Children Are at Heart of New Surgical Practice Recommendations

An unprecedented collaborative effort—featuring the expertise of pediatric and congenital cardiothoracic surgeons, intensive care physicians, anesthesiologists, and nurses—has produced a document that provides guidance to improve the outcomes of pediatric heart surgery in the US.^1,2

Developed under the leadership of the Congenital Heart Surgeons’ Society (CHSS) in tandem with 15 preeminent medical and surgical societies, the “Recommendations for Centers Performing Pediatric Heart Surgery in the United States” addresses integral components of care for this vulnerable patient population, including resources, personnel, surgical volume, structure, and outcome metrics.

“This initiative was a true team sport,” said Ram Kumar Subramanyan, MD, PhD, FACS, coauthor of the guidelines and chief of pediatric cardiac surgery at Children’s Nebraska in Omaha. “We’ve gone above and beyond to ensure that all relevant stakeholders participated in generating these recommendations.”

While best practices for other areas of pediatrics are produced more frequently, recommendations for optimizing high-quality care for children undergoing heart surgery have not been published in the US for more than 20 years.¹

“These recommendations are based on expert understanding and nuanced interpretation of available data,” added Dr. Subramanyan. “Therefore, we felt that they better fit the description of ‘recommendations’ rather than the more strict ‘guidelines’ that are required for standards.”

Why Are Recommendations Necessary?

Advances in operative procedures and technology are linked to improved outcomes for pediatric heart surgery patients in recent years, with overall postoperative mortality now less than 3%.^1,3 For more complex cases, however, early mortality remains as high as 10% to 15%, with nearly one-third of patients experiencing a major complication, according to data cited in the recommendations.

Another factor that led to the development of these recommendations is the wide variability that exists across hospitals related to how care is provided, including variances in staffing, resource allocation, and perioperative care practices. In other words, two pediatric patients afflicted with the same heart defect may experience differing outcomes depending on the center.

“There’s a significant variation in outcomes in the US,” said Carl L. Backer, MD, FACS, lead author of the recommendations document, past-president of the CHSS, and chief of pediatric cardiac surgery for the Joint Pediatric and Congenital Heart Program between Kentucky Children’s Hospital in Lexington and Cincinnati Children’s Hospital Medical Center in Ohio. “Our thoughts were that if there are a number of centers that have excellent results, why can’t we translate what they are doing that makes them so successful and incorporate that into other programs so that we have more uniform outcomes.”

The recommendations are part of an expert consensus statement—co-published in 2023 by The Annals of Thoracic Surgery, World Journal for Pediatric and Congenital Heart Surgery, and The Journal of Thoracic and Cardiovascular Surgery—and provide a blueprint of best practices to help address the quality and consistency challenges many centers face.

“We have a sacred responsibility to lead the discipline to pursue transparent and penetrating analysis of what it does,” said David M. Overman, MD, FACS, chief of cardiovascular surgery at Children’s Minnesota in Minneapolis and current CHSS president.

More than 40,000 patients undergo pediatric and congenital heart surgery in the US each year, with care and outcomes varying widely.

Two-Tier System

The new guidance is offered in two tiers; within each tier, recommendations are related to structure (physical facilities, staffing, technology), processes, and outcome metrics spanning 14 domains: heart surgery program, heart center, hospital, acute care, anesthesia, cardiac intensive care unit, catheterization, electrophysiology, heart failure, imaging, longitudinal follow-up, perfusion, quality and safety, and transplant.¹

The first tier is composed of Essential Care Centers that provide essential services necessary for any program and are fully equipped to manage the majority of standard cases. A minimum of 75 index cases per year is recommended for each center in this tier, which is the minimum number of cases required by the American Board of Thoracic Surgery for initial board certification. A minimum of two surgeons for facilities in this category also is suggested.

“When several centers over the past few years were featured prominently in the newspapers for poor outcomes, one of the problems was that they were single-surgeon centers,” said Dr. Backer. “It is extremely difficult for a single surgeon to be on call 24-7, 365 days a year and provide continuous high-quality pediatric cardiac surgical care.”

The second tier consists of Comprehensive Care Centers, which are defined as facilities that can provide comprehensive high-complexity care, including neonatal open-heart surgery, ventricular assist devices, and in most centers pediatric heart transplantation.¹ It is recommended that each center at this level should perform a minimum of 200 index pediatric heart surgeries per year. The guidelines also suggest Comprehensive Care Centers have three or more surgeons in order to provide adequate coverage, along with other requirements.

Both types of centers are categorized, in part, by patient volume based on recent data from The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. According to the recommendations document, the most recent analysis of STS data from 2017 to 2020, spanning 101 centers and more than 76,000 operations, “showed a significant volume-outcome relationship for both operative mortality and failure to rescue.”¹

“There was a clear transition zone at 190 cases per year, below which there was a sustained uptick in the odds of mortality, a relationship that was most prominent for high-complexity cases,” explained Dr. Backer.

However, it is important to note that volume is only one of 300 separate criteria used to establish these tiers, and none of these factors should be prioritized over others. In fact, the authors specify that certain lower- volume centers may meet all the other recommended structure, process, and outcome criteria regarding Comprehensive Care Centers, aside from volume, and may still be classified as such.

“The paper clearly notes that small-volume programs can have outstanding outcomes,” said Dr. Subramanyan. “We recognize that the optics of volume will always rise up to the top, but nowhere in this recommendation statement do we say that the volume should be the sole criterion, or more importantly, that a low-volume program means poor outcomes. That is not the case, and it is stated very clearly in the document.”

According to Dr. Overman, based on volume criteria alone, there would be only seven states in the US that currently have one or more pediatric heart surgery programs that would not have a Comprehensive Care Center. Five of these states are less populated but do have one existing program serving the state. These programs would be encouraged to meet all of the other criteria for a Comprehensive Care Center and receive a “volume exemption.” Currently, eight less populated states do not have a pediatric heart surgery program. 

“We’re not out to extinguish programs based on volume—that’s not the point,” said Dr. Overman. “The point is to raise the bar to optimize structure and homogenize the environment so that patients and families know their loved one is safe.”

Factors that will help drive this uniformity include access to round-the-clock care. Both Essential and Comprehensive Care Centers are strongly encouraged to have a congenital cardiac surgeon available 24 hours a day, every day of the year, with the ability to arrive at the hospital within 60 minutes (ideally 30 minutes in most geographic locations) of being called.

The recommendations also suggest both center categories have a dedicated pediatric cardiac operating room with cardiopulmonary bypass capabilities and a pediatric cardiac operating room team that includes, at the minimum, a pediatric perfusion team, pediatric cardiac anesthesia team, scrub nurse/technician, circulator, surgeon and assistant, and a pediatric cardiologist to perform and interpret transesophageal and/or transthoracic and epicardial echocardiograms when needed.

Collaboration Across Center Types

Essential and Comprehensive Care Centers are advised to establish paired alliances in order to cultivate collaboration and, in some cases, patient transfer. The recommendations suggest all Essential Care Centers have a relationship with one or more Comprehensive Care Centers that includes a written document outlining the details of the arrangement. According to the recommendations, these pairings should feature “collaborative processes and bidirectional sharing of information related to case discussion and planning, sharing of care protocols, and collaborative quality improvement.”

“A perfect example of how this is meant to work is the Joint Pediatric and Congenital Heart Program between Cincinnati Children’s Hospital Medical Center and Kentucky Children’s Hospital,” said Dr. Backer. “We have an Essential Care Center at Kentucky Children’s Hospital, which does all of the basic cases with dedicated resources to ensure good results for the majority of children living in our geographic area. In addition, we have a very defined relationship with Cincinnati Children’s Hospital, which is a Comprehensive Care Center that does neonatal open heart surgery, pediatric heart and lung transplants, ventricular assist device placement, and other complex procedures requiring specialized areas of expertise. We have the ability to tap into their knowledge for these unique cases on a 24/7 basis.”

Examples of these paired relationships include the Mayo Clinic and Children’s Minnesota and Columbia University Irving Medical Center and Weill Cornell Medicine in New York.

“These relationships are perhaps the most important attribute, developmentally, for the discipline going forward,” observed Dr. Overman. “This approach, this collaboration of care, is a way to broaden the bench horizontally and vertically in terms of knowledge, case volume, and so on.”

Other than sharing best practices protocols and collaborating on rare or complex cases, the recommendations refrain from outlining specific details on how the relationship between Essential and Comprehensive Care Centers should function.

“We leave this relationship up to the individual institutions—and that is how it should be,” added Dr. Overman. “If you get overly prescriptive about this, it won’t work because each locality has different strengths and different challenges.”

How Were the Recommendations Developed?

CHSS leaders, under the initial guidance of the late James S. Tweddell, MD, FACS, formed what would eventually become a 32-member committee in 2019, with the aim of producing updated recommendations for pediatric heart surgery in the US.

The committee, with representatives from surgery and cardiology disciplines and related fields, began meeting in March 2021 via a videoconference platform every other week. Initially, the committee reviewed current care delivery and outcomes, pediatric heart surgery guidelines developed internationally, and standards generated by other related relevant practice areas, including pediatric surgery, neonatal intensive care, and adult cardiac surgery.

Part of the committee’s review process focused on the Optimal Resources for Children’s Surgical Care, published by the ACS, which is a standards document outlining quality improvement and safety processes, data collection, and a verification process to certify children’s surgery programs.

“This resource played a very important role,” explained Dr. Subramanyan. “First of all, in principle, it told us that a precedent existed for us to be able to appropriately oversee the way we provide care. It is where we got the idea of being a multidisciplinary group.”

The complexities associated with pediatric heart surgery cases necessitate a multidisciplinary approach to ensure all the components of these fragile patients’ care are covered.

“Long gone are siloed specialties and visiting the bedside in a series and then later talking to each other,” said Dr. Overman. “It is not possible anymore for one individual provider or one individual discipline to have the line of sight on appropriate decisions and reactions to the developments that happen along the way in a patient’s perioperative course.”

Part of this team-based approach to congenital heart surgical care for children now—perhaps more than ever before—includes the perspectives of parents and families.

“The culture has changed to the point where most pediatric hospitals are now family-centered care, which means parents are actually in the multidisciplinary clinical rounds when we’re caring for the children,” said Dr. Subramanyan. “So, parents are not just becoming more knowledgeable, they’re becoming more involved, and now they’re more willing to voice their opinion.”

In developing the recommendations, the committee solicited input from several parent/patient advocacy groups, including the Children’s Hospital Association (CHA), which represents more than 220 US children’s hospitals. According to Dr. Backer, the CHA’s response to the completed document included the following observation: “Your efforts have great promise for our continued improvement as a national pediatric community.”

Beyond carefully vetted, evidence-based recommendations, parents generally seem most interested in simply having honest and meaningful conversations with their surgical team regarding the center’s capability to provide care.

“In all the conversations I have with families, two things rise to the top,” said Dr. Subramanyan. “Is this institution safe? Are they transparent in giving me the information that I need? Because if those two criteria are not met, parents are willing to uproot their families, change their lives, and go where they will receive transparent information and safe care for their child. It is our responsibility to give them what they want.”

What Are Next Steps?

Future efforts for these recommendations will include an analysis of clinical outcomes and an ongoing refinement of this consensus document based on clinician and patient feedback. The committee may also consider developing a review process for a certification program.

“The first step was to roll out the recommendations, which have been endorsed by the most important societies in congenital heart surgery,” said Dr. Backer. “At some point in the future, we are moving toward a paradigm where the CHSS would be the body that would review and certify programs.”

While the broader implications of these guidelines are yet to be determined, this document may be used today to help bolster conversations between surgeon and cardiology leaders and hospital administrators regarding allocation of resources. “These recommendations provide another tool in our armamentarium to have successful negotiations among peers outside of surgery and with hospital administrators,” observed Dr. Subramanyan.

Ultimately, the goal of these recommendations is to improve the outcomes of congenital heart surgery care provided to the youngest and most vulnerable of patients, and to alleviate any confusion for families regarding the safe, quality surgical care their children are receiving.

Tony Peregrin is the Managing Editor of Special Projects in the ACS Division of Integrated Communications in Chicago, IL.

References

1. Backer CL, Overman DM, Dearani JA, Romano JC et al. Recommendations for Centers Performing Pediatric Heart Surgery in the United States. Ann Thorac Surg. 2023;116(5):871-907.
2. Congenital Heart Surgeons Society. Congenital Heart Surgeons’ Society and Fourteen Professional Organizations Announce Recommendations For Performing Pediatric Heart Surgery In US. Press release. September 29, 2023. Available at: https://www.prnewswire.com/news-releases/congenital-heart-surgeons-society-chss--fourteen-professional-organizations-announce-recommendations-for-performing-pediatric-heart-surgery-in-us-301942262.html. Accessed April 17, 2024.
3. Jacobs JP, He X, Mayer JE Jr, et al. Mortality trends in pediatric and congenital heart surgery: An analysis of The Society of Thoracic Surgeons Congenital Heart Surgery database. Ann Thorac Surg. 2016;102(4):1345‐1352.