Chicago's first participant in the RELIANT (Randomized Evaluation of the Novacor(r) LVAS In A Non-Transplant Population) research study recently went home from Northwestern Memorial Hospital.
Percy Pinkdon, a 70-year-old Chicago man, suffered from irreversible end-stage cardiomyopathy, a weakening of the heart muscle that affects its ability to pump blood.
He received unsuccessful cardiac treatments at other hospitals and an existing bone marrow abnormality ruled out a heart transplant. A friend recommended he come to the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital where he learned about a first-of-its-kind, national, multi-center clinical trial that compares heart pumps from two different manufacturers - the Novacor Left Ventricular Assist System (LVAS) and the standard device, the HeartMate VE LVAS - as destination therapy or a permanent treatment for severely ill patients who are not candidates for a heart transplant.
"The field of heart pump technology is evolving. This research trial is important because we need to understand what type of pump will work best in each patient," said Pinkdon's surgeon, Edwin McGee, MD, surgical director, Advanced Heart Failure Program at the Bluhm Cardiovascular Institute and assistant professor of surgery at Northwestern University's Feinberg School of Medicine.
Heart pumps were initially approved as a "bridge-to-transplant," to assist a person's ailing heart until a donor heart could be found for transplantation. Three years ago, the Food and Drug Administration (FDA) gave approval for the first time for a heart pump to be used as destination therapy.
Left ventricular assist systems assume the pumping function of the left ventricle of the heart, which pumps blood to the large blood vessel that sends blood to the rest of the body. The systems include an implantable heart pump and mobile external components, connected through a line in the skin that powers the pump. Patients typically carry the power components, which are about the size of a deck of cards, in a holder around the waist. "Destination therapy or permanent placement of ventricular assist systems is in its infancy, but the technology is improving constantly and rapidly," says John O'Connell, MD, director of the Bluhm Cardiovascular Institute's Center for Heart Failure. "Soon a proven totally implantable device will be available. While transplantation can be very effective for end stage heart disease, only 2000 are done annually in the United Sates and the number who could benefit from replacement therapy may be as many as 250,000. However, currently destination therapy is available only to those who cannot receive a transplant because of non-cardiac conditions that rule out transplant."
"The results of a clinical trial in 2001 showed that participants with end-stage heart failure who are not transplant candidates live longer, fuller lives if they receive an LVAS as opposed to being treated with optimal medical therapy," said Dr. McGee. "These pumps are the best option for those in the worst stages of heart disease who, for whatever reason, are not candidates for a heart transplant."
"Before getting a heart pump, Mr. Pinkdon was about as sick as you can get," says Dr. McGee. "The highest doses of medicine were no longer working. His heart was not pumping adequate amounts of blood to his body. We had to implant an intra-aortic balloon pump to reduce the workload of his heart and to improve flow of his blood to the coronary arteries. He required intubation and was placed on a ventilator."
Mr. Pinkdon had the device implanted in late August and after a nearly two-month recovery at Northwestern Memorial, he says, "I feel great. I'm no longer out of breath or in pain."
"We are very happy with his progress," says Dr. McGee. "With either of the pumps we're studying, participants should have more energy and can basically return to their normal lives."
The Bluhm Cardiovascular Institute, which relaunched its heart transplant program this spring, offers world-class heart services from evaluation to follow-up. "We want to see those patients who have been told nothing else can be done for their heart conditions," said, Patrick McCarthy, MD, co-director of the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital and chief, Cardiothoracic Surgery, Northwestern Memorial. "We've performed surgery on many patients who've been told they aren't surgical candidates and have done beautifully with complex bypasses or valve repairs. However, when repairs are not possible, we have a team with the experience and knowledge to evaluate patients and offer transplant if at all possible. If not, we can offer the latest generation of heart pumps, and it is hoped that participants will do well with these."
"Cooperation of the primary care physician, cardiologist and heart surgeon is critical to an optimal result,," says O'Connell, who was one of Mr. Pinkdon's cardiologists. "We have assembled a team of nurses, cardiologists and surgeons that work together to personalize the approach to the management of care with the goal of achieving the best outcome possible for each of our patients."