True Flow of the HeartAssist5® confirmed by VAD Implant Center Ramp Studies

ReliantHeart, Inc., an innovative supplier of advanced mechanical circulatory assist technologies that include the HeartAssist5® and the unique feature of True Flow Measurement, have determined that ramp studies performed at LVAD Implant Centers confirm the HeartAssist5® True Flow accuracy.

Clinicians caring for the ever growing LVAD population are vitally aware of the lack of pump performance information required to manage a VAD patient. A startling example is the setting of the pump speed to achieve the desired flow. Typically the speed is set in the operating room and subsequently adjusted on the basis of integration of hemodynamic parameters, device power, speed, and echocardiography.

Modern ramp studies are often conducted to set the patients pump speed to the ideal flow while in the hospital. With other devices, implant centers are required to go to the cath lab and perform a lengthy and uncomfortable ramp study where they use echo and a Swan-Ganz catheter to measure cardiac output which they correlate with aortic valve opening and pump speed.  With the HeartAssist5® system, LVAD implant centers can run this study in the patients’ room in just a few minutes.  The flow wave form demonstrates pump output and valve opening directly so the ideal pump speed (True Flow) can be selected for each patient because each patient is unique.

According to Bryan Lynch, CTO of ReliantHeart, “The HeartAssist5® system transmits True Flow in real time to a clinician friendly bedside device or a web based dashboard hosted on VADlink.com. All other competing LVADs calculate flow as a derivative of pump speed and power consumption, and the calculated flow is seldom correct, especially when you really need it. True Flow management is essential to reducing adverse events and can be monitored 24/7 by the patient’s clinician on VADlink.com. With True Flow, if there is a drop in flow below a minimum threshold, the patient and the clinician or his staff can be notified immediately. Early warning and intervention is key to improving LVAD patient outcomes. True Flow is the best early warning available and the best way to measure pump performance in real time.”

In the example below, the patient’s flow dropped from an average of 5.7 LPM to an average of 4.8 LPM. The most recent day is illustrated on the left of the chart, and the oldest day on the right of the chart, from day one to day 30.

True Flow Wave Form

Notice that on day 12, True Flow dropped by 1 LPM to an average flow of 4.8 LPM. The historical True Flow Wave Form was requested and the result demonstrated that the patient was in Atrial Fibrillation beginning 12 days ago reading from right to left. The chart demonstrates that the clinician can look deep into the heart of a patient from across the world to read True Flow. Notice that the True Flow day 12 to 30 is set to assure the opening of the Aortic Valve by achieving the flat spot or notch on the top of the wave form. This diagnostic approach is not available with any other LVAD.

Wireless sensors to monitor the left atrial pressure (LAP) in hospital settings or at home may also provide information for the early detection of potentially-dangerous conditions such as LVAD-thrombosis. However, the indication of rising LAP may be a late indicator. The LAP wireless sensor is not remotely monitored but remotely interrogated and thus it may be a late indicator of dangerous pump thrombus.

While LAP may help in setting pump speed, there is no substitute for True Flow and actual True Flow Wave Form, in conjunction with speed and power, to optimize LVAD therapy and reveal any problems that may arise before they are critical.

ReliantHeart, Inc. is an innovative supplier of advanced mechanical circulatory assist technologies that are changing the approach to the treatment of advanced heart failure.  It develops and manufactures the HeartAssist5® Ventricular Assist Device.

ReliantHeart’s roots are in Houston, Texas, where it has been generously influenced by the transplant centers of Texas Heart, Methodist DeBakey and Memorial Hermann, and its technology originally inspired by NASA, the Johnson Space Center and Baylor School of Medicine.

IDE Clinical Trial  – United States

ReliantHeart Inc. is currently conducting an FDA Investigational Device Exemption (IDE) Clinical Trial on the HeartAssist5® Ventricular Assist Device System.  The trial is a prospective, 1:1 randomized, multicenter, clinical trial to evaluate the safety and efficacy of 96 patients implanted with the ReliantHeart HeartAssist5® Ventricular Assist Device (VAD) System compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD for left ventricular support while awaiting cardiac transplantation. The trial is expected to run through 2016.

The HeartAssist5® is a device limited by Federal law to investigational use in the United States.

CE Mark – Europe

ReliantHeart HeartAssist5® Ventricular Assist Device is CE Mark approved for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation.