Purpose: To report our early experience in repairing incomplete sealing or nonalignment of thoracic or thoracoabdominal stent-grafts using EndoAnchors.
Methods: Six patients (5 men; mean age 67 years, range 56-76) with thoracic or thoracoabdominal aortic stent-grafts and persistent type I endoleak (n=4), stent-graft migration (n=2), partial stent-graft infolding (n=2), and/or side branch malperfusion (n=1) were treated using the Heli-FX Aortic Securement System. Stent-graft or uncovered stent extension did not improve alignment in 3 patients prior to the use of EndoAnchors.
Results: Intended fixation of the proximal stent-graft in the aortic arch (n=1) and the proximal (n=3) or distal (n=2) descending thoracic aorta was achieved in all 6 patients using 28 EndoAnchors (3-7 per patient). Two to 4 EndoAnchors were placed at the site of the nonalignment and an additional 2 to 4 to fix the entire circumference of the stent-graft. The majority of the EndoAnchors were delivered successfully at the first attempt, but 5 required reapplication during the same intervention (no EndoAnchors were lost). No additional balloon dilation or other adjunctive maneuver was required for improvement of thoracic stent-graft fixation after the deployment of the EndoAnchors. The intraoperative and early postoperative periods were uneventful in 5 patients; however, one TAAA patient with a fenestrated aortic arch stent-graft suffered from multiple visceral and cerebral infarctions and died 4 weeks later. During the mean 11-month follow-up (range 5-22), no stent-graft migration or EndoAnchor dislocation has been observed. There have been no periaortic hematomas or side branch complications.
Conclusion: Although the number of patients treated so far is small, the Heli-FX Aortic Securement System seems to be a feasible and safe treatment option for primary or secondary procedures in patients with complications of proximal or distal thoracic stent-graft nonalignment. However, extensive endovascular interventions in the proximal aortic arch should be performed with caution because of an increased risk of severe embolic events.