HVADTM SYSTEM Urgent product update

Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021, and has notified physicians to cease new implants of the Medtronic HVAD™ System and transition to an alternative commercial LVAD for all future implants. Prophylactic explant of the HVAD™ System is not recommended at this time.

Information for patients

What is advanced heart failure?

The term "heart failure" describes a condition in which the heart muscle becomes too weak to pump sufficient blood around the body. If you’ve been diagnosed with heart failure, you are not alone. In fact, heart failure affects at least 15 million people in Europe.1

Symptoms of heart failure

  • Shortness of breath
  • Swollen feet and legs
  • Persistent lack of energy
  • Sleep disturbances due to breathing problems
  • Cough with frothy sputum
  • Bloated or sensitive abdomen and loss of appetite
  • Increased need to urinate, particularly at night
  • Confusion and/or memory problems 
Infographic showing the Symptoms of Heart Failure

Symptoms of advanced heart failure

The symptoms of advanced heart failure are due to the heart's impaired pump function. Because heart failure is a progressive disease, eventually the medications and treatments will no longer be sufficient to alleviate symptoms and patients will require repeated admissions to hospital due to advanced heart failure. Some of the most common symptoms are listed below.

Fatigue

Heart failure can severely restrict your ability to perform everyday activities. Patients with advanced heart failure feel increasingly tired and daily activities such as walking, climbing the stairs or carrying the shopping, or even simple actions such as getting dressed, become more difficult.

Shortness of breath

Shortness of breath is a common symptom of heart failure. Fluid may collect in the lungs , which can cause you to feel out of breath, even when lying down.

Restrictions in everyday activities

In some cases, you may find yourself avoiding physical activities such as walking the dog, climbing the stairs or general socialising. Many patients with advanced heart failure adjust their lifestyle to their condition.

Further symptoms that may occur with advanced heart failure include:

  • Coughing
  • Unexplained weight gain
  • Loss of appetite
  • Sleep disturbances

Unfortunately, heart failure is a progressive condition, which means that it can deteriorate over time, even when taking the recommended medication. In around 10% of patients with heart failure, the condition is already advanced.2 In many patients, the lifestyle changes and medication are simply no longer sufficient to keep the condition under control. This is when treatment options like implantation of a ventricular assistance device (VAD) may be necessary.

Note

Consult your GP or cardiologist if you have signs of heart failure or if your symptoms worsen.

Your doctor can provide you with comprehensive information about further treatment and hospitals in which VAD therapy is offered — should this be recommended in your case.

Brief Statement

Information contained herein does not replace the recommendations of your healthcare professional. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your Health Care Professional.

References

1

Ambrosy PA et al. The Global Health and Economic Burden of Hospitalizations for Heart Failure. Lessons Learned From Hospitalized Heart Failure Registries. J Am Coll Cardiol.2014;63:1123–1133.

2

Empfehlungen der AHA bei fortgeschrittener Herzinsuffizienz (Stand: 9. Mai 2017). Letzter Zugriff am 10. Mai 2017. http://www.heart.org/HEARTORG/Conditions/HeartFailure/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WRH7S_nyuos.