A multicenter "real-world" study of the valiant NAVION stent graft. (15th May 2021)

• Record Type: Journal Article
• Authors: Reyes-Valdivia, Andrés; Kratimenos, Theodoros; Ferraresi, Marco; Sica, Simona; Lovato, Luigi; Accarino, Giancarlo; Pagliaricco, Gabriele; Tshomba, Yamume; Tinelli, Giovanni; Gandarias, Claudio; Pacini, Davide; Tomais, Dimitrios; Gatta, Emanuele; Schiavon, Sara; Accarino, Giulio; Minelli, Fabrizio; De Nigris, Francesca
• Is Part Of: International journal of cardiology. Volume 331(2021)
• Page Start: 63
• Page End: 68
• Publication Date: 2021-05-15
• Subjects: Navion stent graft -- Thoracic stent graft -- Low-profile thoracic stent graft -- Innovative biotechnologies -- Personalized medicine; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2020.10.064
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: The aim of the present study was to evaluate early results of thoracic endovascular aortic repair (TEVAR) using the Valiant Navion™ stent graft in a "real-world" scenario. Methods: All patients who underwent TEVAR with the Valiant Navion™ endograft between November 2018 and November 2019 were included in this retrospective multicenter study (six European centers). The primary endpoints were technical success, incidence of major adverse events (MAEs), access failure, deployment failure, deployment accuracy, and rate of intraoperative endoleaks (ELs). Results: One hundred-sixteen patients with varying thoracic aortic diseases were included. Eighteen patients (15.5%) were treated for an off-label condition. The technical success rate was 100%, without any access or deployment failures. The proximal and distal deployment accuracy rates were 99.1% and 97.4%, respectively. There were no intraoperative MAEs, including death. Two (1.7%) type Ib ELs were detected at the first postoperative CTA, all of which were in off-label procedures and related to the short length of the sealing neck. No type III ELs were detected. The median hospitalization time was 8 days (IQR 4–12), including a median intensive care unit stay of 1 day (IQR 1–2). The in-hospital mortality rate was 4.3%. At a median follow-up time of 98 days (IQR 39–187), there were no aortic-related mortalities or new onset of endoleaks. Conclusion: Our initial experience with the Valiant Navion™ endograft in a wide variety of aortic diseases showed safe early outcomes, especially for on-label procedures. Highlights: Initial experience of TEVAR with Valiant Navion graft showed safe early outcomes. One hundred-sixteen patients with different thoracic aortic diseases were included. The technical success rate was 100%, without any access or deployment failures. Proximal and distal deployment accuracy rates were 99.1% and 97.4%, respectively. There were no intraoperative major adverse events, including deaths.