The federal government said Friday it is launching an official investigation into reports of least nine babies dying since 2011 after undergoing open-heart surgery at St. Mary's Medical Center in West Palm Beach, Fla.
“We take these allegations very seriously. CMS is actively investigating these complaints," a spokesperson said in an e-mail to Modern Healthcare.
The situation is renewing concerns about the risks patients face at facilities that perform low volumes of complex surgical procedures. Some wonder if the deaths truly reflect poor quality, or the fact that mortality rates are high for pediatric patients with congenital heart defects, a high-risk patient population.
Each year, about 40,000 infants are born with heart defects, making it the leading cause of birth defect-associated infant illness and death, according to the Centers for Disease Control and Prevention. About 25% of infants with the defect are in critical condition and need surgery in their first year of life.
This week, CNN reported on a seemingly high mortality rate at St. Mary's Medical Center. The facility instituted its pediatric cardiac surgery program in 2011 under the direction of Dr. Michael Black. According to the CNN report, the hospital's death rate of 12.5% was three times the national average.
According to Chris Searcy, president and CEO of the law firm Searcy Denney Scarola Barnhart & Shipley, his firm filed lawsuits in 2014 for two of the infants' families: Keyari Sanders and Layla McCarthy. Two other cases are pending. A deposition with Black, the surgeon for both the cases, is set for July 10.
It is unclear whether that number considers risk-adjusted mortality, which takes into account case severity and other inherent risk factors. Not taking risk adjustment into consideration “is really risky,” said David Chang, director of healthcare research and policy development in the department of surgery at Massachusetts General Hospital Harvard Medical School. The omission can lead to incomplete and misleading pictures of hospital performance.
A St. Mary's spokesperson declined to answer questions about the number of open-heart surgeries performed or the actual number of risk-adjusted deaths reported since the pediatric cardiac surgery program started. In an e-mailed statement to Modern Healthcare, a spokesperson called recent media reports “misleading” for relying on “a selective presentation of cases.”
Pediatric patients undergoing surgery for congenital heart defects represent some of the most complicated, fragile cases, said Dr. Jennifer Li, division chief of pediatric cardiology at Duke University Medical Center. But, there are differences in hospitals' ability to immediately recognize and manage complications, especially in the post-operative stages, she said.
Li coauthored a 2012 study in the journal Pediatrics which found death rates following pediatric heart surgery were higher among facilities performing 150 or fewer annual procedures compared to those performing 350 surgeries or more.
Generally, she says, patients do better when there is a fully staffed, highly specialized care team available around the clock. In fact, this year several top-performing cardiac hospitals noted their use of specialized, multidisciplinary teams as a key factor in providing consistent care and boosting quality performance.
“It's really what happens in the middle of the night in a lot of these cases,” Li said. "You can't just hire one or two people; it takes a village and a lot of resources. Lower-volume centers don't necessarily have the patient volume to drive the expense of that.”
Increasingly, studies like Li's are linking low surgical volumes to poor outcomes on measures like mortality and complications. In May, the consumer-facing rating organization U.S. News & World Report began sharing information about the numbers of commonly performed elective procedures done at more than 4,600 facilities nationwide.
Though Chang agrees that higher-volume facilities generally have better outcomes, he cautions against putting too much emphasis on that particular factor. Focusing too much on volume may not capture good decision-making and best practices relative to when it is best to not perform a procedure.
“Volume is necessary but not sufficient,” Chang said. “It's just one piece of a hundred-piece puzzle … but an incomplete assessment of quality.”