One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.
Обработка статьи · этапы, ошибки и управление
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Costa Giuliano, Saia Francesco, Pilgrim Thomas, Abdel-Wahab Mohamed, Garot Philippe, Sammartino Sofia, Gandolfo Caterina, Branca Luca, Latib Azeem, Amat-Santos Ignacio, Mylotte Darren, De Marco Federico, De Backer Ole, Nombela Franco Luis, Akodad Mariama, Ribichini Flavio Luciano, Bedogni Francesco, Mazzapicchi Alessandro, Tomii Daijiro, Laforgia Pietro, Cannata Stefano, Fiorina Claudia, Scotti Andrea, Fezzi Simone, Criscione Enrico, Poletti Enrico, Mazzucca Mattia, Lunardi Mattia, Mainardi Andrea, Andreaggi Stefano, Quagliana Angelo, Montarello Nicholas J, Hennessey Breda, Mon-Noboa Matias, Meier David, Adamo Marianna, Sgroi Carmelo, Reddavid Claudia Maria, Strazzieri Orazio, Crescenzia Motta Silvia, Frittitta Valentina, Dipietro Elena, Comis Alessandro, Melfa Chiara, Calì Mariachiara, Laterra Giulia, Thiele Holger, Webb John G, Sondergaard Lars, Tamburino Corrado, Barbanti Marco
Аннотация
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.