Prenatal Care: Fetal Operation Raises
Hope for Some Parents But Lots of Questions
Is Spina Bifida
Surgery Worth Risk of Premature Birth?
A University Tries to Brand It
By Ron Winslow
The Wall Street Journal
(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.
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
"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
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
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
Aetna has a practice of covering experimental treatments
when done at a leading institution under a research
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
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
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.