Study: More risk in office surgeries

Anesthesia may pose safety issues, especially in cosmetic procedures.

Bob Lamendola | South Florida Sun-sentinel

March 31, 2008

Doctors increasingly perform surgery in their offices instead of at hospitals, but researchers have found a higher risk of death and complications in offices compared with other facilities -- and cosmetic procedures cause the most problems.

The death of Boca Raton cheerleader Stephanie Kuleba after breast surgery at a doctor's office, and a new study of Florida office-surgery risks published three weeks before her death, are leading some medical experts to question whether certain procedures and types of anesthesia should not be done in that setting.

The issue is whether physicians' surgical suites can handle bad reactions to anesthesia. Kuleba is thought to have died from a rare, inherited condition that caused a severe reaction to inhaled anesthesia. The new study found that office procedures in Florida done with general anesthesia were more likely to have bad outcomes than those done with local anesthetics.

"Me personally, I would never have surgery in an office. Never ever," said Dr. David Lubarsky, anesthesiology chairman at the University of Miami medical school. "You never know when something is going to go wrong. Can the doctor in the office handle an emergency as well as in the other settings? I say no."

Yet many health leaders, doctors, insurers and patients support office surgery. The setting is convenient and more private. Physicians can control the schedule and use their own staff, and they usually make more money. There's less risk of infections spread by sick hospital patients.

Because doctors charge low or no facility fees, patients may save hundreds or thousands compared with outpatient surgical centers and hospitals -- important when paying out of pocket for elective procedures such as breast enhancement or tummy tucks not covered by insurance.

As a result, office surgeries have skyrocketed. In 1980, fewer than 20 percent of 10 million U.S. outpatient surgeries were done outside hospitals, the Ambulatory Surgery Center Association reports. Last year, about half of 43 million procedures were done outside hospitals, about 10 million each in doctors' offices and free-standing outpatient centers.

The chairman of Florida's Board of Medicine, which oversees physicians, said he is confident office surgery is safe. After dozens of cosmetic-surgery deaths in the 1990s, the state toughened the rules since 2000 to forbid lengthy operations, demand more training and require an anesthetist be present.

"They [offices] are more efficient and the treatment should be as good as it is in a hospital, as long as the [patients] are properly selected and the doctor and anesthesiologist have the proper training," said board chair Robert Cline, a Fort Lauderdale heart surgeon.


Persistent problems

But researchers reported persistent problems in their new analysis of the 31 deaths and 146 hospitalizations resulting from Florida office surgeries from March 2000 to March 2007. They found:

*Patients suffered anesthesia reactions, heart emergencies, artery-blocking blood clots, internal bleeding, seizures and other complications.

*Cosmetic surgery accounted for about 60 percent of the deaths and hospitalizations. Liposuction using general anesthesia caused one-quarter of deaths and one-eighth of hospitalizations.

*In the emergency cases, at least 92 percent of surgeons were board-certified and credentialed to perform the surgery at a hospital. Of 18 cosmetic-surgery patients who died, three-fourths were classified as very healthy. In other words, office surgery still led to bad outcomes even when the surgeon, setting and patient were ideal, said the study's lead author, Cincinnati dermatologist Brett Coldiron.

"These data reveal and solidify some disturbing trends," Coldiron wrote in the study, published this month in the journal Dermatologic Surgery. "The pattern of deaths and injuries has remained consistent [since] the first year."

The vast majority of complications arose when using general anesthesia that renders patients unconscious, almost none when using local anesthetics that numb a part of the body or leave the patient semiconscious, the study found.

"The continued use of liposuction under general anesthesia must be called into question," Coldiron wrote.

Virtually all cosmetic surgery, except tummy tucks, can be done without general anesthesia and probably should be, Coldiron said. Some doctors advocate banning it in office surgery because of the risks.

"You can do them under local [anesthesia], but the docs don't like it," Coldiron said. "It takes [time] to numb them up. They like to be efficient. They like to knock them out and knock them down."

Study: More risk in office surgeries

A 2003 study found that Florida patients were 12 times more likely to have an emergency in an office surgery than at an outpatient surgical center. The rates: 66 complications per 100,000 office surgeries compared with 5.3 per 100,000 at outpatient centers. Complication rates at outpatient centers have proved to be about the same as at hospitals.

Other researchers who analyzed the same Florida figures found no difference between the safety of office surgeries and outpatient-center surgeries, saying the earlier study miscalculated.

The Kuleba family's attorney, Roberto Stanziale, has questioned why Stephanie's operation wasn't done in a hospital. Her surgeon, Dr. Steven Schuster, would not comment except to say his actions were correct.

Kuleba died March 22, apparently from malignant hyperthermia, which causes a severe reaction to inhaled anesthetics -- not nitrous oxide -- usually when combined with the muscle relaxant succinylcholine. The body super-heats, triggering organ failure and cardiac arrest. Her death will be reviewed by the Florida Department of Health, as is standard in such incidents.

Handling a severe emergency such as Kuleba's can overwhelm an office surgeon and the small staff as precious minutes tick by, anesthesiologists said. The surgeon needs to ice the patient, maintain the heart rate and respiration and inject an antidote that can require mixing dozens of vials to get one dose.

"No matter how good you are, no matter if you do everything right, there's still a chance of death," Lubarsky said.

Dr. Barbara Brandom, an anesthesiologist at the University of Pittsburgh who has tracked and analyzed about 300 malignant-hyperthermia cases nationwide, contends that office surgeons should not use the traditional anesthesia combination.

"The main problem with office setting is that there's not extra people to help if there's a difficulty," Brandom said. "You may not be able to get a recognition of a problem as fast as in a hospital, and you might not get the help right away."

Lubarsky goes further. He suggested inhaled anesthesia be banned in office surgeries.

"There are alternatives. You could argue that in the office-surgery setting, they shouldn't be using drugs that cause MH because a fulminant case like [Kuleba's] is too hard to handle," he said.