HeartWare® Ventricular Assist System HVAD® Pump Waveforms TM00017 Rev03 02/14 Module 8/10 © 2016 HeartWare, Inc. CAUTION: Federal CAUTION: Law (USA) Federal restricts Law (USA) this device restricts to sale thisby device or ontothe sale order by or of on a physician. the order of a physician. Refer to the “Instructions Refer to the For “Instructions Use” for complete For Use” Indications for complete for Use, Indications Contraindications, for Use, Contraindications, 1 Warnings, Precautions, Warnings, Adverse Precautions, EventsAdverse and Instructions Events and prior Instructions to using this prior device. to using this device. Objectives • Review HVAD® Pump Waveform Characteristics • Review sample waveforms CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 2 HVAD® Pump Waveform Overview • The HVAD® Pump is a continuous flow, centrifugal pump, capable of full support • The HeartWare® Ventricular Assist System has a system monitor which displays real-time waveforms of the HVAD pump Pump power (W) Pump flow (L/min) CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 3 HVAD® Pump Performance Overview • Waveforms are a tool to provide insight into the patient’s condition and help with patient management • Pump flow waveform depicts the rate of blood flowing through the pump • The shape of the waveform varies with clinical changes CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 4 HVAD® Pump Waveform: How It’s Derived Inputs Speed Power Processing Viscosity Input Outputs CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 5 HVAD® Pump Waveform: Waveform Characteristics Heart rate • Flow Waveform: difference between afterload (AP) and preload (VP) • Pulsatility: Variation in pump flow relative to native systole and diastole – Dependent on heart contractility and HVAD operating points – Systole max HVAD flow – Diastole min HVAD flow • Waveform Trough: minimum value of the flow waveform Beginning of diastole Pulsatility Waveform Trough Beginning of systole Trough should be >2 L/min There should be >2 L/min of pulsatility CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 6 HVAD® Pump Waveform: Waveform Characteristics • As the heart ejects, additional blood leaves ventricle and enters pump • Despite a constant speed, pump flow increases during systole • Power increases in response to increased blood volume to keep the speed at its pre-set level • Increased power calculates into an increased estimated flow CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 7 HVAD® Pump Waveform: Sample Suction Condition CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 8 HVAD® Pump Waveform: Preload and Afterload • Preload: Volume of blood returning to the RV, LV, or LVAS (RAP, LAP, or LVAS Fill Rate) • Afterload: Arterial pressure or resistance the RV, LV, or LVAS has to pump against to empty (PAP, MAP, SVR, or MAP/residual volume) Contributing Factors – Heart rate and arrhythmias – Hypovolemia • Bleeding • Diuretics • Third spacing – RV dysfunction – Vasodilatation – Vasoconstriction – Elevated MAP and/or SVR – Electrolyte or acid-base imbalance – Tamponade – Pneumothorax – Inflow/outflow obstruction CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 9 Sample Waveform Interpretations Flow waveform analysis is based solely on data provided to the monitor from the controller without independent verification. The assessments of the flow waveform may be indicative of certain patient conditions. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 10 Waveform Interpretation: What Do These Waveforms Represent? Scenario • 68 yr old female, s/p HVAD implant • POD 2, patient stable • On morning rounds, this is what is displayed on the monitor A. Ventricular Fibrillation B. Normal Waveform C. Suction Event D. Concurrent IABP CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 11 Waveform Interpretation: What Do These Waveforms Represent? Scenario • • • • 52yr old male, s/p HVAD implant POD 0, admitted originally with AMI Initially supported by IABP, but remained in shock with no recovery of LV You were told the case went smoothly, except “some Vfib when coming off pump”; patient was shocked x3 with success • This is what is displayed on the monitor A. Ventricular Tachycardia B. Normal Waveform C. Suction Event D. Concurrent IABP 1:1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 12 Waveform Interpretation: What Do These Waveforms Represent? Scenario • 63yr old male, in OR for HVAD implant • Pump started 15 min ago, all was fine • This is what is displayed on the monitor A. Supraventricular Tachycardia B. Normal Waveform C. Artifact D. Suction Event CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 13 Waveform Interpretation: What Do These Waveforms Represent? • • • • Scenario 67 yr old female, s/p HVAD implant POD 0, has been in ICU for 7 hours Patient is stable and being weaned from ventilator - she is waking up, you go in check on her This is what is displayed on the monitor A. Ventricular Tachycardia B. Normal Waveform C. Artifact D. Thrombus CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 14 Waveform Interpretation: What Do These Waveforms Represent? Scenario • 73yr old female, s/p HVAD implant • POD 3, on Milrinone 0.375mcg/kg/min and currently weaning epinephrine • This is what is displayed on the monitor A. Low Mean Arterial Pressure (MAP) B. Hypovolemia C. Excessive Pump Speed D. All of the Above CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 15 Waveform Interpretation: What Do These Waveforms Represent? • • • • Scenario 56yr old male, s/p HVAD implant POD 4, patient has been doing well, all infusions have been weaned except milrinone which is being weaned, currently at 0.25mcg/kg/min He has been out of bed and moving around, and has been aggressively diuresed after surgery This is what is displayed on the monitor A. Ventricular Tachycardia B. Suction Event C. Normal Waveform D. Artifact CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 16 Waveform Interpretation: What Do These Waveforms Represent? • • • • Scenario 33yr old female, s/p HVAD implant for peripartum CMO POD 0, originally supported by IABP, but continued to deteriorate which led to her HVAD implant She has just returned from the OR - you are told case went smoothly This is what is displayed on the monitor. A. Ventricular Fibrillation B. Normal Waveform C. Suction Event D. Concurrent IABP 1:2 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 17 Waveform Interpretation: What Do These Waveforms Represent? Scenario • 72yr old, female, given new antibiotics by primary doctor for upper respiratory infection, on Day 5 of those she calls and says she is experiencing alarms, you bring her to clinic. • This is what is displayed on the monitor. A. Low Flow B. Normal Waveform C. High Watts D. Suction Event CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 18 Waveform Interpretation: What Do These Waveforms Represent? Scenario • 67yr male, comes to clinic and reports he is getting more tired and short of breath than usual, but no other complaints • This is what is displayed on the monitor. A. IABP B. Artifact C. Normal Waveform (Irregular Heart Rate) D. Suction CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. 19