New guidelines issued by the United Network for Organ Sharing will influence which patients get heart transplants and when.
Implemented in September with a second phase underway since October, the guidelines call for six new medical urgency statuses instead of three, requiring patients to have more specific criteria to qualify.
UNOS spokesman Joel Newman said the new policy creates a clearer distinction of status and provides a better way to determine who the most urgent candidates are.
Under the new guidelines, the most urgent need will be considered together with candidates from a new, broader geographic area of 500 miles — with the patient’s current medical condition determining their status on the list.
UNOS officials said they expect the outcomes to result in an increase in transplants for the sickest candidates, more refined priority for the very sickest and wider access to donors. The goal is by increasing priority for the sickest patients, the number of deaths will be reduced.
Dr. Marc Goldschmidt, medical director of the Heart Success and Left Ventricular Assist Device programs at Atlantic Health System’s Morristown Medical Center, said the intent of the new regulations is to ensure the best possible utilization of a limited resource.
“In general, we anticipate that the effect of these new rules will be to direct donor hearts to the sickest patients and to decrease the impact of the patient’s geographic location,” said Goldschmidt.
Heart transplantation, Goldschmidt said, is accepted as the gold-standard therapy for patients suffering from end-stage congestive heart failure.
“Unfortunately, there is a tremendous discrepancy between the number of donor hearts available and the number of patients that could benefit from one,” he said.
Approximately 75,000 patients annually in the U.S. would be considered candidates for heart transplants, but there have never been more than 2,500 donor hearts available in any given year since the mid-1980s, according to Goldschmidt, who said this has resulted in significant numbers of patients dying while waiting on the transplant list.
Patients who are awaiting heart transplantation can be treated with a left ventricular assist device that allows them to be fully functional while at home awaiting a new heart. Also, patients with heart failure that are not considered candidates for transplant can instead receive an LVAD.
Goldschmidt explained that LVADs are implantable pumps that take over the work of the main pumping chamber of the heart. They were first approved in the mid-1990s and have been widely used since 2010.
“LVAD technology is increasingly being used to fill the gap between the growing number of patients in end-stage heart failure and the limited number of donor hearts available,” Goldschmidt said.
Newark Beth Israel Medical Center, an RWJBarnabas Health facility, is one of only 12 hospitals in the country that has performed more than 1,000 heart transplants.
“It is too early to assess the impact of the recent changes to the organ distribution guidelines,” said Dr. Mark Jay Zucker, director of the Cardiothoracic Transplant Program at Newark Beth Israel. “High volume centers such as ours may not begin to experience the effects of these changes for many months.”
Meanwhile, Dr. James Slater, surgical director of the Mechanical Circulatory Support and Heart Success programs at Morristown Medical Center, said while the overall effect of the new UNOS initiative may improve allocation of donor hearts, it is not expected to have a major impact on narrowing the increasing gap between the number of heart patients and donor organs.
“We believe that the use of left ventricular assist devices will continue to increase in the coming years to provide a viable, reliable treatment option for end-stage heart failure patients,” he said.
The Heart Success program at Morristown Medical recently celebrated its 100th implant. The objective of the program, said Slater, is to return patients back to their families so they can enjoy a quality of life they may not have had for years.