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The low flow alarm is set. This should be set at approximately 75% of the desired clinical flow. 

 

There is air circulation around the motor and console. 

 

There are two tubing clamps near each pump. 

Staff should periodically rehearse switching to the backup motor and console using a spare system and training (mock circulatory) loop. 
Refer to the CentriMag Circulatory Support System Operation Manual for details. 

 

Hemodynamic Assessment and Support 

Hemodynamic monitoring during support with the CentriMag system has some special considerations. During LVAD support, the 
arterial pressure waveform will normally show a significantly reduced pulse pressure (Systolic-Diastolic) when the left ventricle is 
completely unloaded. An increase in the pulse pressure will be observed as the ventricle recovers,  when the pump flow is decreased, 
or if the volume status of the patient is increased. A similar change will be seen on the pulmonary artery waveform during RVAD 
support. 

 

Pulmonary artery catheters may prove useful for monitoring during CentriMag system support, but there are some important 
considerations during  RVAD support. First, because the pulmonary artery catheter is inserted and maintained in position with the aid 
of blood flow through the right heart, insertion of a catheter during RVAD support is usually not possible. Pulmonary artery catheters that 
are in  place before RVAD implant may be used for pressure monitoring and mixed venous oxygen saturation only, but often can migrate 
out of the pulmonary artery. Thermodilution or continuous cardiac output determinations are inaccurate during RVAD support. 
Since the inflow and outflow cannulas are placed in the right atrium and pulmonary artery, the majority of the circulating blood 
travels through the pump circuit, rendering the pulmonary artery flow measured by the catheter incorrect. The RVAD flow bypasses the 
thermistors that measure the temperature changes needed for the cardiac output measurement. However, in most cases the mixed 
venous oxygen saturation may be used to estimate changes in total cardiac output based on the Fick principle.  

CAUTION:  The usual thermodilution methods for measuring total cardiac output might be inaccurate, and pump flow may 
not represent total cardiac output. Although the CentriMag system may capture the majority of blood flow, some 
ventricular output may be through the aortic or pulmonic valve. CentriMag system flow may also be elevated due to shunts 
or incompetent valves. 

Adequate volume is essential for pump operation. Fluid balance should be routinely monitored using patient weight, CVP, LAP, and/or 
PCWP, with careful attention to intake and output. 
If there is significant diuresis, intravascular fluid shifts or bleeding, this will adversely affect the available blood volume needed to 
operate the system, and the flow may need to be temporarily reduced while these conditions are treated. If a CVP catheter needs to be 
placed during CentriMag system support, care must be taken to avoid air entrainment during placement.  Consider temporarily 
decreasing the RPMs during insertion. This will make it easier to see the IJ or subclavian. Place the patient in the Trendelenberg 
position, if tolerated.  Be sure there are no signs of negative pressure during insertion (line chatter, ramping of the flows, or flow 
below the minimum alert). Place a stopcock on the open ports of the central line to avoid air being entrained. 

CAUTION: Never leave any ports open to the air, as sudden suction could result in air entrainment and the subsequent air 
embolus will be delivered to the patient. 

Bleeding is a common complication following CentriMag system placement and should be carefully monitored. Excessive bleeding that 
does not  decrease may require a reoperation. Constant attention must be given to maintaining a normal hemoglobin concentration. 
Excessive  diuresis in the post-operative phase should also be carefully monitored, and replacement volume administered as required. 
Inotropic support is often used to support ventricular function, maintain wall motion, and reduce the risk of intra-ventricular 
thrombosis, but should be used conservatively during CentriMag system support. High doses or prolonged use of inotropes may deplete 
myocardial energy stores, making weaning and complete recovery more difficult. Milrinone is the usual drug of choice because of its 
positive inotropic and vasodilatation effects. Inotropic support should be avoided during the initial weaning and assessments of 
recovery, but gradually increased during the CentriMag system explant. 
The pulmonary vascular resistance should be carefully monitored and treated when necessary. Because the PVR is not continuously 
monitored, acute changes may not be observed. A sudden decrease in the LVAD flow is often caused by inadequate intra-ventricular 
volume but may also be an indication of an elevated PVR due to administration of blood products, a response to an infusion, or other 
cause. Pulmonary vasodilators are commonly used in the immediate postoperative period, with inhaled nitric oxide being the most 
effective and safe. Patients with significant bleeding that require transfusions may be expected to have an increase in PVR. Many 
CentriMag system users apply prophylactic nitric oxide and use intravenous vasodilators as a last resort. 
 

Intra-aortic Balloon Pump 

An intra-aortic balloon pump may provide pulsatility during CentriMag system support, but its usefulness with the CentriMag system 
has not been demonstrated. If used with LVAD support, the augmentation or balloon volume should be decreased so that complete 
occlusion of the aorta does not occur. Consider pulling back the sheath to improve distal perfusion, which should be assessed at least 
hourly. The IABP may be removed in the critical care unit after coagulation parameters have normalized. If weaning is anticipated 
within 48 to 72 hours, leaving the IABP in place may be appropriate. 

 

Defibrillation/ Cardioversion 

Defibrillation or cardioversion may be necessary during severe arrhythmias. Cardioversion may be performed without stopping the pump. 
Ensure that a backup console and motor are available, powered and in the immediate vicinity. 
If cardioversion is attempted without discontinuing support, consideration should be given to reducing the speed of the pump (or 
pumps for BiVAD support) to reduce the likelihood of Right-Left imbalance and pump inlet obstruction. Following cardioversion, slowly 
increase the speed (or resume BiVAD support) while monitoring the patient's hemodynamics to ensure adequate volume available for the 
desired flow. 

CAUTION: If you choose to reduce the speed during cardioversion, carefully monitor systemic hemodynamics for adequate 

Содержание CentriMag

Страница 1: ...ENTRIMAG CIRCULATORY SUPPORT SYSTEM Abbott Medical Clinical Technical Support Phone number s United States Emergency HeartLine Support USA Tel 1 800 456 1477 Abbott Medical Main Switchboard Tel 1 925...

Страница 2: ...3 Indicates a trademark of the Abbott group of companies Indicates a third party trademark which is property of its respective owner Pat http www abbott com patents 2019 Abbott All Rights Reserved...

Страница 3: ...14 Intraoperative Device Management 15 Guidelines to Prevent Air Entrainment when Initiating Support 15 Patient Care and Management 15 Guidelines to Prevent Air Entrainment during Support 16 CentriMag...

Страница 4: ...5 Safety and Effectiveness and Results 27 Device Malfunctions and Failures 30 Clinical Study Safety and Effectiveness Conclusions 33...

Страница 5: ...ce The CentriMag Circulatory Support System is indicated for use as a right ventricular assist device Humanitarian Device The system when used as a right ventricular assist device is also authorized b...

Страница 6: ...right ventricular assist device TEE transesophageal echocardiography TEG thromboelastography Description The CentriMag system is designed to provide a versatile and effective means for implementing me...

Страница 7: ...t be set high enough to overcome native cardiac pressure in order to prevent retrograde flow Increasing the RPM will increase the flow of blood through the pump CAUTION If an increase in set speed doe...

Страница 8: ...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 can...

Страница 9: ...plies that may be used for this technique 4 CentriMag pumps Drainage cannulas Return cannulas 2nd Generation CentriMag console with motor and flow probe connected Standard 3 8 ID x 3 32 wall tubing Tw...

Страница 10: ...echnique should be performed using aseptic techniques To prime the pump 1 Fill a large sterile basin with three liters of a warm balanced electrolyte solution 2 Slowly submerge one end of the drainage...

Страница 11: ...ailable venous and arterial cannula may be used at the preference of the clinician For central cannulation it is advisable to use cannulas that are wire reinforced to resist kinking The drainage cannu...

Страница 12: ...clamps are removed before the speed is set higher than 1000 RPMs there is a risk of retrograde flow NOTE If other manufacturers cannulas are used follow standard surgical techniques applicable to thos...

Страница 13: ...tions above for left and right sided support See options above for left and right sided support Two cannulation approaches are shown in the figures below The left ventricle is drained via the left ven...

Страница 14: ...E hemodynamic monitoring palpation and direct visualization of the heart will help to determine the volume of blood available for the circuit and the optimal level of flow After the chest is closed th...

Страница 15: ...econds allowing the patient s vascular system to adjust between each RPM change The pump set speed should be gradually increased to the desired flow If flow drops or tubing chatter is observed the set...

Страница 16: ...during insertion line chatter ramping of the flows or flow below the minimum alert Place a stopcock on the open ports of the central line to avoid air being entrained CAUTION Never leave any ports op...

Страница 17: ...Wound sites should be carefully inspected for signs of tissue breakdown or excessive drainage Undue pressure or torque to the surgical site should be avoided in order to minimize trauma with special c...

Страница 18: ...atient during transport Prior to shutting off the power supply and removal of the patient from the transport vehicle briefly unplug the console s power cord to confirm adequate battery charge and cons...

Страница 19: ...d a decreased dependence on inotropic support Initial assessments of ventricular function should be made without increasing inotropic support IABP support or without volume loading of the ventricles E...

Страница 20: ...5 The new tubing connectors are attached using a wet wet connection while taking care to eliminate air at the junction as well as in the circuit Secure these new connections with bands 6 Ensure that...

Страница 21: ...ents suffering from post cardiotomy cardiogenic shock who were unable to be separated from CPB prior to leaving the operating room Clinical Inclusion Criteria Enrollment in the studies was limited to...

Страница 22: ...pport Not applied to this study All possible measures have been attempted to correct low arterial pH arterial blood gas abnormalities electrolytes hypovolemia hypervolemia inadequate cardiac rate dysr...

Страница 23: ...entriMag system removal Adverse events and complications were recorded throughout the duration of CentriMag system support through device removal and until the patient was discharged from the hospital...

Страница 24: ...1 12 Patients N 32 26 12 25 Sex Male 24 75 15 58 8 67 20 80 Female 8 25 11 42 4 33 5 20 Race White 24 75 4 13 4 13 N A13 N A13 19 76 4 16 2 8 African American Other Age mean years SD 58 13 8 59 11 6 5...

Страница 25: ...seline Laboratory Values FTW from CPB G030052 S21 Variable N Mean SD Median Min Max Blood Urea Nitrogen mg dl 32 39 1 21 3 32 12 94 Creatinine mg dl 32 1 8 0 8 1 6 0 9 4 Total Bilirubin mg dl 31 1 8 1...

Страница 26: ...ut not identical across the studies so direct comparisons are not possible However the table shows that general trends in types and incidence of adverse events were similar across all four studies Tab...

Страница 27: ...otension 1 1 3 5 5 19 2 2 17 0 0 0 8 8 8 Hepatic Dysfunction 1 1 3 8 7 27 3 2 17 0 0 0 12 10 11 Renal Failure Dysfunction 8 8 25 3 3 12 1 1 8 12 12 48 24 24 25 Neurologic Dysfunction 0 0 0 8 8 31 2 2...

Страница 28: ...4 4 Other 1219 9 28 0 0 0 0 0 0 2120 10 40 33 19 20 19 Right arm compartment syndrome bronchorrhea and desaturation cardiogenic shock with suspected platelet dysfunction tear in ventricular tissue nea...

Страница 29: ...valuate the safety of the device These data were obtained by analyzing adverse events associated with marketed CentriMag systems which were reported to Abbott Medical between June 1 2014 and June 30 2...

Страница 30: ...he tables below Table 15 CentriMag Effectiveness in FTW Subjects from CPB Pivotal Study G030052 S21 Survival and Primary Endpoint Clinical Study N Survival to 30 Days Post device Survival To Discharge...

Страница 31: ...y Endpoint Clinical Study N Survival to 30 Days Post device Survival to Discharge Primary Endpoint Success Cardiogenic Shock Trial G030052 22 26 11 26 42 Not Defined RVAS Trial G040029 23 12 7 12 58 N...

Страница 32: ...ing acute myocardial infarction or post cardiotomy failure to wean from cardiopulmonary bypass and in patients with acute right ventricular failure from any cause In all studies the adverse event rate...

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