Page 6 - VAD Guidelines
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Pediatric Ventricular Assist Device (VAD) Guidelines

               When to consider VAD support
               VAD implantation should be considered when medical management is failing to maintain adequate
               circulation. Clearly this is the case in cardiogenic shock but VAD support should also be considered when
               heart failure requires:
                     More than one high dose inotrope
                     End-organ dysfunction
                     Need for persistent mechanical ventilation
               In some instances a VAD may be useful in severe feeding intolerance or failure to thrive despite optimal
               oral and inotropic therapy.

               Device Terminology
               Paracorporeal (previously known as Extracorporeal) mechanical circulatory support devices provide
               support through a pump mechanism and housing that remains outside the body. These devices vary
               from traditional extra corporeal membrane oxygenator (ECMO) to pulsatile (Berlin) and continuous flow
               (PediMag, CentriMag) devices.  The devices require on-going, in-patient management making hospital
               discharge not feasible. Paracorporeal devices can be further subdivided into those referred to as
               “temporary devices” (PediMag, CentriMag), based on FDA approval for device support lasting <72 hours,
               and durable devices (Berlin).  Trends in device subtype usage in pediatrics aimed at optimizing patient
               outcomes through advancements in technology, however, have led to an increasingly blurred distinction
               between “temporary” and durable support.
               Intra corporeal VADs provide support through a pump mechanism and housing contained within the
               thoracic or intra pericardial space while pump control and power supply modules remain outside the
               body communicating through a percutaneous driveline. These devices are similarly subdivided into
               “temporary” (Impella) and durable support systems based on intended/approved duration of support.
               Durable devices are further subdivided into intra pericardial, continuous flow devices (HeartWare,
               HeartMate 3, and Jarvik 2015) and intra-thoracic pulsatile devices (Syncardia).  Though the mechanism
               of support differs between these durable devices, all represent the potential for hospital discharge on
               device support.
               Ventricular assist devices vary by the mechanism of support; pulsatile or continuous.  Blood flow in
               pulsatile devices is facilitated by a pneumatically driven membrane leading to filling and ejection of the
               device.  Continuous flow devices achieve blood flow through either an axial mechanism where blood
               flow is in parallel to the device impeller (Impella, Jarvik 2015) or centrifugal mechanism where blood
               flow is orthogonal to the device impeller (CentriMag, PediMag, HeartWare, HeartMate 3). Fluid
               dynamics and pump function differ considerably between continuous flow mechanisms with the most
               clinically important difference being centrifugal flow devices are significantly afterload sensitive.

               VAD Device Types & Selection
               There are now many devices available.  Device selection is dependent upon several factors including
               patient size, cardiovascular anatomy/physiology, degree of acute cardiovascular instability, need for
               biventricular versus isolated sub-pulmonic or systemic ventricular support, and likelihood of cardiac
               recovery. Two devices are intended to be deployed in acute settings (ECMO, Impella) while the
               remaining devices including PediMag, CentriMag, Berlin, Heartware (HVAD), Heartmate 3 and Syncardia
               require multidisciplinary planning. The Berlin Heart EXCOR is no longer the preferred device for support
               related to poor outcomes in single ventricle (SV) and small (<10 kg) patient populations as well as an
               unacceptable adverse event profile as compared to continuous flow devices.  However, this device may
               still be used in circumstances as deemed appropriate by the multidisciplinary VAD team.



               Updated 12/14/2018                                                                      page 6
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