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15 

 

Intraoperative Device Management

 

After all cannula-to-tubing connections are completed, a clamp is placed on the return tubing of each pump, while all other clamps 
are removed from the circuit. Before the outflow clamp is released, the pump set speed (RPM) is increased to at least 1,000 RPM in 
order to prevent retrograde flow through the system. The set speed is then gradually increased to reach the desired flow rate. As the set 
speed is gradually increased, CPB support can be simultaneously decreased to allow filling of the heart, and then  terminated. During 
weaning from CPB and initiation of CentriMag system support, the patient must be carefully monitored with  hemodynamic monitoring 
(usually CVP, PAP and ABP), echocardiography, manual palpation and visual inspection of the heart to ensure that adequate blood 
volume is available for the desired flow and to reduce the risk of a suction event. For LVAD support, left atrial pressure should be 
maintained between 10 and 15 mmHg in order to avoid suction within the left ventricle and inflow  obstruction, which can lead to air 
entrainment. For RVAD support, right atrial pressure should also be maintained between 10 and 15 mmHg.

 

CAUTION: Ensure that air does not enter into the circuit when the tubing is connected to the cannula. 

 

CAUTION: If CPB support is not decreased as the set speed is increased, suction events may occur due to lack of volume. 

The desired flow rate can be predetermined by calculating the flow needed to achieve a cardiac index of approximately 2.0-2.2 
l/min/m

2

. As the flow is increased, the atria and/or ventricles are monitored for adequate pressure and blood volume. The console 

operator continuously monitors the pump flow, RPM, and blood pressure for signs of suction within the circuit. Suction is most likely 
when filling pressures are <10 mmHg and is accompanied by fluctuations in flow. When suction is detected, the speed of the pump 
must be immediately decreased until the filling pressure and volume are adequate to increase the flow. The system should be 
monitored frequently in the operating room when the patient’s chest is open as this is the period of highest risk for suction and air 
entrainment. 
The central venous pressure, flow rate, total cardiac output, pulmonary capillary wedge pressure, left atrial pressure (valuable, but not 
essential) and arterial blood pressure should be monitored frequently as hemodynamic conditions change rapidly during surgery. 
Communication of hemodynamic parameters between the surgeon, perfusionist, anesthesiologist, and console operator is vital to safe 
support. 
Initially, TEE, 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, the patient can be monitored with conventional 
hemodynamic parameters (CVP, PCWP, MAP, LAP, PADP) and TEE to ensure adequate ventricular unloading, and to permit a gradual 
increase to a target CI between 2.0 and 2.5 l/min/m

2

, consistent with the patient’s physiologic needs. 

CAUTION: After closure of the chest, limited space in the inter-thoracic cavity may cause an observable decrease in flow. 

TEE should also be used to rule out the presence of a patent foramen ovale after left ventricular decompression. A previously 
undetected PFO may develop when the pump begins to decompress the left heart. If present, a significant defect should be repaired to 
prevent right-to-left shunting and the resulting hypoxemia. Unloading of the ventricle(s) during VAD support may also cause atrial or 
ventricular collapse, which may be able to be observed or assessed with manual palpation by the surgeon. 

CAUTION: During closure of the chest, the CentriMag system flow and the patient’s hemodynamics must be monitored as 
cannula position can change, altering flow through the pump. 

 

Guidelines to Prevent Air Entrainment when Initiating Support 

Guidelines to prevent air entrainment when initiating support include the following: 

1.

 

Fill the chest with warm normal saline or CO

2

2.

 

Ensure adequate volume in heart chamber when coming off CPB bypass. 

3.

 

Watch the circuit, flow, CVP, MAP and LAP (if monitored) continuously and be prepared to immediately clamp the outflow tubing 
if air is observed. 

4.

 

Partially inflate the lungs prior to separation from CPB. 

5.

 

Maintain atrial pressures between 10 and 15 mmHg during surgery. 

6.

 

Place the patient in Trendelenburg position. 

7.

 

Check the heart and aorta for air with TEE. 

8.

 

Increase RPM very slowly while initiating support. 

9.

 

Under-perfuse circulation while the chest is open or patient is being moved. 

 

CAUTION: If an increase in flow is not observed with an increase in set speed, suction may be occurring. 

WARNING: If a suction event occurs and is not addressed promptly, there is potential for air entrainment. 

Patient Care and Management

 

Postoperative care with the CentriMag system is similar to other types of mechanical circulatory support. Key principles of care 
include hemodynamic stabilization, adequate anticoagulation, and prevention of wound infection. The intravascular volume must be 
carefully assessed and controlled. Management of bleeding, and prompt blood product replacement, is essential to stabilization and 
recovery. Frequent laboratory assessment of hematology, coagulation, enzymes, and blood chemistry must be used to evaluate end 
organ function and to guide therapy. 

 
 
 

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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