Transcript AngioJet
ACI London 2010 Thrombectomy in STEMI … is the evidence clear? Brad Higginson International marketing manager Options for Management of Thrombotic Lesions • Pharmacologic Therapies • Embolic Protection Devices Filters Balloon Occlusion • Mechanical Thrombectomy Devices Rheolytic thrombectomy (AngioJet) • Aspiration Thrombectomy Devices Dr. Bruce Brodie LeBauer Heart , North Carolina AngioJet history Over ½ million treated WW 500,000 Cumulative Catheters Sold 422,745 352,475 327,981 280,640 233,859 184,582 20 10 09 FY FY 08 FY 07 FY 06 FY 05 FY 04 FY 03 FY 02 FY 01 FY 00 FY 99 FY FY 98 132,610 89,993 56,586 31,196 15,238 6,538 AngioJet technology review CFD analysis – mechanical vs aspiration OCT – aspiration vs mechanical thrombectomy Practice guidelines and devices 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 TAPAS – New England Journal of Medicine (NEJM) 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. TAPAS – NEJM , “respective” caveats Small thrombus burden 49% Thrombectomy was primary procedure 90% Predilation was primary procedure 00% 44% 96% New England Journal of Medicine • Dr. Vetrovec editorial 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. AiMI – not our best effort 30 Day MACE Angiojet Control n=240 n=240 10 P=0.02 P=0.01 8 6.7% 6 4.6% 4 2.1% 1.7% 2 0.8% 0.8% 1.7% 0.4% 0% 0% 0 Death Q wave MI Stroke TLR Total AngioJet for STEMI Cindy L. Grines, M.D. William Beaumont Hospital Royal Oak, Michigan 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) 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 Thrombus burden re-defined Thrombus burden – Harvard style When to use DES in AMI Georgios Sianos, MD, PhD, FESC Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands DES IRA Stent Thrombosis Independent predictor Stent Thrombosis Presentation bifurcational stenting Rheolytic Thrombectomy Large Thrombus burden HR 4.1 5.51 0.12 6.95 95% CI 1.39-12.09 2.32-13.07 0.02-0.86 2.99-16.2 P value 0.01 <0.001 0.036 <0.001 Large thrombus burden impact (LTB) Georgios Sianos, MD, PhD, FESC JetStent JACC, 2010 – LTB predictive ! 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 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 1298-1306 Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, Renato Valenti, Guido Parodi, FranzJosef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators 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 HR 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 1-year MACE Journal of the American College of Cardiology, Volume 56, Issue 16, 12 October 2010, Pages 1298-1306 Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, Renato Valenti, Guido Parodi, FranzJosef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators TCT 2010 symposium - publication • Classify Thrombus Grade • Balloon Predilation Discouraged • Dual Thrombectomy Recommendation STEMI protocol recommendation Aspiration AngioJet