Contemporary One year EVAR Outcomes from the US IDE trial

and ENGAGE Global Registry of the Endurant AAA Endograft Device

Michel S. Makaroun MDDivision of Vascular Surgery

University of Pittsburghfor the US Endurant Pivotal Trial Investigators

37th Annual VEITH Symposium 2010

The Bifurcated Endurant EndoGraft

Endurant

Description

Modular Stent-Graft Multi-filament Polyester Fabric Electropolished Nitinol Stent Active Suprarenal fixation 3 cm Overlap Zone Pt-Ir and Gold Markers

M-shaped proximal stent: good neck conformability

Limb stent geometry designed for flexibility

One-piece, laser-cut, Nitinol suprarenal stent with anchoring pins

The Bifurcated Endurant EndoGraft

Endurant Delivery System

Accurate stepwise proximal deployment of the stentgraft Controlled release of the suprarenal anchoring pins

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

Allows for Slow Deliberate and Accurate Proximal Deployment

Endurant Delivery System

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

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

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

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)

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)

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

The Endurant US Regulatory Study

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

The Endurant US Regulatory Study

Pre-op: Severely angulated and kinked left common Iliac

Left Limb occlusion: Limb folded

or extension poorly expanded in iliac

artery kink.

The Endurant US Regulatory StudyLongNarrowNeck

Distal Neck 15mm Right EIA 4 mm

Compressed and Occluded R Limb

CT on Day 20

Rx: Fem-Fem

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)

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 ImplantStroke 90COPD 128Pulmonary fibrosis 215Lung cancer 267Multiple organ/system failure 280Metastatic bladder cancer 320

Lung cancer 458

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

Imaging: Endoleaks during Follow-up

Endoleaks 1 Month 6 Months 12 MonthN=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)

The Endurant US Regulatory Study

Imaging: Size Changes

Size Changes ≥ 5mm considered significant

1 Month 6 Months53mm 37mm

The Endurant US Regulatory Study

Imaging: Size Changes

The Endurant US Regulatory Study

Change in Max AAA Diameter from 1 - 12 Months

Increase 0.0% (0/136)

Stable 52.9% (72/136)

Decrease 47.1% (64/136)

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

Re-interventions up to one Year

The Endurant US Regulatory Study

Time (Days) Indication Procedure Performed

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

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

ENGAGE OverviewENGAGE 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

ENGAGE Interim AnalysisAcute 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