AUTOLOGS TM ATLAS ON DEMAND DATA WITH EVERY PATIENT VISIT

Transcription

1 AUTOLOGS TM ATLAS ON DEMAND DATA WITH EVERY PATIENT VISIT Introduction The Autologs Atlas will guide your introduction to our new Autologs service and the information recorded by the HeartWare HVAD TM System.

2 HOW TO READ AN AUTOLOGS TM REPORT VERIFY PATIENT INFORMATION Do you have the correct patient? Is the data through the current date? CONFIRM CURRENT VAD PARAMETERS Are speed, flow, and power at expected levels? Consider referring to published data, such as the HVAD TM Pump Power Speed Table, for more information. ANALYZE PUMP PERFORMANCE Are flow, pulsatility, and power consistent? Are there any gradual or sudden deflections? 4 5 IDENTIFY ALARMS AND TRENDS Did you know about this alarm? Do you need clarification on an alarm or fault? Do alarms indicate a need for more patient training? MONITOR BATTERY USAGE Are any batteries above 500 cycles? If so they should be replaced. Is the patient properly rotating batteries?

3 HVAD TM PUMP POWER SPEED TABLE Based on a recent article published in ASAIO, a 224-patient study compared HVAD speed and power consumption to identify HVAD operating regions The article identified, that for a given speed setting, the HVAD power consumption should lie in the green Normal Region. If power consumption lies in either the red Abnormal High Region or blue Abnormal Low Region, the article found the HVAD TM System or patient may require further evaluation.

4 CONSISTENT PUMP PARAMETERS In this example, the patient s system has recorded regular and consistent power, flow, and pulsatility. Consistent flow rates Consistent pulsatility Consistent power consumption Consistent periodicity of power, flow, and pulsatility

5 RAPID DOWNWARD DEFLECTIONS IN FLOW In this case, the system recorded a recent history of intermittent self-clearing suction conditions. Intermittent rapid downward deflections in flow and pulsatility.

6 SHARP INCREASE IN POWER In this example, the system recorded an increase in power consumption outside of the normal range. Upon further evaluation, it was noted there was thrombus in the pump. Increase in power consumption above the historical range

7 SHARP & SUSTAINED DECREASE IN FLOW In this example, the system recorded a rapid and sustained decrease in estimated flow. Field data later confirmed the pump was occluded. Sharp decrease in flow from historical values followed by a sustained low flow

8 GRADUAL DECREASE IN PUMP FLOW & PULSATILITY In this example, the system recorded a decrease in pump flow and pulsatility. Field data later confirmed the patient experienced a gastrointestinal bleed. Decreasing pulsatility Decreasing pump flow

9 LOSS OF FLOW PERIODICITY In this example, the system recorded a loss of periodic rises and falls in flow. Field data later confirmed an interruption of the patient s Circadian Rhythm. Periodic rises and falls in flow Loss of periodicity Return of periodicity

10 LOGGED ALARMS In this example, the system recorded Controller High Watt and Electrical Fault alarms which were later found to be due to damage incurred by the patient s driveline.

11 UNEVEN BATTERY USAGE In this example, the system recorded a significant discrepancy between battery cycle counts, which was later found to be due to the patient not properly rotating batteries. BATTERY SUMMARY Battery ID Cycle Count Though all four batteries were provided to the patient at the same time, battery cycle counts are significantly dissimilar.

12 Publications Feldman, D, et al ISHLT MCS Guidelines. The Journal of Heart and Lung Transplantation, Vol 32, No 2, February References 1 Chorpenning, K, et al. HeartWare controller logs a diagnostic tool and clinical management aid for the HVAD pump. ASAIO. 2014;60: Brief Statement: HVAD TM System Indications: The HeartWare Ventricular Assist System is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter. Contraindications:The HeartWare System is contraindicated in patients who cannot tolerate anticoagulation therapy. Warnings/Precautions: Proper usage and maintenance of the HVAD TM System is critical for the functioning of the device. Never disconnect from two power sources at the same time (batteries or power adapters) since this will stop the pump, which could lead to serious injury or death. At least one power source must be connected at all times. Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency. Do not expose batteries to excessive shock or vibration since this may affect battery operation. Do not grasp the driveline cable as this may damage the driveline. Do not pull, kink or twist the driveline or the power cables, as these actions may damage the driveline. Special care should be taken not to twist the driveline including while sitting, getting out of bed, adjusting the controller or power sources, or when using the shower bag. Do not disconnect the driveline from the controller or the pump will stop. If this happens, reconnect the driveline to the controller as soon as possible to restart the pump. Potential complications: Implantation of a Ventricular Assist Device (VAD) is an invasive procedure requiring general anesthesia, a median sternotomy, a ventilator and cardiopulmonary bypass. There are numerous risks associated with this surgical procedure and the therapy including but not limited to, death, stroke, device malfunction, peripheral and device-related thromboembolic events, bleeding, infection, hemolysis and sepsis. Refer to the Instructions for Use for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions and potential adverse events prior to using this device. The IFU can be found at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. HEARTWARE, Autologs, HVAD, and the HEARTWARE logo are trademarks of HeartWare, Inc HeartWare, Inc. GL1255 Rev01 12/16.