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Patient Care and Management
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HeartMate III Left Ventricular Assist System Instructions for Use
Caring for the Driveline Exit Site
Currently, no clinical trials delineate the best regimen for care of the Driveline exit site. Physician
judgment and experience may vary.
Nevertheless, the following points should be considered:
• A driveline management system, supplied by the implanting center, should be used at all times.
The driveline management system should consist of a dressing and stabilizer
.
• The risk of systemic infection may be reduced by withdrawing all intravascular lines as soon as
is practical.
• Parenteral treatment with antibiotics and surgical drainage has, on occasion, eradicated
infection. However, infections may persist and can result in septicemia and death.
• Fungal infection resulting from organisms such as
Candida albicans
may be associated with
vegetative growth on the Pump. Persistent systemic fungal infection, refractory to antimicrobial
treatment, may necessitate Pump replacement or removal.
• Systemic prophylaxis with anti-fungal agents, such as fluconazole, is reported to have met with
moderate success in preventing fungal infection. However, no clinical trials have been
conducted to verify the efficacy of anti-fungal prophylaxis.
Controlling Infection
Infection among implantable Left Ventricular Assist Device patients is common, especially in
patients with multi-system organ failure who require prolonged stays in the ICU. Infection rates can
be minimized, however, by applying the following approaches to patient management:
• Strict adherence to sterile technique during exit site care.
• Remove all intravascular lines as soon as practical to reduce the risk of systemic infection.
• Administer antibiotic prophylaxis in the postoperative period, and for suspected or confirmed
infections, and antibiotics for surgical drainage, as indicated, in patients with evidence of Pump
pocket infection.
• Adhere to strict blood glucose control.
• Initiate nutritional support to correct nutritional deficits.
Measuring Blood Pressure
Automatic blood pressure monitors may not be accurate. Manual auscultation with a Doppler is
recommended. In circumstances where the flow is pulseless, invasive blood pressure monitoring
(arterial line) may be required.
Blood Pressure Management
Post-implantation hypertension may be treated at the discretion of the attending physician. Any
therapy that consistently maintains mean arterial blood pressure less than 90 mm Hg should be
considered adequate.
Summary of Contents for HeartMate III
Page 1: ...Instructions for Use ...
Page 2: ......
Page 3: ...Thoratec Corporation HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM Instructions for Use ...
Page 4: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ii ...
Page 6: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE iv ...
Page 10: ...Contents viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ...
Page 12: ...1 Introduction 1 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 28: ...1 Introduction 1 18 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 30: ...2 System Operations 2 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 88: ...3 Powering the System 3 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 112: ...3 Powering the System 3 26 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 166: ...4 System Monitor 4 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 208: ...4 System Monitor 4 44 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 210: ...5 Surgical Procedures 5 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 378: ...A A 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 390: ...B B 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 420: ...C C 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 426: ...C C 8 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 428: ...D D 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 448: ...E E 10 HeartMate III Left Ventricular Assist System Instructions for Use ...
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