Gastric Bypass Risk Is Linked To InexperienceJan 4, 2004 | Boston Globe
With thousands of obese Americans opting for gastric bypass surgery, a growing collection of research suggests that this increasingly popular operation can have a hidden risk: inexperienced surgeons.
Over the past several years, dozens of hospitals and physicians have rushed to open weight-loss surgery programs. Most surgeons have begun performing the surgery laparoscopically, guiding pencil-thin tools and video cameras through tiny incisions, a gentler procedure that lessens pain, recovery time, and scarring.
"Gastric bypass is the hottest thing in surgery right now, unfortunately some of that is economically driven," said Dr. Steven Rothenberg, a surgeon at Presbyterian/St. Luke's Medical Center in Denver. "The thing that made it take off is that now it can be done laparoscopically."
Surgeons promote laparoscopic surgery to patients as safer than traditional more invasive surgery. And it is in the hands of experienced doctors.
But the gastric bypass is so difficult, according to physicians who have tracked the results of their cases, that patients of surgeons who have done fewer than 70 to 100 operations have complications more often and a greater chance of death from those complications than patients of more experienced doctors. These results are exacerbating worries that surgeons are rushing into the field without adequate training. Some hospitals allow surgeons to operate after one weekend seminar, during which they do a handful of cases under the guidance of a more experienced surgeon.
"Laparoscopic surgery has opened up this whole new problem," said Dr. Philip Schauer, director of bariatric surgery at the University of Pittsburgh Medical Center and who has performed more than 2,000 laparoscopic bypasses. "Most surgeons didn't get this training. It's a fundamentally different skill."
Surgeons at Tufts-New England Medical Center, for example, have kept a detailed database of their cases, which total more than 700. During their first 100 cases, one patient died a mortality rate of 1 percent and 22 patients, or 22 percent, had infections, bleeding, hernias, or other complications. Over 700 cases, mortality dropped to 0.28 percent, meaning two patients died, and 9.4 percent experienced complications.
Their experience is typical. Dr. Daniel Jones, a surgeon at Beth Israel Deaconess Medical Center, tracked the first 140 cases at the University of Texas Southwestern Medical Center in Dallas, finding all major complications dropped after 70 patients. One of the most serious complications of gastric bypass surgery is when the staples come lose and abdominal fluid leaks and infects the patient's other organs. Surgeons use staples to reduce the stomach to the size of an egg, restricting the amount of food patients can eat. During the surgeons' first 70 operations at the University of Texas, four patients, or 5.7 percent, experienced leaks, compared with one patient, or 1.4 percent, in the second group.
The results of these studies have powerful implications for overweight Americans, who are driving the popularity of gastric bypass surgery. The number of bypass operations grew from 23,100 in 1997 to 63,100 last year, according to estimates from the American Society for Bariatric Surgery. Surgeons say few patients ask how many operations their doctor has performed.
When surgeons began removing gallbladders laparoscopically in the early 1990s, hundreds of patients who had suffered complications from an operation long considered routine filed malpractice claims against their surgeons. Many of these doctors had not undergone much training. The surge in claims occurred three years after the first laparoscopic gallbladder removal, and malpractice specialists expect a similar spike in claims from bariatric surgery patients and their families.
General surgeons are more skilled in the delicate hand-eye coordination of laparoscopic surgery now than when they began removing gallbladders through inch-long incisions in 1989. But gastric bypass is far more challenging, as surgeons must maneuver instruments through layers of fat, patients with diabetes and other medical complications make surgery risky, and intense follow-ups to ensure adjustments to their restrictive new diets are required.
"All these factors will magnify what we saw with gallbladders," said Dr. Sayeed Ikramuddin, co-director of minimally invasive surgery at Fairview University Medical Center, a teaching hospital of the University of Minnesota. "We're at the tip of the iceberg, but some of the red flags are coming up. Surgeons are starting new laparoscopic programs and having to shut them down because of a death or complication."
Last fall, patients died after gastric bypass surgery in Boston, Providence, and Iowa. In at least the Boston and Providence cases, surgeons performed the operations laparoscopically. The chiefs of surgery at both hospitals involved Brigham and Women's Hospital in Boston and Roger Williams Medical Center in Providence said the surgeons were experienced. Even the busiest and longest-running programs in the country see one patient die every 200 to 300 surgeries, and a 10 percent complication rate.
Ann Marie Simonelli, 37, died in October in her hospital bed at the Brigham, minutes after she asked a nurse to help her up from her chair so she could lie down. Surgery chief Dr. Michael Zinner said that Simonelli's surgeon, Dr. David Lautz, had done 40 laparoscopic gastric bypass operations, in addition to other types of complicated laparoscopic surgery, and attended two intensive training programs. The Brigham, which blames a faulty staple gun that did not fully close off Simonelli's stomach, has temporarily suspended laparoscopic gastric bypass surgery while it completes an investigation.
"I don't think lack of volume makes the kind of difference that would have altered the outcome in this case," Zinner said. "She had complications, but generally patients don't die from the type of complication she had."
Dr. Paul Liu, surgery chief at Roger Williams, said the surgeon who performed the operation in which Robert Messa, 27, died was trained in laparoscopic surgery. The hospital also has suspended its weight-loss surgery program while it conducts an investigation.
"The laparoscopic nature of the case is one of the first things we would look at, given the relatively recent development of that technique in our field," Liu said. "But it's unlikely that training or experience was an issue here; he's an excellent laparoscopic surgeon."
At Iowa Methodist Medical Center in Des Moines, seven patients died after gastric bypass surgery in the past two years, six of them in 2003, including several in October. One surgeon involved in the cases, Dr. Akella Chendrasekhar, voluntarily stopped performing the surgery. Hospital spokesman Jon Ferchen, who said physicians do some surgeries laparoscopically, said the hospital is "confident that our numbers are within the range of deaths that other places experience." Ikramuddin disagreed, saying those numbers are "extraordinary."
Amid cases like these, the profession is struggling with how much training surgeons need before performing gastric bypass surgery. Surgeons always have trained on the job, improving as they perform more operations. And the most experienced surgeons in the field, including Jones and Schauer, had worse results when they began. But given that gastric bypass operations are elective, not emergency, surgery and that patients are at greater risk for complications, some surgeons are calling for hospitals to institute stricter training requirements.
"Ideally, every surgeon should be proctored for 40 to 50 cases," said Dr. Jeffrey Peters, a laparoscopic surgeon at the University of Southern California University Hospital. "Most of us feel a weekend course is not enough."