Clinical Outcomes Heli-FX™ EndoAnchor™ System

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.

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.

Primary AAA arm (n = 771)

Baseline patient characteristics

  1. Infrarenal neck diameter: 23.9 mm (mean)
  2. Infrarenal angulation: 36.6° (mean)
  3. Aneurysm diameter: 59.3 mm (mean)
  4. Neck length: 15.0 mm (median)
  5. Conical neck (> 10%/10 mm): 42.5% (276/649)
Aortic illustration of the Heli-FX patient baseline characteristic diagram

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%
Pie chart illustrating the stents grafts used in the primary arm from the ANCHOR registry
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 success

98.8% (738/747)

Average time to place EndoAnchor implants

19.6 min

Average number of EndoAnchor implants

6.0

Average total procedural time

143.7 min

Average total fluoro time

35.1 min

Outcomes

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 5-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 5-year results demonstrate durable, reinforced proximal seal

  • 89.0% FF type Ia endoleak
  • 96.0% FF reinterventions for type Ia
  • 97.7% FF rupture
  • 98.4% FF aneurysm-related mortality (ARM)

    

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Revision AAA arm (N = 261)

Baseline patient characteristics

  1. Infrarenal neck diameter: 26.3 mm (mean)
  2. Infrarenal angulation: 35.6° (mean)
  3. Aneurysm diameter: 69.9 mm (mean)
  4. Neck length: 15.0 mm (median)
  5. Conical neck (> 10%/10 mm): 42.0% (89/212)
Aortic illustration of the Heli-FX patient baseline characteristic diagram

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%
Pie chart illustrating the stents grafts used in the revision arm from the ANCHOR registry

Reasons for EndoAnchor therapy

  • 53.6% type Ia endoleak
  • 13.0% migration
  • 18.4% type Ia and migration without endoleak
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

Flow chart depicting outcomes in index EVAR and ESAR for failed EVAR
ANCHOR revision AAA arm (N = 261) Year 5

Type Ia endoleak

3.7% (1/27)

Sac regressing or stable

65.4% (17/26)

Sac regressing

38.5% (10/26)

Migration

0.0% (0/16)

Durable repair in failed EVAR (N = 261)

5-year revision results over 9 years post-index EVAR

Even in failed EVARs, ESAR delivers durability
  • 91.3% 5Y FF ARM
  • 91.1% 5Y FF rupture
  • 81.4% 5Y FF reinterventions to treat type Ia

    

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Short neck cohort (N = 70)

Baseline patient characteristics (core lab reported)

  1. Infrarenal diameter: 25.7 mm
  2. Infrarenal angulation: 20.6°
  3. Aneurysm diameter: 57.7 mm
  4. Core lab mean neck length: 6.9 mm
  5. Site recorded mean neck length: 12.1 mm
Aortic illustration of the Heli-FX patient baseline characteristic diagram
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 implants

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 3-year results demonstrate strong outcomes and minimal reinterventions in hostile neck patients

  • 98.5% 3Y FF secondary reinterventions for type Ia
  • 88.0% 3Y FF all reinterventions
  • 98.0% 3Y FF rupture
  • 92.4% 3Y FF ARM

    

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Journal articles

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, et al. 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 Vasc Surg. 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, et al. J Endovasc Ther. August 2013;20(4):471-480.

Improving Proximal Fixation and Seal with the HeliFx Aortic EndoAnchor
Deaton DH. Sem 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, et al. 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 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, et al. 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.

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