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.
I: International Journal of Cardiology, Bind 361, 2022, s. 55-60.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 - Publisher Copyright: © 2022 Elsevier B.V.
PY - 2022
Y1 - 2022
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 - 34 mm Evolut R valve
KW - Large aortic annuli
KW - Self-expandable valve
KW - TAVR
KW - Transcatheter aortic valve replacement
U2 - 10.1016/j.ijcard.2022.04.079
DO - 10.1016/j.ijcard.2022.04.079
M3 - Journal article
C2 - 35500820
AN - SCOPUS:85130499095
VL - 361
SP - 55
EP - 60
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -
ID: 320165660