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.
Medtronic offers the first ESAR with EndoAnchor fixation for patients with short aortic necks.†
Clinical outcomes
ANCHOR short neck one-year and two-year clinical results support the use of Endurant II/IIs system + Heli-FX EndoAnchor system in short aortic necks†
- 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.
- Primary Outcomes:
- 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||
- Secondary Outcomes: Index procedure outcomes, device-related events, safety- and effectiveness-related measures
Baseline Anatomical Characteristics
(N = 70) — core lab mean measurements
Mean measurements:
- Infrarenal diameter: 25.7 mm
- Neck calcium thickness: 1.31 mm
- Infrarenal angulation: 20.6°
- Nick Length (Core lab reported): 6.9 mm. Neck Length (Site reported): 12.1mm
- Neck thrombus thickness: 0.85 mm
- Aneurysm diameter: 57.7 mm
148 min: Procedure Duration
17 min: Time for EndoAnchor Implant
35 min: Fluoro Time
5.5: Average Number of EndoAnchor Implants
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)
Favorable 1- and 2-year outcomes
| 1-year | 2-year | |
|---|---|---|
| 2.0% (1/49) |
0.0% (0/32) |
Type Ia Endoleak¶ |
| 1.4% (1/70) |
1.6% (1/63) |
Type Ia-related Secondary Endovascular Procedures# |
| 0% (0/70) |
0% (0/63) |
Conversion to Open Surgical Repair |
| 0% (0/70) |
0% (0/63) |
AAA Rupture |
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
1
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.