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Secondary Intervention in Unfavorable AAA Neck Anatomy

Secondary Intervention in Unfavorable AAA Neck Anatomy. Congress Symposium 2007 John T. Collins, MD Borgess Medical Center Kalamazoo, MI. Powerlink ® System:. Unibody-Bifurcated Design Long Main Body Low-Porosity Proprietary ePTFE Formulation Cobalt Chromium Alloy Stent

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Secondary Intervention in Unfavorable AAA Neck Anatomy

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  1. Secondary Intervention in Unfavorable AAA Neck Anatomy Congress Symposium 2007 John T. Collins, MD Borgess Medical Center Kalamazoo, MI

  2. Powerlink® System: • Unibody-Bifurcated Design • Long Main Body • Low-Porosity Proprietary ePTFE Formulation • Cobalt Chromium Alloy Stent • Single-wire Main Body Construction • Fully Supported

  3. Minimally Invasive Access • 21 Fr Delivery System - Ipsilateral • No introducer sheath used • No upsizing of arteriotomy required • 9 Fr Percutaneous Sheath - Contralateral

  4. Powerlink® U.S. Pivotal Trial • 192 patients enrolled between July 2000 and March 2003 • Eligibility Criteria • Proximal Infrarenal Neck: • >15mm length • <60° angle • 26mm maximum diameter, 18mm minimum diameter • AAA >4.0 cm diameter or rapidly growing AAA • Iliac diameter >7mm on at least one side (for access) • Dispensable inferior mesenteric artery • Preservation of at least one hypogastric artery • Iliac seal zone of >15mm length (<18mm diameter) • Aortic bifurcation diameter >18mm • >18 years old • Not pregnant • Candidate for open AAA repair • Serum creatinine <1.7mg/dlL • Willingness to comply with follow-up schedule • No bleeding disorders • Life expectancy >2 years • No connective tissue disorders

  5. Summary of Significant Early Clinical Findings • † Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, coronary intervention, renal failure, or respiratory failure • * Not device related Carpenter JP, et al. Midterm results of the multicenter trial of the Powerlink bifurcated system for endovascular aortic aneurysm repair. J Vasc Surg 2004;40:849-59.

  6. Secondary Procedures (through 60 months*) 34 procedures in 26 patients • Endoleak –23 (Cuffs, embolization, balloon dilatation) • Type I Endoleak – 5 • Type II Endoleak –18 • Graft Limb Occlusion – 7 • Embolectomy,Stent, PTA, or Lytic Therapy • Native Artery Procedures – 3 • Migration - 1 * As of Dec. 2006

  7. Sac Diameter Over Time† † As of Dec. 2006 * 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab

  8. Sac Volume Over Time† • † As of Dec 2006 • * 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab • ** Some CT scans are not evaluable for some parameters most often due to poor image quality, no contrast, CT’s taken at greater than 3mm slices, etc.

  9. Challenging Infrarenal Aortic Neck Anatomy • Large diameter (>28mm) • Short landing zone (<15mm) • Extreme Angulation • Accessory renal arteries • Reverse tapered neck

  10. Objective • Evaluate the incidence of Type I endoleaks and device migration in patients with reverse tapered neck anatomy • Determine effect on seal zone • Incidence of secondary interventions in patients with this neck geometry

  11. Reverse Tapered Neck Definition Neck Dilation of  2mm within the first 20mm below the most caudal renal artery

  12. Reverse Tapered Neck

  13. Reverse Tapered Neck

  14. Sub-group Analysis • N = 50 test patients (Total group = 192) had reverse tapered neck anatomy • Neck anatomy • Mean Proximal Diameter • 20.94 mm (17.9--26.0) • Mean Distal Diameter • 24.38 mm (21.5 – 28.6)

  15. Implant Procedure • All procedures technically successful • 24 patients (24/50 = 48%) received proximal extensions during procedure • Diameter of stent grafts • 25 or 28mm • 6 patients also received stents during implant procedure • No endoleaks noted at end of procedure

  16. Follow-up of Sub-Group • Mean follow-up: 40.2 months • Range: 1 mo – 64 mo • No AAA-related deaths • No secondary procedures for proximal Type I endoleak • Graft migration: 1 (12.5mm); no clinical sequelae

  17. Courtesy of Rodney White, MD

  18. Courtesy of Rodney White, MD

  19. Differences in CT Assessment • Graft attached to endoskeleton only @ proximal and distal end • Graft “balloons” off stent cage • May allow graft to provide longer seal zone in unfavorable proximal neck geometry Courtesy of Rodney White, MD

  20. Reverse Tapered Neck

  21. Summary of Late Clinical Findings • 97.9 % Freedom from AAA-Related Mortality @ 5 years with the Powerlink System • No aneurysm ruptures • Only 1 late conversion (@ 1 yr.) • No ePTFE graft material failures @ 5 years • No cobalt chromium stent graft failure or fatigue @ 5 years

  22. Conclusions • Simple implantation technique • Minimally invasive access • No proximal Type I endoleak in this group of patients with reverse taper neck anatomy through 5 year follow-up • Sac regression and improving morphology

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