November 21, 2019
Medtronic Presents 1-Year Valiant Navion and 4-Year ANCHOR Registry Outcomes
November 22, 2019—Medtronic announced the presentation of 1-year outcomes for the Valiant Navion thoracic stent graft system for thoracic endovascular repair (TEVAR) and 4-year clinical outcomes from the ANCHOR registry evaluating the company’s Heli-FX EndoAnchor system in patients with hostile neck abdominal aortic aneurysms (AAAs) at the VEITHsymposium held November 19–23 in New York, New York.
Ali Azizzadeh, MD, United States Principal investigator for the Valiant Navion investigational device exemption study, presented data from the full patient cohort of the study, which was composed of 89 patients with thoracic aortic aneurysms (TAAs) or penetrating aortic ulcers (PAUs) who were evaluable for the assessment of the protocol specified by the primary composite endpoint within 1 year.
According to the company, the results demonstrated that Valiant Navion was safe and effective in patients with TAA and PAU. Dr. Azizzadeh reported that through 1 year, there were no access or deployment failures; freedom from secondary procedures was 94.8% based on Kaplan-Meier estimates; 97.4% of aneurysms remained stable or decreased in size through 1 year; and there were no new instances of type 1A endoleaks beyond 30 days.
The 4-year follow-up data from the ANCHOR registry were presented by William Jordan Jr, MD, and Jean-Paul de Vries, MD. ANCHOR is capturing long-term outcomes of endosuture aneurysm repair (ESAR) with the Heli-FX EndoAnchor system and commercially available grafts.
The company noted that > 900 patients with AAAs have been enrolled in the primary and revision arms of the ANCHOR registry. The data presented at the VEITHsymposium 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 4 years. Both groups included a high percentage (> 88%) of patients who met the Society of Vascular Surgery definition of hostile aortic necks.
The investigators reported that a high percentage of EndoAnchors penetrated the aortic wall in both the primary cohort (95.9%) and the revision cohort (93.1%)—a group that consisted of 100% failed endovascular aneurysm repairs (EVARs).
Additionally, the data through 4 years demonstrated the following:
- Freedom from secondary procedures to treat type IA endoleak based on Kaplan-Meier estimate of 97.2% (primary) and 82.4% (revision)
- Positive sac regression despite the hostile anatomy characteristics of 62.1% (primary) and 32.4% (revision)
- Freedom from aneurysm-related mortality based on Kaplan-Meier estimate—which is notable given the hostile neck anatomies of patients in both study arms—of 97.7% (primary) and 89.7% (revision)
“By recreating the durability of a sutured anastomosis, EndoAnchors create both radial and longitudinal fixation, which is especially important in challenging anatomies. These mechanisms help protect against neck dilatation and promote sac regression, which has shown to predict better EVAR long-term survival,” commented Dr. Jordan in Medtronic’s announcement. “Interestingly, we are also observing that patients treated prophylactically with Heli-FX are seeing a significant therapeutic benefit, which tells us that EndoAnchor implants are an opportunity for EVAR improvement in patients at risk for disease progression.”