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Four-Year Results of the Pivotal U.S. Multicenter Trial of the Endologix Powerlink Endograft for EVAR

Four-Year Results of the Pivotal U.S. Multicenter Trial of the Endologix Powerlink Endograft for EVAR. Rodney White, MD Harbor UCLA Medical Center Torrance, CA. Conflicts of Interest & Off-Label Use Disclosure. Investigational trial support from multiple manufacturers

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Four-Year Results of the Pivotal U.S. Multicenter Trial of the Endologix Powerlink Endograft for EVAR

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  1. Four-Year Results of the Pivotal U.S. Multicenter Trial of the Endologix Powerlink Endograft for EVAR Rodney White, MD Harbor UCLA Medical Center Torrance, CA

  2. Conflicts of Interest &Off-Label Use Disclosure • Investigational trial support from multiple manufacturers • Paid consultant and advisory boards for • Medtronic, Boston-Scientific, WL Gore, Endologix, General Electric – OEC, and Volcano

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

  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 II Endoleak – 17 • Type I Endoleak – 6 • Graft Limb Occlusion – 7 • Embolectomy,Stent, PTA, or Lytic Therapy • Native Artery Procedures – 3 • Aortic Neck Dilation - 1 * As of December 16, 2005

  7. Conversion, Rupture, Migrationthrough 60 months* • Surgical conversions – 4 • Intraoperative – 3 • @12 mo. – 1 • Aneursym rupture – 0 • 5 Migrations (> 10mm) • All caudal • None leading to secondary procedure * As of December 16, 2005

  8. Core Lab AnalysisEndoleaks (All Types, New and Persistent)† †As of December 16, 2005

  9. Sac Diameter Over Time† † As of December 16m 2005 * 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab

  10. Sac Volume Over Time† • † As of December 16, 2005 • * 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.

  11. Morphology Change Sub-Analysis Method: • Patients with paired data (both a 1-month and either a 2-year, 3-year, 4-year, or 5-year follow-up CT) as of December 16, 2005 were included in this analysis • Current Analysis N = 78 pts. • All CT’s were analyzed by study core lab utilizing proprietary 3-D reconstruction software (Medical Metrx Solutions, West Lebanon, NH)

  12. Analysis: • Mean max. sac diameter • Mean sac volume • Distance between distal renal and aortic bifurcation • Δ in maximum sac angulation • Sac angle calculation was determined from distal proximal neck to maximum inflection point in the sac to aortic bifurcation (180° = straight line through sac)

  13. Overall Results:

  14. Paired Results:

  15. Example: Pt. w/ 22.6° Straighter Sac Angle 1 – Mth. 3 – Yr.

  16. Distal End of Bifurcated Region

  17. 4-29-05 5-13-05

  18. Summary of Late Clinical Findings • 97.9 % Freedom from AAA-Related Mortality at 4 years with the Powerlink System • No aneurysm ruptures • Only 1 late conversion (@ 1 yr.) • No ePTFE graft material failures at 4 years • No cobalt chromium stent graft failure or fatigue at 4 years

  19. Conclusions: • Powerlink System appears safe and effective in protecting patients from AAA rupture • All cohorts treated w/ Powerlink® experienced: • Aneurysm sac diameter & volume reduction • Remodeling or shrinking of aneurysm sac around device as evidenced by straightening of the aorta • Minimal change in length of aorta from distal renal to bifurcation regardless of sac angle change • Sac remodeling does not appear to contribute to graft migration with the Powerlink stent graft • The column strength and long main body of the Powerlink® may directly influence the classical remodeling of the aneurismal aorta

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