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Professional societies agreed that U.S. centers performing pediatric and congenital heart surgery should be formally reorganized into two tiers with volume requirements designed to maintain surgical quality.

The first tier, the Comprehensive Care Centers, should house services to optimize comprehensive and high-complexity care, including neonatal open-heart surgery and pediatric heart transplant. Each center should perform at least 200 index pediatric heart surgeries per year and have at minimum three surgeons, among other requirements.

The second tier is the Essential Care Centers that can handle less complex cases and ventricular assist device placement in older children in emergent cases. A minimum 75 index cases per year is recommended at each center, where there should be at least two working surgeons.

In both center types, a congenital cardiac surgeon should be available 24 hours a day, 7 days a week, every day of the year, and have the ability to be in the hospital within 60 minutes of being called (ideally within 30 minutes in most geographic locations), according to a from a group led by Carl Backer, MD, a surgeon at Cincinnati Children's Hospital Medical Center, director of the American Board of Thoracic Surgery (ABTS), and past president of the Congenital Heart Surgeons' Society (CHSS).

The recommendations were published in the World Journal for Pediatric and Congenital Heart Surgery, Annals of Thoracic Surgery, and Journal of Thoracic and Cardiovascular Surgery.

Essential and Comprehensive Care Centers are urged to establish paired relationships for collaboration and patient transfer. It is recommended that both tiers participate in the Society of Thoracic Surgeons Congenital Heart Surgery Database, share outcomes transparently, and participate in quality and safety programs.

"In the last several years there have been multiple news stories regarding poor outcomes at different congenital heart centers. These reports have led to understandable concern and confusion on the part of patients and their families about whether their own institution is providing safe, quality care," said co-author David Overman, MD, of the Mayo Clinic-Children's Minnesota Cardiovascular Collaborative in Minneapolis and president of the CHSS, in a press release.

"[O]ur specialty, for the first time, has put forward recommendations for all congenital heart surgery centers," he said. "These guidelines will allow patients and families to better understand what they should expect at their institution and will drive improvement of outcomes across all centers."

In 2019, researchers estimated that the U.S. has more than double the number of congenital heart surgery centers that it needs.

The U.S. currently has over 150 congenital heart surgery centers, many low-volume and in close geographic proximity to each other. Approximately 35% of centers perform at least 250 index cases a year, while about 45% perform fewer than 150 annually, according to estimates from the Society of Thoracic Surgeons.

The new recommendations set standards that may make it hard for some existing congenital heart programs to keep running. The authors estimated that 14 out of the 95 currently reporting centers would not meet the 75-case yearly threshold for Essential Care Centers. However, volume exceptions may be made for centers in less-populated states that otherwise would not have a single Comprehensive Care Center.

Notably, the consensus statement does not set volume requirements for individual congenital cardiac surgeons despite suggestions that the field is training too many people, spreading the pediatric congenital heart cases too thin.

The ABTS currently requires surgeons to log 50 congenital cardiac surgeries a year for maintenance of certification. Meanwhile, a recent showed that of 201 practicing congenital heart surgeons who responded, a quarter reported performing fewer than 50 pediatric cases per year.

Until recently, 1-year fellowships have required candidates to perform a minimum of 75 major pediatric congenital cardiac surgeries as primary surgeons. Many graduated just barely exceeding that threshold -- raising concerns that trainees needed more cases and longer fellowships before entering the workforce.

On July 1, the ABTS started requiring candidates for congenital cardiac surgery fellowships to complete 2 consecutive years in a single accredited program and complete 150 major cases (with a minimum of 50 major cases in the first year of training).

The consensus statement was endorsed by the CHSS, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Academy of Pediatrics, American College of Cardiology, American Heart Association, American Society of Echocardiography, American Society of Extracorporeal Technology, Congenital Cardiac Anesthesia Society, Pediatric & Congenital Electrophysiology Society, Pediatric and Congenital Interventional Cardiovascular Society, Pediatric Cardiac Intensive Care Society, Pediatric Heart Transplant Society, Society of Pediatric Cardiovascular Nurses, and World Society for Pediatric and Congenital Heart Surgery.

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