {Alfredo Nunes} and Stefan Toggweiler and Amat-Santos, {Ignacio J} and Keller, {Lukas S} and Marina Urena and Hasan Ahmad and {Tafur Soto}, Jose and Erika Mu{\~n}oz-Garcia and Ander Regueiro and Leenders, {Geert E} and Gabriela Tirado-Conte and Aditya Sengupta and Angela McInerney and Thomas Couture and {Cuevas Herreros}, Oscar and Tania Rodriguez-Gabella and Annapoorna Kini and Mohammed Ahmed and Syed Zaid and Nieves Gonzalo and Nu{\~n}ez-Gil, {Ivan J} and Mu{\~n}oz-Garcia, {Antonio J} and Pilar Jimenez-Quevedo and Antonio Fern{\'a}ndez-Ortiz and Dominique Himbert and Fabian Nietlispach and Pieter Stella and Dangas, {George D} and Javier Escaned and Carlos Macaya and Josep Rod{\'e}s-Cabau and Luis Nombela-Franco",

year = "2020",

month = aug,

doi = "10.1161/CIRCINTERVENTIONS.120.009047",

language = "English",

volume = "13",

pages = "1--9",

journal = "Circulation. Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams & Wilkins",

number = "8",

}

Armijo, G, Tang, GHL, Kooistra, N, Ferreira-Neto, AN, Toggweiler, S, Amat-Santos, IJ, Keller, LS, Urena, M, Ahmad, H, Tafur Soto, J, Muñoz-Garcia, E, Regueiro, A, Leenders, GE, Tirado-Conte, G, Sengupta, A, McInerney, A, Couture, T, Cuevas Herreros, O, Rodriguez-Gabella, T, Kini, A, Ahmed, M, Zaid, S, Gonzalo, N, Nuñez-Gil, IJ, Muñoz-Garcia, AJ, Jimenez-Quevedo, P, Fernández-Ortiz, A, Himbert, D, Nietlispach, F, Stella, P, Dangas, GD, Escaned, J, Macaya, C, Rodés-Cabau, J & Nombela-Franco, L 2020, 'Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry', Circulation. Cardiovascular Interventions, vol. 13, no. 8, e009047, pp. 1-9. https://doi.org/10.1161/CIRCINTERVENTIONS.120.009047

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry. / Armijo, Germán; Tang, Gilbert H L; Kooistra, Nynke et al.
In: Circulation. Cardiovascular Interventions, Vol. 13, No. 8, e009047, 08.2020, p. 1-9.

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

TY - JOUR

T1 - Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

AU - Armijo, Germán

AU - Tang, Gilbert H L

AU - Kooistra, Nynke

AU - Ferreira-Neto, Alfredo Nunes

AU - Toggweiler, Stefan

AU - Amat-Santos, Ignacio J

AU - Keller, Lukas S

AU - Urena, Marina

AU - Ahmad, Hasan

AU - Tafur Soto, Jose

AU - Muñoz-Garcia, Erika

AU - Regueiro, Ander

AU - Leenders, Geert E

AU - Tirado-Conte, Gabriela

AU - Sengupta, Aditya

AU - McInerney, Angela

AU - Couture, Thomas

AU - Cuevas Herreros, Oscar

AU - Rodriguez-Gabella, Tania

AU - Kini, Annapoorna

AU - Ahmed, Mohammed

AU - Zaid, Syed

AU - Gonzalo, Nieves

AU - Nuñez-Gil, Ivan J

AU - Muñoz-Garcia, Antonio J

AU - Jimenez-Quevedo, Pilar

AU - Fernández-Ortiz, Antonio

AU - Himbert, Dominique

AU - Nietlispach, Fabian

AU - Stella, Pieter

AU - Dangas, George D

AU - Escaned, Javier

AU - Macaya, Carlos

AU - Rodés-Cabau, Josep

AU - Nombela-Franco, Luis

PY - 2020/8

Y1 - 2020/8

N2 - BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

AB - BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

KW - aortic valve stenosis

KW - cohort studies

KW - hemodynamics

KW - humans

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85089171329&partnerID=8YFLogxK

U2 - 10.1161/CIRCINTERVENTIONS.120.009047

DO - 10.1161/CIRCINTERVENTIONS.120.009047

M3 - Article

C2 - 32757657

SN - 1941-7640

VL - 13

SP - 1

EP - 9

JO - Circulation. Cardiovascular Interventions

JF - Circulation. Cardiovascular Interventions

IS - 8

M1 - e009047

ER -

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

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Keywords

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