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ArterX Arterial Surgery

A Novel More Effective Glue-Sealant (Arterx) for Hemostasis at Vascular Suture Lines and Other Sites William M. Stone, MD Mayo Clinic Scottsdale, Arizona. ArterX Arterial Surgery. Bleeding a natural consequence Higher morbidity/operative time Higher costs

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ArterX Arterial Surgery

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  1. A Novel More Effective Glue-Sealant (Arterx) for Hemostasis at Vascular Suture Lines and Other SitesWilliam M. Stone, MDMayo ClinicScottsdale, Arizona

  2. ArterXArterial Surgery • Bleeding a natural consequence • Higher morbidity/operative time • Higher costs • Prosthetics most troublesome (ePTFE)

  3. ArterXIncreasingly Problematic • Increased use of anticoagulants • Higher complexity of arterial reconstructions

  4. ArterXMultiple Attempts to Assist with Hemostasis • Fibrin sealant • Cyanoacrylate • Bovine collagen and thrombin • Polyethylene glycol polymer • Albumin cross-linked with gluteraldehyde

  5. Ideal Agent • High hemostatic and bonding properties • Minimal tissue reactivity • Non-antigenic • Biodegradable • Easy to sterilize • Conform to tissues

  6. ArterX • Glutaraldehyde based • Treated cross-linking agent • Minimizes inflammatory response • Elastic biocompatible gel • Covalently bonds to tissues • Highly conformable

  7. ArterX

  8. ArterXPhase I • Multi-institutional European trial • Open arterial reconstructions with prosthetic materials

  9. ArterX • Primary endpoint-immediate hemostasis • Secondary endpoint-hemostasis at • 1, 3, 5 and 10 minutes • Additional hemostatic measures

  10. ArterX • “Prophylactic” application • Sealant “sets” in 60 seconds • Flow restored and anastomosis observed

  11. ArterXN=32 • 56 prosthetic graft anastomoses • Mean age 66 years (range 46-86) 26 (81%) male 6 (19%) female

  12. ArterXN=56 Subclavian 1 (1.7%) Aorta 10/56 (18%) Carotid 2 (3.5%) Popliteal 4 (7.1%) Iliac 7 (12.5%) Brachial 4 (7.1%) Tibial 4 (7.1%)

  13. ArterX • All anticoagulated • All given aspirin post procedure 19 (33%) ePTFE 38 (67%) Dacron

  14. ArterX Immediate hemostasis in 56/56 100%

  15. ArterX • Pivotal Trial • Randomized, prospective, controlled • United States, multicenter

  16. ArterX • ArterX vs Gelfoam Plus (control) • Vascular reconstructions with prosthetic grafts • Applied prophylactically at completion of anastomosis

  17. ArterX • 217 patients randomized • 331 anastomoses • ArterX group 110 patients • (167 anastomoses) • Control group 107 patients • (164 anastomoses)

  18. ArterXN=110 • Mean age 66.2 years • No statistical difference in comorbidities including use of anticoagulants 69 (62%) male 41 (38%) female

  19. ArterX • Primary endpoint • Immediate hemostasis • Secondary endpoints • Hemostasis at 1, 3, 5 and 10 minutes

  20. ArterXImmediate Hemostasis • ArterX 101/167 (60.5%) • Control 65/164 (39.6%)

  21. ArterXBleeding Status 90 Time After Clamp Release (minutes) ArterX Control 80 70 60 50 Site With No Bleeding (%) 40 30 20 10 0 0 1 3 5 10

  22. ArterX: Cumulative Time to Sealing (Kaplan Meier Results) Time After Clamp Release (minutes) 1.0 ArterX Control 0.9 0.8 0.7 0.6 Site With No Bleeding (%) 0.5 0.4 0.3 0.2 0 1 2 3 4 5 6 7 8 9 10

  23. ArterXStatistically Significant • Immediate hemostasis • Time to hemostasis • No difference in adverse events

  24. WMS3344

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