resources

LVAD FAQs

heartmate™ LVAD FAQs

heart failure FAQs

SJM-HMP-0618-0033

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 include, but are not limited to those 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 pump thrombosis.

References:

1. How life changes with an LVAD. My LVAD Web site. https://www.mylvad.com/patients-caregivers/learn-about-lvads/intro-lvads/how-life-changes Accessed
October 22, 2018. 2. Givertz, M. Ventricular Assist Devices. Important information for patients and families. Circ Heart Failure, 2011;124:e305-e311. 3. Mehra M,
Goldstein D, Uriel N, et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018;378(15):1386-1395. 4. Cowger
J, Naka Y, Aaronson K, et al. Quality of life and functional capacity in the multicenter study of MAGLEV technology in patients undergoing mechanical circulatory
support therapy with the HeartMate 3 MOMENTUM 3 Pivotal Trial. 2017. 5. Park S, Milano C, Tatooles A, et al. for the HeartMate II Clinical Investigators. Outcomes
in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Failure 2012;5(2), 241-248. 6. John R, Naka Y, Smedira N, et
al. Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Annals of Thoracic Surgery 2011;92(4), 1406-1413.
7. Ventricular Assist Device Procedure Details, Results. Mayo Clinic Web site. http://www.mayoclinic.org/tests-procedures/ventricular-assist-device/details/results/
rsc-20167083#!. Accessed October 24, 2018. 8. What is an LVAD? How does it work? MYLVAD Web site. https://www.mylvad.com/patients-caregivers/learn-aboutlvads/
intro-lvads/what-lvad-how-does-it-work. Accessed October 30, 2018. 9. Pagani FD, Miller LW, Russell SD, et al. Extended Mechanical Circulatory Support
With a Continuous-Flow Rotary Left Ventricular Assist Device. JACC. 2009;54:312-321. 10. How Common is heart failure? Heart Failure Society of America Web site.
https://www.hfsa.org/patient/learn/. Accessed on October 31, 2018. 11. Heart failure Diagnosis and Treatment. Mayo Clinic Web site. https://www.mayoclinic.org/
diseases-conditions/heart-failure/diagnosis-treatment/drc-20373148. Accessed on October 22, 2018.

Patient Brochures

HeartMate 3™ LVAD

HeartMate II™ LVAD

Educational Videos

General Heart Failure

 HeartMate 3™ LVAD Patient Education Program

HeartMate II™ LVAD Patient Education Program with MPU

HeartMate II™ LVAD Patient Education Program with Power Module

Educational Materials

Patient Education

SJM-HMP-1018-0043

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 include, but are not limited to those 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 pump thrombosis.

HEARTMATE™ LVAD COMMUNITY NEWSLETTER

The quarterly HeartMate™ LVAD Community Newsletter is for current or prospective HeartMate LVAD patients and their caregivers. In it, you will find interviews with HeartMate LVAD Ambassadors, articles on life with an LVAD, caregiver-focused articles, and tips on things like traveling or exercising with an LVAD.

Newsletter archives

To download past issues of the HeartMate™ LVAD Community Newsletter, click the year and then the issues you’d like, below:

SJM-HMP-1018-0044

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 include, but are not limited to those 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 pump thrombosis.

Glossary

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SJM-HMP-1018-0045

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 include, but are not limited to those 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 pump thrombosis.