TY - JOUR
T1 - One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices
T2 - insights from the OPERA-TAVI registry
AU - Costa, Giuliano
AU - Saia, Francesco
AU - Pilgrim, Thomas
AU - Abdel-Wahab, Mohamed
AU - Garot, Philippe
AU - Sammartino, Sofia
AU - Gandolfo, Caterina
AU - Branca, Luca
AU - Latib, Azeem
AU - Amat-Santos, Ignacio
AU - Mylotte, Darren
AU - De Marco, Federico
AU - De Backer, Ole
AU - Nombela Franco, Luis
AU - Akodad, Mariama
AU - Ribichini, Flavio Luciano
AU - Bedogni, Francesco
AU - Mazzapicchi, Alessandro
AU - Tomii, Daijiro
AU - Laforgia, Pietro
AU - Cannata, Stefano
AU - Fiorina, Claudia
AU - Scotti, Andrea
AU - Fezzi, Simone
AU - Criscione, Enrico
AU - Poletti, Enrico
AU - Mazzucca, Mattia
AU - Lunardi, Mattia
AU - Mainardi, Andrea
AU - Andreaggi, Stefano
AU - Quagliana, Angelo
AU - Montarello, Nicholas
AU - Hennessey, Breda
AU - Mon-Noboa, Matias
AU - Meier, David
AU - Adamo, Marianna
AU - Sgroi, Carmelo
AU - Reddavid, Claudia Maria
AU - Strazzieri, Orazio
AU - Crescenzia Motta, Silvia
AU - Frittitta, Valentina
AU - Dipietro, Elena
AU - Comis, Alessandro
AU - Melfa, Chiara
AU - Calì, Mariachiara
AU - Laterra, Giulia
AU - Thiele, Holger
AU - Webb, John G
AU - Sondergaard, Lars
AU - Tamburino, Corrado
AU - Barbanti, Marco
PY - 2024/1/1
Y1 - 2024/1/1
N2 - BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking.AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice.METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology.RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10).CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.
AB - BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking.AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice.METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology.RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10).CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.
KW - Aortic Valve Stenosis/surgery
KW - Aortic Valve/diagnostic imaging
KW - Heart Valve Prosthesis/adverse effects
KW - Humans
KW - Prosthesis Design
KW - Registries
KW - Stroke/etiology
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85181541550&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-23-00720
DO - 10.4244/EIJ-D-23-00720
M3 - Journal article
C2 - 37982161
SN - 1774-024X
VL - 20
SP - 95
EP - 103
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 1
ER -