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Cook Endovascular Graft for AAA

Cook Endovascular Graft for AAA. Clinical Data From Two Prospective Studies Two Independent Registries Paul Chandeysson DCD/PVDB. Australia-New Zealand Study. August 1994 - December 1998 291 patients at 16 centers Follow-up to June 1999 Implantation success 98.6% 6 Early deaths

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Cook Endovascular Graft for AAA

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  1. Cook Endovascular Graftfor AAA Clinical Data From Two Prospective Studies Two Independent Registries Paul Chandeysson DCD/PVDB

  2. Australia-New Zealand Study • August 1994 - December 1998 • 291 patients at 16 centers • Follow-up to June 1999 • Implantation success 98.6% • 6 Early deaths • 3 AAA ruptures • 3 Late conversions

  3. U.S. Study • January 2000 - July 2001 • 432 patients at 15 centers • 52 roll-in endovascular patients • 200 standard-risk endovascular patients • 100 high-risk endovascular patients • 80 surgical patients • Study patients followed at 1 and 6 months and annually

  4. Hypotheses • Primary: • Superior morbidity index at 30 days • Secondary: • Equivalent survival at 30 days • Equivalent survival at 1 year • Equivalent treatment success at 1 year • Superior clinical utility

  5. Patient Population Roll-in Standard-risk Surgical High-risk Age (yr) 74 71 69 77 Weight (kg) 83.6 89.4 82.1 81.4 Hypertension (%) 67 64 83 68 Alcohol abuse (%) 4 3.6 10 3.1 Still smokes (%) 18 21 35 18 Women (%) 9.6 6.5 11.2 8

  6. Patient Mortality Roll-in Standard-risk Surgical High-risk Patients 52 199 80 100 Within 30 days 1 ( 1.9) 1 (0.5) 2 (2.5) 2 (2) >30 days,<1 yr. 5 ( 9.6) 6 (3.0) 1 (1.25) 7 (7) Within 1 year 6 (11.5) 7 (3.5) 3 (3.75) 9 (9)

  7. Patient Morbidity (30 days) Roll-in Standard-risk Surgical High-risk Patients 52 199 80 100 Morbidity index 0.35 0.26 0.92 0.52 Cardiovascular 1 (1.9) 6 (3.0) 9 (11.2) 14 (14) Pulmonary 0 2 (1.0) 12 (15.0) 2 ( 2) Renal 3 (5.8) 5 (2.5) 8 (10.0) 6 ( 6) Bowel 1 (1.9) 2 (1.0) 3 ( 3.8) 1 ( 1) Wound 2 (3.8) 9 (4.5) 6 ( 7.5) 2 ( 2) Neurological 0 0 2 ( 2.5) 0 Vascular 10 (19.2) 21 (10.6) 25 (31.2) 20 (20)

  8. Effectiveness Data (1 year) Roll-in Standard-risk High-risk Patients 52 200 100 Implant success 52 199 100 Endoleak , 12 mo. 1 14 4 Rupture of AAA 0 0 1 Conversions 0 2 1 Other procedures 3 21 12 Loss of patency 0 2 1 Growth of AAA 0 2 1

  9. Western Australia Registry • Through July 2001 • 170 of 291 patients in A-NZ study • Follow-up up as long as 6 years • 3 late AAA ruptures • 3 late conversions • Survival analysis to 5 years

  10. Eurostar Registry • January 1998 - March 2001 • 828 patients at 45 centers • Follow-up to 3 years • Implantation success 97.7% • 13 Early deaths 1.6% • 1 late AAA rupture 0.1% • 0 late conversions

  11. Additional Clinical Data Being Collected • 2 year follow-up of U.S. endovascular patients • Results of Continued Access IDE Study • Registry of 50 women patients (15 currently enrolled) • Additional Eurostar registry patients • Registry of 438 patients in France • Registry of 515 patients in Australia

  12. Conclusions • A large amount of clinical data • High rate of implantation success • Low rate of operative mortality • All hypotheses met • Does not eliminate aneurysm rupture • Continued follow-up necessary • Additional treatments may be needed • No excess renal failure

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