While surgeons and programs may have monitored their own results, the assessment of those results was limited by the lack of agreed standards for comparison. If any standards were cited, they were derived from publications in the medical literature of exceptional results. Real data from multiple institutions was required to determine realistic standards. Thus began the development of databases in pediatric heart surgery. The first multi-institutional database for this group of patients was initiated in the upper Midwest of the United States to derive data to justify funding for children with congenital heart disease for the state of Minnesota and surrounding states. In 1982 the Northern Great Plains Regional Cardiac Program (NGPRCP) was begun under the leadership of Dr. James Moller of the University of Minnesota [13]. Initially data was collected from five centers: the Mayo Clinic, Minneapolis Children’s Medical Center, the University of Iowa, the University of Nebraska, and the University of Minnesota. Other centers outside of the upper Midwest began to voluntarily join the program. In 1990 the name was changed to the Pediatric Cardiac Care Consortium (PCCC) and the number of programs submitting data exceeded 40 by the year 2000. The database focused on two outcomes: death and length of hospital stay. Data was submitted to a central center with trained coders and was kept confidential with de-identified patient information. Annual center specific reports were made available to each submitting center permitting a comparison to aggregate data from the other participating centers. The PCCC was truly the first database providing data from multiple centers performing pediatric heart surgery allowing realistic information regarding mortality rates for a variety of pediatric cardiac surgical procedures. Benchmarks for mortality of individual operations could now be realistically derived [14].

Another database for patients with congenital heart defects was introduced in 1985 by the Congenital Heart Surgeons’ Society (CHSS). Two members of this group of pediatric heart surgeons, Dr. John Kirklin and Dr. Eugene Blackstone, proposed the pooling of data from the members’ institutions to assess the management outcomes of specific cardiac malformations. This database differed from the PCCC in that only select congenital heart lesions were tracked and each patient was followed annually. The first lesion to be studied was transposition of the great arteries. This was a timely choice that provided useful feedback permitting comparison of atrial redirection operations (Mustard and Senning procedures) to the newly introduced arterial switch operation. Data derived from the CHSS database provided valuable evidence favoring the latter procedure facilitating the pediatric surgical community’s transition to the newer operation for newborns with complete transposition [8]. Other cardiac lesions addressed by the CHSS Database have been pulmonary atresia with intact ventricular septum, pulmonary stenosis, interrupted aortic arch, coarctation of the aorta, critical aortic stenosis, aortic atresia, and tricuspid atresia. The CHSS database continues to serve as a repository of important data from which longer-term outcomes of rare congenital heart anomalies can be determined.

The PCCC and CHSS Databases are representative of the two forms of databases that have become valuable in the assessment of pediatric heart surgery outcomes [15]. The PCCC Database is a registry database in which some data is collected for all of the patients. The amount of data collected on each case is limited to a predetermined set of identifiers and early outcomes. This minimal dataset must be clearly assessable and easily and reliably entered for each patient. Registry databases like the PCCC help determine standard of care references from which benchmarks can be developed. The CHSS Database is an academic database in which “all of the data” is collected on some of the patients. Academic databases investigate specific populations or subgroups of patients to generate new knowledge. An academic database is much more amenable to longitudinal follow-up than a registry database and allows much more detailed studies. Both forms of databases continue to be important in the assessment and improvement of pediatric cardiac surgery quality.

In 1990 an informal group of European congenital heart surgeons (later formalized into what is presently the European Congenital Heart Surgeons Association (ECHSA)) recognized the importance of collecting data from all of the operations performed at their respective centers. This collaboration led to the birth of the European Congenital Heart Defects Database (ECHDD) in 1992, which began under the direction of Dr. Martin Elliot at Great Ormond Street Hospital for Children in London, England. By 1995 31 centers from 18 countries were submitting data. In 1998 the ECHDD relocated to the Children’s Memorial Health Institute in Warsaw, Poland under Dr. Bohdan Maruszewski as director. As congenital data was being collected in the ECHDD, the European Association for Cardio-Thoracic Surgery (EACTS) was developing the European Cardio-Thoracic Surgical Registry (ECSUR). In 1999 it was decided that the ECHDD would be part of the ECSUR. Initially termed the Pediatric ECSUR this registry database would soon be known as the EACTS Congenital Heart Surgery Database. By 2001 84 programs from 34 countries were represented. By 2012 the number of European centers had risen to 265 representing 36 countries. By that time another 147 centers outside of Europe from 43 countries all over the world had been added. Today, these databases include data from over 100,000 patients and 125,000 operations.

Contemporarily with what was happening in Europe, the US Society of Thoracic Surgeons was developing its own registry database for congenital heart surgery in North America. Dr. Constantine Mavroudis at Children’s Memorial Hospital in Chicago, Illinois was responsible for the initial development of the STS Congenital Heart Surgery Database. Centers began joining in 1994 and by 1997 24 North American centers had provided data that included mortality and length of stay derived from over 8,000 patient records. In the late 1990s Dr. Jeff Jacobs of St. Petersburg, Fl. assumed the Chairmanship of the STS Congenital Heart Surgery Database Task Force and has been responsible for the continued maturation and growth of this database [16]. By the end of 2011 there were over 100 participating centers representing more than 80 % of all congenital heart programs in the United States. Data from over 200,000 operations have been submitted from 1994 to today.

The key to the successful development of the congenital databases in Europe and North America was the establishment of a common language or nomenclature to describe the large number of disease entities treated and procedures performed. In addition, it was necessary to determine the minimal set of data required to allow valid linkage with other databases. In 1998 the EACTS and STS collaboratively initiated the International Congenital Heart Surgery Nomenclature and Database Project. By 2000 a minimum dataset was agreed upon and updated in 2001 [17, 18]. In the next few years the International Society for Nomenclature of Paediatric and Congenital Heart Disease (ISNPCHD) was created including surgeons, pediatric cardiologists, and congenital cardiac morphologists. By 2005 the nomenclature working group of the ISNPCHD had cross-mapped the nomenclature of the International Congenital Heart Surgery Nomenclature and Database Project of the STS and EACTS with the European Paediatric Cardiac Code (EPCC) of the Association for European Paediatric Cardiology (AEPC) creating the International Paediatric and Congenital Cardiac Code (IPCCC). With this common language and an agreed upon minimum dataset, the EACTS and STS Databases were up and running and able to combine information from two very large experiences in pediatric heart surgery. Furthermore, the stage was set for linkage with databases from other parts of the world, from other medical disciplines, and even with some administrative databases.

In pediatric cardiac surgery there is a broad spectrum of complexity and risk. The mix of cases at one institution may consist of simple low risk cases whereas the mix at another institution may contain more complex cases subject to significantly higher risk. Comparing the overall mortality of the two institutions would provide a misleading assessment of outcomes. Thus to provide fairer comparisons between centers, stratification schemes were developed. The first scheme (the Risk Adjustment in Congenital Heart Surgery-1 (RACHS-1) method) consisted of six risk categories for surgical procedures. This stratification, which was developed and championed by Dr. Kathy Jenkins at Boston Children’s Hospital, was derived from a consensus of pediatric cardiologists and cardiac surgeons [19]. The application of RACHS-1 to the PCCC dataset for the year 1996 confirmed a spread of mortality rates across RACHS-1 categories with category 1 having a mortality of 0.4 % and category 6 having a mortality of 41.5 %. Another approach to risk stratification, fostered by Dr. Francois Lacour-Gayet who worked at the Eppendorf University Hospital in Hamburg, Germany, applied scores and levels to each operation based on the perceived risk of mortality, morbidity, and the technical difficulty of the procedure [20, 21]. These values were referred to as Aristotle basic complexity (ABC) scores and levels. As with RACHS-1 the ABC scores were derived from expert opinions of experienced clinicians. The Aristotle approach was incorporated in the reports from the EACTS and STS Congenital Databases beginning in 2002 and the RACHS-1 stratification was added to the reports in both databases in 2006. Both approaches provided reasonable risk stratification, but the Aristotle levels classified more operations than did RACHS-1, whereas RACHS-1 provided more discrimination at the higher end of complexity [22]. By 2008 enough data had been collected in both the EACTS and STS Congenital Databases to permit an objective determination of risk from actual surgical outcomes. This new stratification scheme resulted in five “STS-EACTS Mortality Levels” which demonstrated better predictive value for mortality than the RACHS-1 or Aristotle systems [23]. This objectively derived system, now referred to as STAT Mortality Categories, has become the preferred stratification protocol for congenital heart operations and is currently incorporated in all EACTS and STS Congenital Database reports.

Now with an accepted nomenclature and means for risk stratification the EACTS and STS registry databases provide useful quality assessment for centers willing to participate. The formats of these databases continue to evolve to further improve the value of the information collected and analyzed. Periodically data fields are added and subtracted as experience with the information accrues and clinical questions increase and decrease in importance. The validity of the data in the databases must be assured with regular audits and other forms of data verification [24]. Measurement of outcomes has focused mostly on hospital or 30 day mortality. Mortality data alone, however, is insensitive to quality issues experienced by low risk procedures and says little about process failures that may lead to near misses and harm but not death. The hospital length of stay is available in these databases and has served as a proxy for the morbidity of pediatric cardiac surgical procedures. Other measures of morbidity are now being tracked in these databases including unplanned reoperations, postoperative renal failure, and postoperative complete heart block [25–27]. Hopefully tracking these measures will provide a more thorough assessment of process and outcomes for these patients. How these patients do after the initial 30 days following an operation is also important. Although registry databases are poorly suited for longitudinal follow-up, efforts are in progress to create Health Insurance Portability and Accountability Act (HIPAA)-compliant unique patient identifiers that would permit tracking of patients through a series of operations and for longer-term follow-up [28]. As many pediatric cardiac surgical conditions require staging of surgical procedures, the ability to keep track of the same patient through more than one procedure is important in assessing the outcomes of such sequenced approaches for individual patients. HIPAA-compliant unique patient identifiers may also permit linkage with administrative databases to enable assessment of costs or other nonclinical information or to assist with data verification regarding death, length of hospital stay, or other demographics [29].

Pediatric cardiac surgery centers have the ability now to participate in highly developed multi-institutional databases such as the STS and EACTS Congenital Databases, with each center having the ability to compare its own outcomes with those of other database members. For the STS Congenital Heart Surgery Database each center’s outcomes are kept confidential but can be compared to the outcomes experienced in the aggregate of the other centers. In addition, graphical depictions are provided such that an individual center can visualize its outcomes in comparison with those of the other centers in a de-identified manner (Fig. 16.2). Outcome information is provided at a reasonable interval (every six months for the STS Congenital database) to each center who can continuously monitor its outcomes. Of course, not every center will feel assured, as its outcomes may not be satisfactory for every procedure. In fact, analysis of data from the STS Congenital Database has revealed that there is significant variation in outcomes among institutions providing pediatric heart surgery [30, 31]. The degree of variation in terms of mortality is minimal for low risk procedures, but tends to be as high as sixfold with increasing complexity and risk. Variation in outcomes is not only seen between centers but can occur within the same institution and with different surgeons with good results for one operation and much less satisfactory results for another operation [32]. These analyses indicate a spectrum of performance among and within programs providing pediatric cardiac surgery. These findings indicate a need for some programs to reevaluate their performance as a whole or for particular procedures.

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