CARDIOVASCULAR
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With The HeartMate 3 LVAD, You Can Make A Meaningful Difference In Patients' Lives

How your patients live their lives depends on the LVAD you choose. The HeartMate 3™ LVAD can be used for advanced heart failure patients needing short- or long-term mechanical circulatory support (e.g., bridge to transplant (BTT) or myocardial recovery, or destination therapy (DT)).


HeartMate 3 LVAD Delivers Unprecedented* Survival And Safety Outcomes**1

MOMENTUM 3 was the largest left ventricular assist device (LVAD) trial ever conducted.*** The results at 2 years show that the HeartMate 3 LVAD continues to have:

The Highest Survival Rates for Any LVAD in a Randomized Controlled Trial1-3

The Lowest Hemocompatibility-Related Adverse Event Rates of Any LVAD†,††,1-4

Immediate, Significant and Sustained Improvements in Functional Capacity and Quality of Life1

Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.


Outcomes Made Possible by Full MagLev™ Flow Technology

Full MagLev™ Flow Technology maintains gentle blood handling to minimize complications and hemocompatibility-related adverse events.

  • Fully levitated, self-centering rotor that does not require hydrodynamic or mechanical bearings.
  • Large, consistent blood flow pathways to reduce shear stress5
  • Intrinsic pulsatility to reduce stasis and minimize thrombus5,6
Full MagLev Flow Technology compared to hydrodynamic bearing pump
OTHER HEARTMATE 3 LVAD FEATURES AND BENEFITS:
  • Offers up to 17 hours of battery life for patient confidence and convenience
  • Designed for intrapericardial placement
  • Features a thin, mechanical apical cuff lock for pump attachment
  • Incorporates a modular driveline that facilitates replacement of externalized portion


 

*Based on HeartMate 3 LVAD highest published survival in a randomized controlled trial and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-4
** HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
***Ongoing evaluation of more than 2,000 patients on short- and long-term therapy of devices in the U.S.
††Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.

References

1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. New Engl J Med. 2019;380:1618-1627.
2. Rogers JG, Pagani F, Tatooles A, et al. Intrapericardial left ventricular assist device for advanced heart failure. New Engl J Med. 2017;376:451-460.
3. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
4. 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.
5. Bourque K, Cotter C, Dague C, et al. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility. American Society of Artificial Internal Organs. 2016;62:375–383.
6. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta. Artificial Organs. 2006;30:638-642.
7. Data on file at Abbott.
8. Mehra MR. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report for the MOMENTUM 3 Trial. American College of Cardiology (ACC) Annual Meeting; March 17, 2019; New Orleans, LA.

HeartMate 3 LVAD Delivers Unprecedented* Survival And Safety Outcomes**1

MOMENTUM 3 was the largest left ventricular assist device (LVAD) trial ever conducted.*** The results at 2 years show that the HeartMate 3™ LVAD continues to have:


 


 

The Highest Survival Rate for any LVAD in a Randomized Controlled Trial1-3


 


 

The lowest hemocompatibility-related adverse event rates of any LVAD†,††, 1-4


 


 

Immediate, Significant and Sustained Improvements In Functional Capacity And Quality Of Life1


 

 

Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.


NEJM Clinical Paper

Read the details of the clinical study as published in The New England Journal of Medicine.


HeartMate 3 LVAD Provides Immediate, Significant, And Sustained Improvements In Functional Capacity And Quality Of Life1

Significant improvement in NYHA Class, 6-Minute Walk Distance, and Quality of Life1


 

 

80% 24 months

79% of patients improved from NYHA Class IIIB/IV at baseline to NYHA Class I/II by 6 months, with sustained improvement of 80% of patients through 2 year. (P < .0001)1,8

KCCQ Score +30 Points

Quality of life score improved significantly and was sustained at 2 years.1

Significant Increase In 6-Minute Walk Distance

At baseline, tested patients completed the 6-minute walk test at an average of 136 meters. At 2 years after HeartMate 3 LVAD implant, patients completed the test at an average of 323 meters.1

Graphic showing significant increase in 6-minute walk distance

 

*Based on HeartMate 3 LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-4
** HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
***Ongoing evaluation of more than 2,000 patients on short- and long-term therapy of devices in the U.S.1,6,7,8
†For a continuous-flow LVAD in a randomized controlled trial.
††Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.

References

1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. New Engl J Med. 2019;380:1618-1627.
2. Rogers JG, Pagani F, Tatooles A, et al. Intrapericardial left ventricular assist device for advanced heart failure. New Engl J Med. 2017;376:451-460.
3. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
4. 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.
5. Mehra MR. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report for the MOMENTUM 3 Trial. American College of Cardiology (ACC) Annual Meeting; March 17, 2019; New Orleans, LA.
6. Khush KK, Cherikh WS, Chambers DC, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth Adult Heart Transplant Report-2018; Focus Theme: Multiorgan Transplantation. J Heart Lung Transplant. 018;37:1155-1168.
7. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.
8. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-Food and Drug Administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS‡ registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63:1751-1757.

Patient SELECtion

Patients with the following should be referred for evaluation for advanced heart failure therapies, including LVAD therapy.

1: NYHA Class IIIB or IV Heart Failure (INTERMACS 1-6)


 

NYHA CLASS Class III   Class IIIB/IV Class IV  
    7 6 5 4 3 2 1
INTERMACS registry advanced heart failure profiles Advanced NYHA III symptoms.
Living comfortably with limited physical activity
Exertion limited.
Walking wounded
Exertion intolerant.
Housebound
Resting Symptoms.
Frequent flyer
Stable but inotrope dependent.
Dependent stability
Progressive decline in inotropic support.
Sliding on inotropes
Critical cardiogenic shock.
Crash and burn
2. Any One of the Following High-Risk Clinical Triggers1:

         

I

IV Inotropes

N

NYHA IIIB/IV or persistently elevated natriuretic peptides

E

End-organ dysfunction (Cr > 1.8 mg/dL or BUN > 43 mg/dL)

E

Ejection fraction ≤ 35%

D

Defibrillator shocks

H

Hospitalizations > 1

E

Edema (or elevated PA pressure) despite escalating diuretics

L

Low blood pressure, high heart rate

P

Prognostic medication — progressive intolerance or down-titration GDtT

Additional Referral Considerations:
  • CRT nonreponder
  • Physical activity limited or impaired quality of life


 

‡ Indicates a third party trademark, which is property of its respective owner.

References

1. 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. Yancy CW, Januzzi JL Jr, Allen LA, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Jessup M, Lindenfeld J, Maddox TM, Masoudi FA, Motiwala SR, Patterson JH, Walsh MN, Wasserman A. J Am Coll Cardiol. 2018 Jan 16;71(2):201-230. doi: 10.1016/j.jacc.2017.11.025. Epub 2017 Dec 22.

Patient Education

Understanding Heart Failure Patient Education Video
Understanding Heart Failure and Treatment Options
Heartmate 3 LVAD Patient Education Brochure

Share this brochure with your advanced heart failure patients so they can learn more about HeartMate 3 LVAD therapy.

IMPORTANT SAFETY INFORMATION
INDICATIONS, SAFETY & WARNINGS

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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.

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.

Contraindications:

The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events:

Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: 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) or device thrombosis.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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