Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry
Tébar, Daniel (Hospital Universitario La Paz (Madrid))
Carrillo, Xavier (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
García del Blanco, Bruno (Hospital Universitari Vall d'Hebron)
Gómez-Hospital, Joan Antoni (Hospital Universitari de Bellvitge)
Nombela-Franco, Luís (Hospital Clínico San Carlos (Madrid))
Molina, Eduardo (Hospital Universitario Virgen de las Nieves (Granada))
Galeote, Guillermo (Hospital Universitario La Paz (Madrid))
Vilalta, Victoria (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Serra-García, Vicenc (Hospital Universitari Vall d'Hebron)
Muntané Carol, Guillem (Hospital Universitari de Bellvitge)
Jiménez-Valero, Santiago (Hospital Universitario La Paz (Madrid))
Fernandez-Nofrerias, Eduard (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Calabuig Goena, Alvaro (Hospital Universitari Vall d'Hebron)
Jurado-Román, Alfonso
Sánchez-Recalde, Ángel (Hospital Universitario Ramón y Cajal (Madrid))
Velasco, María Fernández (Hospital Universitario La Paz (Madrid))
Boscá, Lisardo (Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares)
Moreno, Raúl (Hospital Universitario La Paz (Madrid))

Data:	2024
Resum:	Background: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. Aims: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. Methods: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. Results: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14. 5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91. 7% vs. 82%, p = 0. 04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. Conclusion: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	ACURATE neo ; ACURATE neo2 ; PVL ; TAVI ; TAVR
Publicat a:	Catheterization and Cardiovascular Interventions, Vol. 103, Núm. 6 (may 2024) , p. 1015-1022, ISSN 1522-726X

DOI: 10.1002/ccd.31032

8 p, 750.6 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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