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AHA: Endurant veith 2010
- 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
- 4. Limb stent geometry designed for flexibility
- 7. Endurant Delivery System Allows for Slow Deliberate and Accurate Proximal Deployment
- 10. 26 sites: Both Academic and Community Hospitals
- 11. 150 patients
- 12. April 2008 to May 2009
- 13. One year follow-up visits completed
- 14. All Imaging reviewed by a Core Lab (M2S)
- 16. Neck length ≥ 10 mm
- 17. Neck angulation ≤ 60 degrees
- 18. Iliac Fixation length ≥ 15 mm
- 21. The Endurant US Regulatory Study Demographics
- 22. The Endurant US Regulatory Study Procedure One AAA ruptured during the procedure which was still completed successfully
- 25. The Endurant US Regulatory Study Long Narrow Neck Rx: Fem-Fem Distal Neck 15mm Right EIA 4 mm CT on Day 20 Compressed and Occluded R Limb
- 28. 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
- 30. CT with and without contrast
- 31. 4 views Abdominal X-rays
- 32. All imaging reviewed by Core lab
- 33. Patients with elevated Cr had non contrast CT with ultrasound duplex or MRA
- 35. The Endurant US Regulatory Study Imaging: Size Changes Size Changes ≥ 5mm considered significant 1 Month 6 Months 53mm 37mm
- 36. The Endurant US Regulatory Study Imaging: Size Changes
- 38. No Migration
- 40. No Conversion to Open Repair
- 41. Limb Compromise from external compression:
- 42. 2 Additional Limb Occlusions
- 46. 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
Notes de l'éditeur
- 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