Loma Linda University Health

From Scope, January-March, 1985

The stretch and yawn of a small, dark-haired, blue-eyed baby girl who underwent a historic heart transplant at Loma Linda University Medical Center last October captured the hearts of millions of people throughout the world for a few short weeks.

The transplant of a baboon heart into a two-week-old girl by a team headed by Leonard L. Bailey, MD, a 1969 graduate of the School of Medicine, was the first of its kind in a newborn ever attempted. The transplant made front page news in virtually every daily newspaper throughout the United States and around the world in such places as London, Paris, Berlin, Tokyo, Hong Kong, Singapore, Cape Town, and Beijing.

Reaction to the news was immediate—and mixed. The San Diego Union, in an editorial on Saturday, November 3, stated in part that “the great medical team at highly respected Loma Linda University Medical Center has demonstrated medical science at its best, which is to say it was willing to dare failure and controversy to save a life that would otherwise have been lost. And even if Baby Fae does not survive, she and her doctors will have advanced medical knowledge for the ultimate benefit of mankind.”

Other newspaper editorial pages expressed similar opinions. The Dayton, Ohio, Journal Herald said, ”It is easy to be distracted by emotional protests that are beside the point.

"We need to focus, rather, on this reality: a baby girl was born with a severe birth defect—hypoplastic heart syndrome—which made the left side of her heart much smaller that the right side. Had nothing been attempted surgically, her impending death was a certainty….

“Dr. Bailey, his colleagues, and his hospital deserve praise, not condemnation, for trying. Their experiment, born of desperation, may yet be tomorrow’s breakthrough for untold numbers of babies.”

Joanne Jacobs, a columnist in the San Jose Mercury-News, said, “I’m glad Baby Fae got a chance too: trying to save her, even at desperate odds with experimental techniques, was the humane thing to do.

“I wouldn’t want to live in a society that let its children die without a fight.”

While news of the surgery came as a surprise to much of the world, research leading up to it has been going on at Loma Linda University School of Medicine for the past seven years. Since 1977, intensive laboratory research in the area of newborn heart transplantation has been conducted by Dr. Bailey and his colleagues.

During this time, Dr. Bailey transplanted dozens of hearts between subspecies of newborn goats, and grafted lamb hearts into baby goats. With only limited doses of anti-injection drugs to suppress their immune reaction to foreign tissue, the goats with lamb hearts lived as long at 165 days, and went without rejection episodes for up to six weeks.

His work, ultimately pointing to the concept of xenografts (transplanting organs from one species to another) was a viable possibility for human beings, especially those newborns who came to him dying of hypoplastic left heart syndrome.

Baboons, according to Dr. Bailey, might prove to be a better source of new hearts for babies than humans.

According to the January 1985 Discover magazine published byTime, Incorporated, “healthy infant hearts are rare among donated organs, primarily because infant hearts are a principal cause of infant deaths. Baboons are easily obtainable—the common savanna varieties are considered pests in their native Africa, and they breed prolifically in captivity.

“Chimpanzees, gorillas, and orangutans are far rarer, though they are all much closer genetically to people. Baboon hearts are nevertheless very similar to human hearts.”

Data from Dr. Bailey’s research suggested that babies born with hypoplastic left heart syndrome may have the potential for survival by having heart transplantation during the first few days of life.

Even though relatively uncommon, one in 12,000 babies is born with a hypoplastic left heart—300 per year in the United States. Most of these babies are otherwise born healthy. Yet for most there is no hope.

These babies “lack nothing more than a biological pump,” Dr. Bailey says. “Many people don’t understand the importance of this. They weren’t watching babies die.”

New and original information from the University’s surgical research laboratory, coupled with the release of a new immunosuppressive agent—Cyclosporine—has opened the way for the unique clinical studies in xenotransplantation.

These clinical trials have been studied and approved by many university and medical center communities including the Loma Linda University Institutional Review Board, the Loma Linda University Bioethics Center, the Medical Center standing transplantation committee, the departments of surgery and pediatrics in the School of Medicine, and the School of Medicine administration.

Baby Fae was born in the middle of October in a California high-desert hospital. She was diagnosed as having a heart defect and transferred to Loma Linda University Medical Center, where she was found to be suffering from hypoplastic left heart syndrome. Subsequently, following a short release period, Baby Fae was readmitted to Loma Linda University Medical Center, where her parents were fully informed about her condition and presented with various options. After many hours of discussion, the parents selected the xenotransplantation procedure.

On Friday morning, October 26, Baby Fae underwent a five-hour surgery (called a xenograft) in an attempt to correct her lethal heart condition.

At approximately 7:30 that morning she was taken from her intensive-care room on the seventh floor of the hospital to a surgery suite. Her body temperature was lowered from 37C, (98.6 F) to 20C (68 F) with the use of a heart-lung machine. This step slows down body functions and makes it easier for surgeons to perform their surgery.

Prior to her surgery, several days of clinical tests were done to select the primate that was most immunologically compatible with Baby Fae. Six baboons (ranging in age from four to 12 months) were initially selected for the tests. These were narrowed down to two baboons and finally to one after various testing procedures.

The process “yielded one of the most important finding of the entire effort: that a baboon’s heart could be more compatible with a patient’s tissue than some human hearts,” according to Discover magazine.

“This discovery came to light during the days just before the operation, after Sandra Nehlsen-Cannarella, PhD, a highly respected immunologist at New York City’s Montefore Medical Center, arrived at Loma Linda to begin screening the baboons to find tissue most compatible with Baby Fae’s.

“She determined quickly that Baby Fae carried no preformed antibodies to baboons, roughly eight out of ten adults humans carry antibodies.”

Dr. Nehlsen-Cannarella, working with Loma Linda University research immunologist, Weldon Jolley, PhD, also evaluated tissue samples from various humans—Baby Fae’s parents, other relatives, and doctors—and matched with samples from Baby Fae.

Baby Fae showed the strongest reaction against the tissues from the doctors and two of the half dozen baboons. Of the remaining baboons, one stimulated a very low response and became the animal of choice.

Shortly after 9:00 a.m. the preliminary operative steps were completed and Dr. Bailey went to the hospital research laboratory where the anesthetized baboon awaited him. Shortly, he returned to the surgical suite with the baboon’s heart in a container of icy saline slush. Then, Dr. Bailey led the surgical team in removing Baby Fae’s defective heart and substituted its replacement.

Three arteries normally rise from the human aortic arch, a big blood-bearing tube that curves over the top of the heart. But only two such arteries protrude from the baboon’s heart. Dr. Bailey solved the problem by leaving much of Baby Fae’s aorta and its connecting arteries in place, opening the baboon’s arch, and sewing the two together.

After the chest cavity was closed, Baby Fae’s temperature was raised. At 11:35 a.m. her new heart began to beat spontaneously.

The people in the operating room were in awe at what had just happened, according to Dr. Nehlsen-Cannarella. “I don’t think there was a dry eye in the room.”

Following the surgery, Baby Fae was transferred to her intensive care suite, where she was carefully monitored around the clock.

A couple of hours after the surgery, the University and Medical Center began receiving telephone calls from the news medial requesting information about the historic transplant.

In anticipation of this event, the University and Medical Center had established a communication and press center in the University’s Randall Visitor’s Center, equipped with a bank of phones, tables, and electrical outlets for computers and typewriters. During the first few days following the surgery, the public relations staff were answering up to 1,500 telephone calls per day from all around the world—Great Britain, France, Italy, Germany, Switzerland, Japan, Australia, Canada, and virtually every corner of the United States.

Television crews from the major American networks set up satellite stations at the University for live and tape-delayed broadcasts. During the first week following the surgery, approximately 275 representatives of the world press visited Loma Linda.

In addition to the news media, small numbers of anti-vivisectionists and advocates of animal rights groups hurried to Loma Linda with protest signs that were translated into news photos that were transmitted around the world.

Some scientists criticized the Loma Linda team. Transplant specialist, John Najarian, MD, of the University of Minnesota observed, “Everything we know indicates that the heart is going to fail. The operation will merely prolong the dying process."

Other critics noted that the only other recipient of a simian heart—a 68-year-old man who was given a chimpanzee’s heart in 1964 by Mississippi surgeon, James Hardy, MD—died within 90 minutes, and that two patients of Christian Bernard, lived only a few days after he coupled simian organs to their failing hearts in a piggyback procedure.

But there were voices of encouragement. Stuart W. Jamieson, MD, a member of the Stanford University heart transplant team, which is widely regarded as the world’s leader in that specialty, said he was “rather disappointed to hear that people in the scientific community have leveled charges that they (the Loma Linda team) were unprepared.

“I don’t believe that any of that is correct, it was a legitimate and timely thing to do.”

In answer to the charges that the Loma Linda team had not sought a human heart before transplanting the baboon heart into Baby Fae, Dr. Jamieson said, “Clearly a human heart would be preferable.” He went on to say that he did not want to be critical of the Loma Linda team, because finding a suitable human heart for Baby Fae the day she needed the operation would have been virtually impossible.

Other scientists concurred with Dr. Jamieson. William DeVries, MD, who implanted the heart in Barney Clark and later William Schroeder said that “we’re watching medical history every day that child lives,” and professed smpathy for what they’re going through.

Following the surgery, the hospital mobilized to insure that Baby Fae remained healthy. After Dr. Bailey’s first press conference (two days following the surgery), he disappeared from the media’s view to keep an almost continuous watch on Baby Fae. A team of physicians, nurses, and other health care specialists monitored her vital signs every moment of the day. Her mother visited her many times a day when she could take Baby Fae out of her hospital crib and hold and fondle her and even rock her in a nearby chair. Space next to her room was set aside for the many toys, cards, and hundreds of letters from a growing body of her fans.

Letters of support for Baby Fae, her parents, and Dr. Bailey poured into Loma Linda. Entire classrooms of school children shared their thoughts and best wishes.

“I’m sending you this card as a sign of courage.” Wrote one sixth-grader from Parker Junior High, in Rocky Mount, North Carolina. “I hope you get better soon."

Another said, “Our class is really sorry about your heart. I hope that we can help you. If I was a little bit younger I would’ve given you my heart because I think babies are nice to have.”

Perhaps the most poignant response came from a mother of a baby girl who died in 1981 of hypoplastic left heart syndrome. In a letter to the surgeon and Baby Fae’s parents, the mother said, “In 1981, I gave birth to a beautiful baby girl that was diagnosed with hypoplastic left heart. I would give anything to trade places with Baby Fae’s parents because I had to watch my beautiful {otherwise} perfect child die in my arms—because at the time there was no surgery to help her.

“I remember saying to the doctors, ‘There’s got to be something you can do.’ So we took our little girl back to begin our agonizing wait. She lived only 24 hours longer. During that 24 hours I still prayed that they were wrong.

“What I am trying to say is that I would gladly trade places with [the parents]. I am glad that now at least Baby Fae has a fighting chance. Our little girl was born a few years too early. I would have given anything to help my baby, as you are doing, even if I had only prolonged her life. You see, all I have left of her is six days of memories—a lifetime crammed into six short days, and I wouldn’t give up that time spent with you for anything.

“My love and prayers are with all three of you at this critical time. And remember, our little baby girls were put on this earth for a reason only God knows. I realize it is very hard to accept what has happened and not lose faith. Hang in there and keep fighting.

“I now have three beautiful healthy children. I often can see a little blond head lined up with my other three. She forever lives in my heart and soul.”

But despite having the best medical care available, Baby Fae died at 9:00 p.m. on November 15.

At a press conference the next day, Dr. Bailey, even though emotionally shattered by Baby Fae’s death—a loss shared by the whole nation—pledged to honor the request of Baby Fae’s mother that this experience not be wasted and that he would attempt the operation again “by and by.”

On Sabbath afternoon following Baby Fae’s death, a memorial service was held at the University Church of Seventh-day Adventists in Loma Linda. Over 2,500 people crowded into the church to pay their respects, many more watched on closed-circuit television.

Baby Fae’s baboon heart failed her. Was it worth it?

Discover magazine believes it was. “In a world where many millions of children are dying for simple want of food, is it right, after all, to spend so much time, effort, and money to try to save one who has so little chance of survival? Perhaps not simply right, but necessary. To cherish the life of one child—‘this precious child,” as Leonard Bailey put it—is to value the lives of all. A rescue mission need not succeed to be brave.”

To view the full-length documentary, visit "Stephanie's Heart."