What is destination therapy?
Destination therapy is the use of a left ventricular assist device (LVAD - also called ventricular assist system or VAS) for long-term, permanent support in patients who are not candidates for a heart transplant. An LVAD is a mechanical pump that is implanted to help the weakened left ventricle (major pumping chamber of the heart) pump blood throughout the body.
The LVAD may provide blood pressure support; maintain or improve other organ function by improving blood flow to the kidneys, liver, brain and other organs; improve the patient’s strength and ability to participate in activities; and allow the patient to be discharged to an outpatient setting.
The goal of destination therapy is to support the patient’s heart function and improve quality of life for the rest of the patient’s life.
Who is eligible for destination therapy?
How does the LVAD work?
An LVAD does not replace the heart. It assists the patient’s own heart to pump blood throughout the body, decreasing the work of the left ventricle.
Blood flows from your heart into the LVAD. Blood is then pumped into the aorta and to the rest of the body.
Destination therapy is a treatment option for certain patients with end-stage heart failure who are not candidates for heart transplant. Destination therapy is considered only when all other treatment options – including medications, lifestyle changes and heart procedures — have been tried and have not effectively managed heart failure.
Your doctor will determine if destination therapy is an appropriate treatment option for you, based on your medical condition, symptoms, body size and presence of other medical conditions.
Destination therapy may not be the appropriate treatment choice for some patients who have blood clotting disorders, irreversible kidney failure, severe liver disease, severe lung disease, or infections that cannot be treated with antibiotics.
What experience do Cleveland Clinic doctors have with destination therapy?
For almost 20 years, Cleveland Clinic doctors have successfully utilized the ventricular assist device in select patients for short-term use. Nearly 500 VADs have been implanted to date for use as a bridge-to-transplant, providing our surgical team with extensive experience in this procedure.
Cleveland Clinic is an approved site for disease-specific care for ventricular assist devices as of December 29, 2008.
To determine if you are a candidate for destination therapy, you will have medical evaluations and tests. After these tests have been completed, the heart failure therapeutics committee will review your case and determine if destination therapy is the best treatment option for you.
Evaluation for Destination Therapy
Tests may include routine blood work, chest X-ray, electrocardiogram (EKG), echocardiogram, left and right heart catheterization or other tests. These tests may be ordered by your heart failure cardiologist or by the surgeon. Some of these tests may have been performed before and will only be repeated if they were not recently performed (within the last 6 to 12 months, depending on the type of test).
You may need to meet with other physicians to confirm that an LVAD is the best treatment option for you. For example, you may need to see a lung specialist or kidney doctor if these organs have been affected by your illness.
Bioethicist and Social Worker Evaluation:
As part of your medical evaluation, you will meet with a bioethicist and a social worker. These professionals will talk with you and ask you questions to make sure you understand how destination therapy will affect your long-term health care decisions.
The Social Worker
The social worker uses counseling skills and community resources to help you and your family during the evaluation, surgery and recovery.
The social worker will assess your strengths, coping resources, and areas of concern regarding your ability to undergo the LVAD implant procedure. The social worker will conduct an evaluation to make sure the necessary resources are available for you during your recovery. He or she will also meet with your family and caregivers to provide support and resources, including information about housing and other community resources.
For Support and Information
Kay Kendall, LISW, Social Work: 216.444.7598
Department of Social Work: 216.444.6552
Pastoral Care: 216.444.2518
Martin Smith, STD, Bioethics: 216.445.2769
Department of Bioethics: 216.444.8720
A clinical trial, also called a research study, tests the value and safety of various interventions. Clinical trials are meant to find new and improved methods of evaluating or treating a condition, or it can test a new way to prevent diseases. Such trials can involve risks, and there is no guarantee regarding a trials’s outcomes.
The HeartMate XVE is approved for use as destination therapy (which means you do not need to be a participant in a research trial to be evaluated for the device).
The Cleveland Clinic is also evaluating different ventricular assist devices used as permanent therapy. You may be asked to participate in a research study, but clinical trial participation is not required. If you meet the criteria for participation in our current research, more information will be provided about the specific trials, so you can make an informed decision about whether or not you would like to participate.
Important: If you do not want to participate in a clinical trial, your treatment and overall course of care will not be affected.
For more information about clinical trials, visit the Clinical Trials website sponsored by the National Institutes of Health at www.clinicaltrials.gov.
What are the components of the VAD?
There are several types and sizes of VADs. The size of the device depends on its function. The type of VAD selected will depend on each patient’s individual needs and medical condition. The components of the VAD vary, according to the specific device used. In general, the device consists of a pump unit (which may be implanted in the abdomen or be outside the body), a control system and an energy supply. Below is a diagram of one type of VAD called the HeartMate II and its components.
Outflow tube (A) attached to the aorta (the large artery that carries blood away from the heart)
Inflow tube (B) (or conduit), attached to the bottom (apex) of the left ventricle
Power source (C) The HeartMate requires either electrical power or battery power to work. Pictured here, the device is operating on battery power.
Pump unit (D)
Driveline (E) that passes from the internal device through the skin, and outside your body to the controller. It contains the electrical cables that power the pump.
External controller (F) (outside the body) that attaches to the pump through the power leads and to either a power base unit or batteries. The controller is a computer that monitors the pump’s function. It displays the status of the system and has alarms that sound when necessary.
When the unit is untethered, rechargeable batteries are used when the patient wants to be mobile. The batteries are changed as needed. The power base unit or alternate source is used to recharge the batteries. The controller and batteries can be worn in a belted waist pack or alternate carrying device.
When the unit is tethered, the power supply is provided by a device called a power base unit that is plugged into an electrical outlet.
Untethered Pump Operation
Tethered Pump Operation
What are the possible risks of the LVAD implantation procedure?
If destination therapy is determined to be the right treatment option, you will receive more detailed information about the treatment, as well as the potential risks and benefits. Your doctor will discuss this information with you.
The risks of the LVAD implant procedure may include:
- Anesthesia complications, such as nausea, vomiting, allergic reaction to medications, sore throat from intubation, sleepiness, headache
- Sleep disturbances
- Emotional/psychosocial disturbances
- Pain or discomfort
- Development of blood clots/thrombus
- Multi-organ failure (lungs, liver, kidneys)
- Damage to the heart valves or other heart structures
- Device power source problems, or device malfunction, failure or movement of the device within your chest
- Leaks or tears at the cannula/graft connections
- Observable operation of the device (sound, vibration, alarms)
- Difficulty adjusting to the device
- Stroke or brain damage that may affect the thoughts, intelligence, movement, and/or the ability to see, hear, swallow, or move properly
- Hemolysis (breakdown of red blood cells)
- Dependence on mechanical ventilation (tracheostomy tube)
Special precautions are taken to decrease your personal risks.
There may be other possible risks. When you meet with your doctor, please ask questions to make sure you understand why the procedure is recommended and all of the potential risks.
How long can I be supported with an LVAD?
Although implantation of a left ventricular assist device as destination therapy is considered permanent therapy, it is not considered a curative procedure for your heart problem.
The amount of time you can receive support from an LVAD is variable, depending on the type of system you receive and your medical condition.
One device and its components will not last you a lifetime. If it is not possible to repair your device, replacement may be necessary.
Cleveland Clinic patients have been supported with an LVAD for more than two years.
To enhance quality of life, patients with an LVAD must carefully follow the guidelines provided by their health care team.
We encourage you to create advance directives to let your doctor and others know your wishes concerning medical treatment in the event that you become unable to communicate your wishes.
If you already have advance directives, please review these documents to make sure that they still reflect your preferences, now that you are a candidate for destination therapy.
Under Ohio law, there are two advance directives forms you can use to make your wishes known:
- Durable power of attorney: This form allows you to appoint someone as your agent to make all health care decisions for you, should you become terminally ill and unable to communicate, or if you become permanently unable to make decisions for yourself. You may want to choose an alternate agent, in case the primary agent is unable to assist.
- Living will: This form allows you to give advance written directions about all of your health care decisions if you become terminally ill and unable to communicate, or if you are in a permanently unconscious state.
The ventricular assist device’s power supply allows it to continue pumping without regard to your medical status. There may come a time when your medical condition or quality of life warrant that the device be turned off, and a living will can communicate your preferences to your health care providers.
Please share information about your advance directives with your surgical team.
The risks of destination therapy on a woman’s fetus are unknown, but device implantation can potentially burden the abdominal area due to the size and position of the device. Therefore, it is very important that women of child-bearing potential use two forms of contraception (birth control) simultaneously for the duration of destination therapy, unless absolute abstinence is the chosen method.
You must use at least one primary contra- ception method, plus a secondary method. Primary forms of contraception include your partner’s vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/ insertable hormone birth control products. Secondary forms of contraception include diaphragms, latex condoms, and cervical caps, each used with a spermicide.
Please be advised that contraceptive tech- niques, other than absolute abstinence, may not be 100 percent successful in preventing pregnancy. Please talk with your gynecologist about the forms of birth control that are right for you.
How will I know how to care for the LVAD?
A detailed education program will be provided to you and your caregivers to ensure safety and proper use of the device. Before you go home, you’ll need to know how to manage the device, including troubleshooting the device’s alarms, and handling potential emergency situations. You’ll also need to demonstrate independence with self-care activities before you go home.
In addition, you’ll be given guidelines about your activities, including swimming, showering, bathing and resuming sexual activity; medications, diet, and when to call the doctor.
At home, you’ll need to have an accurate scale as well as a thermometer. Some patients will need to monitor their blood pressure at home. Your nurse will provide specific guidelines.
Can I go home after receiving the LVAD?
Yes. When you are able to go home will depend on your rate of recovery and your medical condition. You may first be discharged from the hospital to an intermediate care facility. It is our goal to help you recover as quickly as possible so you may be able to go home.
It’s very important to continue making healthy lifestyle changes before and after the LVAD implant procedure, including:
- Stop using tobacco
- Follow your recommended nutrition guidelines
- Stop drinking alcohol
- Don’t use illegal drugs
- Exercise regularly
If you need help making lifestyle changes, your health care providers can assist you with strategies or refer you to other resources such as a dietitian, smoking cessation specialist or cardiac rehabilitation program.
If you need more information or would like to make an appointment with a specialist, click here to contact us, chat online with a nurse or call the Miller Family Heart and Vascular Institute Resource & Information Nurse at 216.445.9288 or toll-free at 866.289.6911. We would be happy to help you.
This information is provided by Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition.
Copyright 2009 Cleveland Clinic. All rights reserved. 12/09