Early Real-World Experience with Endoanchors by Indication. Annals of vascular surgery Ho, V. T., George, E. L., Dua, A. n., Lavingia, K. S., Sgroi, M. D., Dake, M. D., Lee, J. T. 2019

Abstract

The Heli-Fx Endoanchor system is a transmural aortic fixation device with Federal Drug Administration (FDA) approval for treatment of endoleaks, endograft migration, or high-risk seal zones. Published data is primarily from industry-sponsored registries highlighting safety and efficacy. Our objective is to evaluate real-world outcomes of Endoanchor usage after FDA approval across a variety of stent-grafts and indications at a single institution.We retrospectively reviewed our prospectively maintained aneurysm database for patients undergoing endovascular aortic repair with Heli-Fx Endoanchors (EAs). Technical success was defined as successful EA deployment, while procedural success was defined as absence of endoleak on completion aortogram. Cohorts were divided by indication and outcomes assessed via review of clinical and radiographic data.From 2016-2018, 37 patients underwent EA fixation. We divided the cohort by indication: Group A (Prior EVAR with endoleak), B (intraoperative type 1A endoleak), C (high-risk seal zone), and D (TEVAR). In Group A (n=11), all endoleaks were type 1A and a mean of 10 EAs were deployed with 100% technical and 45.4% procedural success. Two perioperative re-interventions were performed (translumbar coil embolization; proximal graft extension with bilateral renal artery stents). At a mean 10.6 months follow-up, 45.4% of patients had persistent endoleaks, with 100% aortic related survival. In Group B (n=10), a mean of 8.7 EAs were used with 100% technical and procedural success. One immediate adverse event occurred (right iliac dissection from wire manipulation, treated with a covered stent). At 13.6 month mean follow-up, there was significant sac regression (mean 9.75 mm) with no type 1A endoleaks. In Group C (n=10), a mean of 9.5 EAs were deployed with 100% technical and procedural success. At 11.2 month mean follow-up, there were no residual endoleaks and significant sac regression (mean 3.4 mm). Overall survival was 100%. In Group-D (n=6), a mean of 8.3 EAs were used with 83.3% technical and 66.6% procedural success. One immediate adverse event occurred, in which an EA embolized to the left renal artery. At 9.4 month mean follow-up, overall survival was 83.3% with a mean 2.2 mm increase in sac diameter.Early experience suggests EAs effectively treat intraoperative type-1A endoleaks and high-risk seal zones, with significant sac regression and no proximal endoleaks on follow-up. In patients treated for prior EVAR with postoperative type-1A endoleaks, fewer than half resolved after EA attempted repair. Further experience and longer-term followup will be necessary to determine which patients most benefit from postoperative EA fixation.

View details for DOI 10.1016/j.avsg.2019.05.006

View details for PubMedID 31201976