Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry. (15th August 2022)

• Record Type: Journal Article
• Authors: 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;
• Is Part Of: International journal of cardiology. Volume 361(2022)
• Page Start: 55
• Page End: 60
• Publication Date: 2022-08-15
• Subjects: Transcatheter aortic valve replacement -- TAVR -- Self-expandable valve -- Large aortic annuli -- 34 mm Evolut R valve; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2022.04.079
• Languages: English
• ISSNs: 0167-5273

Abstract

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. Highlights: There is a lack of data about the performance of the Evolut R 34 mm transcatheter heart valve developed by Medtronic in large annuli. Evidence are limited to small registries in which the device has been compared only with its balloon-expandable competitor This large international multicenter registry aims to provide a larger and real-world analysis of patients with aortic stenosis, treated with the 34 mm Evolut transcatheter heart valve. In our study this device is safe and effective in treating patients with aortic stenosis and is not inferior to other Medtronic-prosthesis size, in terms of device success, despite higher rate of permanent pacemaker implantation.