Medtronic has announced one-year outcomes for the Valiant Navion thoracic stent graft system for thoracic endovascular repair (TEVAR) and four-year clinical outcomes from the ANCHOR registry evaluating the Heli-FX EndoAnchor system in patients with hostile neck abdominal aortic aneurysms (AAA). The data were presented at VEITHsymposium in New York, USA (19–23 November).
One-year Valiant Navion data
New data from the full patient cohort of the pivotal Valiant Navion study were presented by Ali Azizzadeh, professor and director of the Division of Vascular Surgery, Cedars-Sinai Medical Center and US principal investigator for the Valiant Navion investigational device exemption (IDE) study. The data presented includes 89 subjects with thoracic aortic aneurysms or penetrating aortic ulcers who were evaluable for the assessment of the protocol specified by the primary composite endpoint within one year.
The results demonstrated that Valiant Navion was safe and effective in patients with thoracic aortic aneurysms and penetrating aortic ulcers. Through one-year, there were no access or deployment failures. Based on Kaplan-Meier estimates through one-year, freedom from secondary procedures was 94.8%. Furthermore, 97.4% of aneurysms remained stable or decreased in size through one year. Finally, there were no new instances of Type 1a endoleaks beyond 30 days.
Four-year ESAR data
Four-year follow-up data from the ANCHOR registry, which captures long term outcomes of ESAR (EndoSuture Aneurysm Repair) with the Heli-FX EndoAnchor System and commercially available grafts, was presented by William Jordan, professor of surgery and chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine and Jean-Paul de Vries, currently chair Department of Surgery at University Medical Center Groningen (Groningen, The Netherlands).
To-date, more than 900 patients with abdominal aortic aneurysms (AAA) have been enrolled in the primary and revision arms of the ANCHOR registry. The data presented includes AAA patients treated with ESAR in the primary and revision cohorts of the study who were eligible for clinical and imaging follow up through four-years. Both groups included a high percentage (>88%) of patients who met the Society of Vascular Surgery (SVS) definition of hostile aortic necks. A high percentage of EndoAnchors penetrated the aortic wall in both the primary cohort (95.9%) and the revision cohort (93.1%)—a group which consisted of 100% failed EVARs. The data also demonstrated:
- Freedom from secondary procedures to treat Type Iaendoleak based on Kaplan-Meier estimate:
- Through four years: Primary= 97.2%; revision= 82.4%
- Positive sac regression despite the hostile anatomy characteristics:
- At four years: Primary= 62.1%; revision= 32.4%
- Freedom from aneurysm related mortality (ARM) based on Kaplan-Meier estimate, which is notable given the hostile neck anatomies of patients in both study arms:
- Through four years: Primary= 97.7%; revision= 89.7%