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Trial Testing External Power Connections for Heart Pumps

Human heart and arteries (Yale School of Medicine/Wikimedia Commons)

(Yale School of Medicine/Wikimedia Commons)

A clinical trial testing alternative connections for external powering of implanted heart pumps is enrolling patients at University of Maryland Medical Center in Baltimore, one site of the study. Bartley Griffith, a cardiac surgeon and professor of surgery is leading the research for the university, which is funded by Jarvik Heart Inc., maker of one of the devices tested.

The study tests two ways of connecting external power to left ventricular assist devices, which are implanted in the chest and support the heart’s left ventricle, its main pumping chamber. These devices are a long-term option for patients with severe heart failure, but who may not be candidates for a heart transplant.

The issue under investigation is the device’s connection to its external battery pack. The conventional method connects the battery pack with a cord inserted through a packet in the abdominal wall. Griffith says nearly one-third of his patients eventually develop an infection at this insertion site. He attributes the infections to tiny movements of the power cord in the soft, flexible abdominal tissue.

The alternative connection is through a socket in the skull behind the ear. This is the same location used to pass wires through the skull for cochlear implants for the severely hearing impaired. Griffith notes that the skull provides a more stable base for the connection, as well as more blood flow, to help prevent infection. The power connection through the skull for a left ventricular assist device is already approved in Europe.

The trial eventually will enroll 350 patients with heart failure considered candidates for a left ventricular assist device. Patients will be assigned randomly to receive either a HeartMate II Left Ventricular Assist System made by Thoratec Corporation or a 2000 LVAD by Jarvik Heart. The HeartMate II uses the abdominal power connection, while the Jarvik 2000 LVAD system in the trial receives its power through the skull.

The team will monitor the patients for three years, for survival of the patients during the period, as well as averse events such as infections involving the power cords. The researchers will also watch for the need to repair or replace the implanted heart pump, as well as the incidence of stroke after two years.

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