aha: endurant veith 2010
TRANSCRIPT
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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
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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
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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
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Endurant Delivery System
Accurate stepwise proximal deployment of the stentgraft Controlled release of the suprarenal anchoring pins
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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
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Allows for Slow Deliberate and Accurate Proximal Deployment
Endurant Delivery System
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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
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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
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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
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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
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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
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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
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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
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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.
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The Endurant US Regulatory StudyLongNarrowNeck
Distal Neck 15mm Right EIA 4 mm
Compressed and Occluded R Limb
CT on Day 20
Rx: Fem-Fem
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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)
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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
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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
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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
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Imaging: Size Changes
Size Changes ≥ 5mm considered significant
1 Month 6 Months53mm 37mm
The Endurant US Regulatory Study
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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)
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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
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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
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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
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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
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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
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