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37th Annual VEITH  Symposium 2010 <br />Contemporary One year    EVAR Outcomes from the US IDE trial and ENGAGE Global Reg...
The Bifurcated Endurant EndoGraft<br />Description<br />Modular Stent-Graft<br />Multi-filament Polyester Fabric<br />Elec...
The Bifurcated Endurant EndoGraft<br /><ul><li>M-shaped proximal stent: good neck conformability
Limb stent geometry designed for flexibility
One-piece, laser-cut, Nitinol suprarenal stent with anchoring pins</li></li></ul><li>Endurant Delivery System<br /><ul><li...
Controlled release of the suprarenal anchoring pins</li></li></ul><li>Endurant Radio-Opaque Markers<br />“e” marker assist...
Endurant Delivery System<br />Allows for Slow Deliberate <br />and Accurate Proximal Deployment<br />
The Endurant EndoGraft<br />
The Endurant US Regulatory Study<br /><ul><li>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</li></li></ul><li>The Endurant US Regulatory Stu...
Neck length ≥ 10 mm
Neck angulation ≤ 60 degrees
Iliac Fixation length ≥ 15 mm
Suitable Access</li></ul>Endpoints<br /><ul><li>Safety endpoint: MAE rate @ 30 days
Effectiveness endpoint: Composite of Technical and Clinical Success of AAA Rx @ 1 year</li></li></ul><li>The Endurant US R...
The Endurant US Regulatory Study<br />Demographics<br />
The Endurant US Regulatory Study<br />Procedure<br />One AAA ruptured during the procedure which was still completed succe...
The Endurant US Regulatory Study<br />30 Day Results <br /><ul><li>Mortality					0%
Major Adverse Event (MAE)	4.0% (6/150)</li></ul>Myocardial Infarction			0.7% (1/150)<br />	Renal Failure				0.7% (1/150)<b...
The Endurant US Regulatory Study<br />Long<br />Narrow<br />Neck<br />Rx: Fem-Fem<br />Distal Neck 15mm<br />Right EIA   4...
The Endurant US Regulatory Study<br />30 Day Results <br /><ul><li>Any Adverse Event 			28.7% (43/150)</li></ul>Pulmonary ...
The Endurant US Regulatory Study<br />Follow-up<br /><ul><li>Schedule: 1, 6 and 12 months
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AHA: Endurant veith 2010

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  • Endurant implanted (826/829)Endurant not implanted in 3 patients:Subject 05001-018: Implanting physician could not get device through iliac system,iliac arteries calcified circumferentially and tortuous. Diameter Left iliac: 13mm (Right iliac: 18mm) Subject 10201-009: One pin remained under the cap. System could not be deployed or retracted. Pt. converted. This was 1st generation spindle design.Medtronic has made improvements to the spindle edges to make them smoother and much less prone to getting caught up.Subject 10312-15 had an implant attempt, but was not implanted with the Endurant device. This patient is a 62 yr old Male patient (152cm and 44kg) with a maximum AAA diameter of 48 mm. Investigator narrative: ‘Patient 10312-015 was a complex problem. This patient needed to undergo the index procedure on a short term. For that reason we used some devices from our own stock. We first placed the iliac extension, with the idea of placing the main body here after through this extension. Eventually this failed and the main body ended up too high in the aorta, and covered both renal arteries. This case is an estimation- and/or measurement error’. During the procedure it was decided to convert the case to open surgery.Patients were converted to open surgery
  • Transcript of "AHA: Endurant veith 2010"

    1. 1. 37th Annual VEITH Symposium 2010 <br />Contemporary One year EVAR Outcomes from the US IDE trial and ENGAGE Global Registry of the Endurant AAA Endograft Device<br />Michel S. Makaroun MD<br />Division of Vascular Surgery<br />University of Pittsburgh<br />for the US Endurant Pivotal Trial Investigators<br />
    2. 2. The Bifurcated Endurant EndoGraft<br />Description<br />Modular Stent-Graft<br />Multi-filament Polyester Fabric<br />Electropolished Nitinol Stent<br />Active Suprarenal fixation <br />3 cm Overlap Zone<br />Pt-Ir and Gold Markers<br /> Endurant<br />
    3. 3. The Bifurcated Endurant EndoGraft<br /><ul><li>M-shaped proximal stent: good neck conformability
    4. 4. Limb stent geometry designed for flexibility
    5. 5. One-piece, laser-cut, Nitinol suprarenal stent with anchoring pins</li></li></ul><li>Endurant Delivery System<br /><ul><li>Accurate stepwise proximal deployment of the stentgraft
    6. 6. Controlled release of the suprarenal anchoring pins</li></li></ul><li>Endurant Radio-Opaque Markers<br />“e” marker assists with A/P view and identifies contralateral gate<br />Flow divider marker for accurate contralateral limb placement<br />Contralateral gate ring marker assists with cannulation<br />
    7. 7. Endurant Delivery System<br />Allows for Slow Deliberate <br />and Accurate Proximal Deployment<br />
    8. 8. The Endurant EndoGraft<br />
    9. 9. The Endurant US Regulatory Study<br /><ul><li>Non Randomized, Multi-center study
    10. 10. 26 sites: Both Academic and Community Hospitals
    11. 11. 150 patients
    12. 12. April 2008 to May 2009
    13. 13. One year follow-up visits completed
    14. 14. All Imaging reviewed by a Core Lab (M2S)
    15. 15. Clinical Events Committee (CEC) adjudicated all untoward events</li></li></ul><li>The Endurant US Regulatory Study<br />Selected Inclusion Criteria<br /><ul><li>AAA ≥ 5 cm
    16. 16. Neck length ≥ 10 mm
    17. 17. Neck angulation ≤ 60 degrees
    18. 18. Iliac Fixation length ≥ 15 mm
    19. 19. Suitable Access</li></ul>Endpoints<br /><ul><li>Safety endpoint: MAE rate @ 30 days
    20. 20. Effectiveness endpoint: Composite of Technical and Clinical Success of AAA Rx @ 1 year</li></li></ul><li>The Endurant US Regulatory Study<br />Demographics<br />
    21. 21. The Endurant US Regulatory Study<br />Demographics<br />
    22. 22. The Endurant US Regulatory Study<br />Procedure<br />One AAA ruptured during the procedure which was still completed successfully<br />
    23. 23. The Endurant US Regulatory Study<br />30 Day Results <br /><ul><li>Mortality 0%
    24. 24. Major Adverse Event (MAE) 4.0% (6/150)</li></ul>Myocardial Infarction 0.7% (1/150)<br /> Renal Failure 0.7% (1/150)<br /> Respiratory Failure 1.3% (2/150)<br /> Stroke 0.7% (1/150)<br /> Bowel Ischemia 1.3% (2/150)<br /> Procedural Blood Loss ≥ 1000cc 0.7% (1/150)<br /><ul><li>Two patients had limb occlusions on day 1 and day 20</li></li></ul><li>The Endurant US Regulatory Study<br />Left Limb occlusion: Limb folded <br />or extension poorly expanded in iliac artery kink.<br />Pre-op: Severely angulated and kinked left common Iliac <br />
    25. 25. The Endurant US Regulatory Study<br />Long<br />Narrow<br />Neck<br />Rx: Fem-Fem<br />Distal Neck 15mm<br />Right EIA 4 mm<br />CT on Day 20<br /> Compressed and Occluded R Limb <br />
    26. 26. The Endurant US Regulatory Study<br />30 Day Results <br /><ul><li>Any Adverse Event 28.7% (43/150)</li></ul>Pulmonary Complications 3.3% (5/150)<br /> Renal Complications 2.0% (3/150)<br /> CHF 2.0% (3/150)<br /> Fever 6.0% (9/150)<br /> Urologic 4.7% (7/150)<br /> Wound Complications 0.7% (1/150)<br /> Arterial Events 4.0% (6/150)<br />
    27. 27. The Endurant US Regulatory Study<br />Follow-up<br /><ul><li>Schedule: 1, 6 and 12 months
    28. 28. Six Deaths during first year. None AAA related (CEC)</li></ul>Primary Cause of Death Days from Implant<br /> Stroke 90<br /> COPD 128<br /> Pulmonary fibrosis 215<br /> Lung cancer 267<br /> Multiple organ/system failure 280<br /> Metastatic bladder cancer 320<br /> Lung cancer 458<br />
    29. 29. The Endurant US Regulatory Study<br />Imaging Follow-up<br /><ul><li>Schedule: 1, 6 and 12 months
    30. 30. CT with and without contrast
    31. 31. 4 views Abdominal X-rays
    32. 32. All imaging reviewed by Core lab
    33. 33. Patients with elevated Cr had non contrast CT with ultrasound duplex or MRA
    34. 34. 127 patients have completed 12 month FU imaging</li></li></ul><li>The Endurant US Regulatory Study<br />Imaging: Endoleaks during Follow-up<br />
    35. 35. The Endurant US Regulatory Study<br />Imaging: Size Changes<br />Size Changes ≥ 5mm considered significant<br />1 Month 6 Months<br />53mm 37mm<br />
    36. 36. The Endurant US Regulatory Study<br />Imaging: Size Changes<br />
    37. 37. The Endurant US Regulatory Study<br />Follow-up<br /><ul><li>No Fractutres
    38. 38. No Migration
    39. 39. No post-op Ruptures
    40. 40. No Conversion to Open Repair
    41. 41. Limb Compromise from external compression:
    42. 42. 2 Additional Limb Occlusions
    43. 43. 1 Stenosis</li></li></ul><li>The Endurant US Regulatory Study<br />Re-interventions up to one Year<br />
    44. 44. The Endurant Endograft<br />Summary and Conclusions<br /><ul><li>Results up to one year with the Endurant Endograft are quite encouraging
    45. 45. The Endurant Endograft appears to be a Safe and Effective new device for the management of AAA</li></li></ul><li>ENGAGE Overview<br />ENGAGE is a worldwide prospective registry of Post-market use of the ENDURANT endograft in the treatment of AAA <br />Study Plan<br />Enrollment: 1200 patients at 80 sites worldwide (5 year FU)<br />Primary endpoint: Treatment success at 12 months<br />Oversight: Executive committee (7 Investigators)<br />Study Purpose<br />Prospectively collect global ‘real life’ data<br />Real world patients<br />Minimal Inclusion / Exclusion Criteria<br />Real-world practice<br />Patients are followed per institution standard practices<br />
    46. 46. ENGAGE Interim Analysis<br />Acute Procedural Data for first 839 Patients Enrolled<br />Baseline Characteristics<br />AAA Size > 50mm 88.2%<br />Proximal Neck<br /> Length 27.8 mm + 13.4<br /> Length < 15 mm 18.1%<br />Procedural Data<br />Deployment Success 99.6%<br />Implant Duration 90 min (20-300)<br />General Anesthesia 63.3%<br />Length of Stay 5 days (0.5 – 217)<br /> * As of 05 October 2010<br />
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