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1. 37th Annual VEITH Symposium 2010
Contemporary One year
EVAR Outcomes from the US IDE trial
and ENGAGE Global Registry of the
Endurant AAA Endograft Device
Michel S. Makaroun MD
Division of Vascular Surgery
University of Pittsburgh
for the US Endurant Pivotal Trial Investigators

2. The Bifurcated Endurant EndoGraft
Description
 Modular Stent-Graft
 Multi-filament Polyester Fabric
 Electropolished Nitinol Stent
 Active Suprarenal fixation
 3 cm Overlap Zone
 Pt-Ir and Gold Markers
Endurant

3. The Bifurcated Endurant EndoGraft
 M-shaped proximal stent:
good neck conformability
 Limb stent geometry
designed for flexibility
 One-piece, laser-
cut, Nitinol suprarenal
stent with anchoring pins

4. Endurant Delivery System
 Accurate stepwise proximal deployment of the stentgraft
 Controlled release of the suprarenal anchoring pins

5. Endurant Radio-Opaque Markers
“e” marker assists with A/P view
and identifies contralateral gate
Flow divider marker for accurate
contralateral limb placement
Contralateral gate ring marker
assists with cannulation

6. Endurant Delivery System
Allows for Slow Deliberate
and Accurate Proximal Deployment

7. The Endurant EndoGraft
Main Body Iliac Limbs
Graft Size 23-36 10-28
Vessel treated 19-32 8-25
Profile 18 or 20 14 or 16

8. The Endurant US Regulatory Study
 Non Randomized, Multi-center study
 26 sites: Both Academic and Community Hospitals
 150 patients
 April 2008 to May 2009
 One year follow-up visits completed
 All Imaging reviewed by a Core Lab (M2S)
 Clinical Events Committee (CEC) adjudicated
all untoward events

9. The Endurant US Regulatory Study
Selected Inclusion Criteria
 AAA ≥ 5 cm
 Neck length ≥ 10 mm
 Neck angulation ≤ 60 degrees
 Iliac Fixation length ≥ 15 mm
 Suitable Access
Endpoints
 Safety endpoint: MAE rate @ 30 days
 Effectiveness endpoint: Composite of Technical and
Clinical Success of AAA Rx @ 1 year

10. The Endurant US Regulatory Study
Demographics
Age Mean SD 73.1 8.0
Gender Male 91% (137/150)
Co-Morbidities Congestive heart failure 16% (24/150)
Angina 18% (27/150)
Myocardial infarction 30% (45/150)
Coronary Disease 60% (90/150)
PVD 22.7% (34/150)
Renal insufficiency 11.3% (17/150)
COPD 35.3% (53/150)
Diabetes 26.7% (40/150)

11. The Endurant US Regulatory Study
Demographics
Co-Morbidities Hyperlipidemia 85.3% (128/150)
Carotid Artery Disease 20.7% (31/150)
Stroke 8.7% (13/150)
Arrhytmias 39.3% (59/150)
Hypertension 86.7% (130/150)
Liver disease 2% (3/150)
Tobacco use last 10 years 44% (66/150)
Family History of AAA 19.3% (29/150)

12. The Endurant US Regulatory Study
Procedure
Max AAA Size Mean ± SD 57 mm ± 8.3
Duration (min) Mean ± SD 101.5 ± 46.2
General Anesthesia % 83.3% (125/150)
Blood loss (cc) Mean ± SD 184.9 ± 167.9
Blood Transfusion % 0.7% (1/150)
Hospital Stay (days) Mean ± SD 2.1 ± 2.3
Successful Deployment 99.3% (149/150)
One AAA ruptured during the procedure
which was still completed successfully

13. The Endurant US Regulatory Study
30 Day Results
 Mortality 0%
 Major Adverse Event (MAE) 4.0% (6/150)
Myocardial Infarction 0.7% (1/150)
Renal Failure 0.7% (1/150)
Respiratory Failure 1.3% (2/150)
Stroke 0.7% (1/150)
Bowel Ischemia 1.3% (2/150)
Procedural Blood Loss ≥ 1000cc 0.7% (1/150)
 Two patients had limb occlusions on day 1 and day 20

14. The Endurant US Regulatory Study
Left Limb occlusion:
Limb folded
or extension poorly
Pre-op: Severely angulatedin iliac
expanded and kinked left common Iliac
artery kink.

15. The Endurant US Regulatory Study
Long
Rx: Fem-Fem
Narrow
Neck
Distal Neck 15mm Right EIA 4 mm
CT on Day 20
Compressed and Occluded R Limb

16. The Endurant US Regulatory Study
30 Day Results
 Any Adverse Event 28.7% (43/150)
Pulmonary Complications 3.3% (5/150)
Renal Complications 2.0% (3/150)
CHF 2.0% (3/150)
Fever 6.0% (9/150)
Urologic 4.7% (7/150)
Wound Complications 0.7% (1/150)
Arterial Events 4.0% (6/150)

17. The Endurant US Regulatory Study
Follow-up
 Schedule: 1, 6 and 12 months
 Six Deaths during first year. None AAA related (CEC)
Primary Cause of Death Days from Implant
Stroke 90
COPD 128
Pulmonary fibrosis 215
Lung cancer 267
Multiple organ/system failure 280
Metastatic bladder cancer 320
Lung cancer 458

18. The Endurant US Regulatory Study
Imaging Follow-up
 Schedule: 1, 6 and 12 months
 CT with and without contrast
 4 views Abdominal X-rays
 All imaging reviewed by Core lab
 Patients with elevated Cr had non contrast CT with
ultrasound duplex or MRA
 127 patients have completed 12 month FU imaging

19. The Endurant US Regulatory Study
Imaging: Endoleaks during Follow-up
Endoleaks 1 Month 6 Months 12 Month
N=143 N=129 N=130
Type I 0.0% (0) 0.0% (0) 0.0% (0)
Type II 16.1% (23) 11.6% (15) 9.2% (12)
Type III 0.0% (0) 0.0% (0) 0.0% (0)
Indeterminate 0.0% (0) 0.0% (0) 0.8% (1)
Subjects with
any endoleak 16.1% (23) 11.6% (15) 10.0% (13)

20. The Endurant US Regulatory Study
Imaging: Size Changes
Size Changes ≥ 5mm considered significant
1 Month 6 Months
53mm 37mm

21. The Endurant US Regulatory Study
Imaging: Size Changes
Change in Max AAA Diameter from 1 - 12 Months
Increase 0.0% (0/136)
Stable 52.9% (72/136)
Decrease 47.1% (64/136)

22. The Endurant US Regulatory Study
Follow-up
 No Fractutres
 No Migration
 No post-op Ruptures
 No Conversion to Open Repair
 Limb Compromise from external compression:
 2 Additional Limb Occlusions
 1 Stenosis

23. The Endurant US Regulatory Study
Re-interventions up to one Year
Time Indication Procedure Performed
(Days)
0 Femoral occlusion Endarterectomy
0 Undeployed stent in femoral Retrieval of stent
1 External iliac dissection Repair with patch angioplasty
1 Limb graft occlusion Thromboembolectomy and stenting
20 Limb graft occlusion Fem-fem bypass
49 Limb graft occlusion Thrombolysis with stenting
57 Limb graft occlusion Thromboembolectomy and stenting
217 Type II endoleak Cyanobutylacrylate glue
231 Type II Endoleak Coil embolization
304 Limb stenosis PTA with stenting

24. The Endurant Endograft
Summary and Conclusions
 Results up to one year with the Endurant Endograft
are quite encouraging
 The Endurant Endograft appears to be a Safe and
Effective new device for the management of AAA

25. ENGAGE Overview
ENGAGE is a worldwide prospective registry of Post-market use of
the ENDURANT endograft in the treatment of AAA
Study Plan
 Enrollment: 1200 patients at 80 sites worldwide (5 year FU)
 Primary endpoint: Treatment success at 12 months
 Oversight: Executive committee (7 Investigators)
Study Purpose
 Prospectively collect global ‘real life’ data
 Real world patients
 Minimal Inclusion / Exclusion Criteria
 Real-world practice
 Patients are followed per institution standard practices

26. ENGAGE Interim Analysis
Acute Procedural Data for first 839 Patients Enrolled
Baseline Characteristics
AAA Size > 50mm 88.2%
Proximal Neck
Length 27.8 mm + 13.4
Length < 15 mm 18.1%
Procedural Data
Deployment Success 99.6%
Implant Duration 90 min (20-300)
General Anesthesia 63.3%
Length of Stay 5 days (0.5 – 217)
* As of 05 October 2010