The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease was established in 2005 with the goal of providing the infrastructure, spanning geographical and subspecialty boundaries, for collaboration between health care professionals interested in the analysis of outcomes of treatments provided to patients with congenital cardiac disease, with the ultimate aim of improvement in the quality of care provided to these patients. The purpose of these collaborative efforts is to promote the highest quality comprehensive cardiac care to all patients with congenital heart disease, from the fetus to the adult, regardless of the patient’s economic means, with an emphasis on excellence in teaching, research and community service. This manuscript provides the Introduction to the 2008 Supplement to Cardiology in the Young titled: “Databases and The Assessment of Complications associated with the Treatment of Patients with Congenital Cardiac Disease”. This Supplement was prepared by The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.

The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Complication”: “A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval.”

The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease offers the following definition of the term “Adverse Event”: “An adverse event is a complication that is associated with a healthcare intervention and is associated with suboptimal outcome. Adverse events represent a subset of complications. Not all medical errors result in an adverse event; the administration of an incorrect dose of a medication is a medical error, but it does not always result in an adverse event. Similarly, not all adverse events are the result of medical error. A child may develop pneumonia after an atrial septal defect repair despite intra- and peri-operative management that is free of error. Complications of the underlying disease state, which are not related to a medical intervention, are not adverse events. For example, a patient who presents for medical care with metastatic lung cancer has already developed a complication (Metastatic spread) of the primary lung cancer without any healthcare intervention. Furthermore, complications not associated with suboptimal outcome or harm are not adverse events and are known as no harm events. The patient who receives an incorrect dose of a medication without harm has experienced a no harm event, but not an adverse event.”

Based on the above definitions, it is apparent that The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease has taken an inclusive approach to defining the universe of complications. Complications may or may not be associated with healthcare intervention and may or may not be associated with suboptimal outcome. Meanwhile, adverse events must be associated with healthcare intervention and must be associated with suboptimal outcome.

This review discusses the historical aspects, current state of the art, and potential future advances in the areas of nomenclature and databases for the analysis of outcomes of treatments for patients with congenitally malformed hearts. We will consider the current state of analysis of outcomes, lay out some principles which might make it possible to achieve life-long monitoring and follow-up using our databases, and describe the next steps those involved in the care of these patients need to take in order to achieve these objectives. In order to perform meaningful multi-institutional analyses, we suggest that any database must incorporate the following six essential elements: use of a common language and nomenclature, use of an established uniform core dataset for collection of information, incorporation of a mechanism of evaluating case complexity, availability of a mechanism to assure and verify the completeness and accuracy of the data collected, collaboration between medical and surgical subspecialties, and standardised protocols for life-long follow-up.

During the 1990s, both The European Association for Cardio-Thoracic Surgery and The Society of Thoracic Surgeons created databases to assess the outcomes of congenital cardiac surgery. Beginning in 1998, these two organizations collaborated to create the International Congenital Heart Surgery Nomenclature and Database Project. By 2000, a common nomenclature, along with a common core minimal dataset, were adopted by The European Association for Cardio-Thoracic Surgery and The Society of Thoracic Surgeons, and published in the Annals of Thoracic Surgery. In 2000, The International Nomenclature Committee for Pediatric and Congenital Heart Disease was established. This committee eventually evolved into the International Society for Nomenclature of Paediatric and Congenital Heart Disease. The working component of this international nomenclature society has been The International Working Group for Mapping and Coding of Nomenclatures for Paediatric and Congenital Heart Disease, also known as the Nomenclature Working Group. By 2005, the Nomenclature Working Group crossmapped the nomenclature of the International Congenital Heart Surgery Nomenclature and Database Project of The European Association for Cardio-Thoracic Surgery and The Society of Thoracic Surgeons with the European Paediatric Cardiac Code of the Association for European Paediatric Cardiology, and therefore created the International Paediatric and Congenital Cardiac Code, which is available for free download from the internet at [http://www.IPCCC.NET].

This common nomenclature, the International Paediatric and Congenital Cardiac Code, and the common minimum database data set created by the International Congenital Heart Surgery Nomenclature and Database Project, are now utilized by both The European Association for Cardio-Thoracic Surgery and The Society of Thoracic Surgeons. Between 1998 and 2007 inclusive, this nomenclature and database was used by both of these two organizations to analyze outcomes of over 150,000 operations involving patients undergoing surgical treatment for congenital cardiac disease.

Two major multi-institutional efforts that have attempted to measure the complexity of congenital heart surgery are the Risk Adjustment in Congenital Heart Surgery-1 system, and the Aristotle Complexity Score. Current efforts to unify the Risk Adjustment in Congenital Heart Surgery-1 system and the Aristotle Complexity Score are in their early stages, but encouraging. Collaborative efforts involving The European Association for Cardio-Thoracic Surgery and The Society of Thoracic Surgeons are under way to develop mechanisms to verify the completeness and accuracy of the data in the databases. Under the leadership of The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease, further collaborative efforts are ongoing between congenital and paediatric cardiac surgeons and other subspecialties, including paediatric cardiac anaesthesiologists, via The Congenital Cardiac Anesthesia Society, paediatric cardiac intensivists, via The Pediatric Cardiac Intensive Care Society, and paediatric cardiologists, via the Joint Council on Congenital Heart Disease and The Association for European Paediatric Cardiology.

In finalising our review, we emphasise that analysis of outcomes must move beyond mortality, and encompass longer term follow-up, including cardiac and non cardiac morbidities, and importantly, those morbidities impacting health related quality of life. Methodologies must be implemented in these databases to allow uniform, protocol driven, and meaningful, long term follow-up.

The diagnosis and treatment for paediatric and congenital cardiac disease has undergone remarkable progress over the last 60 years. Unfortunately, this progress has been largely limited to the developed world. Yet every year approximately 90% of the more than 1,000,000 children who are born with congenital cardiac disease across the world receive either suboptimal care or are totally denied care.

While in the developed world the focus has changed from an effort to decrease post-operative mortality to now improving quality of life and decreasing morbidity, which is the focus of this Supplement, the rest of the world still needs to develop basic access to congenital cardiac care. The World Society for Pediatric and Congenital Heart Surgery [http://www.wspchs.org/] was established in 2006. The Vision of the World Society is that every child born anywhere in the world with a congenital heart defect should have access to appropriate medical and surgical care. The Mission of the World Society is to promote the highest quality comprehensive care to all patients with pediatric and/or congenital heart disease, from the fetus to the adult, regardless of the patient’s economic means, with emphasis on excellence in education, research and community service.

We present in this article an overview of the epidemiology of congenital cardiac disease, the current and future challenges to improve care in the developed and developing world, the impact of the globalization of cardiac surgery, and the role that the World Society should play. The World Society for Pediatric and Congenital Heart Surgery is in a unique position to influence and truly improve the global care of children and adults with congenital cardiac disease throughout the world [http://www.wspchs.org/].

Clinicians working in the field of congenital and paediatric cardiology have long felt the need for a common diagnostic and therapeutic nomenclature and coding system with which to classify patients of all ages with congenital and acquired cardiac disease. A cohesive and comprehensive system of nomenclature, suitable for setting a global standard for multicentric analysis of outcomes and stratification of risk, has only recently emerged, namely, The International Paediatric and Congenital Cardiac Code. This review, will give an historical perspective on the development of systems of nomenclature in general, and specifically with respect to the diagnosis and treatment of patients with paediatric and congenital cardiac disease. Finally, current and future efforts to merge such systems into the paperless environment of the electronic health or patient record on a global scale are briefly explored.

On October 6, 2000, The International Nomenclature Committee for Pediatric and Congenital Heart Disease was established. In January, 2005, the International Nomenclature Committee was constituted in Canada as The International Society for Nomenclature of Paediatric and Congenital Heart Disease. This International Society now has three working groups. The Nomenclature Working Group developed The International Paediatric and Congenital Cardiac Code and will continue to maintain, expand, update, and preserve this International Code. It will also provide ready access to the International Code for the global paediatric and congenital cardiology and cardiac surgery communities, related disciplines, the healthcare industry, and governmental agencies, both electronically and in published form. The Definitions Working Group will write definitions for the terms in the International Paediatric and Congenital Cardiac Code, building on the previously published definitions from the Nomenclature Working Group. The Archiving Working Group, also known as The Congenital Heart Archiving Research Team, will link images and videos to the International Paediatric and Congenital Cardiac Code. The images and videos will be acquired from cardiac morphologic specimens and imaging modalities such as echocardiography, angiography, computerized axial tomography and magnetic resonance imaging, as well as intraoperative images and videos.

Efforts are ongoing to expand the usage of The International Paediatric and Congenital Cardiac Code to other areas of global healthcare. Collaborative efforts are underway involving the leadership of The International Nomenclature Committee for Pediatric and Congenital Heart Disease and the representatives of the steering group responsible for the creation of the 11th revision of the International Classification of Diseases, administered by the World Health Organisation. Similar collaborative efforts are underway involving the leadership of The International Nomenclature Committee for Pediatric and Congenital Heart Disease and the International Health Terminology Standards Development Organisation, who are the owners of the Systematized Nomenclature of Medicine or “SNOMED”.

The International Paediatric and Congenital Cardiac Code was created by specialists in the field to name and classify paediatric and congenital cardiac disease and its treatment. It is a comprehensive code that can be freely downloaded from the internet (http://www.IPCCC.net) and is already in use worldwide, particularly for international comparisons of outcomes. The goal of this effort is to create strategies for stratification of risk and to improve healthcare for the individual patient. The collaboration with the World Heath Organization, the International Health Terminology Standards Development Organisation, and the healthcare industry, will lead to further enhancement of the International Code, and to its more universal use.

A large body of literature devoted to “patient safety” and error prevention exists and utilizes a nomenclature that can be applied specifically to the field of congenital cardiac disease and aid in the goals of increasing the safety of patients, decreasing medical error, minimizing mortality and morbidity, and evaluating quality of care. The purpose of this manuscript is to suggest and document a quality of health care taxonomy and the appropriate application of this nomenclature of “patient safety” to the specialty of congenital cardiac disease, with special emphasis on the following ten terms: morbidity, complication, medical error, adverse event, harm, near miss, iatrogenesis, iatrogenic complication, medical injury, and sentinel event. Each of these terms is commonly utilized in the medical literature without universal agreement on their meaning and relationship. It is our hope that the standardization of the definitions of these terms, as they are applied to the analysis of outcomes of the treatments applied to patients with congenital and paediatric cardiac disease, will facilitate improved methodologies to assess and improve quality of care in our profession.

This review includes a brief discussion, from the perspective of cardiac surgeons, of the rationale for creation and maintenance of multi-institutional databases of outcomes of congenital heart surgery, together with a history of the evolution of such databases, a description of the current state of the art, and a discussion of areas for improvement and future expansion of the concept. Five fundamental areas are reviewed: nomenclature, mechanism of data collection and storage, mechanisms for the evaluation and comparison of the complexity of operations and stratification of risk, mechanisms to ensure the completeness and accuracy of the data, and mechanisms for expansion of the current capabilities of databases to include comparison and sharing of data between medical subspecialties. This review briefly describes several European and North American initiatives related to databases for pediatric and congenital cardiac surgery the Congenital Database of The European Association for Cardio-Thoracic Surgery, the Congenital Database of The Society of Thoracic Surgeons, the Pediatric Cardiac Care Consortium, and the Central Cardiac Audit Database in the United Kingdom. Potential means of approaching the ultimate goal of acquisition of long-term follow-up data, and input of this data over the life of the patient, are also considered.

This review includes a brief discussion, from the perspective of the pediatric cardiologist, of the rationale for creation and maintenance of multi-institutional databases of outcomes of the treatment of patients with congenital and paediatric cardiac disease, together with a history of the evolution of such databases, and a description of the current state of the art. A number of projects designed to have broad-based impact are currently in the design phase, or have already been implemented. Not surprisingly, most of the efforts thus far have focused on catheterization procedures and interventions, although some work examining other aspects of paediatric cardiology practice is also beginning. This review briefly describes several European and North American initiatives related to databases for pediatric and congenital cardiology including the Central Cardiac Audit Database of the United Kingdom, national database initiatives for pediatric cardiology in Switzerland and Germany, various database initiatives under the leadership of the Working Groups of The Association for European Paediatric Cardiology, the IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment) of the National Cardiovascular Data Registry® of The American College of Cardiology Foundation® and The Society for Cardiovascular Angiography and Interventions (SCAI), the Mid-Atlantic Group of Interventional Cardiology (MAGIC) Catheterization Outcomes Project, the Congenital Cardiac Catheterization Project on Outcomes (C3PO), the Congenital Cardiovascular Interventional Study Consortium (CCISC), and the Joint Council on Congenital Heart Disease (JCCHD) National Quality Improvement Initiative. These projects, each leveraging multicentre data and collaboration, demonstrate the enormous progress that has occurred over the last several years to improve the quality and consistency of information about nonsurgical treatment for congenital cardiac disease. The paediatric cardiology field is well-poised to move quickly beyond outcome assessment and benchmarking, to collaborative quality improvement.

The Congenital Cardiac Anesthesia Society was formed in 2005 by representatives from many of the busiest congenital cardiac surgical programs in North America and is now in the process of partnering with The Society of Thoracic Surgeons to create a joint congenital cardiac surgery and congenital cardiac anaesthesia database. Even the busiest of congenital cardiac programs have a low frequency of anaesthesia-related cardiac complications and deaths. One of the only mechanisms for accurately determining the incidence and outcomes of low frequency events is to aggregate large amounts of data from multiple sources. To that end, the Congenital Cardiac Anesthesia Society has joined with the Society of Thoracic Surgeons Congenital Database Task Force to incorporate anaesthesia-specific data points into their surgical registry, which is now the largest single reporting site for children and adults undergoing surgical repair of congenital cardiac malformations in North America. The Joint Congenital Cardiac Anesthesia Society – Society of Thoracic Surgeons Database will therefore become an optional module of The Society of Thoracic Surgeons Congenital Heart Surgery Database. Initial data fields have been selected and are presented in this article.

Efforts are ongoing to make this initiative a global project. Initial collaborative discussions have taken place about the possibility of linking this initiative with the European Association of Cardiothoracic Anesthesiologists. It is certainly possible and desirable that the planned anaesthesia module of The Society of Thoracic Surgeons Congenital Heart Database has an identical module in the congenital heart database of The European Association for Cardio-Thoracic Surgery and The European Congenital Heart Surgeons Association. This project should also ideally spread beyond North America and Europe. Efforts to involve Africa, Asia, Australia, and South America are necessary and already underway. The creation of a joint cardiac surgery and anaesthesia database is another step towards the ultimate goal of creating a database for congenital heart disease that spans both geographical and subspecialty boundaries.

The development of databases to track the outcomes of children with cardiovascular disease has been ongoing for much of the last two decades, paralleled by the rise of databases in the intensive care unit. While the breadth of data available in national, regional and local databases has grown exponentially, the ability to identify meaningful measurements of outcomes for patients with cardiovascular disease is still in its early stages.

In the United States of America, the Virtual Pediatric Intensive Care Unit Performance System (VPS) is a clinically based database system for the paediatric intensive care unit that provides standardized high quality, comparative data to its participants [https://portal.myvps.org/]. All participants collect information on multiple parameters: (1) patients and their stay in the hospital, (2) diagnoses, (3) interventions, (4) discharge, (5) various measures of outcome, (6) organ donation, and (7) paediatric severity of illness scores. Because of the standards of quality within the database, through customizable interfaces, the database can also be used for several applications: (1) administrative purposes, such as assessing the utilization of resources and strategic planning, (2) multi-institutional research studies, and (3) additional internal projects of quality improvement or research.

In the United Kingdom, The Paediatric Intensive Care Audit Network is a database established in 2002 to record details of the treatment of all critically ill children in paediatric intensive care units of the National Health Service in England, Wales and Scotland. The Paediatric Intensive Care Audit Network was designed to develop and maintain a secure and confidential high quality clinical database of pediatric intensive care activity in order to meet the following objectives: (1) identify best clinical practice, (2) monitor supply and demand, (3) monitor and review outcomes of treatment episodes, (4) facilitate strategic healthcare planning, (5) quantify resource requirements, and (6) study the epidemiology of critical illness in children.

Two distinct physiologic risk adjustment methodologies are the Pediatric Risk of Mortality Scoring System (PRISM), and the Paediatric Index of Mortality Scoring System 2 (PIM 2). Both Pediatric Risk of Mortality (PRISM 2) and Pediatric Risk of Mortality (PRISM 3) are comprised of clinical variables that include physiological and laboratory measurements that are weighted on a logistic scale. The raw Pediatric Risk of Mortality (PRISM) score provides quantitative measures of severity of illness. The Pediatric Risk of Mortality (PRISM) score when used in a logistic regression model provides a probability of the predicted risk of mortality. This predicted risk of mortality can then be used along with the rates of observed mortality to provide a quantitative measurement of the Standardized Mortality Ratio (SMR). Similar to the Pediatric Risk of Mortality (PRISM) scoring system, the Paediatric Index of Mortality (PIM) score is comprised of physiological and laboratory values and provides a quantitative measurement to estimate the probability of death using a logistic regression model.

The primary use of national and international databases of patients with congenital cardiac disease should be to improve the quality of care for these patients. The utilization of common nomenclature and datasets by the various regional subspecialty databases will facilitate the eventual linking of these databases and the creation of a comprehensive database that spans conventional geographic and subspecialty boundaries.

The introduction of the reporting of medical and surgical outcomes to the public and the potential implementation of initiatives involving pay-for-performance have invigorated debates about the relative benefits of administrative and clinical databases for comparing rates of mortality at the level of the hospital and surgeon. While general agreement exists that public performance report cards must use the highest quality data available, debate continues regarding whether administrative or clinical data should be utilized for this purpose. Clinical databases may contain information more relevant to risk-adjustment, but the currently available clinical databases are voluntary and suffer from validity concerns. Administrative data, however, suffer from inaccuracies of coding and a lack of potentially informative covariates. Particularly problematic to congenital heart surgery is the non-uniform application of coding algorithms to define complex reconstructive procedures for which there is no unique code assignment. The purposes of this manuscript are; therefore, to discuss the relative advantages and limitations of both clinical and administrative data, and to provide a brief introduction to currently available databases germane to the study of congenital cardiac disease.

It is universally agreed that efforts to improve quality benefit from the analysis of outcomes. Yet, it is challenging to compare results across institutions because factors other than performance also impact outcomes. Two factors that complicate the analysis of outcomes after congenital cardiac surgery are case-mix and random statistical variation. Case-mix refers to differences in the mix of patients and their risk-factors at different institutions that may cause some centres to have more frequent complications and lower survival regardless of their true performance. Random statistical variation refers to fluctuations in outcomes that occur at random and follow the laws of probability. A variety of statistical methods exist to address these issues and make provider comparisons more fair. We explain a few common approaches including stratification, regression analysis, and confidence intervals. Concepts are illustrated using artificial data from two hypothetical hospitals, as well as real data from a multi-institution registry.

Meaningful evaluation of quality of care must account for variations in the population of patients receiving treatment, or “case-mix”. In adult cardiac surgery, empirical clinical data, initially from tens of thousands, and more recently hundreds of thousands of operations, have been used to develop risk-models, to increase the accuracy with which the outcome of a given procedure on a given patient can be predicted, and to compare outcomes on non-identical patient groups between centres, surgeons and eras.

In the adult cardiac database of The Society of Thoracic Surgeons, algorithms for risk-adjustment are based on over 1.5 million patients undergoing isolated coronary artery bypass grafting and over 100,000 patients undergoing isolated replacement of the aortic valve or mitral valve. In the pediatric and congenital cardiac database of The Society of Thoracic Surgeons, 61,014 operations are spread out over greater than 100 types of primary procedures. The problem of evaluating quality of care in the management of pediatric patients with cardiac diseases is very different, and in some ways a great deal more challenging, because of the smaller number of patients and the higher number of types of operations.

In the field of pediatric cardiac surgery, the importance of the quantitation of the complexity of operations centers on the fact that outcomes analysis using raw measurements of mortality, without adjustment for complexity, is inadequate. Case-mix can vary greatly from program to program. Without stratification of complexity, the analysis of outcomes for congenital cardiac surgery will be flawed. Two major multi-institutional efforts have attempted to measure the complexity of pediatric cardiac operations: the Risk Adjustment in Congenital Heart Surgery-1 method and the Aristotle Complexity Score. Both systems were derived in large part from subjective probability, or expert opinion. Both systems are currently in wide use throughout the world and have been shown to correlate reasonably well with outcome.

Efforts are underway to develop the next generation of these systems. The next generation will be based more on objective data, but will continue to utilize subjective probability where objective data is lacking. A goal, going forward, is to re-evaluate and further refine these tools so that, they can be, to a greater extent, derived from empirical data. During this process, ideally, the mortality elements of both the Aristotle Complexity Score and the Risk Adjustment in Congenital Heart Surgery-1 methodology will eventually unify and become one and the same. This review article examines these two systems of stratification of complexity and reviews the rationale for the development of each system, the current use of each system, the plans for future enhancement of each system, and the potential for unification of these two tools.

When designed in 2000, the Aristotle Complexity Score was entirely based on subjective probability. This approach, based on the opinion of experts, was considered a good solution due to the limited amount of data available. In 2008, the next generation of the complexity score will be based on observed data available from over 100,000 congenital cardiac operations currently gathered in the congenital cardiac surgery databases of the Society of Thoracic Surgeons and the European Association for Cardio-Thoracic Surgery.

A mortality score is created based on 70,000 surgeries harvested in the congenital databases of The Society of Thoracic Surgeons and The European Association for Cardio-Thoracic Surgery. It is derived from 118 congenital cardiovascular operations, representing 91% of the operations and including 97% of the patients. This Mortality Index of the new Aristotle Complexity Score could further be stratified into 5 levels with minimal within-group variation and maximal between-group variation, and may contribute to the planned unification of the Aristotle Complexity Score with the Risk Adjustment for Congenital Heart Surgery system.

Similarly, a score quantifying morbidity risk is created. Due to the progress of congenital cardiac surgery, the mortality is today reduced to an average of 4%. No instrument currently exists to measure the quality of care delivered to the survivors representing 96% of the patients. An objective assessment of morbidity was needed. The Morbidity Index, based on 50,000 operations gathered in the congenital databases of The Society of Thoracic Surgeons and The European Association for Cardio-Thoracic Surgery, is derived from 117 congenital cardiovascular operations representing 90% of the operations and including 95% of the patients. This morbidity indicator is calculated on an algorithm based on length of stay in the hospital and time on the ventilator.

The mortality and morbidity indicators will be part of the next generation of the complexity score, which will be named the Aristotle Average Complexity Score. It will be based on the sum of mortality, morbidity, and subjective technical difficulty. The introduction of objective data in assessment of mortality and morbidity in congenital cardiac surgery is a significant step forward, which should allow a better evaluation of the complexity of the operations performed by a given centre or surgeon.

Accurate, complete data is now the expectation of patients, families, payers, government, and even media. It has become an obligation of those practising congenital cardiac surgery. Appropriately, major professional organizations worldwide are assuming responsibility for the data quality in their respective registry databases.

The purpose of this article is to review the current strategies used for verification of the data in the congenital databases of The Society of Thoracic Surgeons, The European Association for Cardio-Thoracic Surgery, and The United Kingdom Central Cardiac Audit Database. Because the results of the initial efforts to verify data in the congenital databases of the United Kingdom and Europe have been previously published, this article provides a more detailed look at the current efforts in North America, which prior to this article have not been published. The discussion and presentation of the strategy for the verification of data in the congenital heart surgery database of The Society of Thoracic Surgeons is then followed by a review of the strategies utilized in the United Kingdom and Europe. The ultimate goal of sharing the information in this article is to provide information to the participants in the databases that track the outcomes of patients with congenitally malformed hearts. This information should help to improve the quality of the data in all of our databases, and therefore increase the utility of these databases to function as a tool to optimise the management strategies provided to our patients.

The need for accurate, complete and high quality Congenital Heart Surgery outcome data has never been more pressing. The public interest in medical outcomes is at an all time high and “pay for performance” is looming on the horizon. Information found in administrative databases is not risk or complexity adjusted, notoriously inaccurate, and far too imprecise to evaluate performance adequately in congenital cardiac surgery. The Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery databases contain the elements needed for assessment of quality of care provided that a mechanism exists within these organizations to guarantee the completeness and accuracy of the data. The Central Cardiac Audit Database in the United Kingdom has an advantage in this endeavour with the ability to track and verify mortality independently, through their National Health Service.

A combination of site visits with “Source Data Verification”, in other words, verification of the data at the primary source of the data, and external verification of the data from independent databases or registries, such as governmental death registries, may ultimately be required to allow for optimal verification of data. Further research in the area of verification of data is also necessary. Data must be verified for both completeness and accuracy.

The interest of professional medical societies in research about outcomes, mixed with the recent accessibility to management of data on the internet, has moved many societies to create national databases or registries for their specialty. In societies with procedure-based specialties such as surgery, these databases will help with the care of patients by predicting prognosis, defining risk-factors, and aiding with the selection of patients who are the best candidates for these procedures. These databases eventually will also help to establish standards of care. The latter is rapidly growing in importance as governments attempt to create “pay-for-performance” programs in many of the surgical specialties. It is essential to create a database from which a specialty can provide accurate data and standards to its members, its patients, and third parties, such as regulatory bodies and agencies of re-numeration. Unfortunately, surgeons often only care for their patients in the short-term peri-operative period, typically lasting weeks to months; and therefore, the ability of surgeons to create databases with long-term follow-up has been limited. The introduction of “personal health information” into a surgical database, with the intention of linking with other societies or national databases that have long-term follow-up, can remedy this weakness. This article describes the investigation by one surgical society into the available national registries of death and examines their accuracy, accessibility, cost, and their suitability in respect to the goals of that society. The information gathered, the comparisons outlined, and the processes used to determine the best combination of indices of death for this society should be translatable and hopefully useful for other societies and registries who wish to empower their databases with long-term national data about mortality.

A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval.

The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease has set forth a comprehensive list of complications associated with the treatment of patients with congenital cardiac disease, related to cardiac, pulmonary, renal, haematological, infectious, neurological, gastrointestinal, and endocrinal systems, as well as those related to the management of anaesthesia and perfusion, and the transplantation of thoracic organs. The objective of this manuscript is to examine the definitions of operative morbidity as they relate specifically to the cardiac system. These specific definitions and terms will be used to track morbidity associated with surgical and transcatheter interventions and other forms of therapy in a common language across many separate databases.

The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease has prepared and defined a near-exhaustive list of cardiac complications, including intraoperative complications and cardiopulmonary bypass-related complications. These cardiac complications are presented in the following subgroups:

1) Cardiac (general)

2) Cardiac – Metabolic

3) Cardiac – Residual and Recurrent cardiac lesions

4) Arrhythmia

5) Cardiopulmonary bypass and Mechanical circulatory support, and

6) Operative/Procedural.

Within each subgroup, complications are presented in alphabetical order. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, quality improvement initiatives, reporting of complications, and comparing strategies for treatment.

A detailed hierarchal nomenclature of arrhythmias is offered with definition of its applications to diagnosis and complications. The conceptual and organizational approach to discussion of arrhythmias employs the following sequence: location – mechanism – aetiology – duration. The classification of arrhythmias is heuristically divided into an anatomical hierarchy: atrial, junctional, ventricular, or atrioventricular. Mechanisms are most simplistically classified as either reentrant, such as macro-reentrant atrial tachycardia, previously described as atrial flutter, or focal, such as automatic or micro-reentrant tachycardia, for example, junctional ectopic tachycardia. The aetiology of arrhythmias can be either iatrogenic, such as postsurgical, or non-iatrogenic, such as genetic or congenital, and in many cases is multi-factorial. Assigning an aetiology to an arrhythmia is distinct from understanding the mechanism of the arrhythmia, yet assignment of a possible aetiology of an arrhythmia may have important therapeutic implications in certain clinical settings. For example, postoperative atrial arrhythmias in patients after cardiac transplantation may be harbingers of rejection or consequent to remediable imbalances of electrolytes. The duration, frequency of, and time to occurrence of arrhythmia are temporal measures that further refine arrhythmia definition, and may offer insight into ascription of aetiology. Finally, arrhythmias do not occur in a void, but interact with other organ systems. Arrhythmias not only can result from perturbations of other organ systems, such as renal failure, but can produce dysfunction in other organ systems due to haemodynamic compromise or embolic phenomena.

The International Consortium for Evidence-Based Perfusion (www.bestpracticeperfusion.org) is a collaborative partnership of societies of perfusionists, professional medical societies, and interested clinicians, whose aim is to promote the continuous improvement of the delivery of care and outcomes for patients undergoing extracorporeal circulation. Despite the many advances made throughout the history of cardiopulmonary bypass, significant variation in practice and potential for complication remains. To help address this issue, the International Consortium for Evidence-Based Perfusion has joined the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease to develop a list of complications in congenital cardiac surgery related to extracorporeal circulation conducted via cardiopulmonary bypass, extracorporeal membrane oxygenation, or mechanical circulatory support devices, which include ventricular assist devices and intra-aortic balloon pumps. Understanding and defining the complications that may occur related to extracorporeal circulation in congenital patients is requisite for assessing and subsequently improving the care provided to the patients we serve. The aim of this manuscript is to identify and define the myriad of complications directly related to the extracorporeal circulation of congenital patients.