Impella Ins & Outs CarVasz November 21 2014 10:45 12:15 Nicolas M. Van Mieghem, MD, PhD, FESC Clinical Director of Interventional Cardiology Thoraxcenter, Erasmus MC Rotterdam
Background IABP is widely used for LV support in high-risk PCI & cardiogenic shock The increase in cardiac output by IABP is limited Measurable effects on clinical outcome is scarce
What we need Assist Device should be safe User-friendly Effective LV support Measurable (clinical) benefit
LV Support in EP? Ventricular Tachycardia & EP-Ablation High Risk for Hemodynamic Instability Complex congenital heart disease (Fontan, ) Poor LV function Ischemic Non-ischemic LV support to overcome BP drop while inducing & ablating VT
IMPELLA
Impella CP 14 Fr Cannula 4.66mm 5 Strut Inlet Cage Optimized Impeller Up to 4L/min continuous flow
Impella Principle
8 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 2.5 + PCI Primary Endpoint = 30-day Composite MAE* rate Follow-up of the Composite MAE* rate at 90 days
Hemodynamic Support Effectiveness Impella 2.5 vs. IABP Cardiac Power Output Maximal Decrease in CPO on device Support from Baseline IABP Impella N=138 N=141-4.2 ± 24 p=0.001-14.2 ± 27 CPO data available only for 279 patients (N=138 IABP and N=141 Impella) CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (Fincke R, Hochman J et al JACC 2004; 44:340-348) 9
Learning curve - Impella 2.5 vs. IABP Per Protocol Population 90day Outcome (N=423) IABP IMPELLA N=82 N=82 N=63 N=63 N=65 N=68 10
Impella 2.5 and CP Mean Flow Rate (L/min) Impella 2.5 2.3-2.5 Impella CP > 1 L/min additional Flow Catheter Size 9 Fr 9 Fr Pump Size 12 Fr 14 Fr Insertion Method Guidewire Placement Measurement Cannula Geometry Percutaneous via 13 Fr or 14 Fr Introducer Sheath 0.018 Silicone Wire Fluid-filled Pressure Lumen Curved, Pigtail Percutaneous via 14 Fr Introducer Sheath 0.018 PTFE Wire Fluid-filled Pressure Lumen Curved, Pigtail RPM 51,000 46,000
VT Ablation with Impella or not Miller et al. JACC 2011;58:1363-71
Impella in VT Ablation
Impella in VT Ablation
15 Heart Pumps and Hemolysis? Heart Pumps apply shear forces to red blood cells that if strong enough can damage cell structure Shear forces result from differences in blood velocity (i.e. force) from one side of RBC to the other Shear forces in a heart pump are strongest in regions of high blood velocity differences and small flow channels Shear Force Cannula Wall / Fixed Structure Speed low due to dragging along the wall Hgb Hgb Hgb Speed high away from wall Hgb Shear forces pull apart or distort cell membrane and can cause rupture
Hemolysis with Impella and Other Heart Pumps in Bench Testing? 16 1 2 2 1 1 1 CentriMag/Industry standard data Levitronix Website 2 FDA Comparative Bench Test Data for Impella 2.5 510(k) Clearance
Thoratec PHP
HeartMate PHP Low-profile Designed to provide high forward flow at low RPMs to unload the LV and perfuse end organs Designed to deliver 4-5 lpm average flow Cannula Outlet Impeller Coated Cannula Cannula Inlet Collapsible elastomeric impeller within expandable nitinol cannula 13F insertion profile Expands to 24F when unsheathed Insertion Sequence
HeartMate PHP
Thoratec PHP Pivotal CE Mark study kick-off Q3 2014 Up to 50 patients undergoing high-risk PCI at up to 10 sites in Europe and South America Primary performance endpoint: Freedom from hemodynamic compromise during PCI Primary safety endpoint: Composite of major adverse events.
PulseCath ivac 2L
PulseCath Principle 17F catheter across aortic valve is connected to an extracorporeal membrane pump Pulsecath actively aspirates blood from the left ventricle in systole and ejects this blood into the ascending aorta during diastole Pump is compatible with standard IABP console as a driver
PULSECATH ivac 2L
Hemodynamics Pulsecath 100 40 4,0 3,5 3,0 2,5 2,0 1,5 1,0 0,5 0,0 C.O. C.Output Counterpulsation 100 Diastolic Pressure increases 40 MAP increases C.O. increases*
PULSECATH ivac 2L
LV Support & Access Strategy
PULSECATH ivac 2L Large caliber system (17F) Pulsatile LV Support Genuine IABP console Compared to IABP: C.O. X3 LV Support replacement Safety & efficacy Study ongoing in Rotterdam
In Conclusion LV support is valuable in particular clinical settings Powerful devices are entering the clinical field LV support may also serve complex EP procedures