At first, when Linda qualified for the heart transplant waiting list, she never wandered far from a phone, expecting a call any day telling her to get to the hospital quick. The 52-year-old chemical engineer, who lives in Oakland, California, was told that the typical waiting time was six to 24 months, and not to travel farther than four hours’ driving distance from the Stanford Hospital operating room — the clock starts ticking as soon as a donor heart is found.
Then she waited. And waited.
That was over a year and a half ago, just after her cardiologist had diagnosed right-side heart failure. He had pointed out on her echocardiogram how the blood streamed straight through the right side of the heart without the valve even pumping, “just like it was an open pipe.” Diagnosed almost 20 years ago with right ventricular dysplasia, a rare genetic disease that causes dangerous heart rhythm abnormalities, she has been living with a surgically implanted device that jolts her heart back into a normal beat — on occasion knocking her to the ground to keep her alive. Finally at 50, her cardiologist said the disorder had greatly enlarged her heart, and she was running out of time.
“He told me this is just going to get worse so I went through a battery of tests to be qualified for the heart transplant list,” says Linda, who has asked to use her first name only. “I told a few friends and my family, prepared for surgery, and then nothing happened.”
Despite advancements in medications and mechanical assist devices, heart transplant remains the best treatment for heart disease at its most severe. It’s a successful procedure that adds years to the lives of deathly ill patients. The problem is that an estimated 20,000 people across the nation, including Linda, could benefit from receiving a new heart, with only a few thousand receiving transplants on average per year.
Many wait for years. Many die waiting.
The general assumption is that there simply are not enough donor hearts available to meet a growing demand. But new research is questioning that assumption. Some researchers and surgeons claim that thousands of donor hearts that could be used are turned away each year. The hearts are considered marginal because they come from older, sicker or riskier donors, but many argue they are safe for transplant, and could be saving lives.
“As patients wait longer, they often get sicker, and we often lose patients,” says Stanford cardiologist Kiran Khush, MD, whose research reports that 65 percent of available heart donations are discarded because of stringent acceptance criteria. Yet the criteria have not been critically evaluated, she says. “Increasing the supply of donor hearts is, of course, a great concern of mine.”
Linda says she doesn’t understand all the criteria for choosing or rejecting a donor heart, but she does know she wants to get a new heart as soon as possible. She’s open to considering a “high-risk” heart, but like most people, isn’t sure what that means. The definition seems to vary depending on whom you ask. As a patient, it’s doubtful she’ll play much, if any, role in choosing her own donor heart anyway.
“At first I would think, well no, of course I wouldn’t accept a high-risk heart. You are taking a higher risk than if you wait. But the trade-off is, if you wait, it may be too late.”
How you get a donor heart
The process that matches recipients with donor hearts is complex and somewhat astounding. Many factors figure into the national system that matches kidney, liver, lung, pancreas, and small bowel donations with recipients, but heart transplants are particularly fraught because of the short shelf life of a donor heart. Ideally, a heart should be transplanted within two to four hours of its removal.
The process begins with a phone call.
On a recent Wednesday, John Nguyen — a nurse who leads a team that coordinates organ donations for the Oakland-based Donor Network West — receives two such phone calls. One is from a hospital in nearby Walnut Creek, the other from a hospital in Modesto, about 80 miles east. The first call is to report that a 40-something woman had suffered a large, hemorrhagic stroke. The second, to tell him about a young man who has shot himself in the head. Both are approved as potential heart donors.
Donor Network West is one of 58 federally designated organ procurement organizations set up across the country as the first gatekeepers for donor organs. They are the middlemen who connect donations with transplant centers. Nguyen and his team provide care and procurement of organ donations in Northern California and Nevada. Once potential organ donors have been declared brain dead — as was the case of the patients in Walnut Creek and Modesto — Nguyen sends his team members into the hospital’s intensive care unit to facilitate care of the donor. Over the next 36-72 hours, they will evaluate the organs, provide medical care for the donor to keep the organs functioning well, and give support to grieving family members often still at the bedside.
“Technically the patient is dead because their brain has complete and irreversible loss of function — but the heart is still beating,” Nguyen says. “But they are still in the ICU and still on a ventilator to maintain organ function. From a distance, they look like any other ICU patient.”
This is the first point in the screening process for organ donations. In the case of most organs, including hearts, if they are too sick or damaged, too infected or old, they’ll get rejected here. To determine whether a heart is donation-worthy, the team orders blood tests to check for infectious diseases. Electrolyte replacement helps optimize organ function, antibiotics ward off any potential infections and medications maintain blood pressure. An EKG and echocardiogram test the functioning of the heart.
Ultimately, the goal of the organ procurement organizations is to approve and offer as many hearts as possible to patients on the waiting lists. The hearts that get rejected by these middlemen, in this case the team led by Nguyen, tend to be from donors over 65, and those with advanced coronary artery disease or other serious heart diseases — any hearts from donors over 45 get tested for these. Cancer is another variable that will get a heart rejected. Or HIV infection or hepatitis C.
After reviewing the two potential California donors’ medical history records and the results of their tests, Nguyen’s team clears them both for transplant.
The hearts can now be offered to transplant centers. Nguyen enters basic information into a federal electronic database — age, height, weight, blood type of the donor — and gets back the name of the sickest patient on the waiting list in his area that matches. He then calls the patient’s transplant center. A representative at the center collects any pertinent information, including the results of the heart tests, and then calls the patient’s surgeon immediately, no matter the time, day or night.
Now the future of the heart is in the surgeon’s hands. Rarely do patients themselves have a say in whether the heart is accepted or rejected at this point. Most often, it’s the surgeon, or the surgeon and the patient’s cardiologist who decide.
Transplant surgeons say no to donor hearts for many reasons: In addition to the factors that Nguyen’s team has already screened for, others include small size, advanced age and illnesses such as hypertension and diabetes.
“Beyond that, there are a lot of criteria that vary from surgeon to surgeon and center to center,” Khush says. “With factors like mild thickening of the heart muscle, as can be seen in donors with high blood pressure, or drug abuse, it is really up to the transplant center or the surgeon.”
In this case, Nguyen is able to successfully match both hearts. The heart from the young suicide victim gets accepted on the first offer to nearby Stanford Hospital. For the heart from the 40-something stroke victim, he had to return to the waiting list five times before it was finally accepted outside the region at Loma Linda University Medical Center in Southern California.
“It was an older donor and was a little complicated because of the small size. Size matching can be complicated. No one locally was able to use the heart.”
Nguyen says he has recently seen a disturbing uptick in the number of hearts he offers for transplant that get rejected.
“We work up these hearts because we feel they have potential for transplant,” he says. “Then we see differences in acceptance practices from area to area. Sometimes we offer a heart throughout the whole nation and it’s not accepted. Some hearts get wasted.”
Nguyen has joined the growing number of medical professionals concerned that potential organ donations are going to waste. He co-authored a study with Stanford’s Khush that found a majority of donor hearts do, in fact, get rejected. And that number has been increasing.
The study, published in February in the American Journal of Transplantation, also found that the rejection of “marginal” donor hearts — those with undesirable qualities, such as being small or coming from an older donor — varied significantly across geographical regions. In other words, some hearts rejected in one region of the country are accepted in another.
“We’ve become more conservative over the past 15-20 years in terms of acceptance, which is particularly troubling because of the national shortage of donor hearts and the growing number of critically ill patients awaiting heart transplantation,” says Khush, who has begun a new study to provide some of the missing, scientifically based criteria for choosing or rejecting a donor heart by collecting data from 5,000 donors over a period of five years.
To look at national trends in donor-heart use for transplant, the recent study examined data from the federal government’s Organ Procurement and Transplantation Network on all potential adult cardiac donors from 1995-2010.
Of 82,053 potential donor hearts, 34 percent were accepted and 48 percent were declined. (Eighteen percent were used for other purposes, such as research.)
“Only one in three available donor hearts is currently accepted for transplantation, which greatly limits heart transplant rates nationwide,” the study says.
Other studies have shown similar concerns about other organs for donation. A recent analysis of organ sharing data by surgeons at the University of California found that 84 percent of patients who died waiting for a liver had received at least one organ offer and an average of six offers. Most were declined by the surgeons due to donor age or quality of the organ. The author cited stigma associated with “non-ideal” livers as the reason for rejection, not lack of available donations.
Heart surgeons themselves admit it can be a difficult decision for them to make.
“There are multiple variables to consider and donor suitability may vary by region,” says heart surgeon Joseph Woo, MD, professor and chair of cardiothoracic surgery at Stanford. “In Europe, surgeons are much more proactive in using older hearts. Europeans would say we are giving up on too many hearts. One of our counterarguments would be we have very good outcomes. However, I do think we could expand our donor criteria and utilize more hearts.”
Jon Kobashigawa, MD, director of the largest heart transplant center in the nation, at Cedars-Sinai Medical Center in Los Angeles, points out that because of improvements in helmet and speeding laws over the past two decades, younger donors are becoming much less prevalent. Statistics show that the average donor heart is much sicker and older today than 20 years ago. If heart transplant lists are going to get shortened, surgeons have to be more open to using more of the older, higher risk hearts.
“It’s really a complex issue,” he says. “I still question myself. I know hearts are not being used that could be used. Everyone wants a 20-year-old donor. But if you are a 58-year-old heart failure patient on the waiting list and you won’t take anything but a 20-year-old heart, you’re not going to make it.”
The competing variables that come into play in order to choose a heart also make it easier for outside influences to hold sway. Increased scrutiny by regulatory agencies of the 140 or so transplant centers across the country may also have had the unintended consequence of making transplant surgeons more risk averse, Khush says. As a result, the decision of whether to accept a heart is not based solely on scientific criteria.
“Creating a more systematic way of evaluating these hearts based on scientific evidence could increase the number of heart transplants,” Nguyen says.
The surgeon’s decision
When Texas-based heart surgeon Gonzalo Gonzalez-Stawinski gets a call from an organ procurement organization offering a donor heart, it’s usually the middle of the night, say around 3 a.m.
“When I get the call, I ask right then for the story,” says Gonzalez-Stawinski, chief of heart transplantation at Baylor University Medical Center in Dallas. “At 3 in the morning you want to hear about it and get it done. They might say it’s a 26-year-old female who died of a gunshot wound to the head, who is currently in Nashville, Tennessee. The echo shows an ejection fraction of 55 percent and there are no IV drips delivering medication to help the heart contract.”
Most often Gonzalez-Stawinski says yes to the heart. He’s earned a reputation as an aggressive surgeon who will accept high-risk hearts at an institution with the second-highest volume of heart transplants in the country, averaging about 100 a year. He says that by making small changes in the donor acceptance criteria, his transplant team has been able to greatly increase the center’s volume, while maintaining low mortality rates.
“My next question is: Who does it come up for? Who do we match for?” After reviewing the history of the patient on the waiting list matched with the heart being offered, he next wants to know the size of the donor heart and its blood type. Then he starts to search for red flags. He asks about the donor’s medical history, smoking, diabetes, obesity, all indicators that the heart needs to be screened for coronary artery disease. “If there’s jail time or drug use, you think of viruses.”
It’s the variability in selection criteria from surgeon to surgeon and region to region that concerns researchers like Khush. She wants more broadly defined acceptance criteria based on scientific research available to all players involved in screening donor hearts. This would entail a more clear definition of what “high risk” actually means, and when, or if, those hearts can be used for transplant.
“High-risk” hearts as defined by the Centers for Disease Control are those that come from donors who were IV drug users, hemophiliacs or prostitutes, or anyone with high-risk sexual activity, exposure to HIV or time spent in jail. If a surgeon accepts any of those hearts for transplant, this is the one time he or she is required to get patient approval before transplantation.
“Twenty percent of our donors are ‘high-risk,’ according to the CDC definition,” says Gonzalez-Stawinski. With high-risk factors such as prostitution, drug use or prison time, the fear is transmission of viral diseases. But, according to Gonzalez-Stawinski, “everybody screens for those, and if the screening tests are negative, there is zero chance of infection.” Others aren’t so certain, so the issue often comes under debate.
For hearts from donors with a history of any of these high-risk factors, he always talks to the patient about the risks, and explains that he would never offer any heart to a patient that he wouldn’t accept himself.
As Gonzalez-Stawinski considers the many variables involved with matching a heart with a patient, location comes into play. One of the benefits of being centrally located in Texas is that the surgical fellow with an ice cooler who flies out to surgically remove and bring back the donor heart can be most anywhere in the continental United States within three hours. This further broadens the number of donor hearts available to him, Gonzalez-Stawinski says.
“I can push transport time out to six hours with a young heart,” he says. “That’s where the secret of donor matching comes into play.”
A heart shouldn’t immediately be rejected because it’s too old, too far away or comes from a patient with a history of infectious disease, he says. “If the heart comes from a 61-year-old retired physician-triathlete who had fallen from the back of his truck and cracked his head, and your selection criteria uses 60 as a cutoff age, you’ve lost a good heart.” If your only option is a donor heart infected with hepatitis C, perhaps you still transplant it, but then treat its new owner with hepatitis C medications.
“For some people it is black and white,” he says. “What I believe is that if you understand your risk factors, you can use them to your advantage to avoid having a problem.”
What it comes down to is this, he says: “The guy who is donating the heart is definitely not on a heart transplant waiting list, so what’s the problem?”
For Linda, the chemical engineer who has been on the waiting list for more than a year and half, no one has yet called offering her a “high-risk” heart. She’s still waiting for any call at all. For now, she focuses on limiting her activities, taking a multitude of medications, reserving her energy, carefully monitoring her diet — a Chinese-food meal, notorious for high sodium content, could put her in the ER — and doing her best to be grateful she is alive. Unfortunately, she’s learned that there is almost zero chance of her getting a call as long as she’s able to live outside of the hospital. There will always be a heart-failure patient who is sicker than she is higher on the waiting list.
“The thing my cardiologist is most worried about is that I’ll go into this rapid degradation and be hospitalized but not get a heart in time. Even though I seem OK, I struggle to do a lot of things. And I hide it. I’m kind of faking my way through life right now.
“I would get a transplant today if I could,” she says.