11 Dec How to Monitor and Improve the Outcomes of Pediatric Cardiac Surgery
Outcomes of Database Management:
The growth in the successful care of patients with congenital heart defects and the development of national and international database management have coincidentally paralleled each other for the last four decades. Participation in multicenter congenital heart disease databases and registries have been instrumental in accumulating large volumes of data on the surgical treatment of complex congenital heart disease. In turn, this data has contributed so positively to our understanding of best surgical practices that it has become a fundamental component of pediatric cardiac surgical care. Pediatric heart diseases are particularly well-suited to this management, as each individual care program location has access to only a relatively limited number of diagnoses and procedures in any given calendar year. Combining data from multiple institutions allows for a far more accurate contemporaneous assessment of treatment modalities and adverse outcomes. Additionally, the data can be used for outcome benchmarks, allowing for individual institutions to measure their progress against the field as a whole and focus quality improvement efforts, and clinical research opportunities and efforts to be maximized within existing data structures. Efforts are ongoing to support further collaboration and integration across data sets, with the goal of improving efficiency, expanding the utility of the data collection infrastructure and the information collected, and enhancing return on investment for participating institutions.
Improving Database Management Benefits:
There are currently numerous benefits to participating in the American Society for Thoracic Surgery National Database, or the European Association for Cardiothoracic Surgery Database and recently the World Pediatric Cardiac Surgery Database: the improvement of patient outcomes, the improvement of quality assurance, the benchmarking of results against those of other centers, the provision of access to data for assessment of new technology and surgical approaches, the creation of research opportunities, the enablement of risk modeling for new procedures, the transfer of information across the Pediatric Cardiac Surgical field, the provision of options for public and government reporting, the facilitation of transparency and accountability, and in some countries, the facilitation of care cost.
Reporting the outcomes of pediatric cardiac surgical procedures to hospitals and providers, as noted above, is increasingly common. However, whether to release cardiac surgical outcomes to the public itself is a matter of debate. An important consideration in both private and public release of report cards is the accuracy of risk adjustments to account for case-mix differences between hospitals. Specifically, tertiary or quaternary referral centers may provide surgery to patients at high-risk of death, whereas other centers’ case-mixes may be lower risk overall. Valid benchmarking of hospital performance is contingent on risk adjustment models that adequately account for patient characteristics across the full range of illness. The analysis also involves a strict test of statistical confidence, to assure at least a 95% likelihood that the result is accurate. These are vital safeguards for the release of information to the public.
Issues to Address:
The major difficulty in disclosing data is that individual participants own their local data, both before and its harvesting by a contracted, independent data warehouse service provider. Some difficulties are arising from this strict ownership. Process improvement within an institution may use the data and outcomes from its own database or collected for and by the National database submission process as benchmarking for continuous quality improvement impact. Similarly, internal quality assurance and quality improvement process monitoring; individual participant-specific data may be used for clinical research by that participant. Such internal utilization may satisfy institution quality assurance requirements for such factors as mortality, morbidity review and confidential service conference discussions, even though they don’t place the institution within context of treatment as a whole. Furthermore, under the terms of its agreements with hospitals, the society can’t release a hospital’s star rating or data without the hospital’s consent. As a result, parents of congenital heart surgery patients at those hospitals may not know that their children are at higher risk than patients at other institutions. Not even the Society of Thoracic Surgeons leaders who run the congenital heart surgery public-reporting project can peer behind the curtain. Only the center where the data is analyzed, the Duke Clinical Research Institute, and the hospitals themselves know their scores. And Duke isn’t allowed to publish what it knows.
A large percentage of pediatric cardiac surgery groups in the U.S., voluntarily submit their performance data to the STS Adult Cardiac Surgery Database. Submission is, however, not mandatory. Furthermore, ratings on the Consumer Reports website include only those groups that have agreed to let them publish their performance results. Together, these two factors further compromise the accuracy of publically-available information.
The consequences have real impact on patients’ lives. Negative outcomes crystalize the importance of tracking and publicly reporting on the quality of care at children’s institutions. For example, since 2012 higher than expected mortality were reported at seven Pediatric Cardiac Surgery Programs across major US Children’s Hospitals. Even worse, poor results were hidden behind the façade of quality assurance, case complexity and program growth. Granted, the results were debated strongly, yet even so many hospital administrators and CEO’s chose to promote their Pediatric Cardiac Surgery Program on a basis of financial return, without being aware of the current and factual poor results. In such a context, database confidentiality and quality assurance are not the positive factors they should be. These seven Pediatric Cardiac Surgery Programs without any specific orders, are:
- Kentucky Children’s Hospital, Lexington, Kentucky.
- St-Mary’s Hospital, Miami, Florida.
- All Children’s Hospital, St-Petersburg, Florida.
- Barbara Bush Children Maine Center, Maine.
- Children’s Hospital of The King’s Daughters, Norfolk, Virginia.
- Nationwide Children’s Hospital, Columbus, Ohio.
- North Carolina Children’s Hospital, Chapel Hill, North Carolina.
Results in the tables below show that the expected average mortality across the country is around 3%, confirmed by the STS benchmark data information, despite risk stratification. A mortality of 6% and in some programs over 8%, is unacceptably high. Although there is not enough information reported in these tables, evidence in the literature suggests that any centers with fewer than 100 cases per year would have difficulty to keep the skills and personnel necessary to maintain a Pediatric Cardiac Surgery Program. “It is unlikely that any program could reach and sustain high standards of performance when performing less than two heart operations per month,” Dr. Jeff Jacobs concluded in his report to the Florida Agency for Health Care Administration, 2016.
Top Hospitals with High Patient Volumes and Fewer Deaths Than Expected
|HOSPITAL||4-YEAR TOTAL PATIENTS||4-YEAR ACTUAL DEATHS|
|Children’s Hospital of Wisconsin||1410||26|
|Ann & Robert H. Lurie Children’s||1205||18|
|Le Bonheur Children’s||1039||17|
|Penn State Hershey Children’s||616||7|
Society of Thoracic Surgeons (STS) data from 2012 to 2015 show that all but one of the eight hospitals granted the top rating of three stars were high-volume centers.
Sources: STS, U.S. News analysis
Hospitals with More Deaths Than Expected
|HOSPITAL||4-YEAR TOTAL PATIENTS||4-YEAR ACTUAL DEATHS||*|
|Nationwide Medical Center||1348||62||44|
|Children’s Hospital of the King’s Daughters||367||16||9|
|Maine Medical Center||269||12||5|
Fourteen hospitals in the STS database were granted the lowest rating, one star. Only three allowed the STS to publish their data. Two of three cared for fewer than 100 congenital heart surgery patients a year, making them low-volume programs.
Sources: STS, U.S. News analysis
Tabulation of Common Issues
The common issues among these centers were tabulated in two very extensive reviews: 1) The 1994 Report of the Manitoba Pediatric Cardiac Surgery Inquest (436 pages), and 2) The 2001 Bristol Royal Infirmary Inquiry Report (529 pages). These substantial and highly-representative studies, as well as the years of combined information from the STS database, the European database, and the World database (since 2017), show that outcomes across congenital heart centers are highly variable. For example, mortality following the Norwood operation ranges from 10% to 40% across hospitals. Although volume is not the only important factor, multiple studies have shown a relationship between higher volume and better outcomes. This association is not unexpected, given the extensive resources and personnel required to provide high-quality care for children with heart disease. Importantly, there is also a relationship between volume, quality, and cost, with the highest-volume centers tending to deliver the highest-quality care at the lowest costs, particularly for children with the most complex heart diseases. These issues are:
- program patient volume
- surgical case volume
- surgeon skills (critical mass of cases)
- staff recruitment and retaining
- maintaining staff skills, including among nurses and other health care workers
- adequate resources (beds, equipment, latest technology)
- monitoring program issues, mortality and morbidity
- quality of internal quality assurance and reporting
- lack of database reporting and transparency
- reporting of human and medical errors
- process for inappropriate professional conduct
- administrative decision-making
- lack of leadership
- lack of administrative transparency
- lack of accountability
- inappropriate information and communication to families
- prestige of maintaining a program
- inappropriate competition
- for-profit income decision influencing patient care decisions.
Impact on Programs
The lack of transparency is negatively impacting the field. I am very distraught after a 35 years career as a pediatric cardiac surgeon, having been involved in the early development of The Canadian and the STS databases, the development of Quality Assurance Programs across the continuum of Pediatric and Adult Congenital Heart Disease Care, and after having participated in national and international panels on pediatric cardiac care, that I am witnessing the closure of several pediatric surgical programs directed and managed by my own colleagues. I have been to numerous scientific meetings listening to these bright, upcoming surgeons and specialists. Sure, in the early days, 60’s, 70’s and even 80’s, we lacked the depth of pediatric cardiac information and the quality assurance available today. Sure, babes and infants were dying because of lack of surgical technologies, advancement, equipment and understanding of the most complex anatomo-pathophysiology, but the pediatric cardiologists and cardiac surgeons, pediatric anesthesiologists, heart lung technicians, nursing and others, worked really hard to move the field of pediatric cardiac heart disease forward. Families understood our quest for better treatment, better cure, and better results for their loved babies, infants and children. I would like to believe we, and certainly me, never took for granted the privilege and honor we had to care for these children.
I am appalled that in 2014 to 2019, poor results and high mortality in some pediatric cardiac surgical programs are accepted, supported, even defended, on the basis of so-called case complexity, or on plainly hidden results by lack of transparency, and the potentiality of decreasing referral and insurance income. This lack of integrity and professionalism is even more unacceptable, considering that difficulties with these programs were brought to public eyes by suffering families, not by conscientious colleagues and administrators. All these people are responsible for the lost lives of these defenseless children. It’s as if collectively we have learned little in all these pioneering years of hard work and great strives in the care of children with heart defects. I refuse to accept that. We should all refuse to accept that.
- Sara K. Pasquali, MD, Justin B. Dimick, MD, Richard G. Ohye, . Time for a More Unified Approach to Pediatric Health Care Policy? The Case of Congenital Heart Care JAMA. 2015;314(16):1689-1690.
- Cohen E. Patient safety evaluated at St Mary’s hospital. http://www.cnn.com/2015/06/26/health/st-marys-hospital-heart-surgeries-evaluated/index.html. Accessed June 29, 2015.
- Welke KF, O’Brien SM, Peterson ED, Ungerleider RM, Jacobs ML, Jacobs JP. The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database. J Thorac Cardiovasc Surg. 2009;137(5):1133-1140.
- Jacobs JP, O’Brien SM, Pasquali SK, et al. Variation in outcomes for benchmark operations: an analysis of the Society of Thoracic Surgeons Congenital Heart Surgery database. Ann Thorac Surg. 2011;92(6):2184-2191.
- Pasquali SK, Jacobs ML, He X, et al. Variation in congenital heart surgery costs across hospitals. Pediatrics. 2014;133(3):e553-e560.
- Lundström NR, Berggren H, Björkhem G, Jögi P, Sunnegârdh J. Centralization of pediatric heart surgery in Sweden. Pediatr Cardiol. 2000;21(4):353-357
- Mainwaring RD, Reddy VM, Reinhartz O, et al. Outcome analysis for a small, start-up congenital heart surgery program. J Card Surg. 2008;23(6):622-626.