“Cardiovascular disease kills one in three Americans. Severely ill heart failure patients have few options since there is a shortage of donor hearts for transplant. This has increased the need for functional and safe heart pump technology to not only keep patients alive but to also extend the quality of their lives”, reports E. Albert Reece MD, PhD, Vice President for Medical Affairs, and Dean of the University of Maryland’s School of Medicine.
Cardiac surgeons and cardiologists at the University of Maryland Heart Center as part of a multi-center clinical trial, are evaluating the efficacy of powering heart pumps by using a skull-based connector behind the ear. Typically, these devices for patients with severe heart failure are energized through an electrical cord connected at an abdominal site but unfortunately this is where potentially deadly infections can develop.
There are major problems is dealing with infections. In the early days of heart pump technology, infection was less of an issue due to the limited durability of the devices. Infections was low on the list of concerns but with the development of more durable ventricular assist device therapies, infection is much more of an issue.
“Today, over time, nearly one-third of our patients surviving with the assistance of an implanted blood pump develop an infection at the site where the power cord exits the skin. All it takes to set the stage for infection is tiny micro-movements of the power cable at the abdominal entrance. This complication may be lethal but if not, it is always a difficult problem,” said Principal Investigator, Bartley P. Griffith MD. Professor of Surgery at the School of Medicine and a Senior Cardiac Surgeon at the University Medical Center.
The 350 patients to be enrolled in the study named “Randomized Evaluation of Long-term Intraventricular VAD Effectiveness” (RELIVE) will randomly be assigned to one of two groups. One treatment group will receive a Jarvik 2000 Left Ventricular Assist Device (LVAD) equipped with an investigational post-auricular connector from Jarvik Heart Inc. The Jarvik skull model has already been approved for use in Europe.
Control group patients will be given a heart pump that employs an abdominal connector, the Thoratec Corporation’s HeartMateII Left Ventricular Assist System which is the most widely used FDA approved LVAD for destination therapy.
According to Dr. Griffith, the bone in the skull is a better substrate to locate a foreign body because there is good blood flow and no motion. Since the Jarvik implantation involves the head and neck, the cardiac team has formed an unusual collaboration with Otorhinolaryngology-Head and Neck Surgery department where the surgeon extends the internal Jarvik power cord through the neck and places the socket in the skull.