Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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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
Аннотация
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.