Notice for Patients with the Medtronic HVAD™ (HeartWare) Device
Recently Medtronic stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because of an increased risk of neurological events and a potential for the internal pump to stop.
For more information, see the Michigan Health blog post HVAD risks: What you need to know.
Please visit the LVAD Online Decision Guide or talk to your cardiologist to determine if an LVAD is right for you.
What is an LVAD?
A Left Ventricular Assist Devices (VAD or LVAD) is a mechanical device that helps your heart do its job of pumping blood. The LVAD is attached to your heart during major surgery.
How does an LVAD work?
LVADs work by pumping blood from the left ventricle (lower part of the heart) and pushing it out the aorta, a blood vessel that carries blood from the heart to the rest of the body. In other words, it assists the weakened heart. The pump is implanted inside the body to your heart and is connected to a protected electrical wire that runs outside of the body, connecting to a power source.
Are ventricular assist devices new?
A LVAD have been used for more than two decades. LVADs have been used as bridge to transplant (BTT), providing patients with valuable time until a transplant is available, and as a long-term or destination therapy (DT) for patients who are not transplant candidates. Overall, LVADs improve survival and quality of life for advanced heart failure patients.
What is Bridge to Transplant (BTT)?
Bridge to transplant is when a LVAD is used to help extend the life of someone waiting for a heart transplant.
What is Destination Therapy (DT)?
Destination therapy is when a LVAD is used as a long-term treatment for patients who are not candidates for transplant.
Who is a candidate for an LVAD?
LVADs are for people with heart failure who meet certain criteria. Generally, these are people with advanced heart failure who are considered Class III or IV by the New York Heart Association classification system (see below). LVADs are not appropriate for some people with advanced heart failure if they also have other conditions such as kidney failure, liver disease, lung disease, or blood clotting disorders.
New York Heart Association Classification (Classes III & IV)
- Class III – Patients with cardiac disease resulting in significant limitation of physical activity. They are comfortable only at rest.
- Class IV – Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. Any physical activity causes an increase in discomfort.
How long can I live with an LVAD?
The expected survival for people with a VAD continues to improve with newer technology. Some patients have survived up to 13 years.
Are LVADs portable?
Yes, LVADs are portable and can be operated on batteries, so patients can be discharged from the hospital and live at home.
What are the risks?
Implanting an LVAD requires major surgery and the need to stay in the hospital for about two weeks. Some risks of the procedure include bleeding, blood clots, stroke, and infection.
What will my life be like with a Left Ventricular Assist Device?
Most patients have improved circulation after LVAD implantation. This will enable the patient to return to their daily lives with very few restrictions on activity. Most LVAD patients are able to reclaim their lifestyles; enabling them to shop, travel, visit friends etc...
Will I need to take any medications?
In addition to post-surgery pain medication and your current regimen of heart failure medications, you will require a blood thinning medication.
How will the LVAD affect my daily routine?
You should be able to resume your normal activities. Some patients have returned to their work and activities they enjoy. You will be encouraged to make healthy lifestyle choices and monitor your health closely. You will have to take your weight, temperature and other vitals daily to ensure that you are healthy and are not having any problems.
Can I shower with an LVAD?
Showering is only permitted with the direction of your doctor, patients are given permission to shower only after their surgical site has healed. The external LVAD system components are not waterproof; they need to be protected with a specially designed shower kit.
Can I take a bath or swim with an LVAD?
No, you will not be able to take a bath or swim. Water can damage the external components and your pump could stop working.
Can I exercise with an LVAD?
Physical exercise is essential to help prevent the unhealthy effect of bed rest and inactivity. Individuals are able to walk as well as participate in light strength training. A physical therapist will participate in your care and will help to develop exercise guidelines and goals with you. In general, activity restrictions include contact sports and swimming.
Can I travel with an LVAD?
You may travel if you are healthy and have no ongoing issues. Your LVAD team can help you plan your trip, which would include contacting other VAD care centers that will be near the place you plan to visit.