Specialists at University of Iowa Hospitals and Clinics Heart and Vascular Center became the first in Iowa to use technology recently approved by the Food and Drug Administration (FDA) to treat patients with heart failure. David Helman, MD, a cardiothoracic surgeon at the UI Heart and Vascular Center, talks about this advanced technology:
What is the current standard for patients in heart failure?
Patients that develop heart failure are usually initially treated with medicines to help the heart pump blood more effectively, as well as make it easier for the heart to pump blood to the body. These medications commonly are used to help remove excess fluid that can build up in patients with heart failure.
There are many different types of causes of heart failure, but a number of patients may benefit from a surgical procedure such as coronary bypass grafting or valve repair or replacement that might improve the symptoms of heart failure adequately so that they would eliminate symptoms which can include fatigue and shortness of breath. However, if medications aren't adequate, then surgical procedures can be considered that are what we can call advanced options.
At what point does a heart failure patient become a candidate for a heart ventricular assist device?
Ventricular assist devices are one of the advanced options available for patients with heart failure. The other primary advanced option is heart transplantation. Ventricular assist devices can be used in several different ways.
First, they are used to support patients who develop heart failure who are expected to recover their heart function with medical treatment.
Second, if recovery is not possible, ventricular assist devices can be used as what we call a bridge to transplantation--to support a patient until a donor heart can be found for a transplant.
Third, for patients who are not eligible for transplantation--and this can be due to a number of factors such as age and other medical conditions. In those patients, the ventricular assist device can be used as what we call a destination therapy, meaning it's implanted as a permanent support of therapy.
What is the newly approved FDA technology for heart failure?
The new pump, approved by the FDA in April, is called the HeartMate II. It's manufactured by a company called Thoratec to support patients that are waiting for heart transplants. The pump impeller spins at a rate of about 10,000 revolutions per minute and this allows it to pump blood from the left ventricle (which is the major pumping chamber of the heart) out to the aorta (which is the major blood vessel that supplies blood to the rest of the body).
How is the HeartMate II better then previous heart pumps?
The HeartMate II is significantly smaller than previously pumps. The nice thing about this is we hope it will allow us to use this pump in smaller patients who have previously not been eligible for heart pumps. The pump size will allow smaller women and some children to be supported--patients we haven't been able to n support easily with long-term pumps. The other significant improvement with the new pump is that we hope that it will prove to be more reliable than previous pumps.
What are the advantages of the HeartMate II?
The important things are the smaller size, the improved reliability. One of the important beneficial factors about this pump, is that it allows patients to go home after the pump has been in place, so they don't have to stay in the hospital. When they do go home, we find that they're able to resume most of their normal activities at home.
Who is a good candidate to receive this new assist device?
Currently, the candidates we will offer the HeartMate II pump to are patients with severe heart failure who are awaiting heart transplants. We expect in the future there's the likelihood that this pump will also be approved for patients who are not eligible for transplants, and once again that's referred to as destination therapy.
There are clinical trials for that use of that pump, for destination therapy, that are currently ongoing. We hope to have the results of those trials soon, so that this pump will be FDA-approved for that purpose in the future, as well.
Do all patients who receive a HeartMate II go on to receive a heart transplant?
At present, most patients who receive the HeartMate II pump do go on to receive a transplant. This may change in the future as the FDA analyzes whether this is a suitable pump also for long-term support, which it looks like it will be.
The other exciting possibility with HeartMate II pump support is that as molecular and cellular therapies improve, it may be possible that we can support a patient with this pump, while at the same time treating them with other therapies that allow their heart muscle to recover. And the long-term goal is that in these patients it might be possible at some point to actually remove the pump and to let their native heart function be sufficient to support them.
What resources does a hospital need to be able to support patients with the HeartMate II pump?
It's a complicated procedure to put the pump in and it really draws on all the resources of an academic medical center like University of Iowa.
It begins with heart failure cardiologists and nurses who are important in getting the patient ready for the operation. There are many people involved in the operation itself in the operating room, including:
- Cardiac anesthesiologists
- Perfusionists, experts in of blood pumps and who run the pump during the operation,
- Operating room nurses
Postoperatively, patients require an intensive care unit stay and the intensive care unit staff and nurses are very important in their care management. There's a continuing collaboration between the cardiologists and the cardiothoracic surgeons to take care of these patients and have a successful period of support with the device.
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