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perfusion, and immediately increase the speed to reach target flow when cardioversion is complete. 

 

Anticoagulation 

Generally, no anticoagulation therapy is used in the first 6 to 24 hours after initiation of support due to usual postoperative 
bleeding. Cases where CPB was not used prior to initiation of support, and bleeding is minimal, low dose anticoagulation with 
heparin should be started sooner. Pump thrombosis may be minimized by maintaining flow of at least 3.0 LPM. Intravenous heparin 
is usually started after the chest tube drainage is less than 50 ml/hour for at least 2 to 3 hours. The initial target ACT is 160-180 
seconds, the target PTT is 1.3-1.6 times the laboratory normal, or the anti-Xa assay shows 0.3-0.7 IU/mL. 
As anticoagulation and hemostasis may be affected by end organ function, platelet levels, platelet function, CentriMag system flow, 
native cardiac output, and other factors, anticoagulation must be individualized for each patient by the attending physicians. 

CAUTION: Monitor and administer anticoagulation carefully, as risk of bleeding or thrombosis may occur with inappropriate 
management. 

Heparin-induced thrombocytopenia is a complication of heparin therapy that presents with bleeding and consumption of platelets. 
Treatment for HIT consists of withholding or reversing heparin. Aspirin, bivalirudin, warfarin, and a variety of other anticoagulants may 
be considered as alternatives to heparin, depending on clinical objectives, experience at the individual center, and hepatic  and/or 
renal function.

 

Existing institutional protocols for managing HIT should be implemented as appropriate. A hematology consult can also 

be valuable in the management of these patients. 

Thromboelastography is used by some centers for the management of anticoagulation. Its use for VAD patients is not universally 
accepted, although some centers with TEG equipment, experienced personnel, and well-defined protocols have found it useful and 
reliable. If TEG is used, teams should be trained to ensure consistent results. The TEG should be initially reviewed carefully every day to 
assess antiplatelet needs until stable and satisfactory levels are achieved. Anticoagulation needs vary by patient and should be adjusted 
based on clinical judgment.

 

Wound Care 

If the cannulas are tunneled, postoperative wound care should be consistent with standard surgical protocols. A standard occlusive 
dressing should be used at the surgical sites to minimize the risk of infection. Cannula exit sites should be under a separate dressing 
from the chest tube exit sites if possible. 
Aseptic technique should be used by all staff when handling the surgical sites during dressing changes and other wound care. The 
importance of consistent hand washing practices by staff and caretakers cannot be overemphasized. 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 care to secure the wound site taken during patient ambulation or transportation. 

 

Nutrition 

 

Enteral or parenteral feeding should be implemented when feasible during support. It is important that patients who achieve 
explantation receive proper nutritional education from the hospital nutritionist to optimize recovery. 

 

Physical Therapy 

When feasible, the patient should receive passive and active range of motion physical therapy as tolerated. Some patients have also been 
able to ambulate during CentriMag system support. 
Should ambulation be considered, care must be taken to protect the cannulas, tubing and pump from any kinks or tension on the 
circuit. It is advisable to ensure additional securing features (i.e., bands) on all connection sites of the circuit. Furthermore, if 
ambulation is considered ensure that there is an appropriate number of staff available to monitor and support both patient and 
circuitry. Before movement of the patient or circuit, inspect all connections of the circuit to be sure they are intact. 

CAUTION: Ensure that the length of the tubing is adequate for ambulation to avoid the risk of disconnection, cannula 
migration, or dislodgement. 

Bedside range of motion or other light exercise is possible with extreme care, and useful for patients on support for multiple weeks. 

 

Patient Transport 

In some cases, a patient on CentriMag system support may need to be transported to another location within the hospital or to another 
medical center. The CentriMag system meets international standards for air and ground transport and is designed for ease of use during 
transport between medical centers. The system has been designed for portability in acute and critical care situations. 
When transporting a patient within the hospital, consider the following: 

 

Care must be taken to avoid dislodgement or disconnection of the cannula and tubing connections. 

 

The pump and motor unit should be on a stable cart or placed in the bed with the patient and secured, or placed in the 
CentriMag system transporter which has been attached to the bed. 

 

If the motor is placed on the patient’s bed, the cable length from the console to the motor is usually sufficient to transport the 
console on its cart alongside of the patient’s bed. 

 

If the motor is placed on the patient’s bed, ensure that the pump and tubing are visible at all times. If necessary, the console  can 
be detached from its cart and placed on the bed. Because of the weight of the motor and the console, these items should not be 
placed on top of the patient. 

 

The motor, when operating, is warm to the touch. A barrier between the motor and the patient can be used to ensure that heat 
from the motor does not come in contact with the patient’s skin. 

CAUTION: Do not cover the motor or console with blankets to prevent them from overheating. 

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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