作者
Giuliano Costa,Francesco Saia,Thomas Pilgrim,Mohamed Abdel‐Wahab,Philippe Garot,Sofia Sammartino,Caterina Gandolfo,Luca Branca,Azeem Latib,Ignacio J. Amat‐Santos,Darren Mylotte,Federico De Marco,Ole De Backer,Luis Nombela‐Franco,Mariama Akodad,Flavio Ribichini,Francesco Bedogni,Alessandro Mazzapicchi,Daijiro Tomii,Pietro Laforgia,Stefano Cannata,Claudia Fiorina,Andrea Scotti,Simone Fezzi,Enrico Criscione,Enrico Poletti,Mattia Mazzucca,Mattia Lunardi,Andrea Mainardi,Stefano Andreaggi,Angelo Quagliana,Nicholas J Montarello,Breda Hennessey,Matías Mon-Noboa,David Meier,Marianna Adamo,Carmelo Sgroi,Claudia Reddavid,Orazio Strazzieri,S. Motta,Valentina Frittitta,Elena Dipietro,Alessandro Comis,Chiara Melfa,Mariachiara Calì,Giulia Laterra,Holger Thiele,John G. Webb,Lars Søndergaard,Corrado Tamburino,Marco Barbanti
摘要
Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking.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.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.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).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.