Ray Matthews MD Professor of Clinical Medicine Chief of Cardiology University of Southern California
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1 High Risk PCI Making Possible the Impossible Ray Matthews MD Professor of Clinical Medicine Chief of Cardiology University of Southern California
2 Disclosures Abiomed Research Support Consulting Agreement St Jude Medical Research Support Consulting Agreement
3 High Risk PCI 93 year old female with NSTEMI* Recurrent angina on medications Cath shows calcified distal left main bifurcation lesion Echo: EF 35% Anteroapical severe hypokinesis Surgical referral. suggest stenting * Protect II pateint
4 Principles of Impella Design Replicates Heart s Natural Function Inflow (ventricle) Outflow (aortic root) EDV, EDP AOP Flow O 2 Demand O 2 Supply Cardiac Power Output
5 IMPELLA HEART PUMP: HOW IT WORKS Placement in Left Ventricle Impeller and blood outflow 2.5 = 2.5 l/min CP = 4 l/min Animation Click here
6 HEMODYNAMICS OF IMPELLA IN AMI CARDIOGENIC SHOCK 6 Pressure Tracings, Harvi 1 Case Example* 49 Yrs, Male Cold, Clammy skin Tachycardia MAP 51 mmhg (61/44) Impella CP On Circulatory Support (Increased MAP) 72 mmhg (75/71) Cardiac Output: 3.3 L/min Wedge Pressure: 22 mmhg 75% Left main LVEDP 28 mmhg Ventricular Unloading (Reduced LVEDP) 20 mmhg MAP 51mmHg, LVEDP 28 mmhg Time (60 seconds) 1. Physiologic computational modeling, Am J Physiol 1991 * Not all patients will experience the same clinical outcomes or hemodynamic responses
7 PROTECT II Trial Design Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on Unprotected LM/Last Patent Conduit and LVEF 35% OR 3 Vessel Disease and LVEF 30% IABP + PCI R 1:1 IMPELLA PCI Primary Endpoint = 30-day Composite MAE* rate Follow-up of the Composite MAE* rate at 90 days *Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin), Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure
8 PROTECT II MACCE** Per Protocol Population, N=426 Death, Stroke, MI, Repeat revasc. IABP IMPELLA Log rank test, p=0.04 **Using x8uln threshold for biomarkers or Q-wave for Peri-procedural MI (Stone et al Circulation 2001;104: ) 647) and 2xULN threshold for biomarkers for Spontaneous MI (Universal MI definition) 8
9 PROTECTED PCI INDICATION & SAFETY INFO. 9 INDICATION FOR USE The Impella 2.5 System is a temporary ( 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. CONTRAINDICATIONS The Impella 2.5 is contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle Presence of a mechanical aortic valve or heart constrictive device Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) Moderate to severe aortic insufficiency (echocardiographic assessment graded as +2) Severe peripheral arterial disease precluding placement of the Impella 2.5 System POTENTIAL ADVERSE EVENTS Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with the Impella 2.5. Visit to learn more.
10 Anatomy vs. CABG Risk When to choose supported PCI? 10 STS score SYNTAX score PROTECT II patients
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17 High Risk PCI 73 year male NSTEMI Refractory recurrent angina ESRD S/P AVR with prosthetic valve restenosis Severely Calcified coronaries EF 35% STS for AVR/CABG = 28% mortality
18 High Risk PCI PCI desirable but calcification makes very difficult PCI in combination with valve in valve TAVR as staged procedure best option Planning long rotablator total runs due to severe calcification in the setting of reduced LV function and aortic stenosis
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22 AV gradients: 63 mmhg max 33 mmhg mean Vmax 4.0 m/sec
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28 Future Technologies pvad Smaller with higher flows Right sided support
29 *CAUTION HeartMate PHP Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use. US-THO Approved for US Use Only 29
30 HEARTMATE PHP PERCUTANEOUS HEART PUMP A NOVEL ACUTE MCS THERAPY Catheter-based percutaneous heart pump delivered through 14F introducer; expands to 24F when unsheathed Designed to deliver > 4 lpm of flow at low RPMs Breaking the Link Between Size and Flow* High Cannula Inlet Cannula Outlet Low Flow Rates (LPM) Coated Cannula Impeller IABP Smaller Impella 2.5 Impella CP Tandem Heart PHP Insertion Profile Impella 5.0 Larger *CAUTION HeartMate PHP Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use. Seyfarth, Sibbing, et al. J Am Coll Cardiology. 2008;52(19): Impella and Tandem Heart estimates based on manufacturer labeling. HeartMate PHP Percutaneous Heart Pump estimates based on preclinical bench testing. Impella is a trademark of Abiomed, Inc. Tandem Heart is a trademark of Cardiac Assist, Inc. US-THO Approved for US Use Only 30
31 HEARTMATE PHP PERCUTANEOUS HEART PUMP CLINICAL STUDY ACTIVITY Completed CE Mark study leading to approval in patients undergoing high-risk PCI (HRPCI) Primary endpoints: avoidance of major adverse events at 30 days, device and procedural success Pivotal US IDE underway 425 patients undergoing high-risk PCI Randomized 2:1 against Impella 2.5 *CAUTION HeartMate PHP Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use. US-THO Approved for US Use Only 31
32 IMPELLA RP Temporary RV Support for RV Infarction RV failure after durable VAD Post cardiotomy RV failure Massive pulm embolus Others 32
33 END
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