HOSTILE NECK ENDOSUTURE ANEURYSM REPAIR Endurant II Stent Graft Systems

Watch the story of how an aortic patient with complex anatomy was treated with Endurant system + ESAR.

Naomi's ESAR Story

Overview

The Endurant™ II/IIs AAA stent graft system used in combination with the Heli-FX™ EndoAnchor™ system is the first AAA short neck solution independent of renal stenting. Where approved for this use, Endurant II/IIs with Heli-FX EndoAnchor system is indicated for hostile aortic neck treatment*. For Successful EndoAnchor implantation, neck must be free from significant thrombus, calcification, or plaque.

CLINICAL OUTCOMES

• 70 patients enrolled
• 93% ASA class III/IV
• 6.9 mm mean proximal neck length, (4.06–9.97 mm)

ANCHOR REGISTRY SHORT NECK COHORT

• Design: Post-market, prospective, multi-arm registry with core lab analysis
• Enrollment: 70 subjects in the short neck cohort were analysed at 19 U.S. and 3 EU sites ‡
• Eligibility: Proximal neck length ≥ 4 mm and < 10 mm, as measured by the core lab
  • The neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.
  • Type Ia endoleak rate at 1 month (core laboratory assessed)
  • Type Ia endoleak rate at 12 months (core laboratory assessed)
  • Re-intervention rate through 12 months §
  • Technical success rate ||

  Baseline Anatomical Characteristics

  (N = 70) — core lab mean measurements

  Mean measurements:

  1. Infrarenal diameter: 25.7 mm
  2. Neck calcium thickness: 1.31 mm
  3. Infrarenal angulation: 20.6°
  4. Nick Length (Core lab reported): 6.9 mm. Neck Length (Site reported): 12.1mm
  5. Neck thrombus thickness: 0.85 mm
  6. Aneurysm diameter: 57.7 mm

  

  number of 148 minutes procedure duration of the ANCHOR Registry short neck cohort" />

  

  

  

  SUCCESSFUL INITIAL IMPLANT PROCEDURES

  Overall procedural success: 97.1% (68/70)

  Two investigator-reported cases of unsuccessful procedures: 1) failure to deliver the main body endograft to intended landing zone, 2) persistent Type Ia endoleak.

  Successful and accurate deployment of EndoAnchor implants: 92.9% (65/70)

  There were 4 cases where the investigator assessed that one EndoAnchor™ implant did not penetrate the aortic wall and 1 case of unsuccessful implantation of EndoAnchor™ implants.

  Technical success: 88.6% (62/70)

  FAVOURABLE 1- AND 2-YEAR OUTCOMES

  Type Ia Endoleak ¶

  Type Ia-related Secondary Endovascular Procedures #

  IMPROVED SAC REGRESSION

  Heli-FX EndoAnchor Implants Used with Endurant Stent Graft Promote AAA Sac Regression **

  AAA Sac Diameter Changes — Core Lab
  

  1-year, N = 52

  • 0% Expansion
  • 44% Regression
  • 56% Stable

  

  2-year, N = 34

  • 0% Expansion
  • 65% Regression
  • 35% Stable

  

  Resources

  Arko FR 3rd, Stanley GA, Pearce BJ, et al. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. Published online March 5, 2019.

  Neck length measured as: Proximal neck length. Proximal neck length is defined as the non-aneurysmal aortic neck length measured from the lowest main renal artery to where the dilatation of the aneurysm begins (i.e., less than 10% increase from the diameter at the lowest renal artery).

  AAA neck length ≥ 4 mm and < 10 mm.

  Data on file as of April 2017.

  Re-interventions are defined as any endovascular or surgical procedure performed following the completion of the operative initial implantation procedure (thus on subsequent occasion after final closure of the last artery access site) which involves the targeted vascular segment treated by the Endurant™ stent graft system, including access sites and bypasses of the targeted vascular segment in which there is either manipulation of the implanted Endurant™ stent graft, or implantation or usage of additional devices.

  Technical success defined as: successful delivery and deployment of the endograft and each EndoAnchor™ implant without unintentional coverage of the renal arteries.

  As measured by core lab.

  One patient received an additional graft extension and sac embolisation to treat a Type Ia endoleak on day 9, which resolved.

  AAA diameter increase is defined as > 5 mm increase in maximum diameter measured at 1 year as compared to 1 month post-implantation measurement. AAA diameter decrease is defined as a > 5 mm decrease in maximum diameter at 1 year as compared to a 1 month post-implantation measurement.

  The short neck indication is indicated for necks < 10 mm down to 4 mm.

  All indications related to Endurant™ II/IIs Stent Graft System + Heli-FX™ EndoAnchor™ System Short Neck Indication are not approved globally. Please check your local regulatory approval status. Refer to the complete Instructions for Use manual of the Endurant II/IIs stent graft system for the indication for use approved in your geography.

  For complete product and risk information, visit manuals.medtronic.com. Consult instructions for use at this website. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat Reader with the browser.

  Adobe and Acrobat reader are registered trademarks of Adobe Systems incorporated in the United States and/or other countries.