A multicenter “real-world” study of the valiant NAVION stent graft

Background: The aim of the present study was to evaluate early results of thoracic endovascular aortic repair (TEVAR) using the Valiant NavionTM stent graft in a “real-world” scenario. Methods: All patients who underwent TEVAR with the Valiant NavionTM endograft between November 2018 and November 2019 were included in this retrospective multicenter study (six European centers). The primary end- points were technical success, incidence of major adverse events (MAEs), access failure, deployment failure, de- ployment 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 de- ployment 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 postoper- ative 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 NavionTM endograft in a wide variety of aortic diseases showed safe early outcomes, especially for on-label procedures.