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Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry

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Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry. / Gallo, Francesco; Gallone, Guglielmo; Kim, Won-Keun; Reifart, Jörg; Veulemans, Verena; Zeus, Tobias; Toggweiler, Stefan; De Backer, Ole; Søndergaard, Lars; De Marco, Federico; Regazzoli, Damiano; Reimers, Bernhard; Muntané-Carol, Guillem; Estevez-Loureiro, Rodrigo; Hernandez, Ubaldo; Moscarelli, Marco; Airale, Lorenzo; D'Ascenzo, Fabrizio; Armario, Xavier; Mylotte, Darren; Bhadra, Oliver Daniel; Conradi, Lenard; Donday, Luis Alfonso Marroquin; Nombela-Franco, Luis; Barbanti, Marco; Reddavid, Claudia; Criscione, Enrico; Brugaletta, Salvatore; Nicolini, Elisa; Piva, Tommaso; Tzanis, Giorgos; Ronco, Federico; Barbierato, Marco; Rodes-Cabau, Josep; Mangieri, Antonio; Colombo, Antonio; Giannini, Francesco.

In: INT J CARDIOL, Vol. 361, 15.08.2022, p. 55-60.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Gallo, F, Gallone, G, Kim, W-K, Reifart, J, Veulemans, V, Zeus, T, Toggweiler, S, De Backer, O, Søndergaard, L, De Marco, F, Regazzoli, D, Reimers, B, Muntané-Carol, G, Estevez-Loureiro, R, Hernandez, U, Moscarelli, M, Airale, L, D'Ascenzo, F, Armario, X, Mylotte, D, Bhadra, OD, Conradi, L, Donday, LAM, Nombela-Franco, L, Barbanti, M, Reddavid, C, Criscione, E, Brugaletta, S, Nicolini, E, Piva, T, Tzanis, G, Ronco, F, Barbierato, M, Rodes-Cabau, J, Mangieri, A, Colombo, A & Giannini, F 2022, 'Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry', INT J CARDIOL, vol. 361, pp. 55-60. https://doi.org/10.1016/j.ijcard.2022.04.079

APA

Gallo, F., Gallone, G., Kim, W-K., Reifart, J., Veulemans, V., Zeus, T., Toggweiler, S., De Backer, O., Søndergaard, L., De Marco, F., Regazzoli, D., Reimers, B., Muntané-Carol, G., Estevez-Loureiro, R., Hernandez, U., Moscarelli, M., Airale, L., D'Ascenzo, F., Armario, X., ... Giannini, F. (2022). Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry. INT J CARDIOL, 361, 55-60. https://doi.org/10.1016/j.ijcard.2022.04.079

Vancouver

Gallo F, Gallone G, Kim W-K, Reifart J, Veulemans V, Zeus T et al. Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry. INT J CARDIOL. 2022 Aug 15;361:55-60. https://doi.org/10.1016/j.ijcard.2022.04.079

Bibtex

@article{840c3dacf7ea444699a5ff3a4b6c10d6,
title = "Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry",
abstract = "OBJECTIVES: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota).BACKGROUND: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting.METHODS: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes.RESULTS: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157).CONCLUSIONS: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.",
keywords = "Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnosis, Heart Valve Prosthesis, Humans, Prosthesis Design, Registries, Retrospective Studies, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",
author = "Francesco Gallo and Guglielmo Gallone and Won-Keun Kim and J{\"o}rg Reifart and Verena Veulemans and Tobias Zeus and Stefan Toggweiler and {De Backer}, Ole and Lars S{\o}ndergaard and {De Marco}, Federico and Damiano Regazzoli and Bernhard Reimers and Guillem Muntan{\'e}-Carol and Rodrigo Estevez-Loureiro and Ubaldo Hernandez and Marco Moscarelli and Lorenzo Airale and Fabrizio D'Ascenzo and Xavier Armario and Darren Mylotte and Bhadra, {Oliver Daniel} and Lenard Conradi and Donday, {Luis Alfonso Marroquin} and Luis Nombela-Franco and Marco Barbanti and Claudia Reddavid and Enrico Criscione and Salvatore Brugaletta and Elisa Nicolini and Tommaso Piva and Giorgos Tzanis and Federico Ronco and Marco Barbierato and Josep Rodes-Cabau and Antonio Mangieri and Antonio Colombo and Francesco Giannini",
note = "Copyright {\textcopyright} 2022 Elsevier B.V. All rights reserved.",
year = "2022",
month = aug,
day = "15",
doi = "10.1016/j.ijcard.2022.04.079",
language = "English",
volume = "361",
pages = "55--60",
journal = "INT J CARDIOL",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

RIS

TY - JOUR

T1 - Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry

AU - Gallo, Francesco

AU - Gallone, Guglielmo

AU - Kim, Won-Keun

AU - Reifart, Jörg

AU - Veulemans, Verena

AU - Zeus, Tobias

AU - Toggweiler, Stefan

AU - De Backer, Ole

AU - Søndergaard, Lars

AU - De Marco, Federico

AU - Regazzoli, Damiano

AU - Reimers, Bernhard

AU - Muntané-Carol, Guillem

AU - Estevez-Loureiro, Rodrigo

AU - Hernandez, Ubaldo

AU - Moscarelli, Marco

AU - Airale, Lorenzo

AU - D'Ascenzo, Fabrizio

AU - Armario, Xavier

AU - Mylotte, Darren

AU - Bhadra, Oliver Daniel

AU - Conradi, Lenard

AU - Donday, Luis Alfonso Marroquin

AU - Nombela-Franco, Luis

AU - Barbanti, Marco

AU - Reddavid, Claudia

AU - Criscione, Enrico

AU - Brugaletta, Salvatore

AU - Nicolini, Elisa

AU - Piva, Tommaso

AU - Tzanis, Giorgos

AU - Ronco, Federico

AU - Barbierato, Marco

AU - Rodes-Cabau, Josep

AU - Mangieri, Antonio

AU - Colombo, Antonio

AU - Giannini, Francesco

N1 - Copyright © 2022 Elsevier B.V. All rights reserved.

PY - 2022/8/15

Y1 - 2022/8/15

N2 - OBJECTIVES: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota).BACKGROUND: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting.METHODS: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes.RESULTS: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157).CONCLUSIONS: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.

AB - OBJECTIVES: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota).BACKGROUND: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting.METHODS: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes.RESULTS: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157).CONCLUSIONS: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnosis

KW - Heart Valve Prosthesis

KW - Humans

KW - Prosthesis Design

KW - Registries

KW - Retrospective Studies

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.ijcard.2022.04.079

DO - 10.1016/j.ijcard.2022.04.079

M3 - SCORING: Journal article

C2 - 35500820

VL - 361

SP - 55

EP - 60

JO - INT J CARDIOL

JF - INT J CARDIOL

SN - 0167-5273

ER -