Heart-transplant patient survival rates on the rise, Ottawa Heart Institute study shows

By Pauline Tam, The Ottawa Citizen
OTTAWA — A long-term study of Canadian heart-transplant patients has found that survival rates have improved markedly, with the biggest gains being made within the past 10 years.

The study, which followed 461 patients at the University of Ottawa Heart Institute since 1984, found that as a result of medical advances over the past decade, nine out of 10 transplant patients now live longer than eight years.

The younger the patient at the time of the transplant, the more likely they are to live longer, the study concluded.

Dr. Marc Ruel, the study’s author, attributed the gains to improved pre-surgical and post-operative care, including the advent of anti-coagulant drugs that permanently thin a patient’s blood, removing the risk of life-threatening clots.

Patients are also being kept alive longer due to the improved management of organ rejection and infection following surgery.

“It’s better surgery, better medicine, better team work, better organ procurement organizations. Just every single step is better understood and has been optimized,” said Ruel, who’s surgical director of the heart transplant program at the heart institute.

The results of the study were presented Monday at the Canadian Cardiovascular Congress in Vancouver.

Among the heart-institute patients who received transplants over the 25-year study period, nine out of 10 were still alive one year after they received a donated heart. An estimated eight out of 10 patients were alive five years later, six out of 10 a decade later and more than a third lived to see 20 years.

An international heart-transplant registry found that nearly seven out of 10 patients are still alive seven years after surgery, so the heart institute results compare favourably.

The oldest person to receive a donated heart during the study period was 74, and the youngest was three.

Transplants can be done after the age of 65 with good results, but doctors carefully screen patients to avoid those with significant kidney or liver illnesses that could compromise lifespan or quality of life, said Ruel.

Patients are considered candidates for transplant if they have exhausted all other available therapies and have less than a year to live. Nearly half of all transplant patients have heart failure due to some kind of genetic defect; the other half are patients who have survived multiple heart attacks and are living with end-stage heart disease.

An estimated 500,000 Canadians live with heart failure and 50,000 new patients are diagnosed each year. Last year, 167 Canadians received new hearts, while another 135 were on the waiting list.

Modern heart transplantation became available in 1980. Since then, survival rates have improved to the point where for every 10 transplants performed, two more patients survive longer than a decade, the study found.

The leading cause of death following a transplant is a condition called vasculopathy, a form of chronic rejection that narrows the blood vessels of the transplanted heart.

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Miniature Cardiac Pump Saves Lives as Children Wait for Hearts

By Michelle Fay Cortez Bloomberg

Miniature pumps that take over for a damaged heart can keep the smallest children alive as they wait, sometimes for months, until a donated organ is available, a study found.

Researchers tracked the fate of nine children ranging from a 12-day-old infant to a 17-year-old youth who received the tiny device made by Berlin Heart GmbH under a special program for those with no other options. While machines from Thoratec Corp., World Heart Corp., Ventracor Ltd. and HeartWare Ltd. are available or under development for adults and older children, the smallest patients in the U.S. have few treatment options.

The study in the journal Circulation found eight of the nine children survived, with the youngest dying from kidney damage that worsened after surgery to install the device. All the others treated at Saint Louis Children's Hospital in Missouri received transplants after as many as 77 days using the device, known as the Excor, and are doing well. The pumps kept the children strong until they underwent surgery for a heart transplant.

``These kids are going into the operating room in very good physical shape,'' said lead author Sanjiv Gandhi, surgical director of the heart failure program at Washington University School of Medicine in Saint Louis, in a telephone interview. ``It's a huge difference compared to a patient in the intensive care unit on a bunch of machines, immobilized.''

Waiting List

More than 250 children age 17 and under are waiting for heart transplants in the U.S., according to the Organ Procurement and Transplantation Network.

Larger heart pumps are approved for U.S. use in adults and children aged 5 and older. Children who don't qualify for the device typically undergo a treatment where the blood is removed from the body, oxygenated, then slowly returned. The approach isn't effective for long-term use, carries side effects that can include infections and neurological impairment, and requires the child to be immobilized, the researchers said.

The small heart pumps cost about $50,000 and have been available in Europe for several years, Gandhi said. Germany's Berlin Heart started a study in December 2007 that may help win U.S. Food and Drug Administration approval of its device. No similar products are approved now in the U.S. for children under age 5, Gandhi said.

Cost Justified

The cost is well worth the expense, Gandhi said. The children who get the device can wait on a normal hospital floor, rather than the intensive care unit, for a donated heart to become available. They also tend to fare well after the operation, which may save on future bills, he said.

There are risks to the surgery. More than half the children needed the external pump replaced at least once, often because of blood clots. Infections occurred in four of the nine children, and one device malfunctioned. While stroke and death rates were low in the study, so was the number of children treated, Gandhi said. Overall, about 75 percent of children survive until they receive a transplant, much better than their odds without the machine.

The findings were originally presented at the American Heart Association's annual Scientific Sessions last November.

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Infant Heart Transplants Raise Questions on Criteria for Death

From Bloomberg.com:

By Nicole Ostrow

Aug. 14 (Bloomberg) -- Doctors have reignited a debate over when an organ donor should be declared dead after a study reported on the first three known successful cardiac transplants from infants who were pronounced dead after their hearts stopped.

The research, published by the New England Journal of Medicine, reported on transplants from babies whose hearts had stopped after life support was removed. Infant donor hearts usually are removed only after the child is considered brain dead, which has limited the number of hearts available for infant transplant.

About one-fourth of babies needing heart transplants die before organs become available. The finding that a heart that irreversibly ceases to beat in one infant can be restarted and give new life to another raises ethical and medical questions about donor death, doctors said in three commentaries in the journal. The U.S. now has 44 infants awaiting heart transplants.

The findings ``open the door'' to heart transplantation following cardiac death, wrote Robert Veatch, a professor of medical ethics at Georgetown University in Washington, in a commentary in the journal accompanying the study. They also raise the question: ``When can death be pronounced on the basis of loss of heart function?'' he wrote.

A declaration of cardiac death requires that the cessation of function of the heart and circulatory system be irreversible. To ensure a viable heart from a cardiac death donor, procurers of organs try to minimize the time from when a heart stops to when death is pronounced. Death usually isn't pronounced for at least two to five minutes after the heart stops, the journal article said.

Current data suggests that cardiac arrest becomes irreversible in 60 seconds or less, according to a 2000 report by the Institute of Medicine.

Speed is Critical

In the transplant study, the time between cardiac death and pronouncement of death for one infant was 3 minutes. For two other donors, it was 1.25 minutes. Physicians not involved in the care of the heart recipients, with the consent of the babies parents, decided to end mechanical life support that had been keeping the infants alive, the article said.

The three transplants were done at the Denver Children's Hospital from 2004 to 2007. All three recipients are still alive, according to the study.

``The fact that the children did reasonably well suggests that this could be a viable technique if people wish to use it,'' said Jeffrey Drazen, editor in chief of the New England Journal of Medicine, in an Aug. 12 telephone interview. The study ``raises significant issues concerning the use of organs in the setting of both the pediatric and even the adult intensive care,'' he said.

The commentary authors called for review of current transplant rules.

Defining Death

``It may ultimately be deemed acceptable to amend either the dead donor rule or the brain-based definition of death,'' Veatch said in his commentary. ``But whether or not any such legal changes come to pass, any successfully transplanted heart cannot have come from a person who was declared dead on the basis of irreversible stoppage of the heart.''

Robert Truog, professor of medical ethics at Harvard University and author of one of the commentaries, said it was wrong to conclude from the study that doctors are ``doing something unethical.''

``We sort of set ourselves up for people to believe that the dead donor rule is a fundamental and inviolable principle that we need to follow in the ethics of organ transplantation,'' Truog said. ``The worrisome thing that people might take away from the study is that doctors are doing something unethical in order to increase the number of organs for transplantation. That would be the wrong conclusion.''

Irreversible Heart Death

Mark Boucek, the study's lead author and director of cardiovascular services at Joe DiMaggio Children's Hospital in Hollywood, Florida, said cardiac death of the donors was irreversible because parents had decided they didn't want the children to be resuscitated.

The hearts were restarted in other babies because there was nothing wrong with the organ in the donors, Boucek said.

``It's simplistic to say that a heart that can't work in one individual can't work in another individual. It depends on the environment that the heart is working in,'' Boucek said in an Aug. 12 telephone interview.

More than 6,000 children have received transplanted hearts from donors who were declared brain dead over 25 years, according to the study. Children who need a heart face higher risk of dying while awaiting a transplant than kids waiting for other organs, the researchers said.

Three-Year Study

Over the three-year study, 12 potential donors who died from cardiocirculatory causes were identified. If their hearts had been used, the number of transplants at Denver Children's Hospital would have increased 70 percent during that time, the study said. During those years, one pediatric heart donor was declared brain dead. No other newborns' hearts could be harvested under traditional criteria at the hospital, according to the study.

``It's terribly frustrating to lose a child while awaiting transplant,'' said Boucek. ``I'm hopeful that the study will make it possible for children or at least infants to have more donor organs and for more children to have the opportunity at life.''

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