Treating very short necks ( 4mm <10mm) using the Endurant stent graft + EndoAnchors: 1-year results and current insights
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1 Treating very short necks ( 4mm <10mm) using the Endurant stent graft + EndoAnchors: 1-year results and current insights G Pratesi, MD Vascular Surgery University of Rome Tor Vergata
2 Disclosure Giovanni Pratesi, M.D. I have the following potential conflicts of interest to report: Consulting: Abbott, Bolton, Cook, Cordis, Medtronic, WL Gore Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Defining the challenging proximal aortic neck Short (< 10 mm) Wide (>30 mm) Angulated (>60 ) Conical Thrombus Calcification
4 A significantly higher rate of type I endoleaks within 30 days was seen in Challenging (CHA) compared with Regular (REG) and Intermediate (INT) Broos PP et al., J Vasc Surg 2015
5 Treating very short necks with standard EVAR
6 Treating very short necks with standard EVAR Urgent 21 m
7 Endovascular fixation: Heli-FX System 3 mm Cross Bar 1.0 mm 3.5 mm
8 Why a prophylactic use of Heli-Fx endoanchors? Standard procedure No additional access/techniques required Infrarenal sealing is maintained Visceral vessels are not involved Does not prevent any future option (ChEVAR, fevar)
9 J Vasc Surg 2014
10 ANCHOR Registry Capturing Real-World Usage 670 pts ANCHOR REGISTRY 487 pts PRIMARY ARM 183 pts REVISION ARM EndoAnchor implants placed during Index procedure either prophylactically or to treat an intra-operative type Ia endoleak.
11 ANCHOR Registry: Primary Use in Index Setting Kaplan-Meier Estimates 12 months 24 months Freedom from ACM 94.7% (466) 88.5% (367) Freedom from ARM 98.5% (466) 98.5% (367) Freedom from Rupture 100.0% (466) 100.0% (367) Freedom from 2 nd Procedures 95.8% (459) 93.3% (352)
12 ANCHOR Registry: Primary Use in Index Setting Core Lab 12 months 24 months Type 1a Endoleak 1.0% (3/292) 1.3% (2/159) Endograft Migration 0.0% (0/203) 0.0% (0/87) Core Lab 12 months 24 months AAA sac increase 1.7% (5/289) 2.5% (4/159) AAA sac decrease 45.7% (132/289) 59.1% (94/159) AAA sac stable 52.6% (152/289) 38.4% (61/159)
13 Endurant + Endoanchors in short aortic neck
14 Endurant + Endoanchors in short aortic neck
15 Endurant + Endoanchors in short aortic neck
16 Endurant + Endoanchors in short aortic neck
17 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Anchor Registry Patients Primary Revision Endurant Stent Graft Other Brands 70 Patients with Hostile Necks (length 4 mm and < 10 mm)
18 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Baseline Anatomical Characteristics* (N=70) Core Lab Infrarenal Diameter: 25.7 mm Neck Length: 6.86 mm ( mm) Avg Neck Calcium Thickness: 1.31 mm Avg Neck Calcium Thickness: 0.85 mm Infrarenal Angulation: 20.6 Aneurysm Diameter: 57.7 mm
19 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Concern for late failure 56% Treatment of type Ia endoleak 21% Prevention of neck dilatation 23% 84% (59/70) received a 28mm Endurant graft
20 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Technical Success*: 88.6% (62/70) *defined as deployment of the desired number of EndoAnchor(TM) Implants, adequate penetration of the vessel wall, and absence of EndoAnchor fracture Procedural Success**: 97.1% (68/70) **defined as technical success without a type Ia endoleak at completion angiography Avg. duration of Procedure (min) Avg. time to EndoAnchor implant (min) Avg. Fluoro time (min) Avg. number of EndoAnchor implants
21 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Core Lab 1 month 12 months Type 1a Endoleak 6.8% (4/59) 1.9% (1/53) Endograft Migration N/A 0.0% (0/41) 2 nd Endo Procedure 4.3% (3/70) 4.7% (3/64)
22 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Kaplan-Meier Estimates 12 months Freedom from ACM 92.7% Freedom from ARM 94.3% Freedom from 2 nd Procedures 95.4% Freedom from rupture 100%
23 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Adverse Events through 12 months Patients with Events EndoAnchor Implant-Related SAE 0 0.0% Aneurysm Rupture 0 0.0% AAA-Related Mortality 4 5.9% Open Surgical Conversion 0 0.0%
24 ANCHOR Registry Hostile Neck Cohort Endurant + Heli-Fx short neck cohort (N=70) Aneurysm sac at 12 months Core Lab 12 months AAA sac decrease 42.6% (1/53) AAA sac stable 57.4% (0/41) AAA sac increase 0.0% (3/64)
25 Short Neck Indication: Endurant with Heli-FX Endoanchors Proximal neck length <10 mm down to 4 mm Endurant + Heli-FX indication validation In vitro bench studies Simulated use Seal testing Finite element analysis 10mm X Ø (19-32 mm) 4 mm min neck Neck Length definition: 10% diameter increase FDA and CE approved/indicated
26 Conclusion Endurant + HeliFx Endoanchors demonstrated to be a safe approach through 1-year in challenging patients with proximal neck between 4 and 10 mm Proper procedural technique is critical to clinical success HeliFx Endoanchors represent a complimentary treatment option still under investigation for long-term durability
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28 Treating very short necks ( 4mm <10mm) using the Endurant stent graft + EndoAnchors: 1-year results and current insights G Pratesi, MD Vascular Surgery University of Rome Tor Vergata
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