Clinical evidence
Heli-FX™ EndoAnchor™ system
Review the results of clinical studies and trials related to the effectiveness of the Heli-FX™ EndoAnchor™ system.
ANCHOR Registry and publications
Wide neck cohort (n = 72)
Wide proximal aortic necks experience suboptimal outcomes after standard EVAR
Wide necks† are1:
- 6.7 times more likely to have type Ia endoleak (p = 0.001)
- 10 times more likely to have sac expansion (p = 0.009)
- 5.1 times more likely to rupture (p = 0.01)
(N = 6,602 f/u ranged from 2.7 years [mean] to 3.9 years)
ESAR in wide necks: reinforced seal2,3, redefined outcomes4–8
ANCHOR Registry wide neck data
ESAR reinforces and protects the proximal seal, leading to better outcomes in wide necks. View data on wide necks from literature compared to the three-year wide neck results from the ANCHOR Registry.
ANCHOR Registry wide neck cohort three-year data (N = 72)5
(Wide necks ≥ 28 mm and ≤ 32 mm mean neck diameter 29.5 mm)
- 98.5% three-year FF type Ia endoleak (One patient presented with a type Ia at their 30-day follow-up, self-resolved)
- 100% three-year FF secondary procedures to treat type Ia
- 100% three-year FF migration
- 100% three-year FF rupture
- 93.4% (28/30)‡ sacs regressing/stable at three years
- 66.7% (20/30)‡ sac regression at three years
The relevance of ANCHOR Registry wide neck data
Hear from Professor Michel Reijnen on the importance of the ANCHOR three-year wide neck data. (03:33)
Using the ANCHOR Registry to help treat patients
Dr. William Jordan Jr. discusses the ANCHOR Registry and how it captures real-world usage and long-term outcomes of EndoAnchor™ implant fixation in EVAR. (01:10)
Primary AAA arm (n = 771)4
ANCHOR Registry real-world outcomes
Learn about the ANCHOR Registry design methods, results, and proven durability of ESAR with the Heli-FX™ EndoAnchor™ system in challenging AAA patients. (02:21)
Baseline patient characteristics
- Infrarenal neck diameter: 23.9 mm (mean)
- Infrarenal angulation: 36.6° (mean)
- Aneurysm diameter: 59.3 mm (mean)
- Neck length: 15.0 mm (median)
- Conical neck (> 10%/10 mm): 42.5% (276/649)
Stent graft used (N = 750)
- Endurant™ II/IIs stent graft system: 61.5%
- Excluder™* AAA endoprosthesis: 26%
- Zenith™* AAA endovascular graft: 9.9%
- Other: 2.6%
| ANCHOR primary AAA arm | N = 771 |
|---|---|
| Female | 21.3% |
| Average age | 73.5 years |
| Hostile necks | 88.7% (572/645) |
| ASA Class III/IV | 87.8% (674/768) |
| Urgent or emergent | 17.9% (119/664) |
Perioperative outcomes
| ANCHOR primary AAA arm | N = 771 |
|---|---|
| Technical success9 | 98.8% (738/747) |
| Average time to place EndoAnchor™ implants | 19.6 min |
| Average number of EndoAnchor™ implants | 6.0 |
| Average total procedural time9 | 143.7 min |
| Average total fluoro time | 35.1 min |
Outcomes10
| ANCHOR primary AAA arm (N = 771) | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
|---|---|---|---|---|---|
| Type Ia endoleak | 2.5% (14/568) |
1.7% (6/346) |
2.9% (7/238) |
3.2% (5/154) |
4.8% (4/84) |
| Migration | 0.0% (0/368) |
0.0% (0/180) |
0.0% (0/114) |
0.0% (0/72) |
0.0% (0/37) |
ESAR promotes sac regression
Strong five-year sac regression in hostile necks
- 62.5% (50/80) sac regressing
- 88.8% (71/80) of stable or regressing
Long-term clinical durability (N = 771)
ANCHOR five-year results demonstrate durable, reinforced proximal seal
- >89.0% FF type Ia endoleak10
- 96.0% FF reinterventions for type Ia
- 97.7% FF rupture
- 98.4% FF aneurysm-related mortality (ARM)
Revision AAA arm (n = 261)11
Baseline patient characteristics
- Infrarenal neck diameter: 26.3 mm (mean)
- Infrarenal angulation: 35.6° (mean)
- Aneurysm diameter: 69.9 mm (mean)
- Neck length: 15.0 mm (median)
- Conical neck (> 10%/10 mm): 42.0% (89/212)
Stent graft used (N = 260)
- Endurant II/IIs stent graft system: 23.5%
- Excluder AAA endoprosthesis: 19.6%
- AneuRx™: 14.6%
- Zenith AAA endovascular graft: 13.8%
- Talent™*: 11.2%
- Other: 17.4%
Reasons for EndoAnchor™ therapy
- 53.6% type Ia endoleak
- 18.4% migration and type Ia endoleak
- 3.0% migration (without endoleak)
- 7.3% neck dilatation
- 7.7% other
| ANCHOR revision AAA arm | N = 261 |
|---|---|
| Female | 15.3% |
| Average age | 77.8 years |
| Hostile necks | 88.7% (188/212) |
| ASA Class III/IV | 89.2% |
| Urgent or emergent | 23.8% (58/244) |
Perioperative outcomes
| ANCHOR revision AAA arm | N = 261 |
|---|---|
| Technical success | 95% |
| Average time to place EndoAnchor™ implants | 25.2 min |
| Average number of EndoAnchor™ implants | 7.4 |
| Average total procedural time | 145.5 min |
| Average total fluoro time | 32.5 min |
Outcomes
(For 4.6 years, see reference 12.)
| ANCHOR revision AAA arm (N = 261) | Year 5 |
|---|---|
| Type Ia endoleak9 | 3.7% (1/27) |
| Sac regressing or stable11 | 65.4% (17/26) |
| Sac regressing11 | 38.5% (10/26) |
| Migration9 | 0.0% (0/16) |
Durable repair in failed EVAR (N = 261)
Five-year revision results over nine years post-index EVAR
Even in failed EVARs, ESAR delivers durability
- 91.3% five-year FF ARM
- 91.1% five-year FF rupture
- 81.4% five-year FF reinterventions to treat type Ia
Short neck cohort (n = 70)13
Baseline patient characteristics (core lab reported)
- Infrarenal diameter: 25.7 mm
- Infrarenal angulation: 20.6°
- Aneurysm diameter: 57.7 mm
- Core lab mean neck length: 6.9 mm
- Site recorded mean neck length: 12.1 mm
| ANCHOR short neck cohort | N = 70 |
|---|---|
| Female | 27% |
| Average age | 71 years |
| Hostile necks | 100% |
| ASA Class III/IV | 93% |
| Urgent or emergent | 31% |
Perioperative outcomes
| ANCHOR short neck cohort | N = 70 |
|---|---|
| Overall procedural success | 97.1% |
| Successful and accurate deployment of EndoAnchor implants14 | 92.9% |
| Average time to place EndoAnchor implants | 17.1 min |
| Average number of EndoAnchor implants | 5.5 |
| Average total procedural time | 148 min |
| Average total fluoro time | 35.5 min |
Outcomes (site reported values)
| ANCHOR short neck cohort (N = 70) | Year 1 | Year 2 | Year 3 |
|---|---|---|---|
| Type Ia endoleak | 2.0% (1/51) |
2.7% (1/37) |
6.5% (2/31) |
| Sac regressing or stable | 100% (53/53) |
97.3% (36/37) |
93.7% (30/32) |
| Sac regressing | 35.8% (19/53) |
54.1% (20/37) |
46.9% (15/32) |
| Migration | 0 migrations at any time point |
||
ESAR in short necks (N = 70)
Durable results, minimal reinterventions
Short neck cohort three-year results demonstrate strong outcomes and minimal reinterventions in hostile neck patients
- 98.5% three-year FF secondary reinterventions for type Ia15
- 88.0% three-year FF all reinterventions
- 98.0% three-year FF rupture15
- 92.4% three-year FF ARM
- One-year Results of the ANCHOR Trial of EndoAnchors for the Prevention and Treatment of Aortic Neck Complications after Endovascular Aneurysm Repair
Jordan WD Jr, Mehta M, Ouriel K, et al. Vascular. April 2016;24(2):177–186. - Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-graft Migration in Patients with Challenging Proximal Aortic Neck Anatomy
Jordan WD Jr, de Vries JP, Ouriel K, et al. J Endovasc Ther. April 2015;22(2):163–170. - Outcome of the Pivotal Study of the Aptus Endovascular Abdominal Aortic Aneurysms Repair System
Mehta M, Henretta J, Glickman M, et al. J Vasc Surg. August 2014;60(2):275–285. - Successful Treatment of a Proximal Type I Endoleak with HeliFX EndoAnchors
Hogendoorn W, Schlösser FJ, Aruny JE, Indes J, Sumpio B, Muhs B. Ann Vasc Surg. April 2014;28(3):737. - A Proof-of-Concept In Vitro Study to Determine if EndoAnchors Can Reduce Gutter Size in Chimney Graft Configurations
Niepoth WW, de Bruin JL, Yeung KK, et al. J Endovasc Ther. August 2013;20(4):498–505. - EndoAnchor Placement in Thoracic and Thoracoabdominal Stent-Grafts to Repair Complications of Nonalignment
Kasprzak P, Pfister K, Janotta M, Kopp R. J Endovasc Ther. August 2013;20(4):471–480. - Improving Proximal Fixation and Seal with the HeliFx Aortic EndoAnchor
Deaton DH. Semin Vasc Surg. December 2012;25(4):187–192. - Primary Endoanchoring in the Endovascular Repair of Abdominal Aortic Aneurysms with an Unfavorable Neck
Perdikides T, Melas N, Lagios K, et al. J Endovasc Ther. December 2012;19(6):707–715. - The use of EndoAnchors in repair EVAR cases to improve proximal endograft fixation
Avci M, Vos JA, Kolvenbach RR, et al. J Cardiovasc Surg. August 2012;53(4):419–426. - Helical EndoStaples Enhance Endograft Fixation in an Experimental Model Using Human Cadaveric Aortas
Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton D. J Vasc Surg. June 2012;55(6):1726–1733. - Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm
Arko FR 3rd, Stanley GA, Pearce BJ, et al. J Vasc Surg. September 2019;70(3):732–740. - Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling
Chaudhuri A, Badawy A. Vascular. June 2021;29(3):315–322. - The use of EndoAnchors in endovascular repair of abdominal aortic aneurysms with challenging proximal neck: Single-centre experience
Giudice R, Borghese O, Sbenaglia G, et al. JRSM Cardiovasc Dis. April 24, 2019;8:2048004019845508. - Rethinking EVAR: Is Longer Seal Zone the Only Answer for Enhancing Durability?
Milner R, et al. EV Today. Available at: https://evtoday.com/articles/2018-nov/rethinking-evar-is-longer-seal-zone-the-only-answer-for-enhancing-durability. Accessed March 15, 2022. - Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors
Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. J Vasc Surg. June 2018;67(6):1699–1707. - Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry
Reyes Valdivia A, Chaudhuri A, Milner R, et al. Vascular. February 2022;30(1):27–37. - The Current Landscape of EndoSuture Aneurysm Repair (ESAR)
Nassiri N, Chen JF, Jordan WD, et al. EV Today. Available at: https://evtoday.com/articles/2022-aug/the-current-landscape-of-endosuture-aneurysm-repair-esar. Accessed September 19, 2022.