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Ann Thorac Surg 2000;69:S2-S17
© 2000 The Society of Thoracic Surgeons

Congenital Heart Surgery Nomenclature and Database Project: overview and minimum dataset

^a Department of Surgery, Division of Cardiovascular-Thoracic Surgery, Northwestern University Medical School, Children’s Memorial Hospital, Chicago, Illinois, USA
^b Division of Thoracic and Cardiovascular Surgery, All Children’s Hospital, University of South Florida College of Medicine, St. Petersburg, Florida, USA

Address reprint requests to Dr Mavroudis, Division of Cardiovascular-Thoracic Surgery, Children’s Memorial Hospital, 2300 Children’s Plaza, m/c 22, Chicago, IL 60614
e-mail: c-mavroudis{at}nwu.edu

Presented at the International Nomenclature and Database Conferences for Pediatric Cardiac Surgery, 1998–1999.

Abstract

The International Congenital Heart Surgery Nomenclature and Database Project was organized for the purpose of standardizing nomenclature and reporting strategies that would establish the foundations for an international database. Worldwide representatives met for a series of conferences, at which time, issues of nomenclature were discussed and debated. Authors were chosen to review the various congenital heart diagnoses and reflect the mediated debate that followed. Manuscripts were prepared that reviewed the appropriate extant nomenclature, made recommendations for an inclusive rather than an exclusive method of reporting, and determined a hierarchical database scheme that would allow several levels of reporting based on the data input. This manuscript outlines two datasets for an international congenital heart surgery database, a minimum dataset and a comprehensive dataset. The comprehensive dataset includes all the imagined variables, in a hierarchical scheme, which are detailed enough to generate risk stratification analyses. The minimum dataset will include data points that would create an essential dataset, which would be mandatory for data sharing and would lend itself to basic interpretation of trends. The minimum dataset has four drop-down menus for short lists of: (1) noncardiac abnormalities/general preoperative risk factors, (2) diagnoses, (3) procedures, and (4) complications, from which clinicians can choose for entry into the minimum dataset. There was universal agreement for these datasets and short lists by the assembled members of the Society of Thoracic Surgeons-Congenital Heart Surgery Database Committee and representatives from the European Association for Cardiothoracic Surgery. The datasets and short lists were also unanimously approved by the Congenital Heart Surgery Committee of The European Association for Cardiothoracic Surgery and adopted by the European Congenital Heart Surgeons Foundation.

The idea of an International Congenital Heart Surgery Nomenclature and Database Project was conceived for a number of reasons. The development of the Society of Thoracic Surgeons (STS)-Summit Medical Systems National Congenital Heart Surgery Database and the obvious need for an international structure that would standardize nomenclature and reporting strategies were the important elements that propelled this initiative. The first reports of the STS-National Congenital Heart Surgery Database Committee were recently published [1, 2] and included data from 24 centers that joined the program at various dates of entry between 1994 and 1997. There were 18,894 enrolled patient records, from which 8,149 patient records were used to compile the relevant clinical features of 18 congenital heart categories over the 4-year period. Outcome data included operative death, complications, and length of stay, among others. Outcome analyses were segregated for age or weight at operation where appropriate, which varied from diagnosis to diagnosis. The data analysis was largely descriptive in character. Similar to the STS adult cardiac surgery database, this first report generated a massive amount of data. These data depicted many trends and were largely predictive of the established previous clinical reports from different centers. The analysis also demonstrated the strengths and weaknesses of a database, which, by necessity, limited the data input. On one hand, the four-page data form was readily available and concise; on the other hand, the information was limited and did not allow discriminating features that are necessary to establish risk stratification analysis. Unlike the STS adult cardiac surgery database, the STS Congenital Heart Surgery Database has numerous disease entities to analyze, and by the nature of the subspecialty requires increased complexity in data analysis in order to produce meaningful risk stratification.

During the same time period, the European Congenital Heart Defects Database was founded through the European Congenital Heart Surgeons Foundation. By 1995, under the direction of Martin J. Elliott, this database had collected data from 31 centers representing 18 countries. These data included the entire dataset from four countries and gathered data on over 10,000 patients in the first 2 years. Uniform software was utilized for data collection, but the state of the art of database software at that time was problematic. Like the first report of the STS-National Congenital Heart Surgery Database Committee [1], data analysis was largely descriptive in character. Furthermore, the dataset was difficult to manage. This experience of the European Congenital Heart Defects Database of the early and mid 1990s also demonstrated the differences between data collection for adult heart surgery and congenital heart surgery. The European experience, like the STS experience, clearly demonstrated that the numerous disease entities cared for by congenital heart surgeons require increased complexity in data analysis in order to produce meaningful risk stratification.

As this initiative moves to an international focus, some agreement as to what to call things becomes imperative. The location of a lesion is not so controversial as to what it is called. What some call a conal ventricular septal defect (VSD), others call a subarterial or type I VSD; what some call a type I truncus arteriosus, others call a type A1. Worse, in some cases, the classification schemes are not interchangeable and the scientific basis for the difference continues to be debated by well-established, well-intentioned, and well-known pediatric cardiac pathologists. Our solution to this problem is based on inclusion rather than exclusion. The contributing authors have reviewed the nomenclature literature on their assigned topic and made best efforts to include all the nomenclature schemes and integrate them by assigning the various appellations to the specific lesion, ie, VSD, type 1 (subarterial VSD) (supracristal VSD) (conal septal defect) (infundibular VSD). In this manner, different centers can use their own preference by simply placing the preferred version first. In time, a standardized version will evolve based on scientific principals and popular usage.

The inaugural efforts of the STS National Congenital Heart Surgery Database Committee and the European Congenital Heart Defects Database established the necessary foundation for future efforts to create an International Congenital Heart Surgery Database. The groundwork was created in areas of data organization for analysis. Important lessons learned from these initial databases will shape the development of the next generation database, which will be computer based in cyberspace rather than limited by the size of four sheets of paper. This will allow for the collection of increased data input, the elimination or at least reduction of missing data points, and the generation of data specific enough to possess discriminating features necessary to establish risk stratification analysis. This next generation database will need to meet the dual goals of facilitating multiinstitutional data analysis as well as providing data to support clinical programs, research, and teaching at individual institutions. The potential exists to create the first comprehensive international database for a medical subspecialty.

To meaningfully share data on a multiinstitutional international level, two requirements must be met: minimum datasets for sharing data must be determined, and a consensus on nomenclature terminology must be reached. This manuscript will outline two datasets for an international congenital heart surgery database, a comprehensive dataset and a minimum dataset. The comprehensive dataset will include all imagined variables and be inclusive enough to generate detailed information. The minimum dataset will include data points that would create an essential dataset, which would be mandatory for data sharing and would lend itself to basic interpretation of trends. This minimum dataset could still be useful for risk stratification, but in this case, the comparative variables will be between different diagnoses, not within a given diagnoses. (For instance, the comprehensive database will be able to make risk stratification distinctions within the diagnosis of truncus arteriosus referable to truncal insufficiency, interrupted aortic arch, age at operation, coronary artery anomalies, etc. The minimum database, which will code all atrial septal defects (ASDs), VSDs, and truncus arteriosus as such without subcategories, can very effectively provide enough variables to make risk stratification distinctions between diagnoses such as comparing mortality and morbidity between ASD and VSD.)

The distinctions between the two approaches are obvious. On the one hand, the comprehensive database is time consuming and sophisticated, which by virtue of its complexity increases the chance of error and heterogeneous reporting. If done correctly, however, the product is powerful and extremely informative. On the other hand, the minimum database is powerful in its simplicity and convenience. The chance of error is reduced, the chance of institutional compliance is increased, and the cost of implementation, maintenance, and manpower is reduced. (Of course, the minimum dataset will not allow complex comparisons such as postoperative arrhythmia’s between sinus venosus ASDs and secundum ASDs, effect of coronary artery anatomy on the arterial switch operation, and the difference in complete heart block between inlet VSDs and outlet VSDs, etc.) Our purpose is to provide the necessary risk factors and data points for both types of databases. The key, of course, is to standardize what we call things so we can compare apples to apples and oranges to oranges regardless of the complexity of the respective database configuration.

The following manuscripts have been organized in a specific diagnosis-driven manner. The authors have: (1) reviewed and synthesized the nomenclature literature, (2) determined a hierarchical scheme for data collection, and (3) offered potential database studies and outcome analyses specific for each diagnosis in tabular form. Each manuscript was presented at one or more of the following meetings:

The First International Nomenclature Conference for Pediatric Cardiac Surgery, Chicago, Illinois, September 19–20, 1998.

The Second International Nomenclature Conference for Pediatric Cardiac Surgery, San Antonio, Texas, January 23, 1999.

The Spring Meeting of the European Congenital Heart Surgeons Foundation, Rome, Italy, April 10, 1999.

The Third International Nomenclature Conference for Pediatric Cardiac Surgery, New Orleans, Louisiana, April 23, 1999.

The International Nomenclature for Pediatric Cardiac Surgery Subcommittee Meeting, Orlando, Florida, August 14–15, 1999.

The Congenital Heart Surgery Business Meeting of the European Association for Cardiothoracic Surgery, 13th Annual Meeting of the European Association for Cardiothoracic Surgery, Glasgow, Scotland, September 5–8, 1999.

The Subcommittee Meeting of the International Nomenclature for Pediatric Cardiac Surgery Executive Advisory Committee at the 9th Annual Farouk S. Idriss, M.D. Lecture, Chicago, Illinois, October 1–2, 1999.

Subcommittees for difficult subjects such as hypoplastic left heart syndrome, double-outlet right ventricle, and single ventricle were organized to facilitate discussion.

In the end, agreement was reached by all participants on all topics, making the manuscripts all the more important. Those participating (in alphabetical order) are:

Carl L. Backer, MD Chicago, IL Nancy D. Bridges, MD Philadelphia, PA Redmond P. Burke, MD Miami, FL Duke E. Cameron, MD Baltimore, MD Victor F. Chu, MD Montreal, Canada Andrew D. Cochrane, FRACS Melbourne, Australia Gordon K. Danielson, MD Rochester, MN Barbara J. Deal, MD Chicago, IL Joseph A. Dearani, MD Rochester, MN Ralph E. Delius, MD Sacramento, CA Ali Dodge-Khatami, MD Chicago, IL Martin J. Elliott, FRCS London, England J. William Gaynor, MD Philadelphia, PA J. René Herlong, MD Durham, NC Andreas Hoschtitzky, MB, BS London, England Jeffrey P. Jacobs, MD St. Petersburg, FL Marshall L. Jacobs, MD Philadelphia, PA James J. Jaggers, MD Durham, NC Cassandra Joffs, MD Charleston, SC Tom R. Karl, MD Melbourne, Australia François Lacour-Gayet, MD Paris, France John J. Lamberti, MD San Diego, CA Bohdan Maruszewski, MD Warsaw, Poland Constantine Mavroudis, MD Chicago, IL John E. Mayer Jr, MD Boston, MA Sanjay M. Mehta, MD Hershey, PA Surindra N. Mitruka, MD San Diego, CA John L. Myers, MD Hershey, PA Khanh H. Nguyen, MD New York, NY James A. Quintessenza, MD St. Petersburg, FL W. Steves Ring, MD Dallas, TX Albert P. Rocchini, MD Ann Arbor, MI Nathalie Roy, MD Montreal, Canada Robert M. Sade, MD Charleston, SC Thomas L. Spray, MD Philadelphia, PA Jaroslav Stark, MD London, England Stephen A. Tahta, MD Montreal, Canada Christo I. Tchervenkov, MD Montreal, Canada Ross M. Ungerleider, MD Durham, NC Henry L. Walters III, MD Detroit, MI Paul M. Weinberg, MD Philadelphia, PA James L. Wilkinson, FRCP Melbourne, Australia

The debt of gratitude that these authors and participants are owed is too much for any one person or guest editor to acknowledge. Their gratification is knowing that they performed an important task, which will significantly impact the way global information is shared well into the 21st century.

Special heartfelt thanks and noted appreciation are extended to Ms Karen Graham, Project Coordinator, for her dedication and energy, which drove this project to completion.

Manuscripts discussing lesion-specific nomenclature

Subsequent manuscripts will present unified nomenclature proposals for the major disease entities of congenital heart surgery. A unified nomenclature proposal does not need to choose one classification proposal over another. Instead, a system can be developed allowing for congenital heart surgery centers utilizing any of the common nomenclature systems to meaningfully share data. This system would need to be inclusive of all nomenclature systems rather than exclusive. Furthermore, it should be hierarchical so that it permits each center to choose the level of detail to which it codes lesions and allows for the utilization of historical cases that might not be described and coded to the last level of the hierarchy.

The myriad of more detailed coding choices is extremely manageable with the use of computer generated coding, where only the subdivision of each hierarchy compatible with the previous hierarchical selection (one level above) is visualized at any time during data entry. Thus, long lists of diagnoses are available in drop-down menus in cyberspace, while only short lists of coding possibilities are seen at any given time.

At any given level of coding, many surgeons might consider further description and classification into additional more detailed hierarchical choices as irrelevant. The advantage of this hierarchical nomenclature system is that these surgeons can stop at any level and still share data with other surgeons who choose to code in more detail. This more detailed coding might not play a role in multiinstitutional data analysis, but it will clearly increase the clinical utility of the database at any given institution.

Each lesion will be discussed utilizing the following format:

Background
A brief presentation of some of the more commonly utilized nomenclature systems for the lesion will be given.

Analysis: a unified nomenclature system
This section will present the hierarchical nomenclature for the diagnosis of given lesions. A proposal for standardized hierarchical nomenclature for the lesion will be given. Within any given level of the hierarchy, new coding choices will be presented in boxes. Inside each box, the new feature of any given coding choice will appear in boldface type. Definitions of terms utilized in this hierarchical nomenclature system will be presented after each new level of the hierarchy. Only controversial or non-self-explanatory terms will be defined.

In addition to the basic lesion-based nomenclature given in this section, several other nomenclature issues must be addressed and coded in other areas of the database. Of primary importance, the segmental anatomy of the heart will need to be documented elsewhere in the database so that it is known when analyzing the lesion nomenclature. The database will offer the option of utilizing the segmental approach of Van Praagh and Vlad [3, 4], the sequential segmental approach advocated by Anderson and Macartney [5–7], or both. The database will have a default to normal segmental anatomy as demonstrated below so that this information will not need to be reentered for all cases with normal segmental anatomy.

The Van Praagh segmental approach documents the three major cardiac segments {atria, ventricles, great arteries} in a venoarterial sequence. Letters are coded in braces to describe the visceroatrial situs (S = situs solitus, I = situs inversus, A = ambiguous), the ventricular loop (D = D-loop, L = L-loop), and the great artery position (S = normally related great arteries, I = inverted normally related great arteries, D = D-transposition or D-malposition, and L = L-transposition or L-malposition) [8]. Thus, a normal heart would default to: {S,D,S}.

Many surgeons and centers code segmental anatomy and connections by the sequential segmental approach advocated by Anderson. This approach has been applied utilizing the following terminology: visceroatrial situs [situs solitus, situs inversus, left isomerism, right isomerism], atrio-ventricular connection [Types: concordant, discordant, ambiguous, double inlet, absent right connection, or absent left connection; Modes: two perforate valves, single perforate valve, one perforate and one imperforate, and common valve], ventriculo-arterial connection [concordant, discordant [transposition], double outlet, single outlet—common arterial trunk, single outlet—solitary aortic trunk with pulmonary atresia, single outlet—solitary pulmonary trunk with aortic atresia, single outlet—solitary arterial trunk]. Although Anderson never described the side of the aortic arch in the sequential segmental analysis, many clinicians have added this descriptor to the sequential segmental approach: aortic arch side [L = left aortic arch, R = right aortic arch]. Thus, while the "Andersonian" approach never advocated an alphabetical shorthand, many clinicians would describe a normal heart as [SCCL or situs solitus, concordant atrio-ventricular connection, concordant ventriculo-arterial connection, left aortic arch].

Nomenclature for treatment options
A proposal for standardized hierarchical nomenclature for the lesion’s treatment options will be given utilizing the format described above.

In addition to the basic treatment options given in this section, several other therapeutic issues must be addressed and coded in other areas of the database. First, a separate module of the database must allow for coding of chest wall incisions (median sternotomy, submammary incision, right thoracotomy, left thoracotomy, minimally invasive incisions [partial sternotomy, parasternal incision, "mini-thoracotomy"], etc). Second, a separate part of the database must allow for coding of cardiac incisions (aortotomy, pulmonary arteriotomy, right atriotomy, right ventriculotomy, left atriotomy, left ventriculotomy, etc). Third, a separate module of the database must permit coding of patch materials (Dacron, Gore-Tex, bovine pericardium, autologous pericardium, gluteraldehyde-fixated autologous pericardium, etc), conduit materials (Gore-Tex, Impra, Hemashield, etc), homografts (fresh, chemically preserved, cryopreserved, etc), valves (valve type and brand), pacemaker data, and AICD data.

Diagnosis and procedure short lists
Many centers may choose to utilize a list of diagnoses and procedures less cumbersome than the hierarchical nomenclature lists. A short list of: (1) noncardiac abnormalities/general preoperative risk factors, (2) diagnoses, (3) procedures, and (4) complications will be provided that will be compatible with the hierarchical nomenclature lists. For some lesions, this short list may be only the first level (hierarchy) of the hierarchical nomenclature list (rarer lesions such as anteroposterior [AP] window); while for other lesions, this list will be equivalent to the second or even third levels of the hierarchy (more common lesions such as ASD, VSD, or single ventricle).

This short list will allow data sharing between institutions coding lesions in great detail with those institutions coding to the short list only.

GUEST EDITORS’ NOTE: Personal communication with Professor Robert Anderson at the 13th Annual Meeting of The European Association for Cardiothoracic Surgery, Glasgow, Scotland, September 5–8, 1999 reveals that Professor Anderson prefers the term "functionally single ventricle" rather than the term "single ventricle" because these hearts generally have a functional single ventricle in addition to a diminutive or hypoplastic ventricle. We agree that the hearts that we classify as "single ventricle" in reality have a single well-developed ventricle and may also have an additional incomplete, rudimentary, or hypoplastic ventricle. Thus, our concept of "single ventricle" is consistent with Professor Anderson’s concept of "functionally single ventricle." Our reluctance to using the term "functionally single ventricle" in this database scheme stems from the popular use of the term "single ventricle" in the surgical literature. As these initiatives progress, more debate by surgeons, anatomists, and pediatric cardiologists may result in nomenclature changes that will keep these initiatives as "works in progress" with the eventual goal of establishing a uniform nomenclature system across geographic boundaries and specialty preferences.

Potential diagnostic-related (lesion-specific) risk factors
Specific variables to be tracked related to a given lesion will be presented. This will be for specific lesion-related variables not included in the minimum dataset or comprehensive dataset described above and presented below.

Database studies and outcome analysis
Outcome reports for the given lesions will be presented. These reports will represent standard outcome reports to be generated by the database, from the data, on both single institutional and multiinstitutional levels.

An example of a comprehensive dataset relating to preoperative, intraoperative, and postoperative risk variables is presented under the section "Comprehensive Database Example."

The minimum database dataset (Appendices I and II) and the associated four short lists of: (1) noncardiac abnormalities/general preoperative risk factors (Appendix III), (2) diagnoses (Appendix IV), (3) procedures (Appendix V), and (4) complications (Appendix VI), agreed upon at The Society of Thoracic Surgeons Third International Nomenclature Conference for Pediatric Cardiac Surgery, New Orleans, Louisiana, April 23, 1999, is presented under the section "Minimum Database Set."

This minimum database dataset and the associated four short lists have also been adopted by the European Congenital Heart Surgeons Foundation, whose members are listed in Appendix VII. The minimum database dataset and the associated four short lists were also unanimously approved by the Congenital Heart Surgery Committee of the European Association for Cardiothoracic Surgery (EACTS) at their business meeting during the 13th Annual Meeting of the EACTS in Glasgow, Scotland, September 5–8, 1999.

A parallel listing of diagnoses has simultaneously been developed by the Association of European Pediatric Cardiologists (AEPC) [9], based on the anatomical descriptions of Professor Robert Anderson of the Great Ormond Street Hospital for Children. These anatomic descriptions led to the Brompton codes later developed by Ron Brower and the team in Utrecht in The Netherlands and utilized by the Dutch Heart Foundation. Rodney Franklin of Harefield Hospital then revised and extended these codes; he further modified these codes for the AEPC. The AEPC listing of diagnoses is scheduled for publication during the same time period as this publication. The editors of this publication as well as Professor Anderson view these two diagnostic hierarchies as complementary and not as competitive. Clearly, future work will need to be done by a joint committee involving members of the International Congenital Heart Surgery Nomenclature and Database Project Committee and the developers of the AEPC diagnostic lists. This joint committee will be able to establish the manner in which these two coding systems best relate to each other and develop a possible mapping of one system to the other. Early efforts are already underway to organize this project. Additional work will also need to be done to further involve societies of pediatric cardiac surgery and cardiology from Africa, Asia, Australia, and South America.

Comprehensive database example
Potential Preoperative Risk Variables

Demographic data:

Age at surgery

Weight at surgery

Height at surgery

Gender

Race

Preoperative risk factors

Preoperative inotrope requirement

Preoperative nitric oxide requirement

Preoperative pulmonary hypertension

Preoperative mechanical ventilation

Associated preoperative cardiac anomalies (coded separately)

Preoperative signs and symptoms

Preoperative heart failure (New York Heart Association [NYHA] classification)

Preoperative medications (Digoxin, diuretics, antiarrhythmics, NaHCO₃, vasodilators)

Preoperative diagnostic studies (echocardiography, cardiac catheterization, or both)

Preoperative noncardiac anomalies

Potential Intraoperative Risk Variables

ASA classification

Operative time (time spent in operating theater)

Procedure time (time from skin incision to dressing)

Cardiopulmonary bypass time

Aortic cross-clamp time

Circulatory arrest time

Cardioplegia type, method of delivery, dose number, dose interval

Modified ultrafiltration utilization

Utilization of heparin-bonded (Carmeda) tubing on bypass circuit

Potential Postoperative Risk Variables

Postoperative nitric oxide requirement

Postoperative inotrope requirement

Postoperative length of ventilation

Postoperative length of intensive care unit (ICU) stay

Postoperative length of hospital stay

Blood product (transfusion) requirement

Postoperative functional status (NYHA classification)

Mortality

In operating theater

Before discharge

After discharge

< 30 days

30 days

Complications
This would come from a standard list of postoperative complications applicable to all operations. Clearly, certain elements would be more critical to track for specific lesions. For example, VSD analysis should key in on certain specific complications:

Heart block

Delayed sternal closure

Need for mechanical circulatory support

Residual VSD

Qp:Qs 1.5:1 versus Qp:Qs < 1.5:1

Reoperation for residual VSD

Minimum database set

The minimum database dataset is comprised of 28 items (Appendices I and II). Four of these items: (1) noncardiac abnormalities/general preoperative risk factors, (2) diagnoses, (3) procedures, and (4) complications] will have drop-down menus consisting of short lists from which the appropriate entry can be chosen. For example, one or more entries can be selected from a noncardiac abnormalities/general preoperative risk factors short list (Appendix III). Multiple diagnoses are handled by selecting entries from a diagnoses short list (Appendix IV) and establishing one primary diagnosis, which is followed in order of importance by the other secondary diagnoses. Procedures are handled in a similar manner and are also chosen from a Procedures Short List (Appendix V) and listed in order of importance. Likewise, complications are selected from the Complications Short List (Appendix VI).

In the short lists, the abbreviation "NOS" represents "not otherwise specified." This designation allows for patient entries from other database schemes if no specific subtype is characterized or assigned.

The data in the minimum database dataset can be entered electronically or on a single sheet of paper for each case. This Minimum Data Entry Form is described in Appendix I and presented in Appendix II.

View larger version (30K): [in this window] [in a new window]   . Appendix II. Congenital Heart Surgery Database—minimum data entry

The period of data collection for the minimum database will end when both of the following two criteria have been satisfied: (1) the patient has been discharged from the hospital after the operation, and (2) 30 days have passed since the operation.

Mortality for the minimum database

The minimum database will document two types of mortality: (1) operative mortality, and (2) mortality assigned to this operation.

Operative mortality

This field will designate any death during the period of data collection for the minimum database, regardless of whether or not the mortality is related to surgery.

In other words, this field will designate any death that occurs before the following two criteria have been satisfied: (1) the patient has been discharged from the hospital after the operation, and (2) 30 days have passed since the operation.

This is the same definition of operative mortality that has been widely accepted and used for reporting postoperative death.

Mortality assigned to this operation

Reoperations during the same hospital admission tend to be problematic. The difficulty is how to assign death. Under traditional systems, it is possible to assign death to all operations that were done during the same admission, which would increase the overall mortality inappropriately. We have addressed this problem by creating a field called "mortality assigned to this operation."

Thus, a patient undergoing multiple operations during a given hospitalization may have the field "operative mortality" answered "yes" for each operation; however, the field "mortality assigned to this operation" will be answered "yes" for only one operation. The surgeon will therefore assign the operative mortality to the most appropriate operation.

There are many examples of this problem. In most, but not all examples, the mortality is assigned to the first operation of the hospitalization. For instance, consider a patient with atrioventricular canal who undergoes complete repair, then during the same admission undergoes reoperation for mitral valve replacement, which is followed by heart block, pacemaker insertion, and subsequently ends in the patient’s death. To which operation is the death assigned? Most would say that the death should be assigned to the first operation. In the aforementioned scheme, death is assigned only once and the data analyzer can make the decision.

This system also works for the less common situation where the mortality would not be assigned to the first operation of the hospitalization. For example, a patient with transposition of the great arteries who presents late for an arterial switch operation can undergo a preparatory pulmonary artery band and a systemic-to-pulmonary artery shunt. During the same admission, this patient can have an arterial switch operation and die from a coronary artery problem. Where does one assign the death? Under the aforementioned scheme, most surgeons would assign the death in this case to the arterial switch operation. A similar example is a patient with cardiomyopathy who has surgery for placement of a ventricular assist device, then undergoes heart transplantation during the same hospitalization, and then dies from acute rejection during the same hospitalization. Under the aforementioned scheme, most surgeons would assign the death in this case to the heart transplantation operation. Clearly, the data analyzer can easily segregate these cases and others like it (cases involving preparatory operations and planned reoperations during the same admission) by appropriate inquiries. The tenet, in this case as with all the others, holds true to the idea that only one death can be assigned to any one patient regardless of the number of operations that he/she had during the same admission.

Reoperations during the same hospital admission

Reoperations during the same hospital admission will be treated by simply filling out another Minimum Data Entry Form for each subsequent operation. Items 23 and 24 of the minimum database dataset address the issue of "reoperations during the same hospital admission":

23. Reoperation after this operation in this admission? (yes or no)

24. Is this operation a reoperation during this admission? (no, yes—planned reoperation, or yes—unplanned reoperation).

Other procedural issues will no doubt confound this database scheme. Revisions in a timely manner may very well be needed in the future.

Appendix I. Minimum database data set Optional or Mandatory 1. Unique identifying number (hospital three-letter code plus hospital number) M 2. Last name M 3. First name M 4. Date of birth M 5. Gender M 6. Date of admission M 7. Antenatal diagnosis? (yes or no) O 8. Noncardiac abnormalities/general preoperative risk factors (from Noncardiac Abnormalities/General Preoperative Risk Factors Short List) M 9. Number of prior total cardiothoracic operations and prior open cardiothoracic operations M 10. Date of surgery M 11. Case category (cardiopulmonary bypass [CPB], non-CPB, extracorporeal membrane oxygenation (ECMO), thoracic, interventional cardiology, other) M 12. Weight at operation M 13. Height at operation O 14. Diagnosis (primary diagnosis and additional diagnoses from Diagnoses Short List) M 15. Operation (primary procedure and additional procedures from Procedures Short List) M 16. Consultant/attending O 17. Surgeon M 18. Resident O 19. CPB time (does not include circulatory arrest time) O 20. Aortic cross-clamp time M 21. Circulatory arrest time M 22. Complications (from Complications Short List) M 23. Reoperation after this operation in this admission? (yes or no) M 24. Is this operation a reoperation during this admission? (no, yes—planned reoperation, or yes—unplanned reoperation) O 25. Date of discharge M 26. Date of mortality M 27. Operative mortality? (yes or no) M 28. Mortality assigned to this operation? (yes or no) O

Appendix III. Noncardiac abnormalities/general preoperative risk factors short list Asplenia Polysplenia Down’s syndrome Turner’s syndrome DiGeorge Williams Beuren syndrome Alagille syndrome (intrahepatic biliary duct agenesis) 22q11 deletion Other chromosomal abnormality Rubella Marfan’s syndrome Preoperative mechanical circulatory support (IABP, VAD, ECMO, or CPS) Preoperative complete AV block Preoperative arrhythmia Preoperative shock Preoperative acidosis Preoperative pulmonary hypertension crises (PA pressure > systemic pressure) Preoperative mechanical ventilatory support Preoperative tracheostomy Preoperative renal failure (creatinine > 2) Preoperative renal failure requiring dialysis Preoperative bleeding disorder Preoperative endocarditis Preoperative septicemia Preoperative neurological deficit Preoperative seizures Other preoperative noncardiac abnormality Other preoperative risk factor

Appendix IV. Diagnoses short list Septal defects ASD PFO ASD, secundum ASD, sinus venosus ASD, coronary sinus ASD, common atrium (single atrium) ASD, NOS VSD VSD, single VSD, multiple VSD, NOS AV canal AVC (AVSD), complete (CAVSD) AVC (AVSD), intermediate (transitional) AVC (AVSD), partial (incomplete) (PAVSD) (ASD, primum) AVC (AVSD), NOS AP window AP window (aortopulmonary window) Pulmonary artery origin from ascending aorta (hemitruncus) Truncus arteriosus Truncus arteriosus Pulmonary venous anomalies Partial anomalous pulmonary venous Partial anomalous pulmonary venous connection (PAPVC) Partial anomalous pulmonary venous connection (PAPVC), scimitar Total anomalous pulmonary venous Total anomalous pulmonary venous connection (TAPVC), type 1 (supracardiac) Total anomalous pulmonary venous connection (TAPVC), type 2 (cardiac) Total anomalous pulmonary venous connection (TAPVC), type 3 (infracardiac) Total anomalous pulmonary venous connection (TAPVC), type 4 (mixed) Total anomalous pulmonary venous connection (TAPVC), NOS Cor triatriatum Cor triatriatum Pulmonary venous stenosis Pulmonary venous stenosis Systemic venous anomalies Anomalous systemic venous connection Systemic venous anomaly Systemic venous obstruction Right heart lesions Tetralogy TOF TOF, AVC (AVSD) TOF, absent pulmonary valve Pulmonary atresia Pulmonary atresia Pulmonary atresia, IVS Pulmonary atresia, VSD (Including TOF, PA) Pulmonary atresia, VSD-MAPCA (pseudotruncus) MAPCA(s) (major aortopulmonary collateral[s]) (without PA-VSD) Tricuspid valve disease and Ebstein’s Ebstein’s anomaly Tricuspid regurgitation, non-Ebstein’s related Tricuspid stenosis Tricuspid regurgitation and tricuspid stenosis Tricuspid valve, other RVOT obstruction, IVS Pulmonary stenosis, valvar Pulmonary stenosis Pulmonary artery stenosis (hypoplasia), main (trunk) Pulmonary artery stenosis, branch, central Pulmonary artery stenosis, branch, peripheral (beyond the hilar bifurcation) Pulmonary stenosis, NOS DCRV Pulmonary valve, other Conduit stenosis/insufficiency Conduit failure Pulmonary insufficiency Pulmonary insufficiency Pulmonary insufficiency and pulmonary stenosis Left heart lesions Aortic valve disease Aortic stenosis, subvalvar Aortic stenosis, valvar Aortic stenosis, supravalvar Aortic stenosis, NOS Aortic valve atresia Aortic insufficiency Aortic insufficiency and aortic stenosis Aortic valve, other Sinus of Valsalva fistula/aneurysm Sinus of Valsalva aneurysm LV to aorta tunnel LV to aorta tunnel Mitral valve disease Mitral stenosis, supravalvar mitral ring Mitral stenosis, valvar Mitral stenosis, subvalvar Mitral stenosis, subvalvar, parachute Mitral stenosis, NOS Mitral regurgitation and mitral stenosis Mitral regurgitation Mitral valve, other Hypoplastic left heart Hypoplastic left heart syndrome (HLHS) Cardiomyopathy Cardiomyopathy Constrictive pericarditis Pericardial effusion Pericarditis Pericardial disease, other Single ventricle Single ventricle Single ventricle, DILV Single ventricle, DIRV Single ventricle, mitral atresia Single ventricle, tricuspid atresia Single ventricle, unbalanced AV canal Single ventricle, heterotaxia syndrome Single ventricle, other Single ventricle, NOS Transposition of the great arteries Congenitally corrected TGA Congenitally corrected TGA Transposition of the great arteries TGA, IVS TGA, IVS-LVOTO TGA, VSD TGA, VSD-LVOTO TGA, NOS DORV DORV DORV, VSD type DORV, TOF type DORV, TGA type DORV, remote VSD (uncommitted VSD) DORV, NOS DOLV DOLV DOLV Thoracic arteries and veins Anomalous origin of coronary artery Anomalous origin of coronary artery from pulmonary artery Coarctation of aorta (All types) Coarctation of aorta Aortic arch hypoplasia Coronary artery fistula Coronary artery anomalies Interrupted arch Interrupted aortic arch Patent ductus arteriosus Patent ductus arteriosus Vascular rings and slings Vascular ring Pulmonary artery sling Aortic aneurysm Aortic aneurysm (including pseudoaneurysm) Aortic dissection Lung disease Lung disease Lung disease, benign Lung disease, malignant Pectus excavatum, carinatum Pectus Tracheal stenosis Tracheal stenosis Tracheal disease, other Electrophysiologic Electrophysiologic Arrhythmia Arrhythmia, heart block, acquired Arrhythmia, heart block, congenital Arrhythmia, heart block, NOS Arrhythmia, pacemaker, indication for replacement Miscellaneous Atrial Isomerism, left Atrial Isomerism, right Aneurysm, ventricular, right Aneurysm, ventricular, left Aneurysm, pulmonary artery Aneurysm, other Hypoplastic RV Hypoplastic LV Mediastinitis Endocarditis Prosthetic valve failure Myocardial infarction Cardiac tumor Pulmonary AV fistula Pulmonary embolism Pulmonary vascular obstructive disease, NOS Pulmonary vascular obstructive disease (Eisenmenger’s) Primary pulmonary hypertension Persistent fetal circulation Meconium aspiration Pleural disease, benign Pleural disease, malignant Pneumothorax Pleural effusion Chylothorax Empyema Esophageal disease, benign Esophageal disease, malignant Mediastinal disease, benign Mediastinal disease, malignant Diaphragm paralysis Diaphragm disease, other Cardiac, other Thoracic and/or mediastinal, other Peripheral vascular, other Miscellaneous, other Normal heart

Appendix V. Procedures short list Septal defects ASD PFO, primary closure ASD repair, primary closure ASD repair, patch ASD repair, device ASD, common atrium (single atrium), septation ASD creation/enlargement ASD partial closure Atrial septal fenestration ASD repair, NOS VSD VSD repair, primary closure VSD repair, patch VSD repair, device VSD, multiple, repair VSD creation/enlargement Ventricular septal fenestration VSD repair, NOS AV canal AVC (AVSD) repair, complete (CAVSD) AVC (AVSD) repair, intermediate (transitional) AVC (AVSD) repair, partial (incomplete) (PAVSD) AVC (AVSD) repair, NOS AP window AP window repair Pulmonary artery origin from ascending aorta (hemitruncus) repair Truncus arteriosus Truncus arteriosus repair Pulmonary venous anomalies Partial anomalous pulmonary venous connection PAPVC repair PAPVC, scimitar, repair Total anomalous pulmonary venous connection TAPVC repair Cor triatriatum Cor triatriatum repair Pulmonary venous stenosis Pulmonary venous stenosis repair Systemic venous anomalies Anomalous systemic venous connection Atrial baffle procedure (non-Mustard, non-Senning) Anomalous systemic venous connection repair Systemic venous stenosis repair Right heart lesions Tetralogy TOF repair, no ventriculotomy TOF repair, ventriculotomy, nontransanular patch TOF repair, ventriculotomy, transanular patch TOF repair, RV-PA conduit TOF, AVC (AVSD), repair TOF, absent pulmonary valve, repair TOF repair, NOS Pulmonary atresia Pulmonary atresia—VSD (including TOF, PA), repair Pulmonary atresia—VSD-MAPCA (pseudotruncus), repair Unifocalization MAPCA(s) Occlusion MAPCA(s) Tricuspid valve disease and Ebstein’s anomaly Valvuloplasty, tricuspid Valve replacement, tricuspid (TVR) Valve closure, tricuspid (exclusion, univentricular approach) Valve excision, tricuspid (without replacement) Valve surgery, other, tricuspid RVOT obstruction, IVS RVOT procedure Pulmonary stenosis 1 1/2 ventricular repair PA, reconstruction (plasty) PA, reconstruction (plasty), main (trunk) PA, reconstruction (plasty), branch, central PA, reconstruction (plasty), branch, peripheral (beyond the hilar bifurcation) DCRV repair Conduit stenosis/insufficiency Conduit reoperation Pulmonary insufficiency Valvuloplasty, pulmonic Valve replacement, pulmonic (PVR) Conduit, placement, RV to PA Conduit, placement, LV to PA Valve surgery, other, pulmonic Left heart lesions Aortic valve disease Valvuloplasty, aortic Valve replacement, aortic (AVR) Valve replacement, aortic (AVR), mechanical Valve replacement, aortic (AVR), bioprosthetic Valve replacement, aortic (AVR), homograft Aortic root replacement Aortic root replacement, mechanical Aortic root replacement, homograft Ross procedure Konno procedure Ross-Konno procedure Other annular enlargement procedure Aortic stenosis, subvalvar, repair Aortic stenosis, supravalvar, repair Valve surgery, other, aortic Sinus of Valsalva fistula/aneurysm Sinus of Valsalva, aneurysm repair LV to aorta tunnel LV to aorta tunnel repair Mitral valve disease Valvuloplasty, mitral Mitral stenosis, supravalvar mitral ring, repair Valve replacement, mitral (MVR) Valve surgery, other, mitral Hypoplastic left heart Norwood procedure HLHS biventricular repair Transplant, heart Cardiomyopathy Transplant, heart Transplant, heart and lung Partial left ventriculectomy (LV volume reduction surgery) (Batista) Constrictive pericarditis Pericardial drainage procedure Pericardiectomy Pericardial procedure, other Single ventricle Single ventricle Fontan, Atrio-pulmonary connection Fontan, Atrio-ventricular connection Fontan, TCPC, lateral tunnel, fenestrated Fontan, TCPC, lateral tunnel, nonfenestrated Fontan, TCPC, lateral tunnel, NOS Fontan, TCPC, external conduit, fenestrated Fontan, TCPC, external conduit, nonfenestrated Fontan, TCPC, external conduit, NOS Fontan, Other Fontan, NOS (Additional procedures are listed under the "Palliative Procedures" section so as to avoid repetitive listings. However, these procedures will be discussed in the "Single Ventricle" Paper) Transposition of the great arteries Congenitally corrected TGA Congenitally corrected TGA repair, atrial switch and ASO (double switch) Congenitally corrected TGA repair, atrial switch and Rastelli Congenitally corrected TGA repair, VSD closure Congenitally corrected TGA repair, VSD closure and LV to PA conduit Congenitally corrected TGA repair, other Congenitally corrected TGA repair, NOS Transposition of the great arteries Arterial switch operation (ASO) Arterial switch operation (ASO) and VSD repair Senning Mustard Rastelli REV TGA, Other procedures (Nikaido, Kawashima, LV-PA conduit, other) DORV DORV DORV, intraventricular tunnel repair DORV repair, NOS DOLV DOLV DOLV repair Thoracic arteries and veins Anomalous origin of coronary artery Anomalous origin of coronary artery from pulmonary artery repair Coarctation of aorta (all types) Coarctation repair, end to end Coarctation repair, end to end, extended Coarctation repair, subclavian flap Coarctation repair, patch aortoplasty Coarctation repair, interposition graft Coarctation repair, other Coarctation repair, NOS Aortic arch repair Coronary artery fistula Coronary artery fistula ligation Coronary artery bypass Coronary artery procedure, other Interrupted arch Interrupted aortic arch repair Patent ductus arteriosus PDA closure, surgical PDA closure, device PDA closure, NOS Vascular rings and slings Vascular ring repair Pulmonary artery sling repair Aortic aneurysm Aortic aneurysm repair Aortic dissection repair Lung disease Lung disease Lung biopsy Transplant, lung(s) Lung procedure, other Pectus excavatum, carinatum Pectus repair Tracheal stenosis Tracheal procedure Electrophysiologic Electrophysiologic Pacemaker implantation, permanent Pacemaker procedure ICD (AICD) implantation ICD (AICD) ([automatic] implantable cardioverter defibrillator) procedure Arrhythmia surgery—atrial, Surgical Ablation Arrhythmia surgery—ventricular Surgical Ablation Interventional cardiology procedures ASD creation, balloon septostomy (BAS) (Rashkind) ASD creation, blade septostomy Balloon dilation Stent placement Device closure RF ablation Coil embolization Palliative procedures Shunt, systemic to pulmonary, modified Blalock-Taussig Shunt (MBTS) Shunt, systemic to pulmonary, central (from aorta or to main pulmonary artery) Shunt, systemic to pulmonary, other Shunt, systemic to pulmonary, NOS Shunt, ligation and takedown PA banding (PAB) PA debanding Damus-Kaye-Stansel procedure (DKS) (creation of AP anastomosis without arch reconstruction) Bidirectional cavopulmonary anastomosis (BDCPA) (bidirectional Glenn) Glenn (unidirectional cavopulmonary anastomosis) (unidirectional Glenn) Bilateral bidirectional cavopulmonary anastomosis (BBDCPA) (bilateral bidirectional Glenn) Hemifontan Palliation, other Miscellaneous Aneurysm, ventricular, right, repair Aneurysm, ventricular, left, repair Aneurysm, pulmonary artery, repair Cardiac tumor resection Pulmonary AV fistula repair/occlusion Pulmonary embolectomy Pleural drainage procedure Pleural procedure, other Decortication Esophageal procedure Mediastinal procedure Intraaortic balloon pump (IABP) insertion ECMO procedure Right/left heart assist device procedure Mediastinal exploration Bronchoscopy Diaphragm plication Diaphragm procedure, other VATS (video-assisted thoracoscopic surgery) Minimally invasive procedure Bypass for noncardiac lesion Delayed sternal closure Mediastinal exploration Sternotomy wound drainage Thoracotomy, other Cardiotomy, other Cardiac procedure, other Thoracic and/or mediastinal procedure, other Peripheral vascular procedure, other Miscellaneous procedure, other

.

Appendix VI. Complications short list Reoperation during this admission (unplanned reoperation) Postoperative cardiac arrest Postoperative mechanical circulatory support (IABP, VAD, ECMO, or CPS) Postoperative complete AV block requiring temporary pacemaker Postoperative complete AV block requiring permanent pacemaker Postoperative arrhythmia Postoperative low cardiac output Postoperative acidosis Sternum left open Pericardial effusion requiring drainage Systemic vein obstruction Pulmonary vein obstruction Postoperative pulmonary hypertension crises (PA pressure > systemic pressure) Postoperative respiratory insufficiency requiring mechanical ventilatory support > 7 days Postoperative tracheostomy Pneumonia Pneumothorax Pleural effusion requiring drainage Chylothorax Acute renal failure requiring temporary dialysis Acute renal failure requiring permanent dialysis Bleeding requiring reoperation Wound dehiscence Wound infection Mediastinitis Postoperative endocarditis Postoperative septicemia Phrenic nerve injury/paralyzed diaphragm Recurrent laryngeal nerve injury/paralyzed vocal cord Postoperative neurological deficit persisting at discharge Postoperative new onset seizures Other postoperative complication

Appendix VII. European Congenital Heart Surgeons Foundation 1. Hakan E. Berggren, MD, PhD Goteborg, Sweden 2. William J. Brawn, FRCS Birmingham, England 3. Thierry P. Carrel, MD Berne, Switzerland 4. Juan V. Comas, MD, PhD Madrid, Spain 5. Antonio F. Corno, MD Lausanne, Switzerland 6. Giancarlo Crupi, MD Bergamo, Italy 7. Duccio di Carlo, MD Rome, Italy 8. Tjark Ebels, MD, PhD Groningen, The Netherlands 9. Martin J. Elliott, FRCS London, England 10. Siegfried Hagl, MD Heidelburg, Germany 11. Vladimir N. Iliyn, MD Moscow, Russia 12. François Lacour-Gayet, MD Paris, France 13. Harald L. Lindberg, MD, PhD Oslo, Norway 14. Bohdan Maruzewski, PhD Warsaw, Poland 15. Gösta Pettersson, MD, PhD Cleveland, Ohio 16. Jean E. Rubay, MD Brussels, Belgium 17. Heikki I. Sairanen, MD Helsinki, Finland 18. BabulalSethia, FRCS Birmingham, England 19. Aram K. Smolinsky, MD Tel-Hashomer, Israel 20. Giovanni Stellin, MD Padova, Italy 21. Andreas E. Urban, MD St. Augustin, Germany 22. Pascal R. Vouhé, MD Paris, France 23. Carin Von Doorn, MD Leeds, England 24. Alfred E. (Freddie) Wood, FRCSI Dublin, Ireland 25. Gerhard Ziemer, MD Tübingen, Germany

Acknowledgments

The Guest Editors would like to acknowledge and herald the significant contribution of Patricia Heraty, Medical Editor, for her uncompromising attention to the content and detail of this daunting project.

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