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37th Annual VEITH Symposium 2010       Contemporary One year EVAR Outcomes from the US IDE trial and ENGAGE Global Registr...
The Bifurcated Endurant EndoGraft             Description   Modular Stent-Graft   Multi-filament Polyester Fabric   Ele...
The Bifurcated Endurant EndoGraft                   M-shaped proximal stent:                    good neck conformability ...
Endurant Delivery System Accurate stepwise proximal deployment of the stentgraft Controlled release of the suprarenal an...
Endurant Radio-Opaque Markers                “e” marker assists with A/P view                and identifies contralateral ...
Endurant Delivery System    Allows for Slow Deliberateand Accurate Proximal Deployment
The Endurant EndoGraft                 Main Body Iliac LimbsGraft Size         23-36      10-28Vessel treated     19-32   ...
The Endurant US Regulatory Study Non Randomized, Multi-center study 26 sites: Both Academic and Community Hospitals 150...
The Endurant US Regulatory Study                Selected Inclusion Criteria AAA ≥ 5 cm Neck length ≥ 10 mm Neck angulat...
The Endurant US Regulatory Study                          DemographicsAge              Mean     SD                  73.1  ...
The Endurant US Regulatory Study                          DemographicsCo-Morbidities   Hyperlipidemia              85.3% (...
The Endurant US Regulatory Study                        ProcedureMax AAA Size           Mean ± SD       57 mm ± 8.3Duratio...
The Endurant US Regulatory Study                    30 Day Results   Mortality                        0% Major Adverse E...
The Endurant US Regulatory Study                Left Limb occlusion:                     Limb folded                 or ex...
The Endurant US Regulatory StudyLongRx: Fem-FemNarrowNeck              Distal Neck 15mm   Right EIA 4 mm                  ...
The Endurant US Regulatory Study                     30 Day Results   Any Adverse Event                 28.7% (43/150)   ...
The Endurant US Regulatory Study                        Follow-up   Schedule: 1, 6 and 12 months   Six Deaths during fir...
The Endurant US Regulatory Study                  Imaging Follow-up Schedule: 1, 6 and 12 months    CT with and without ...
The Endurant US Regulatory Study           Imaging: Endoleaks during Follow-upEndoleaks         1 Month      6 Months     ...
The Endurant US Regulatory Study            Imaging: Size Changes Size Changes ≥ 5mm considered significant  1 Month      ...
The Endurant US Regulatory Study             Imaging: Size ChangesChange in Max AAA Diameter from 1 - 12 MonthsIncrease   ...
The Endurant US Regulatory Study                    Follow-up   No Fractutres No Migration No post-op Ruptures No Conv...
The Endurant US Regulatory Study               Re-interventions up to one Year Time             Indication                ...
The Endurant Endograft                Summary and Conclusions   Results up to one year with the Endurant Endograft    are...
ENGAGE OverviewENGAGE is a worldwide prospective registry of Post-market use of       the ENDURANT endograft in the treatm...
ENGAGE Interim Analysis       Acute Procedural Data for first 839 Patients EnrolledBaseline CharacteristicsAAA Size > 50mm...
Aha endurant veith 2010
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Aha endurant veith 2010

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Aha endurant veith 2010

  1. 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 Pittsburghfor the US Endurant Pivotal Trial Investigators
  2. 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. 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. 4. Endurant Delivery System Accurate stepwise proximal deployment of the stentgraft Controlled release of the suprarenal anchoring pins
  5. 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. 6. Endurant Delivery System Allows for Slow Deliberateand Accurate Proximal Deployment
  7. 7. The Endurant EndoGraft Main Body Iliac LimbsGraft Size 23-36 10-28Vessel treated 19-32 8-25Profile 18 or 20 14 or 16
  8. 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. 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. 10. The Endurant US Regulatory Study DemographicsAge Mean SD 73.1 8.0Gender 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. 11. The Endurant US Regulatory Study DemographicsCo-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. 12. The Endurant US Regulatory Study ProcedureMax AAA Size Mean ± SD 57 mm ± 8.3Duration (min) Mean ± SD 101.5 ± 46.2General Anesthesia % 83.3% (125/150)Blood loss (cc) Mean ± SD 184.9 ± 167.9Blood Transfusion % 0.7% (1/150)Hospital Stay (days) Mean ± SD 2.1 ± 2.3Successful Deployment 99.3% (149/150) One AAA ruptured during the procedure which was still completed successfully
  13. 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. 14. The Endurant US Regulatory Study Left Limb occlusion: Limb folded or extension poorlyPre-op: Severely angulatedin iliac expanded and kinked left common Iliac artery kink.
  15. 15. The Endurant US Regulatory StudyLongRx: Fem-FemNarrowNeck Distal Neck 15mm Right EIA 4 mm CT on Day 20 Compressed and Occluded R Limb
  16. 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. 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. 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. 19. The Endurant US Regulatory Study Imaging: Endoleaks during Follow-upEndoleaks 1 Month 6 Months 12 Month N=143 N=129 N=130Type 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 withany endoleak 16.1% (23) 11.6% (15) 10.0% (13)
  20. 20. The Endurant US Regulatory Study Imaging: Size Changes Size Changes ≥ 5mm considered significant 1 Month 6 Months 53mm 37mm
  21. 21. The Endurant US Regulatory Study Imaging: Size ChangesChange in Max AAA Diameter from 1 - 12 MonthsIncrease 0.0% (0/136)Stable 52.9% (72/136)Decrease 47.1% (64/136)
  22. 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. 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. 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. 25. 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
  26. 26. ENGAGE Interim Analysis Acute Procedural Data for first 839 Patients EnrolledBaseline CharacteristicsAAA Size > 50mm 88.2%Proximal Neck Length 27.8 mm + 13.4 Length < 15 mm 18.1%Procedural DataDeployment 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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