Friday, April 4, 2003

Hospitals looking to open door on fetal surgery center

Program could allow closer option for early lifesaving

By Tim Bonfield
The Cincinnati Enquirer

[photo] Dr. Giancarlo Mari (front), UC's director of prenatal diagnosis and fetal treatment, demonstrates a fetal endoscope with part of a team developing a fetal surgery program. Also pictured are (from rear left) Scott Baker, research associate; Dr. Baha Sibai, professor and chairman of the Department of Obstetrics and Gynecology; and Angella Friedman, research associate.
(Gary Landers photo)
| ZOOM |
Somewhere in Greater Cincinnati almost every day, a diagnostic test reveals that a baby still months from birth has developed a serious problem.

A spinal column deformed by spina bifida. Twins suffering life-threatening blood flow complications. Fluid on the brain. Dangerous abdominal hernias and other potentially deadly conditions.

In most cases, anxious parents must wait until after the baby is born before doctors can attempt treatment, assuming the baby lives that long. But in recent years, more families have turned to the small-but-growing field of fetal surgery for help rescuing their unborn children.

For Tristate families, getting fetal surgery has meant traveling to Philadelphia, San Francisco or to a handful of other leading centers.

But within a few months, that need to travel could be sharply reduced because a coalition of hospitals is working to bring fetal surgery to the Tristate. If successful, the fetal surgery program would be the only one of its kind in Ohio, Kentucky and Indiana.

The fetal surgery project is the brainchild of doctors at Good Samaritan Hospital's high-risk pregnancy program, Cincinnati Children's Hospital Medical Center and University Hospital. Launching the program could cost $5 million to $10 million, officials say.

"Fetal surgery is just the tip of the iceberg," says Dr. Baha Sibai, chairman of obstetrics and pediatrics at the University of Cincinnati. "This program could open the front for many other things in the future."

Dr. Richard Azizkhan, surgeon-in-chief at Cincinnati Children's, said fetal surgery is part of a bigger fetal therapeutics program that has been developing for more than three years.

"Despite significant advancements in neonatal and surgical care, many babies with correctable birth defects succumb before birth," Azizkhan said. "With scientific advances driven by the now-completed human genome project, the future will hold surgical, genetic and organ-based therapies that will correct many life-threatening disorders in utero."

What is fetal surgery?

Fetal surgery involves operating on a baby while it is still in the womb. This can be done with an "open" incision through the mother's abdomen to allow direct access for the surgeon's hands. Once the surgery is complete, the womb is sutured and the mother delivers the child weeks or months later.

More recently, surgeons have increased efforts to develop minimally-invasive techniques, which involve long, thin instruments poked through small ports and guided by the latest diagnostic scanners. Early studies indicate that such techniques reduce the risk of complications, such as premature labor.

Though still considered experimental in most cases, several hundred such surgeries have been performed in Europe and the United States. Despite those cases, the fact that surgery in the womb is possible at all remains a wonder - and a subject of ethical debate.

The world's first successful open fetal surgery was performed in 1981 at the University of California San Francisco to treat a urinary tract obstruction. The San Francisco center has been working ever since to expand the types of problems that can be treated with fetal surgery.

Children's Hospital of Philadelphia has emerged as a leading center for fetal surgery. And in recent years, Vanderbilt University in Nashville has performed more than 150 "open" fetal surgeries just to treat spina bifida.

Since the early 1980s, fetal surgery has been used with mixed success for several conditions, including urinary tract obstruction, diaphragmatic hernia, twin-twin transfusion syndrome and a type of tumor at the base of the spine called a sacrococcygeal teratoma.

UC already has recruited one fetal medicine expert to town - Dr. Giancarlo Mari, who is expected to focus on minimally invasive techniques. UC also has begun acquiring special equipment and lining up support staff needed to launch a fetal surgery service.

Meanwhile, Cincinnati Children's has been negotiating for months with a pediatric surgeon that Azizkhan would only refer to as "world-renowned" to lead the overall program.

That doctor would recruit additional fetal surgeons and scientists to the city, and would work with experts at UC and Good Samaritan. More than 15 experts from Cincinnati Children's in surgery, neonatology, pediatric cardiology, genetics, radiology, pathology and laboratory medicine would be involved.

Fetal surgery would add a powerful boost to the fetal therapeutics program launched in July 2002 at Good Samaritan Hospital. The hospital's Seton Center for Advanced Obstetrics and Gynecology is the Tristate's leading program for high-risk pregnancies, delivering more than 1,200 babies a year after difficulties with early labor and other complications.

Since July, a 15-member team of specialists has been meeting every Thursday to discuss extreme cases. Of more than 100 cases a year that need intense care, about a half-dozen involve problems that require surgery to treat, said Dr. William Polzin, a maternal/fetal medicine specialist at the Seton Center.

"Not every city would need a program like this. But it makes sense in Cincinnati because of the presence of Children's Hospital, because of the high volume of cases at Good Samaritan, and because of the city's central, Midwest location," Polzin said.

A few other medical centers have launched fetal surgery programs, including Vanderbilt University and the University of North Carolina in Chapel Hill. But because the science is so new, the demand for fetal surgery and the ability to provide it remains limited, said Dr. N. Scott Adzick, surgeon-in-chief and director of the Center for Fetal Diagnosis and Treatment at Children's Hospital of Philadelphia.

It could take five to 10 years for a fledgling program in Cincinnati to mature into a significant program, Adzick predicted.

"The key is, who will do the surgery? It's very hard, and it costs a lot of money to do it right," he said.

A wrinkle in abortion debate

The very existence of fetal surgery has added complications to the already controversial abortion debate.

While some argue that abortion does not differ from infanticide, or the killing of a baby shortly after birth, others say there is a fundamental difference between killing a fully developed baby and ending the development of a fetus that could not survive outside the womb.

Increasingly, fetal surgery can be performed in early stages, before functioning lungs develop. When successful, the treatment avoids otherwise certain miscarriage and death.

And that raises some difficult questions.

Should a fetus have a right to receive surgical treatment, independently of the mother's self-interest and legal rights? Will the existence of a treatment alternative lead to efforts to ban even early-term abortions for fetuses with diagnosed birth defects?

Does a mother have the right to refuse a surgery because she's afraid of the risk to herself? And if insurers balk at paying for fetal surgery, who would pay? Parents? Taxpayers?

Longer term, are families, schools and other public agencies prepared to cope with technology that would likely produce larger numbers of babies born with severe medical problems and life-long disabilities?

While the technology races ahead, many such ethical questions have not been fully addressed, writes Monica Casper, a sociologist with the University of California Santa Cruz, in her 1999 book, The Making of the Unborn Patient.

The future of fetal surgery

Sibai and others who support fetal surgery say that the biggest benefits will emerge as the technology develops.

Replacing open fetal surgery with minimally invasive techniques - when possible - has already shown reductions in fetal deaths from premature labor.

As complication rates drop, the types of problems that can be treated with fetal surgery will expand. And as genetic therapies improve, the entire field of fetal medicine will transform, he predicts.

For example, bone marrow, stem cell and organ transplants done early enough in fetal development would face no chance of tissue rejection because the baby hasn't developed an immune system yet, Sibai said.

Launching Cincinnati's fetal surgery program now gives the program a better chance of being a major player as the field evolves, he said, even though it will likely remain small for the next several years.


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