Matt Thompson St Georges Vascular Institute, London, UK

EVAS FORWARD Global Registry Early Results in 300 Patients Treated with Nellix

Disclosures

Endologix – Research funding / Consultancy

PI – Global Registry

Endovascular Aortic Repair (EVAR) Challenges 1-4

!  Hostile Morphology –  Endoleaks

–  Migration

!  Reinterventions / Late Rupture

!  Ongoing Costs of Surveillance –  Financial Costs

–  Psychological Stress

–  Radiation / Contrast

1Schanzer A, et al. Circulation 2011;123:2848-55. 2Becquemin J-P, et al. J Vasc Surg 2011;53:1167-73. 3Lederle FA, et al. N Engl J Med 2012;367:1988-97. 4Karthikesalingam A, et al. Eur J Vasc Endovasc Surg 2013;46:440-45.

Endovascular Aneurysm Sealing (EVAS)

Nellix (EVAS) – a unique therapy !  New generation endovascular AAA therapy !  Designed to seal the entire aneurysm and overcome limitations with

conventional endografts !  Very limited evidence base

Study Design and Status

•  Enrollment completed September, 2014 (enrollment period 10 months)

•  Mean follow-up 165 days; range 0 to 1 year

Total Patients (n=300*)

Cohort 1 (n=190)

Cohort 2 (n=41)

Cohort 3 (n=31)

Cohort 4 (n=12)

26 (9%) CTs still in review

!  Principal Investigators –  Andrew Holden, MBChB, Auckland, NZ –  Matt Thompson, MD, London, UK

!  300 patients, 30 centers with five year follow-up !  Real-world experience; no prospective

screening of patients !  CT scan core lab analysis (Cleveland Clinic

Core Lab) !  Independent adverse events adjudication !  Primary outcomes typical of therapy

N=41 Neck Length 5 -10mm Infrarenal Angle 61 - 90°

Cohort Descriptions

N=190 Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

N=31 Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal / Pararenal

N=12 Ruptured AAA EVAR revisions

Cohort 1 69%

Cohort 2 15%

Cohort 3 11%

Cohort 4 5%

26 (9%) CTs still in review

16 Chimney Procedures

EVAS Forward Global Registry Includes Many More Complex AAAs than Other Studies

0%

5%

10%

15%

20%

Neck Length <10mm

Neck Angle >60°

Chimney Procedure

Rupture or EVAR Repair

17,0%

9,0%

5,7% 3,5%

2,2%

6,0%

0,1% 0,0% 1,5% 0,0% 0,5%

2,5%

EVAS Global Registry

ENGAGE Registry

GREAT Registry

8

Baseline Aneurysm and Vascular Characteristics

Parameter 1

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

2 Neck Length 5 -10mm Infrarenal Angle 61° - 90°

3 Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

Maximum Sac Diameter, mm 60 (55-65) 60 (56-66) 63 (58-71)

Neck Length, mm 27 (19-39) 10 (7-18) 5 (3-15)

Neck Diameter, mm 25 (23-28) 25 (22-27) 27 (22-29)

Neck Angulation° 29 (13-42) 44 (26-66) 34 (24-54)

Results are given as a median (25th, 75th %itle)

Procedural Characteristics

>60, ≤90 min

35%

>120 min

25%

96 95

120

60

80

100

120

140

160

Procedure Time (min)

11 12

18

5

10

15

20

25

30

35

Fluoroscopy Time (min)

Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3

p = NS p = 0.001

MAEs ≤30 days N=298

>30 days N=284

Patients with one or more MAE 3.0% 0.7%

All Cause Death 1.0% 1.1% Renal Failure 0.3% 0% Myocardial Infarction 0.7% 0.5% Bowel Ischemia 0% 0% Respiratory Failure 0.7% 0% Stroke 0.3% 0% Blood loss >1000 mL 1.4% 0.4%

Major Adverse Events

Mean follow-up 6 months

Endoleaks ≤30 days

Total N=289

Cohort 1 N=190

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

Cohort 2 N=41

Neck Length 5 -10mm Infrarenal Angle 61° - 90°

Cohort 3 N=31

Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

All Patients 6 (2.1%) 6 (3.2%) 0 0

Type IA 5 (1.7%) 5(2.6%) 0 0

Type IB 0 0 0 0 Type II 1

(0.3%) 1 (0.5%) 0 0

Type III 0 0 0 0 Type IV 0 0 0 0

•  Five (5) Type IA endoleaks attributed to malpositioning and/or under-filling •  Majority of Type 1A occurred during early learning curve •  One (1) Type II endoleaks show <0.2mL blood flow into aneurysm with no

clinical sequelae

26 (9%) CTs still in review

Endoleaks at 30 days

Total N=289

Cohort 1 N=190

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

Cohort 2 N=41

Neck Length 5 -10mm Infrarenal Angle 61° - 90°

Cohort 3 N=31

Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

All Patients 2 (0.7%) 2 (1.1%) 0 0

Type IA 1 (0.3%) 1 (0.5%) 0 0

Type IB 0 0 0 0 Type II 1

(0.3%) 1 (0.5%) 0 0

Type III 0 0 0 0 Type IV 0 0 0 0

•  One (1) Type II endoleak shows <0.2mL blood flow into aneurysm with no clinical sequelae

26 (9%) CTs still in review

Reinterventions and Conversions ≤30 days

Cause of reinterventions

Total N=289

Cohort 1 N=190

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

Cohort 2 N=41

Neck Length 5 -10mm Infrarenal Angle 61° - 90°

Cohort 3 N=31

Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

Endoleaks 3 (1.0%) 3 (1.6%) 0 0 Occlusions 3 (1.0%) 2 (1.1%) 1 (2.4%) 0 Conversion 1 (0.3%) 0 0 1 (3.2%) Other 4 (1.4%) 1 (0.5%) 3 (7.3%) 0

•  3 Type 1a EL and 3 occlusions successfully treated •  One intra-operative conversion •  “Others” include two renal stenting and one iliac extension

Reinterventions and Conversions > 30d

Cause of reinterventions

Total N=285

Cohort 1 N=188

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

Cohort 2 N=40

Neck Length 5 -10mm Infrarenal Angle 61° - 90°

Cohort 3 N=31

Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

Endoleaks 1 (0.4%) 1 (0.5%) 0 0 Occlusions 0 0 0 0 Conversion 1 (0.4%) 1 (0.5%) 0 0 Other 1 (0.4%) 1 (0.5%) 0 0

•  One Type IA endoleak at day 81 successfully treated •  One late conversion at day 120 •  One Ilio-fem bypass at day 32

Mean follow-up 6 months

Total N=285

Cohort 1 N=188

Neck Length ≥ 10mm Infrarenal Angle ≤ 60°

Cohort 2 N=40

Neck Length 5 -10mm Infrarenal Angle 61° - 90°

Cohort 3 N=30

Neck Length < 5mm Infrarenal Angle > 90° Juxtarenal - Pararenal

All Patients 3 (1.1%) 3 (1.6%) 0 0

Type IA 2 (0.7%) 2 (1.1%) 0 0 Type IB 0 0 0 0 Type II 1 (0.4%) 1 (0.5%) 0 0 Type III 0 0 0 0 Type IV 0 0 0 0

Total Endoleaks >30d

26 (9%) CTs still in review

•  Type IA endoleaks related to catheter malpositioning and/or under filling

Mean follow-up 6 months

Overall Endoleak Rates at 6 Months

17

•  EVAS Forward Global Registry: Mean follow-up 6 months •  1-year results shown for Aorfix and Incraft (6 month data not reported)

0,0%

5,0%

10,0%

15,0%

20,0%

25,0%

30,0%

35,0%

40,0%

45,0%

Nellix Registry

AFX Zenith IDE Endurant IDE Talent IDE Aorfix IDE Excluder

IDE Incraft CE Study Ovation

IDE Type IA, IB Type II Type III/IV Undetermined

1% 5%

9% 12% 14% 17% 20%

40% 42%

Conclusions

!  Very encouraging results in the 1st EVAS real-world, all-comers prospective registry –  Early experience underscores importance of training

and best procedural practices !  Low rates of endoleak and reintervention

despite treating a broad range of challenging anatomies across multiple cohorts

Matt Thompson St Georges Vascular Institute, London, UK

EVAS FORWARD Global Registry Early Results in 300 Patients Treated with Nellix