Patient Management; Postoperative Management; Emergency Management; Anticoagulation - HeartWare Ventricular Assist System Instructions For Use Manual

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12) Close sternum and skin incision per routine.
Once HVAD Pump is explanted rinse gently with NaCL.
13) ®
14) Place HVAD ® Pump in 5% Formaldehyde for at least 2 days.
15) Allow the HVAD Pump to thoroughly dry.
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16) Follow the packaging instructions provided in the Explant Kit (provided by HeartWare) and return the HVAD
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16.0 PATIENT MANAGEMENT

16.1 Postoperative Management

After implantation, the patient is returned to the intensive care unit. Fluids are given to maintain pump flow index (pump flow ÷ BSA) at greater than 2.0 L/min/m
pressure and left atrial pressure less than 20 mm Hg. Some vasopressor and/or vasodilatory pharmacologic assistance can be used as required to adjust vasomotor tone. Patients may
require inotropic assistance of right ventricular function.
To mitigate the risk of stroke, please adhere to the following patient management guidelines:
Maintain MAP at <85 mm Hg, as tolerated. The HVAD
◗ ◗
Ramp speed and flows more slowly during the first few weeks (e.g., 30 days) post-implant to avoid excessive hemodynamic forces that may damage fragile blood vessels that have
◗ ◗
undergone remodeling secondary to the lower pressures and reduced flow associated with medically-treated heart failure. There is no apparent need to exceed a cardiac index of
2.6 L/min/m until patients have fully recovered from the implant surgery and physical performance improves. A cardiac index of 2.6 L/min/m
2
healthy adult.
Maintain anticoagulation within the recommended INR range of 2.0-3.0.
◗ ◗
Check for ASA resistance with a reliable test (e.g., VerifyNow
◗ ◗
plus extended-release dipyridamole) or daily ASA 81 mg plus Plavix

16.2 Emergency Management

In the event of an emergency, such as a cardiac arrest, patients with the HeartWare
be left on, nothing needs to be turned off or disconnected. If chest compressions are performed, confirm function and positioning of HVAD
CAUTION: Chest compressions may pose a risk due to pump location and position of the outflow graft on the aorta—use clinical judgment. If chest compressions have been
administered, confirm function and positioning of HVAD

16.3 Anticoagulation

Prior to HVAD Pump implantation, many patients with refractory heart failure have abnormal coagulation due to abnormal liver function and chronic use of anticoagulation. Prolonged
®
INR can be associated with significant postoperative bleeding. The INR, PTT, and platelet count should be performed prior to HVAD
parameters to a normal range prior to HVAD
Anticoagulation should be individualized for each patient. In general, begin low-dose heparin at 10 units/kg/hr on postoperative day one to a target PTT of 40-50 seconds. Prior to
initiation of anticoagulation, chest tube drainage should be less than 40 ml/hr for approximately three hours, the HCT should be stable without the need for transfusion of blood products,
and coagulation factors approaching normal. Gradually increase the heparin dosage to maintain the a PTT in a range of 50-60 seconds.
The recommended long term oral anticoagulation regimen for the HVAD
day within 24 hours after implant if there are no postoperative bleeding complications. However, if ASA alone is the medication chosen for anti-platelet therapy, a check for ASA resistance
with a reliable test (e.g., VerifyNow ® ) is recommended to establish the dose or to select an alternative medication. Multi-drug options include:
ASA 81 mg plus Aggrenox (ASA (25 mg) plus extended-release dipyridamole (200 mg)).
®
◗ ◗
ASA 81 mg plus clopidogrel 75 mg daily
◗ ◗
For patients who are aspirin sensitive or otherwise intolerant, clopidogrel at doses of 75-150 mg/day is a viable alternative. A clopidogrel loading dose of 300 mg followed by 75 mg/day
is recommended to reduce the lag time in reaching full therapeutic benefit (typically a 3-4 day lag). Warfarin should be started within 4 days post-op and titrated to maintain an INR of
2.0 to 3.0.

16.4 Infection Control Guidelines*

For prevention of infection, remove unnecessary IV lines and replace old IV lines before HVAD
nosocomial and microbial sensitivity profile with sufficient coverage for staph aureus, staph epidermidis and enterococcus. Use pre-operative scrub with antiseptic the night before and
again the morning of the operation. After HVAD
appropriate. Early extubation, removal of monitoring lines, and patient ambulation are encouraged. Rapid restoration of oral nutrition should be attempted using tube feeding if
necessary. Turning the patient side to side can start once the patient is clinically stable. Physical therapy and active range of motion can begin on the first postoperative day. The patient
can be moved to a chair and can/should use an exercise bicycle or treadmill as soon as possible. Nursing measures to decrease infection include frequent hand washing and strict aseptic
technique during contact with invasive lines and during HVAD
*
Infection Control Guidelines and Driveline Care based on recommendations from "Multicenter Experience: Prevention and Management of Left Ventricular Assist Device Infections". Chinn
et al. ASAIO Journal 2005; 51:461-470
I
28 HeartWare Ventricular Assist System
®
® Pump is sensitive to both preload and afterload.
) and adjust ASA mono-therapy accordingly or consider combination therapy such as ASA 81 mg plus Aggrenox
®
75 mg. In general, mono-therapy with ASA is not encouraged in the absence of testing for resistance.
®
®
Pump.
®
Pump implantation is an important goal.
®
Pump is a combination of warfarin and aspirin. In general, aspirin should be started at a dose such as 325 mg/
®
® Pump implantation, continue systemic antimicrobials prophylaxis for 48 to 72 hours. Remove mediastinal and pleural drains as soon as
Pump dressing changes.
®
® Pump in the Explant Kit.
System may be defibrillated with either an internal or external defibrillator. The HeartWare
® Pump implantation. Administer antimicrobial prophylaxis based on the hospital's
with central venous
2
is the lower limit of normal for a
2
®
Pump once the patient is stable.
®
® Pump implantation. The return of each of these
(ASA
®
System can