Left Ventricular Assist Devices

Left Ventricular Assist Devices

A left ventricular assist device (LVAD) is a pump for patients with advanced heart failure. Once implanted, the device is designed to help the left ventricle of your patient’s heart pump blood to the rest of their body. LVADs can be used as bridge-to-transplant therapy and/or destination therapy. LVADs are an important therapy option for patients with Class IIIB or IV heart failure. The LVAD you choose can impact your patient's quality of life.

For a complete listing of potential adverse events, please see the HeartMate II and HeartMate 3 LVADs Adverse Events section listed below.

References

*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial in the continuous-flow LVAD category of devices in the U.S.^1,2-6

**HeartMate 3™ LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.

1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019;380:1618-1627.
2. Abbott data on file as of July 20, 2020.
3. Based on clinical and device tracking data as of June 9, 2020.
4. Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, ... Gregoric ID. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med. 2017;376(5):451-460.
5. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
6. Uriel N. Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL.

Indications, Safety & Warnings

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions For Use 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 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 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™ 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™ 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 pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis.