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ACI London 2010
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  1. ACI London 2010 Thrombectomy in STEMI … is the evidence clear? Brad Higginson International marketing manager

  2. Options for Management of Thrombotic Lesions • Pharmacologic Therapies • Embolic Protection Devices • Filters • Balloon Occlusion • Mechanical Thrombectomy Devices • Rheolytic thrombectomy • Aspiration Thrombectomy Devices • Pharmacologic Therapies • Embolic Protection Devices • Filters • Balloon Occlusion • Mechanical Thrombectomy Devices • Rheolyticthrombectomy (AngioJet) • Aspiration Thrombectomy Devices Dr. Bruce Brodie LeBauer Heart , North Carolina

  3. AngioJet history Over ½ million treated WW

  4. AngioJet technology review

  5. CFD analysis – mechanical vs aspiration

  6. OCT – aspiration vs mechanical thrombectomy

  7. Practice guidelines and devices

  8. Is a Class 1 , Level A guideline attainable? • Challenging the Class one distinction? • TAPAS • Bias between treatment arms • AiMI – AngioJet in Myocardial Infarction • Mortality endpoint • TIMI 3 flow baseline imbalance between treatment arms

  9. TAPAS – New England Journal of Medicine (NEJM)

  10. TAPAS – NEJM Conclusion • Thrombus aspiration is applicable in a large majority of patients with myocardial infarction with ST-segment elevation, and it results in better reperfusion and clinical outcomes than conventional PCI, irrespective of clinical and angiographic characteristics at baseline.

  11. TAPAS – NEJM , “respective” caveats Small thrombus burden 49% 44% 90% Thrombectomy was primary procedure 96% Predilation was primary procedure 00%

  12. New England Journal of Medicine Dr. Vetrovec editorial

  13. NEJM – technique editorial Dr. Vetrovec summarized Some operators believe that direct stenting without multiple balloon inflations reduces the risk of distal emboli. The majority of patients in the conventional-PCI group had balloon angioplasty followed by stenting, which might have increased the relative incidence of embolization in the conventional-PCI group.

  14. AiMI – not our best effort

  15. 30 Day MACE Angiojet Control n=240 n=240 P=0.02 P=0.01 6.7% 4.6% 2.1% 1.7% 1.7% 0.8% 0.8% 0.4% 0% 0% Death Q wave MI Stroke TLR Total

  16. AngioJet for STEMI Cindy L. Grines, M.D. William Beaumont Hospital Royal Oak, Michigan

  17. AiMI Control Arm Mortality is Far Lower than in the Meta-Analysis PCI Arm There is extremely low, p=0.0007, chance that a new PCI trial would observe mortality of 0.8% or less AiMI PCI Arm is an outlier, extreme observation, or in the tail, as compared to the body of PCI evidence (N=124 Study Arms)

  18. Is a Class 1, Level A guideline attainable? • Better science • TAPAS 2 • JETSTENT • Thrombus caveats • Large vs Small • Fresh vs Organized • Platelet rich versus Fibrin rich • Better science • TAPAS 2 • JETSTENT • Thrombus caveats • Large vs Small • Fresh vs Organized • Platelet rich versus Fibrin rich

  19. Thrombus burden re-defined

  20. Thrombus burden – Harvard style

  21. When to use DES in AMI Georgios Sianos, MD, PhD, FESC Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands

  22. DES IRA Stent Thrombosis

  23. Large thrombus burden impact (LTB) Georgios Sianos, MD, PhD, FESC

  24. JetStent JACC, 2010 – LTB predictive !

  25. LTB and JetStent study – JACC 2010 Pts with STEMI admitted within 12 hours from symptom onset • Lysis • Stroke < 30 days • Surgery < 6 weeks • Pre-stented IRA After angiography and IRA wiring: thrombus grade 3 to 5 After angiography and IRA wiring: thrombus grade 3 to 5 Randomization 1:1 N = 500 Rheolytic Thrombectomy + DS Direct Stenting (DS) Journal of the American College of Cardiology, Volume 56, Issue 16, 12 October 2010, Pages 1298-1306Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, RenatoValenti, Guido Parodi, Franz-Josef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators

  26. Predictors of ST-Segment Resolution and 1-Year MACE 30 min ST Reduction ≥ 50% OR 95%CI p value Randomization to RT 1.70 1.03 – 2.82 .039 Anterior AMI 0.29 0.17 – 0.47 <.001 Final TIMI 3 flow 2.10 1.17 - 3.80 .013 1-year MACEHR 95%CI p value Randomization to RT 0.50 0.31 – 0.82 .006 Age (yrs) 1.02 1.01 – 1.04 .023 Bleeding 4.33 1.80 – 10.42 .001 Journal of the American College of Cardiology, Volume 56, Issue 16, 12 October 2010, Pages 1298-1306Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, RenatoValenti, Guido Parodi, Franz-Josef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators

  27. TCT 2010 symposium - publication • Classify Thrombus Grade • Balloon Predilation Discouraged • Dual Thrombectomy Recommendation

  28. STEMI protocol recommendation Aspiration AngioJet