This information is provided for educational purposes. Individual experiences, symptoms,
situations, and circumstances may vary. Please consult your physician or qualified
healthcare provider regarding your condition and appropriate medical treatment.
Indications: The HeartMate II LVAS is intended for use
as a bridge to transplantation in cardiac transplant candidates at risk of imminent
death from non-reversible left ventricular failure. The HeartMate II
LVAS is also indicated for use in patients with New York Heart Association (NYHA)
Class IIIB or IV end-stage left ventricular failure who have received optimal medical
therapy for at least 45 of the last 60 days, and who are not candidates for cardiac
transplantation. The HeartMate II LVAS is intended for use both inside
and outside the hospital.
Contraindications: The HeartMate II LVAS is contraindicated
in people who cannot tolerate or are allergic to anticoagulation therapy.
Complications and adverse events: Complications of VAD surgery
are similar to the potential complications of any open heart surgery procedure.
You will be asked to sign a surgical consent form prior to the operation, as well
as a consent form for blood transfusions. Your surgeon will discuss potential risks
and benefits with you prior to the procedure.
Possible serious adverse events include the following:
Bleeding, during surgery or after surgery
Cardiac arrhythmia (irregular heartbeat)
Sepsis (serious infection)
Right heart failure
Driveline or pocket infection
Renal failure (inability of the kidneys to remove waste from the blood)
Neurologic dysfunction (problems affecting the brain or nervous system)
Thromboembolic event, peripheral (blood clots)
Hemolysis (breakdown of red blood cells)
Hepatic dysfunction (liver problems)
Device thrombosis (formation of a blood clot inside the device)
Myocardial infarction (heart attack)