A thoracic stent graft system was safe and effective at 1 year in patients requiring thoracic endovascular aortic repair, according to new data presented at VEITHSymposium.
In the cohort of 89 patients (mean age, 71 years; 40% women) treated with the system (Valiant Navion, Medtronic) for thoracic aortic aneurysms or penetrating aortic ulcers, the 1-year rate of freedom from secondary procedures was 94.8%, Ali Azizzadeh, MD, director of vascular surgery, vice chair of surgery and associate director of the Heart Institute at Cedars-Sinai, said during a presentation.
At 1 year, 4% of patients had a type Ib endoleak and 2.7% of patients had a type II endoleak, he said, noting there were no new type Ia endoleaks beyond 30 days.
In addition, 97.4% of patients had a stable or decreasing aneurysm sac at 1 year, he said.
“The design enhancements of Valiant Navion demonstrate positive clinical performance,” Azizzadeh said during the presentation. “One-year clinical results are encouraging. There were no access or deployment failures in tortuous anatomy.”
The mean duration of the procedure was 88.6 minutes and mean total fluoroscopy time was 12.1 minutes. Percutaneous access was used in 49% of patients.
Access artery tortuosity was severe in 73.7% of patients, whereas thoracic aorta tortuosity was high in 86.5% of patients, Azizzadeh said, noting that intended landing areas were calcific in 60% of patients and thrombus in 15.2% of patients.
The investigational device exemption study was used to support regulatory approval of the device, Azizzadeh said, noting FDA approval was granted in October 2018 and a CE mark was granted in November 2018. – by Erik Swain
Azizzadeh A, et al. Session 58. New or updated endovascular devices for treating descending aortic lesions (TEVAR) and TAAAs. Presented at: VEITHSymposium; Nov. 19-23, 2019; New York.
Disclosures: The study was funded by Medtronic. Azizzadeh reports he received research funding and honoraria from and consults for Medtronic and W.L. Gore and Associates.