Prenatal Care: Fetal Operation Raises Hope for Some Parents But Lots of Questions

Is Spina Bifida Surgery Worth Risk of Premature Birth?

Should Insurers Cover It?

A University Tries to Brand It
By Ron Winslow

The Wall Street Journal
Page A1
(Copyright (c) 1999, Dow Jones & Company, Inc.)

NASHVILLE, Tenn. -- Even in a time when breakthrough medical feats seem commonplace, what goes on in Operating Room No. 5 at Vanderbilt University Medical Center is extraordinary.

Shortly after Jennifer Harless was wheeled into the room, doctors carefully took her uterus out of her belly through a Caesarean section cut and placed it on her abdomen. Inside the uterus was Nolan, a 28-week-old fetus who was about to undergo a procedure that his parents hoped would change the course of his life.
Nolan, ultrasound testing had shown, had spina bifida, the failure of the skin to close completely over the spine. Many spina - bifida babies are paralyzed below the waist, have little control over their bowels and bladders and face a childhood full of surgery to relieve such problems as a buildup of fluid in their brains.

Two surgeons here told the Harlesses they might be able to spare Nolan at least some of these dire effects by closing the hole over his spine two months before he was born. During the next hour, they made a small opening in Mrs. Harless's uterus, sewed up the lesion in Nolan's back, sealed the uterus, and put it -- and Nolan -- back inside his mother. Eight weeks later, Nolan was born.

"We think we can alter the natural history of this disease and avert its devastating consequences," says Noel Tulipan, one of the surgeons. He and colleague Joseph P. Bruner have done the procedure on 40 women, 31 of whom have had their babies so far, with few complications. And while it is too soon for firm conclusions, the doctors are encouraged by indications the infants are benefiting.

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For one thing, they seem to have a much lower incidence of fluid buildup in the brain. "The babies we are doing aren't perfect," Dr. Bruner says, but "the gut feeling of everybody involved is that the data will show an impact." Their technique doesn't just push back medicine's technical frontier. It also challenges some economic and social boundaries in health care today. It raises, for instance, one of the toughest questions of the era of managed care and medical cost-control efforts: When does an elaborate and experimental treatment cross the threshold into mainstream medicine, and become something insurers pay for? In this case, that is a question with a twist: This fetal procedure, though costly, has the potential to prevent even-more-expensive care later on.

The case reflects, too, the great pressure that academic medical centers face nowadays to convert innovation quickly into revenue, and the rivalries that can erupt as institutions vie for market leadership. Vanderbilt is unabashedly promoting this surgery. Its fetal-surgery program has a Web site that provides couples with information about the procedure and also serves to market it.

"Our short-term goal is to brand the name Vanderbilt for this procedure," says Stephen S. Entman, chairman of obstetrics and gynecology. "We want to be recognized as the place where this is done." This entrepreneurial approach has provoked a vituperative clash with a rival team in Philadelphia. And it has hurt the Vanderbilt surgeons' efforts to publish an article about their work in a major medical journal, a crucial step in winning acceptance by the medical community -- as well as by insurers. The New England Journal of Medicine rejected a paper from the Vanderbilt surgeons partly because they had already put some of the data on the Web.

The emotionally charged field of reproductive ethics is in this mix, too. Up to now, the highly specialized field of fetal surgery has limited itself to defects that would prove fatal if not corrected. Spina bifida isn't lethal.

Its effects vary widely.

"It is a major philosophical shift to think about treating a fetus without a life-and-death abnormality," says N. Scott Adzick, chief of fetal diagnosis and treatment at Children's Hospital of Philadelphia, who trained with the field's pioneers at the University of California at San Francisco.

The biggest risk is premature birth. If labor begins during the surgery, the tiny fetus may have to be delivered by Caesarean section. The baby could die or be vulnerable to respiratory or other ills much worse than spina bifida 's effects. One did have to be delivered during the surgery; it has survived. Most are delivered at least a couple of weeks earlier than the standard term, but that isn't much of a problem.

The prematurity danger prompts some critics to suggest that these parents are putting their infants at risk in a misguided quest for a perfect baby.

On Vanderbilt's Web site, a 28-year-old man with spina bifida, Keith Piskur, wrote: "I wouldn't have wanted my mother to risk my life in an effort to make me `perfect.' My life has been and continues to be VERY rewarding." Mr. Piskur, of St. Cloud, Minn., who walks with the aid of ankle braces and a cane, is engaged to marry a woman who has spina bifida and uses a wheelchair.

But supporters see the procedure very differently. To them, it offers a hopeful new option for parents beyond either giving birth to a child who may be seriously disabled or aborting the fetus.

"Other doctors were telling us we could either terminate the baby or let it be born the way it is," says Dan Blaha, a young father-to-be in Cleveland.

"It was kind of depressing to hear there were no other options." His wife, Betty, had the procedure last month and expects to deliver a baby boy in May.

Spina bifida afflicts about one of every 2,000 newborns, or about 2,000 infants born in the U.S. each year, making it the most common birth defect that leads to permanent disabilities. Estimates are that an additional 2,000 fetuses are aborted after the condition is diagnosed.

The defect occurs in the first few weeks of pregnancy, when certain cells fail to organize into so-called neural tubes. (This is the defect that adequate folic acid in a woman's diet is thought to deter.) A blood test can detect the flaw, but it is most commonly discovered during a routine ultrasound exam between the 15th and 20th week of pregnancy.

Typically, spina - bifida newborns have surgery right away to repair the defect. But the damage already has been done. And most babies need more operations, such as to place a shunt to drain the fluid buildup in the brain, a condition known as hydrocephalus.

Recent animal studies indicate that part of the harm doesn't occur until late in the pregnancy, when the amniotic fluid grows toxic. "When the spina cord is laid open, the amniotic fluid can be damaging to the vulnerable nerves," Dr. Bruner explains. "As the baby gets bigger," he adds, injury may occur when it "bumps up against the uterine wall." So he and Dr. Tulipan figured they might be able to limit spina bifida 's damage by closing the gap over the spinal cord well before birth. After years of laboratory work, they operated on four patients between 1994 and 1996.

They used an endoscope. That is, they operated by inserting thin instruments though a tiny, "keyhole" incision. The uterus stayed where it was.

It was "an unmitigated disaster," Dr. Bruner says. Two fetuses died, and two were delivered prematurely. Chastened, the doctors evaluated their experience. "We felt our theory was sound but our approach was mistaken," he says.

They decided to forget keyholes and use an open surgical procedure. And to get better access, they decided to lift the uterus out of the woman's body -- possible because anesthesia relaxes the ligaments that hold it in place. This they did for the first time in April 1997. They performed three more such operations that year and several early in 1998.

Then an article in Woman's Day magazine, the launch of the Web site and recently a "Dateline NBC" segment prompted a surge of inquiries and a jump in the number of surgeries they did.

Meanwhile, Dr. Adzick and colleagues at Children's Hospital of Philadelphia, leaders in fetal surgery to correct fatal flaws, had done a spina - bifida repair last June, on a fetus only 23 weeks old. In November, they published a short paper on the case in the Lancet, the British medical journal, in which they called it the "first successful in-utero surgical repair of open spina bifida in an early-gestation fetus." That incensed Drs. Bruner and Tulipan back in Nashville, who by then had done more than 20 operations. They sent a scathing letter to the Lancet, assailing the paper for not acknowledging their work and for drawing "unsubstantiated conclusions" about benefits based on a single case. This in turn triggered a letter from the Adzick team, which acknowledged the Vanderbilt surgeons' pioneering role by recounting their unsuccessful first cases, and criticized their cooperation with the mass media.

Though the quarrel is partly over medical issues such as how old a fetus should be for the surgery, it is also about competition. "What we're talking about is creating a totally new health-care market, and there is huge incentive for institutions and departments to do this," Vanderbilt's Dr.

Bruner says. "You get the revenue, the media attention, the prestige and the respect that comes from being on the cutting edge." The revenue part, of course, depends significantly on health insurers. They generally won't pay for procedures that are experimental, which is how most view this. But Aetna Inc.'s Aetna U.S. Healthcare unit, despite a reputation for hardball negotiation on fees, is paying for the surgery at Vanderbilt.

Aetna has a practice of covering experimental treatments when done at a leading institution under a research protocol.

And it happened that two of Aetna's senior doctors were very familiar with spina bifida and its impact. "The human and monetary cost of dealing with these kids forever is extraordinary," says one of them, Aetna's chief medical officer, Arthur Leibowitz, a pediatrician who has cared for many children with spina bifida . Company doctors went to Vanderbilt to watch the surgery, met with social workers and ethicists there, and negotiated a contract to pay for the operation.

Besides a better result for the infants, Aetna hopes for a better outcome economically. The fetal operation costs $25,000 to $30,000. Aetna's data show the typical baby born with spina bifida incurs medical costs of $30,000 in the first year and up to $30,000 more each year through age five. To Dr. Leibowitz, covering the surgery "is a no-brainer. This made as great sense from an economic perspective as it did from a human perspective." But Mrs. Harless and her husband, Kevin, didn't have insurance through Aetna. And shortly before they flew to Nashville last August for the procedure, their carrier, Prudential Health Care, ruled it experimental and denied coverage. The Kansas City, Mo., couple went ahead with the surgery anyway, then spent more than six months trying to get it covered. Mr.

Harless himself appeared before insurance officials.

His argument: The C-section incision and opening of the uterus weren't experimental -- nor was repair of the lesion on his son. "The only thing that was different was the timing," he says. Prudential didn't buy it.

(Aetna has since agreed to acquire Prudential; it's unclear how that might affect Prudential's policy.) To couples confronting spina bifida, of course, the economics and professional rivalries pale next to the personal issues. The same ultrasound test that brings the unwelcome news of a birth defect is commonly the one that reveals to the parents their baby's sex, and enables them to see its heart beat for the first time. For couples who go on to have the surgery, these first visceral details of their baby's existence often serve to reinforce feelings against terminating the pregnancy.

"He's our son," Mr. Harless explains, recalling his and his wife's response to the ultrasound exam at the 17th week of pregnancy. "He's not a cake we baked and screwed up and could throw away." Their decision to have fetal surgery is a journey from despair to hope that is echoed in the stories of other couples. After seeing a lesion that looked like a little balloon on the ultrasound test, Mrs. Harless, 28, searched the Internet for information about spina bifida . It was bleak: Her son might be unable to walk, might face a life with bladder, bowel and sexual dysfunction and possibly would be mentally impaired. "I didn't think I could handle a child like that," she says. One worry was how much time it would take from their other child, 3 1/2-year-old Hanna.

The darkest moment for Mr. Harless came about two weeks later. Unable to sleep, he went for a drive, ending up at his parents' house at 2 a.m. During his childhood, his relationship with his father, a high-school coach, had centered on sports; as a father himself, how, Mr. Harless wondered, would he relate to a son who might be unable to walk? "I woke up my dad," he recalls, "and I asked him, `If you never got the chance to play catch with me, would you still have loved me?'" His father assured him that he would have. "I knew he would say that," Mr. Harless says now. "But I had to hear it from him. Once I did, I was ready to accept whatever was going to happen." Then three days later, his sister read an article about the Vanderbilt procedure in Woman's Day, and the cloud began to lift. They gave the baby a name: Nolan.

Over the next several weeks, they learned from the Vanderbilt team that the outcome for spina - bifida patients, even without the surgery, wasn't always as dire as Mrs. Harless's Internet search had suggested. They learned that Nolan's lesion was low on his back, providing hope that his case might be mild. And though their doctors in Kansas City opposed risking the surgery, they felt reassured by Dr. Bruner's confidence.

Unprompted, a friend arranged for an airline to give them free tickets to Nashville. Mrs. Harless's co-workers at Kemper Mutual Funds, where she processes requests from brokers, raised $7,500 through bake sales and other events, enough for a down payment on the surgery. "God led us down there" to Nashville, says Mr. Harless, who is a salesman. "Things just sort of fell into our laps." They underwent two days of grueling discussions with doctors, nurses, a social worker and ethicists, all intended to be sure they wanted to go through with the surgery. They almost didn't. They had decided on the 28th week of pregnancy for it, figuring this offered the least risk of a poor outcome in case of a premature birth. But Vanderbilt took them to the neonatal intensive-care unit, where Mrs. Harless saw an infant born at 28 weeks, hooked up to a tangle of tubes. "I was going back to the hotel to pack my bags," she says. "We couldn't risk it." That wasn't the last word, though. Tests indicated Nolan didn't have hydrocephalus or club feet, an indication that so far the effects of spina bifida were mild. But he still had several weeks to go, plenty of time, they figured, for more problems to develop. "If I went home without the procedure and he developed hydrocephalus or club feet, I never would have forgiven myself," Mrs. Harless says. She went ahead with the surgery.

Nolan was born Oct. 13. He had no hydrocephalus. His feet appeared normal.

The baby has a "goofy bladder," his mother says, "but if that's all we have to deal with, we're lucky." Early this month, Nolan was brought back for two days of tests at Vanderbilt, where, like the other pioneers in this procedure, he will be tracked for years. Nolan's prognosis appears excellent. But it will be several months more at least before the Harlesses know whether or how well he will be able to walk. And they probably won't ever know for certain whether the surgery made a difference -- whether he might have fared just as well without it.

Shortly after Nolan was born, Mrs. Harless was vilified in an Internet chat room for her decision. But she and her husband feel sure they were right in going ahead. "People think we're doing it for vain reasons," Mrs. Harless says. "It wasn't to make my child perfect but to give him every chance possible in life.



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