CARDIOVASCULAR
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CONSIDERING A LEFT VENTRICULAR ASSIST DEVICE (LVAD)

Some people suffering from advanced heart failure can be helped with a heart pump, also known as a left ventricular assist device (LVAD). An LVAD is a mechanical device that is designed to help people when their hearts are too weak to pump blood.

Because LVADs help pump oxygen-rich blood throughout the body, patients using an LVAD often have more energy than before and can resume activities they enjoy. Sometimes an LVAD can help the heart rest and regain its ability to pump blood on its own.

HOW LVADS WORK

An LVAD does not replace the heart. It assists the heart in pumping oxygen-rich blood throughout the body so that the organs and muscles can function properly. The LVAD system has parts that work inside and outside the body. Inside, a heart pump is attached to the left side of the heart. Outside, a controller, batteries and driveline help to power and control the heart pump.

SYSTEM COMPONENTS

An LVAD system has four main parts:

  • Heart pump—connects to the left side of your heart; moves blood from your heart to the rest of your body
  • Batteries—provide power when the system is not plugged into an outlet
  • Driveline—transfers power and information between the controller and the heart pump
  • Controller—powers and checks the pump and driveline; alerts you to how the system is working and includes emergency backup power
WHO IS AN LVAD FOR?

Some patients with advanced heart failure use LVADs to help their hearts pump blood while awaiting heart transplant surgery, also known as bridge-to-transplantation. Other patients may not be eligible for heart transplant surgery but may still benefit from an LVAD. These patients keep the LVAD for the long term, which is called destination therapy.

Consult your doctor and medical team to determine if LVAD therapy is an option for you.

IMPORTANT SAFETY INFORMATION

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. 

HeartMate 3™ LVAS Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short-and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage 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 Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter. 

HeartMate 3 LVAS and HeartMate II LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy. 

HeartMate 3 LVAS and HeartMate II LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis. 

 

INDICATIONS, SAFETY & WARNINGS

SJM-CV WEB-0718-0058

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