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Early Real-World Experience with EndoAnchors by Indication
Vy T Ho1, Elizabeth L George1, Anahita Dua1
1Division of Vascular Surgery, Department of Surgery, Stanford University, Stanford, CA.
Annals of Vascular Surgery
|June 16, 2019
Summary
The Heli-FX EndoAnchor (EA) system shows promise for treating intraoperative type 1A endoleaks and high-risk seal zones in aortic repair. However, its effectiveness in resolving postoperative endoleaks after prior EVAR requires further investigation.
Area of Science:
- Vascular Surgery
- Medical Devices
- Endovascular Repair
Background:
- The Heli-FX EndoAnchor (EA) is an FDA-approved transmural aortic fixation device.
- Existing data on EA systems are mainly from industry-sponsored registries.
- This study evaluates real-world outcomes of EA usage across various stent grafts and indications.
Purpose of the Study:
- To assess the real-world effectiveness and safety of the Heli-FX EndoAnchor (EA) system.
- To evaluate outcomes based on different indications for EA use.
- To analyze EA performance in diverse patient groups and stent graft types.
Main Methods:
- Retrospective review of a prospectively maintained aneurysm database.
- Inclusion of patients undergoing endovascular aortic repair (EVAR) with Heli-FX EAs.
- Categorization of patients by indication: prior EVAR with endoleak, intraoperative type 1A endoleak, high-risk seal zone, and thoracic EVAR.
Main Results:
- 100% technical success for EA deployment across most groups.
- High procedural success in treating intraoperative type 1A endoleaks (100%) and high-risk seal zones (100%).
- Lower procedural success (45.4%) for postoperative type 1A endoleaks, with persistent endoleaks in 45.4% of these patients.
Conclusions:
- Heli-FX EndoAnchors are effective for intraoperative type 1A endoleaks and high-risk seal zones, showing sac regression.
- Fewer than half of postoperative type 1A endoleaks resolved after EA repair.
- Further research and long-term follow-up are needed to identify optimal patient candidates for postoperative EA fixation.
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