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.

There are many reasons for seeking to create a global database with which to record the outcomes of therapy for congenital heart disease. Such a database can function as a tool to support a variety of purposes:

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.

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 pulmonary 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.

As surgical survival in children with congenital cardiac disease has improved in recent years, focus has necessarily shifted to reducing the morbidity of congenital cardiac malformations and their treatment. A comprehensive list of pulmonary complications is presented. This list is a component of a systems-based compendium of complications that will standardize terminology and thereby allow the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

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 renal 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.

Although renal dysfunction and renal failure are known risks of congenital heart surgery, accurate estimates of the incidences of these complications are limited. This lack of knowledge is in part due to the lack of uniform definitions of these postoperative complications. The purpose of this effort is to propose consensus definitions for renal complications following congenital cardiac surgery so that collection of such data can be standardized. Clinicians caring for patients with congenital heart disease will be able to use this list for databases, quality improvement initiatives, reporting of complications, and comparing strategies for treatment.

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 haematological system and to infectious complications. 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 haematological and infectious complications. 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 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 endocrine 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 neurological 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.

Although neurological injury and adverse neurodevelopmental outcome can follow procedures for congenital cardiac defects, much of the variability in neurological outcome is now recognized to be more related to patient specific factors rather than procedural factors. Additionally, the recognition of pre and postoperative neurological morbidity requires procedures and imaging modalities that can be resource-intensive to acquire and analyze, and little is known or described about variations in “sampling rate” from centre to centre.

The purpose of this effort is to propose an initial set of consensus definitions for neurological complications following congenital cardiac surgery and intervention. Given the dramatic advances in understanding achieved to date, and those yet to occur, this effort is explicitly recognized as only the initial first step of a process that must remain iterative. This list is a component of a systems-based compendium of complications that may help standardize terminology and possibly enhance the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease may be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

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 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 gastrointestinal 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.

Although serious gastrointestinal complications are relatively uncommon after congenital cardiac surgery, accurate estimates of the incidences of these complications are limited, in part due to lack of standardized reporting and the absence of universal nomenclature that defines organ-specific complications. The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease has prepared and defined a list of gastrointestinal complications that may be temporally associated with congenital cardiac surgery. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

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 a collection of loosely related topics that include the following groups of complications: 1) Complications of the Integument, 2) Complications of the Vascular System, 3) Complications of the Vascular-Line(s), 4) Complications of Wounds. 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.

As surgical survival in children with congenital cardiac disease has improved in recent years, focus has necessarily shifted to reducing the morbidity of congenital cardiac malformations and their treatment. A comprehensive list of complications is presented. This list is a component of a systems-based compendium of complications that will standardize terminology and thereby allow the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

Interventional cardiology for paediatric and congenital cardiac disease is a relatively young and rapidly evolving field. As the profession begins to establish multi-institutional databases, a universal system of nomenclature is necessary for the field of interventional cardiology for paediatric and congenital cardiac disease. The purpose of this paper is to present the results of the efforts of The International Society for Nomenclature of Paediatric and Congenital Heart Disease to establish a system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease, focusing both on procedural nomenclature and on the nomenclature of complications associated with interventional cardiology. This system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease is a component of The International Paediatric and Congenital Cardiac Code. This manuscript is the first part of a two-part series. Part 1 will cover the procedural nomenclature associated with interventional cardiology as treatment for paediatric and congenital cardiac disease. This procedural nomenclature of The International Paediatric and Congenital Cardiac Code will be used in the IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment) of the National Cardiovascular Data Registry® of The American College of Cardiology. Part 2 will cover the nomenclature of complications associated with interventional cardiology as treatment for paediatric and congenital cardiac disease.

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 endocrine 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.

As surgical survival in children with congenital cardiac disease has improved in recent years, focus has necessarily shifted to reducing the morbidity of congenital cardiac malformations and their treatment. A comprehensive list of endocrinal complications is presented. This list is a component of a systems-based compendium of complications that will standardize terminology and thereby allow the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

Interventional cardiology for paediatric and congenital cardiac disease is a relatively young and rapidly evolving field. As the profession begins to establish multi-institutional databases, a universal system of nomenclature is necessary for the field of interventional cardiology for paediatric and congenital cardiac disease. The purpose of this paper is to present the results of the efforts of The International Society for Nomenclature of Paediatric and Congenital Heart Disease to establish a system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease, focusing both on procedural nomenclature and the nomenclature of complications associated with interventional cardiology. This system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease is a component of The International Paediatric and Congenital Cardiac Code. This manuscript is the second part of the two-part series. Part 1 covered the procedural nomenclature associated with interventional cardiology as treatment for paediatric and congenital cardiac disease. Part 2 will cover the nomenclature of complications associated with interventional cardiology as treatment for paediatric and congenital cardiac disease.

A complication is an event or occurrence associated with a disease or a healthcare intervention, which constitutes 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 an 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 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 patients who have received transplantation of the heart, heart and lung(s) or lung(s). These specific definitions and terms will be used to track morbidity associated with transplantation in a common language across many separate databases.

The complications of transplantation are known risks of congenital cardiac surgery. The purpose of this effort is to propose consensus definitions for post-transplant complications following cardiac surgery so that collection of such data can be standardized. Clinicians caring for patients who have had transplantation of thoracic organs will be able to use this list for databases, quality improvement initiatives, reporting of complications, and comparing treatment strategies.

Congenital heart defects are the most common cause of death in infants and young children in the developed world. As the mortality in this population has declined to less than 5%, more attention is being focused now on reducing post-procedural morbidities that may seriously impact the patient and their families. Because of multiple reasons, paediatric cardiac surgery and anaesthesia is a perfect model for studying human errors and their impact on patient safety. Congenital cardiac disease is a common lesion causing much morbidity, pain, and loss of life. Over 44,000 surgical procedures are performed yearly to repair congenital cardiac problems in the United States alone. The reduction or elimination of iatrogenic adverse outcomes, given the current mortality rates of 4.2%–4.5%, might lead to as many as 500 children achieving better outcomes or shorter hospitalizations.

Efforts to quantify the frequency of complications related to anaesthesia in patients undergoing congenital cardiac surgery have been difficult to date because of the low occurrence of this surgery compared to other surgeries on children and the relatively rare incidence of complications related to anaesthesia in this population. Anaesthesiologists play a crucial role in the reduction, recognition, and timely treatment of medical errors that impact this morbidity. Paediatric cardiac surgery encompasses many complex procedures that are highly dependent upon a sophisticated organizational structure, effective communication, coordinated efforts of multiple individuals working as a team, and high levels of cognitive and technical performance. Human factor error analysis in this patient population has shown how frequently both minor and major errors occur. The goal of this paper is to outline the frequency and sources of these errors and to suggest treatment strategies which may minimize their occurrence.