Treatment changes coming in heart and lung transplants

New guidelines for the management of heart transplant patients are coming from the International Society for Heart & Lung Transplantation (ISHLT). "The last version of the currently advocated guidelines was approved in consensus form in 1992," said Mandeep Mehra, M.D., an ISHLT board member and the head of the division of cardiology at the University of Maryland School of Medicine in Baltimore. "Since that time, the management of congestive heart failure [CHF] has changed dramatically," he said.

"We must provide organ centers with clear guidelines to help them update their policies regarding waiting lists and the management of potential transplant recipients," Mehra said, adding that final approval of these guidelines is ongoing, and the document is subject to further review prior to journal submission.

According to Mehra, ISHLT established three different task forces to develop the guidelines for heart transplantation: a task force for developing recommendations for listing candidates for transplantation; another panel for developing guidelines regarding the pharmacologic and nonpharmacologic management of those listed for heart transplantation; and a third group for developing recommendations for the use of mechanical devices, such as pacemakers in heart transplant recipients.

Mehra reported that the committee also extrapolated data from the African-American Heart Failure Trial (A-HeFT) to the general population. This trial evaluated the effect of a combination of hydralazine and isosorbide dinitrate (BiDil, NitroMed) in African-American patients with stable New York Heart Association Class III-IV heart failure who were also on standard therapy. The panel recommended that a combination of hydralazine and nitrates strongly be considered for those whose symptoms persisted despite receiving recommended doses of neurohormonal antagonists.

Mehra said that the group also made recommendations regarding the management of those with decompensated heart failure. The task force recommended that intravenous vasodilators be considered prior to the initiation of ionotropic therapy in those with decompensated heart failure and inadequate blood pressure. The committee also recommended that the need for ionotropic therapy be frequently reassessed in those on continuous ionotropic support.

Jonathan Orens, M.D., medical director of Johns Hopkins Lung Transplantation Program at Johns Hopkins University Medical Center, said that advances in treatment have also changed the way that those with primary pulmonary arterial hypertension (PAH) are managed as they await lung transplantation. With the approval of epoprostenol (Flolan, GlaxoSmithKline) and bosentan (Tracleer, Actelion), these patients can be kept alive for a much longer period of time than in the past, he said. He also pointed out that sildenafil (Viagra, Pfizer) has potential for use as a dilator of the pulmonary vasculature. Since then, sildenafil has been approved to treat PAH under the brand name Revatio by Pfizer.

The bottom line, Orens said, is that lung transplantation has become a treatment of last resort for those with PAH. The lung transplant task force plans to include in the guidelines a phrase to the effect that those with PAH should not be offered lung transplantation until they have failed full medical therapy, including intravenous prostacyclin.

Mehra pointed out that the United Network for Organ Sharing (UNOS) strongly recommends that at least one clinical pharmacist be included on each core transplant team (see Drug Topics May 16). He said pharmacists are involved in the evaluation of potential transplant candidates and other aspects of the preoperative decision-making process.

Orens explained that after transplantation, patients must be kept on a broad range of medications, including prophylactic antibiotics; immunosuppressants; and drugs to counter the effects of the immuosuppressants, such as diabetes, hypertension, and hyperlipidemia. He said that it is not unusual for transplant recipients to be taking at least 10 different medications to control their condition.

Charlotte LoBuono is a clinical writer based in New Jersey.