1/21/2016. HeartMate II Indications for Use. Ventricular Assist Device Overview. Jon G. Echterling MSN, CCRN, FNP-BC. Learning Objectives

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1 Ventricular Assist Device Overview Jon G. Echterling MSN, CCRN, FNP-BC February 5, 2016 Learning Objectives Identify the components and operation of the HeartMate II LVAD Describe the path blood follows in patients with the HeartMate II LVAD Identify the purpose and function of each of the buttons and symbols on the System Controller Describe appropriate interventions in the event of an emergency HeartMate II Indications for Use The HeartMate II is indicated for in-patient and out-patient use in bridge-to-transplantation and destination therapy. Bridge-to-Transplant (BTT) FDA approval 2008 Non-reversible left heart failure Imminent risk of death Candidate for cardiac transplantation Destination Therapy (DT) FDA approval 2010 NYHA Class IIIB or IV heart failure Optimal medical therapy 45 of last 60 days Not candidate for cardiac transplantation 3 1

2 Worldwide HMII Clinical Experience HeartMate II LVAD System Components HM II Components: Implantable titanium blood pump System Controller Shared Components: System Monitor (inpatient) Display Module (EPC only) Power Sources Power Module Batteries & Clips Accessories HeartMate II LVAD Pump Continuous flow device Anastomosed to LV apex and ascending aorta 2

3 Equipment Overview HeartMate II System Controller Delivers power to the pump Controls and monitors system operation Pocket Controller Identifies alarm conditions and initiates Hazard and Advisory Alarms Records and stores alarm data and device performance EPC 8 Pocket System Controller User Interface Battery Button Pump Running Symbol Battery Gauge Silence Alarm Button Display Screen Display Button 9 3

4 Pocket System Controller Alarm Indicators Black Power Lead Symbol White Power Lead Symbol Driveline Symbol Battery Advisory Symbol Hazard Battery Symbol Red Heart Hazard Symbol Yellow Wrench Advisory Symbol 10 Pocket System Controller Driveline Connector Driveline connector uses a double lock feature Lowers risk of accidentally disconnecting the driveline Safety tab must be unlocked to connect or disconnect the driveline Release Button Driveline Connector Safety Tab Safety tab unlocked Safety tab locked EPC System Controller User Interface Test Select Button Battery Fuel Gauge Battery Symbol (Yellow & Red) Silence Alarm Button Power Symbol Cell Module Symbol Red Heart Symbol 4

5 EPC System Controller Perc Lock Design implemented to prevent accidental percutaneous lead disconnections from the EPC system controller HeartMate II Power Sources AC power from Power Module (PM) DC power from a pair of 14-volt lithium-ion batteries and clips- last hours of operation Universal Battery Charger Rapid charging of batteries 4 hours for 4 batteries Continuous diagnostic testing and automatic calibration Highly portable 8 pounds 5

6 Power Module Supplies AC power to HM II Provides 30 minutes of backup power in case of AC power failure Repeats alarms generated by the System Controller Powers the System Monitor for programming and monitoring purposes Display Module Needed to visualize pump parameters when the EPC controller is in use. Fixed Speed 9600 PI 5.5 Flow 4.5 Power 8.2 Do NOT connect the Display Module to the Power Module if the patient is using a Pocket Controller. *Display Module NOT Compatible with Pocket Controller 17 Battery Powered Operation 6

7 Tethered Operation 19 Advisory & Hazard Alarms Advisory Alarms Yellow Power Cable Disconnected Low Voltage Replace System Controller Replace Backup Battery Low Speed Driveline Fault Backup Battery Not Installed Controller Clock Not Set Hazard Alarms RED PUMP OFF DRIVELINE DISCONNECTED NO EXTERNAL POWER LOW FLOW LOW VOLTAGE Viewing Alarm History Last 6 Hazard alarms can be viewed on Pocket Controller display Simultaneously press silence alarm & display buttons To view the next alarm, press display button 7

8 Patient Management Key Points.. No or intermittent palpable pulse (continuous flow device) Standard measures for BP and pulse oximetry may not be reliable Pump is preload dependent and afterload sensitive Patient Assessment Patient assessment includes: Pump function Pump speed, flow, power, pulse index (PI) System controller settings, alarm status Driveline is connected to system controller and safety tab is in locked position Exit site status, immobilization of driveline Airway & respiratory status Vital signs, peripheral circulation Mental status, level of consciousness Anticoagulation precautions typically on ASA and Coumadin 8

9 Vital Signs HR: use EKG for rate/rhythm BP: Manual cuff + Doppler. Goal mmhg SpO2: may/may not be accurate Potential Patient Complications Bleeding GI bleeding TIA/Stroke Arrhythmias Right Heart Failure Volume Overload Dehydration Cardiac Tamponade Hypertension Hypotension Aortic Insufficiency Recurrence of Heart Failure Symptoms Infection: Drive Line, Pump Pocket, Septicemia Hemolysis DRIVELINE = LIFELINE Dressing changes Sterile dressing on site at all times Cleansed with Chlorohexidine Secured with an anchor and/or stabilization belt 9

10 Care of the Percutaneous Lead Damage to the percutaneous lead, depending on the degree, may cause the pump to stop Do not severely bend, kink or twist the percutaneous lead Do not catch the percutaneous lead in the zipper of the carrying case Do not severely bend the lead multiple times or wrap it tightly. Keep the percutaneous lead clean and dry Defibrillation / Cardioversion External defibrillation or cardioversion Do not stop the pump Patient may tolerate dysrhythmia longer than non-vad patient Many patients will have internal ICD/pacer May be performed on battery or AC power Cardiac Arrest Potential risks associated with external chest compressions Outflow graft & LV apex anastomosis disruption Recommend no external chest compressions Troubleshoot VAD first Patient connected? Power/ Power/ Power? 10

11 Thoratec Resources Call the LGH LVAD Coordinator on call with any questions HeartLine (24 Hour Clinical & Technical Support) (not for patient use) Published Reference Materials Questions? Comments? Concerns? Call the VAD Team Pager (24/7):