Tufts Medical Center’s Duc Thinh Pham, MD and David DeNofrio, MD are investigators in this study, examining the safety and efficacy of the HeartWare LVAD system in patients diagnosed with refractory, advanced heart failure, who are listed for heart transplantation. An LVAD system is a mechanical device that is surgically implanted in a patient to help the heart pump blood to the rest of the patient’s organs and body.

Tufts Medical Center is the only hospital in New England participating in the study, and therefore we are currently the only medical center in the area offering this investigational device to patients.

Tufts Medical Center is participating in this study along with other elite institutions in the country, including Cleveland Clinic, Johns Hopkins Medical Center, and Mayo Clinic. Approximately 100 patients have received this LVAD across the country since the study’s inception in late 2008.

“Our Heart Failure and Cardiac Transplantation Program’s participation in this clinical trial affords us the opportunity to explore the added value of this advanced medical technology for our sickest patients from across New England,” said Dr. Pham, Surgical Director of Tufts Medical Center’s Heart Failure and Cardiac Transplant Center. “It speaks to our commitment as a medical center to our patients and the treatment of heart failure.”

Stage D heart failure, or refractory heart failure, is the most advanced stage of heart failure. A patient with Stage D heart failure has just a 20% chance of surviving more than one year with medication intervention alone, so for these patients, LVAD systems or heart transplants are the only treatment options.

LVAD systems are sometimes used as an alternative to heart transplantation, but they were primarily intended to help patients who are at risk of dying from heart failure survive until heart transplantation could occur. Because only approximately 2,200 patients receive a new heart each year in the U.S., having an LVAD system implanted can add years to a patient’s life.

The advanced technology of the new HeartWare LVAD, which is smaller than previous LVAD devices, has the potential to offer heart failure patients a speedier recovery, with fewer complications, and greater long-term reliability. The new device can fit in the palm of a hand and is implanted in the pericardium, the sac around the heart. Earlier LVADs were much larger and needed to be implanted in the abdominal space. The HeartWare LVAD uses a floating magnet to pump blood throughout the body, so there is no wear and tear due to friction, as was the case in the earlier models. Physicians are hopeful that the lack of friction will lead to greater durability. All LVAD options are powered by an external battery pack. The drive line that connects the pump to the battery on this new device is one-third the size of that of its predecessors, and potentially reduces a patient’s risk of infection.

Dr. DeNofrio, Medical Director of the Heart Failure and Cardiac Transplant Center sees great potential for this new device. “Based on results of this trial, our hope is that this new device will gain FDA approval and will offer improved outcomes and quality of life for thousands of patients who are currently awaiting heart transplantation,” said Dr. DeNofrio.