REAL WORLD OUTCOMES WITH ENDOANCHORS

Daniel Clair, MD

Chairman, Department of Surgery

The Four Horsemen of Vulnerable Aorta

Calcification

IrregularityThrombus

Tortuosity

Challenging Proximal Necks

3

Short Neck Tortuous Neck

IMPLICATIONS OF ADJUNCTS

• 553 pts over 8 years (2001-2009)

• Trying to determine causes for reinterventions

• 86 reinterventions (15% at 3 years)

• Intra-operative adjuncts were an independent risk factor for

reinterventions

• HR – 2.62 (1.18-3.76)

More Disclosures

• I think Alexis Carrel had it right we he

introduced the interrupted suture as the

foundation of vascular anastomosis

• I’m biased towards technologies that have

been repeatedly proven for over 100 years

Principles of Open Surgery

• Deep suture bites in normal tissue with permanent suture material• Ligate all tributaries• Flexible fabric

prostheses

Lost in Translation- Different Language

• Device based EVAR fixation & seal

• Distributed (length, angle, shape, disease of neck)

• Not measurable

• Unpredictable

• Unverifiable

• Little control of outcome

• Suture based fixation & seal

• Focused…at site of suture

• Independent of length, angle, shape, disease

• Measurable

• Verifiable – CT exam of adventitia penetration / X-ray

• Increased control of outcome

Endovascular Interrupted Suture System

Heli-FX EndoAnchor Implant System

Six EndoStaples surpasses hand sutured anastomosis fixation

Increase in fixation is proportional to the number of EndoStaples

EndoStaple fixation sometimes outweighs the stent grafts’ integrity

Aortic transectionGraft disruption

Best endograft alone fixation

Average 325% increase

Anastomotic Strength Approximate Ranges

0

20

40

60

80

100

120

140

Endograft Hand Suture Endoanchor

Endograft

= stent graft pledgeted suture

Patients with Proximal Neck lengths < 12mm: 17%

Patients with Proximal Neck lengths < 10mm: 12%

Proximal Neck Zone

Type I Endoleaks*0%

STAPLE 2: Aptus IDE trial42 patients ≤ 15 mm neck length

3

15

24

36

1921

13 12

7

2 3 510152025303540

Cou

nt

0 10 20 30 40 50

100.0%99.5%97.5%90.0%75.0%50.0%25.0%10.0%2.5%0.5%0.0%

maximum

quartilemedianquartile

minimum

5050

48.238.94

2919.9

148.64.9

22

QuantilesMeanStd DevStd Err MeanUpper 95% MeanLower 95% MeanN

22.20258111.0530770.887804523.95642820.448733

155

MomentsM2S AAA Proximal neck Length (mm) - Length between Prox End Diameter and Dist End Diameter

<10N pull-out alone

No Late Term Type 1 Endoleaks

Endoleak Evaluation by Core LabEndoleak Type 30 day F/U

% (n/N)6 mo F/U% (n/N)

1 year F/U% (n/N)

2 year F/U% (n/N)

3 year F/U % (n/N)

4 year F/U % (n/N)

5 year F/U % (n/N)

Type-I0%

(0/149)

0%

(0/141)

0%

(0/132)

0%

(0/107)

0%

(0/81)

0%

(0/64)

0%

(0/62)

• No EndoAnchor Displacement or Fracture in 5yrs F/U

Time from Procedure to Proximal Neck-Related Reintervention

• 3 secondary interventions undertaken in 2 patients to address proximal neck issues

151 145 136 122 106 85 68

0 500 1000 1500 2000

Time in Days

0.0

0.2

0.4

0.6

0.8

1.0

Surviv

al Prob

ability

At Risk

Censored

Product-Limit Survival Estimatewith Number of Subjects at Risk

151 145 136 122 106 85 68

0 500 1000 1500 2000

Time in Days

0.0

0.2

0.4

0.6

0.8

1.0

Surviv

al Prob

ability

At Risk

Censored

Product-Limit Survival Estimatewith Number of Subjects at Risk

Endurant + Heli-FX Short Neck Indication

• <10mm down to 4mm length*

• 19 – 32mm diameters

• ≤ 60˚ infrarenal angulation

• Femoral-only approach

• No renal instrumentation

• Off-the-shelf

• 18 – 20 Fr OD

* Core Lab defined neck length: length over which neck diameter remains within 10% of infrarenal diameter

Short AAA Neck IndicationEndurant™ II, IIs stent graft with Heli-FX™ implants

Neck Length:<10mm down to 4 mm

Neck Length Definition:Length over which the aortic

diameter remains within 10%

of the infrarenal diameter

Proximal Neck Diameter:

19 to 32 mm

Infrarenal Angulation: ≤60 degrees

Infrarenal

Diameter:

25.7 mm

Infrarenal

Angulation:

20.6°

Neck Length:

6.86 mm

Aneurysm

Diameter:

57.7 mm

Avg Neck

Calcium

Thickness:

1.31 mm

Avg Neck

Thrombus

Thickness:

0.85 mm

Endurant + Heli-FX Short Neck Cohort (N=70)

Clinical EvaluationANCHOR Registry Short Neck Cohort

Anchor Registry

Patients

Primary Revision

Endurant

Stent Graft

Other

Devices

70 Endurant Patients with Short Necks

(<10 mm down to 4 mm)

Baseline Anatomical Characteristics per Core Lab

Infrarenal

Diameter:

25.7 mm

Infrarenal

Angulation:

20.6°

Neck Length:

6.86 mm

Aneurysm

Diameter:

57.7 mm

Avg Neck

Calcium

Thickness:

1.31 mm

Avg Neck

Thrombus

Thickness:

0.85 mm

Endurant + Heli-FX Short Neck Cohort (N=70)

Baseline Anatomical Characteristics per Core Lab

93% ASA Class III/IV

26% ASA Class IV

17% Symptomatic presentation

Increased risk of morbidity/mortality

31% Urgent/Emergent cases

Require an off-the-shelf solution

Mean Age: 71.3 Years

Male: 73% Female: 27%

§Technical Success: 88.6% (62/70)

§Procedural Success: 97.1% (68/70)

1 month 12 months

Type 1a Endoleak 6.8% (4/59) 1.9% (1/53)

Endograft Migration N/A 0.0% (0/41)

2nd

Endo Procedure 2.9% (2/70) 4.7% ( 3/64)*

Aneurysm Expansion at 12 months N=54

Decrease 43%

Increase 0%

Stable 57%

Avg. duration

of Procedure (min)

148

Avg. time to implant

(min)

17

Avg. Fluoro time

(min)

35

Avg. number of

EndoAnchor implants

5.5

1-Year Outcomes

* 1.6% (N=1) 2nd Procedure to treat proximal neck

Endurant + Heli-FX Short Neck Cohort (N=70)

Adverse Events through 12 months Patients with EventsEndoAnchor Implant-Related SAE 0/70 0.0%

AAA-Related Mortality 4/68 5.9%

Open Surgical Conversion 0/64 0.0%

Kaplan-Meier Estimates 12 months Freedom from ACM 92.7%

Freedom from ARM 94.3%

Freedom from 2nd

Procedures 95.4%

Freedom from rupture 100%

1-Year Outcomes

Endurant + Heli-FX Short Neck Cohort (N=70)

ENDOANCHORS

• 99 Propensity score matched pairs with and without anchors

• Scoring matched by 19 anatomic measurements

• Outcomes assessed at 2 years

• Freedom from Type Ia endoleak 97.4% vs 94%

• Sac Regression in 81% anchor vs 49% no anchor

• Control subjects with wide neck or neck thrombus had lower

sac shrinkage – No difference for anchor patients

• Each added hostile neck criteria = 23% reduction in sac

shrinkage

In a propensity-matched study design, significantly greater AAA

regression at 2 years post-EVAR

EndoAnchor™+EVAR81.1% ± 9.5%

P-value = 0.01

EVAR48.7% ± 5.9%

Methodology§Pre-EVAR CTs by core lab

§Neck lengths >20 mm

§2 cohorts:

•99pts EVAR

•99pts EVAR+EndoAnchor

§Propensity matching on

19 variables

EndoAnchor & Proximal Seal –Impact on sac regression

Muhs, BE et al. J Vasc Surg. 2017, Article in press

ENDOANCHORS

• ANCHOR Registry

• 100 patients / mean f/u 13 mos

• Primary 73/ revision 27

• 83% hostile neck (>27mm; <10mm; >60 degrees)

• Freedom from Type Ia endoleak 95% (primary) and 77%

(revision)

• Sac shrinkage >5mm in 45% primary and 25% revision

• 1 patient with sac growth

J Vasc Surg. 2014;60:885–892.e2.

HeliFX in Short Angulated Neck -2011

Axial slice at L renal / lowest

HeliFX in Short Angulated Neck

Pre-Op 1 Month 1 Year

• T2 resolved spontaneously

• Massive AAA shrinkage

• Proximal neck “grows”…more proximal apposition

Limitations of Endoanchors

• Poor surgical technique

• Failure to penetrate adventitia

• Less than 4 endoanchors

• Poor distribution

• Smaller targets(short necks) require

more technical expertise

• Tissue integrity - the limit of all

surgical reconstruction

Cross Bar

3

mm

1.0 mm

3.5 mm

Bottom Line• Endoanchors

• Creates “surgical grade” anastomotic strength and

sealing

• Independent of many variables that limit endograft

fixation and seal

• Resist radial expansion - “radial fixation”

• Easy technique

• Widely and rapidly available (1 item on shelf)

• Verifiable on X-ray and CT

• Reimbursed

CONCLUSION

• Adjuncts allow treatment acutely of problem neck

anatomic variable

• Long-term, all patients who “require” adjuncts have

increased need for reintervention

• Anchors may provide benefit in non-hostile necks

by increasing sac shrinkage rates

• Anchors may provide benefit in hostile necks - at

least early – by reducing the impact of these

unfavorable anatomic characteristics