9
WARNING: The safety and effectiveness of use of the CentriMag system in an ECMO circuit (i.e. cardiopulmonary support > 6
hours) has not been demonstrated.
WARNING: The safety and effectiveness of use of the CentriMag system for use > 30 days has not been demonstrated.
Patients undergoing cardiac surgery who fail to be weaned from cardiopulmonary bypass due to poor cardiac function or high risk of
dysrhythmias may benefit from continued circulatory support with a ventricular assist device.
In this post-cardiotomy scenario,
CentriMag system support can be initiated quickly without significant additional resources. Patients can then be transferred to a
recovery area or intensive care unit in a hemodynamically stable condition. Further patient assessment and treatment options can then
be considered.
Types of Support
The CentriMag system can be used as an LVAD, RVAD, or BiVAD as described in the sections below.
Isolated LVAD Support
When compromised or impaired left ventricular function results in a patient being unable to wean from cardiopulmonary bypass,
CentriMag LVAD support may be beneficial. Cannulation options include placement of a drainage cannula in the left atrium or left
ventricle with a return cannula placed or attached to the ascending aorta, axillary artery, or a femoral artery.
Isolated RVAD Support
Patients who may require isolated RVAD support include those in cardiogenic shock due to acute right ventricular failure
or those
whose right ventricular function is too compromised to wean from cardiopulmonary bypass. Patient history and pre-implant
assessment of the heart using cardiac echocardiography and a determination of PVR should help to identify patients who will benefit
from RVAD support for cardiogenic shock. Cannulation options are placement of a drainage cannula in the right atrium, right ventricle,
superior vena cava, or inferior vena cava, with a return cannula in the pulmonary artery.
RVAD Support following LVAD Implantation
RVAD support may be required following implantation of a durable LVAD. Initiating LVAD support can cause an acute decrease in left
ventricular pressure that can change the position of the intra-ventricular septum, lead to distention of the right ventricle, and an
increase in right atrial pressure. Under these conditions, right atrial pressures above 15-20 mmHg are suggestive of right ventricular
dysfunction. Such a condition is often associated with a decrease in right ventricular contractility and tricuspid insufficiency. If
adequate LVAD flow cannot be achieved, and there are signs of right heart failure, it may be necessary to temporarily support the right
ventricle with a CentriMag
TM
RVAD. Diagnostic assessments include cardiac echocardiography, measurement of right heart pressures,
and if possible, direct visualization of right ventricular function.
Biventricular Support
Biventricular support may be necessary in instances where the entire heart is functioning too poorly to wean a patient from
cardiopulmonary bypass.
Preparing for CentriMag System Use
The CentriMag system components and supplies are often stored in the operating room area to be immediately available when needed.
The consoles must be connected to AC power during storage to ensure that the batteries are always fully charged. A backup system must
always be close to the patient in the event it becomes necessary to switch to backup system components.
System Setup
System setup and initiation of support is often performed under emergent conditions. The procedure for setting up the CentriMag system,
as described in the CentriMag Circulatory Support System Operation Manual, may be tailored to meet the anatomical and clinical
conditions of individual patients. Different methods for priming the pump and circuit are discussed below.
After the setup and priming steps are completed, all of the connections should be secured with bands.
CAUTION: Ensure that the tubing is secured with bands on a portion of the connection where the two components overlap ( i.e.
where the tubing covers the pump inlet). The tubing should be over the lip of the pump connector.
Alternatives for Pump Priming and De-airing
Priming should be performed using either a priming pack or circuit submersion technique that follows standard surgical protocols.
Two alternatives are described below.
Priming Pack Technique
Typical Contents
The following is a suggested list of equipment and supplies that may be used with a pre-assembled circuit or priming pack.
1
Humanitarian Use. The effectiveness of this device for this use has not been demonstrated.
2
Humanitarian Use. The effectiveness of this device for this use has not been demonstrated.
3
For the pumps, you will need one for univentricular support, two for biventricular support, plus a backup. For the console with motor and flow probe connected, you will need one of
