A novel low-profile thoracic endograft was safe at 30 days in patients with descending thoracic aortic aneurysms, researchers reported at the Society for Vascular Surgery Vascular Annual Meeting.
The researchers conducted Valiant EVO, a prospective, nonrandomized single-arm trial of the endograft (Valiant Navion, Medtronic) in 87 patients (38% women; 86% with high thoracic aortic tortuosity).
Outcomes of interest included access success, deployment success and 30-day major device effects, endoleaks and secondary procedures.
Mean procedure duration was 88.7 minutes, mean estimated blood loss was 94 cc and most patients could be treated with percutaneous access, Ali Azizzadeh, MD, director of the division of vascular surgery at Cedars-Sinai, said during a presentation.
No procedures had access or deployment failures and 25% of patients received the covered seal configuration as their proximal device, according to the researchers.
Major device effects at 30 days were observed in 2.3% of patients (one-sided 97.5% upper confidence limit, 8.06%; P < .0001) and 2.5% of patients had endoleaks at 30 days, Azizzadeh and colleagues found.
At 30 days, two patients had died, with one death being device-related, for a freedom from mortality rate of 97.7%, and two patients required reintervention, one for retrograde type A dissection and one for aortic arch rupture, according to the researchers.
“In these short-term outcomes from the Valiant EVO global clinical trial, access/deployment failures, major device effects and endoleaks were rare,” Azizzadeh and colleagues wrote in an abstract. “The low-profile delivery and high stent graft conformability of the Valiant Navion thoracic stent graft system has shown encouraging early-term results and trial subjects will be continued to be followed through 5 years.” – by Erik Swain
Disclosure: The study was funded by Medtronic. Azizzadeh reports receiving research funding from, consulting for and receiving honoraria from Gore and Medtronic.