About 90 percent of patients with advanced heart failure can be managed by a left ventricular assist device (LVAD). But for the 5 to 10 percent of patients with biventricular failure, an LVAD is not adequate. These patients have no option but a heart transplant or the current version of a total artificial heart.
Baylor University Medical Center, part of Baylor Scott & White Health, has been chosen as one of seven clinical trial sites for the world’s most advanced total artificial heart. The FDA-approved early feasibility study is expected to start in the fourth quarter of this year with an enrollment of approximately 10 patients.
“No major changes have occurred in the field of total artificial heart in more than 30 years, so we are very excited to be able to offer access to participation in a clinical trial for this innovative pump to our patients who qualify,” says Dan Meyer, MD, Chief of Cardiac Transplantation and Advanced Cardiac Circulatory Support, Baylor University Medical Center. “The new total artificial heart is a novel device that could have a major impact on some patients with biventricular failure.”
Developed in France over the last 10 years, the device is the first auto-regulating bioprosthetic artificial heart that is able to mimic the natural physiology of the human heart. Instead of plastic lining, as in the current total artificial heart, the new device has a bioprosthetic lining, similar to what is used in artificial heart valves. The blood-contacting surface is designed to reduce the need for anticoagulation and the risk of excessive bleeding.
“The new device is lined with a material that is resistant to blood clot formation,” says Michael Mack, MD, Chair of the Cardiovascular Service Line for Baylor Scott & White Health. “It seems to address many of the problems that have plagued the current LVADs and total artificial heart. In addition, the batteries are improved and less bulky, so there is reason to think there is a better quality of life than some of the other options that have been available. It has had success in Europe with 15 patients having received the device with very promising results.” The study protocol includes 10 transplant-eligible subjects limited to the seven U.S. hospitals chosen for the study. The primary endpoint of the study is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. The trial is a staged study with a progress report of the first three patients after 60 days before the enrollment of the next seven patients.