Massachusetts General Hospital has suspended its pediatric cardiac surgery program after two babies recently suffered serious complications following errors made during open-heart surgery.
The Harvard teaching hospital had expanded the small program and taken on more complex cases after hiring a heart surgeon two years ago to operate solely on children. But that plan has not worked out as hoped, and hospital executives said they shut down the program last week, at least temporarily.
State public health officials began investigating the two cases afterMass. General notified them on Tuesday that the hospital had stopped taking young heart surgery patients and was evaluating whether to reopen the program.
Dr. David Torchiana, head of the Massachusetts General Physicians Organization, said both babies survived their operations, although one suffered neurological damage. That child, who was operated on at the end of January, has since been transferred to Children’s Hospital Boston. The second infant had surgery in March and is still at Mass. General and recovering well, Torchiana said. In both cases, technical errors were made during the surgeries, Torchiana said, though he declined to go into detail because of what he called patient privacy concerns.
The hospital’s decision to expand its program, and now to suspend it, goes to the core of a long-standing debate in pediatric medicine: should hospitals run small surgery programs or should care be consolidated in a few large programs, where physicians and nurses can sharpen their skills by caring for large numbers of patients?
In Boston, Children’s Hospital operates on the hearts of about 1,100 babies and children a year, making it the largest pediatric heart surgery program in the country, officials there said. Mass. General performed 90 pediatric heart surgeries in the last 20 months, while Tufts Medical Center did 24 last year.
State health officials recommend a minimum 300 cases annually for hospitals to operate adult heart surgery programs, but they do not set a standard for pediatric heart surgery.
Dr. Peter Manning, director of cardiothoracic surgery at Cincinnati Children’s Hospital Medical Center, said that while the research is not conclusive, there is some evidence that quality is more variable in small programs than in larger ones.
But, he said, it’s hard for regulators to push small programs to close because the data are not conclusive; some small programs have achieved good results, usually in part by referring some of the most complex cases to major centers. And, Manning added, cardiac surgery can be lucrative and prestigious for hospitals, making the programs especially desirable.
Mass. General’s "numbers are pretty small," Manning said. "When you get below 100 cases you really worry that, unless they’re pretty straightforward, whether the [surgeon] is doing enough to keep their skills up." He said it may have been "very wise to close the program."
Mass. General has had a pediatric heart surgery program since the 1960s, Torchiana said, but for most of those years, heart surgeons who operate mostly on adults have included children as part of their practice. It wasn’t until 2007 that the hospital decided to hire a dedicated pediatric heart surgeon, Dr. Jeff Myers, and began doing more complex operations and operations on infants. Myers is board certified in both thoracic and general surgery, according to the hospital’s website, and trained at Georgetown University, Duke University, and the University of California at Los Angeles,completing his training in 2002. He couldn’t be reached for comment.
When they decided to expand the program, Torchiana said, hospital leaders realized that the small number of patients could be a drawback, so Mass. General put in place special monitoring for pediatric cardiac surgery. The hospital also sent some of the most complex cases to Children’s Hospital, he said.
Hospital officials conducted an in-depth review last year because some caregivers were concerned about how the program was working, Torchiana said. He declined to detail the findings but said physician reviewers suggested improvements. "We felt the program was moving along in a satisfactory way," he said. "We felt there were some things that could have been improved. But if we had felt there was a significant quality problem, we would not have resumed."
He said there has been one death out of the 90 operations in the past 20 months.
But the two recent cases led the hospital to reconsider its decision, Torchiana said, and Mass. General likely will hire outside reviewers to help decide whether to reopen the program.While every field of surgery has patients that experience poor outcomes, Tochiana said, they are more worrisome in a program where the number of cases is low.
"Can you do this stuff at moderate to low volume with a high degree of safety?" Torchiana asked. "We’re looking very hard at this question and we’ll make a decision on it. Pediatric heart surgery is difficult and complicated and we will have to figure out if we’re doing the right thing."
State health officials said that when they receive the internal reviews from Mass. General, they will decide whether to conduct an on-site investigation, which could lead the health department to recommend improvements.
Asked about its low number of children’s heart cases, aTufts Medical Center spokeswoman said officials there believe they run a safe program because they send very complex cases to Mass. General or Children’s.
"We have looked at our mortality rates and they compare very favorably with national standards," said spokeswoman Brooke Tyson Hynes. "It’s important for us to have a program. We are very well known for our high-risk pregnancy service and we have a [neonatal intensive care unit.] Cardiac surgery provides services to patients in those programs."
Liz Kowalczyk can be reached at kowalczyk@globe.com.
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