Northwestern Memorial First To Trial Smallest Full Support Heart Assist Device

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials;  Transplants / Organ Donations
Article Date: 28 Apr 2009 - 5:00 PDT

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Northwestern Memorial Hospital's Bluhm Cardiovascular Institute is the first center in Illinois and among the first in the country to implant a new experimental left ventricular assist device (LVAD) into subjects with advanced heart failure, a condition where the heart cannot pump enough blood to the body's organs. The HeartWare® Ventricular Assist System (HeartWare® System) features the HVAD™ Pump, the smallest LVAD to provide full cardiac support currently under investigation in the United States. The HeartWare® System is intended as a bridge to heart transplantation. Northwestern Memorial surgeons have implanted four subjects with the device, and are the first in the country to transplant a subject as part of this trial.

Individuals with advanced heart failure experience symptoms such as swelling, fatigue, shortness of breath and are not able to exert themselves. Medications are often successful for managing symptoms in the earlier stages of heart failure, but for patients in the late-stages heart transplantation is considered the best treatment option. However, with just over 2,000 donor hearts becoming available each year, the wait for a transplant can be long. The smaller model is being studied as a less cumbersome LVAD procedure in subjects with advanced-stage heart failure who need support to survive until a donor heart becomes available. In subsequent trials the HVAD™ Pump will be trialed in subjects that are not transplant candidates.

Edwin McGee Jr., MD, the principal investigator of the trial, cardiac surgeon and the surgical director of Heart Transplantation and Mechanical Assistance at the Bluhm Cardiovascular Institute, lead the team that implanted the four subjects. The national clinical trial hopes to enroll up to 150 subjects. Twenty-two subjects have been enrolled in the U.S to date.

"The small size and unique configuration of this particular model allows us to place it adjacent to the ventricle itself, as opposed to implanting the device in the abdominal wall," commented Dr. McGee. "This is a major step forward, as it is intended to reduce the potential risks associated with a more extensive surgery such as bleeding and infections. We are also able to cast a wider net of potential subjects and can include more women in the trials since the device is significantly smaller than previous models."

The device is a tiny centrifugal blood pump, with a levitating impeller that spins to continuously move blood from the heart to the rest of the body. A driveline cable attaches to the pump and connects to a portable controller, powered by a pair of battery packs, worn by the subject.

According to the American Heart Association, 4.9 million patients in the United States suffer from heart failure, with an additional 550,000 diagnosed each year. The National Institutes of Health estimates that in the US, approximately 100,000 patients per year could benefit from an LVAD.

"Heart failure is a growing epidemic in this country and we hope that this trial will lead to better outcomes and fewer complications for patients with severe heart failure," said Dr. McGee. This LVAD is the next step in the evolution of heart assist devices, which, in the future, could result in a fully-implantable model.

Source:
Amy Dobrozsi
Northwestern Memorial Hospital

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