Development and Implementation of a New Data Registry in Congenital Cardiac Anesthesia David F. Vener, MD, Nina Guzzetta, MD, Jeffrey P. Jacobs, MD, and Glyn D. Williams, MB Departments of Pediatrics and Anesthesia, Baylor College of Medicine and Texas Children’s Hospital, Houston, Texas; Department of Anesthesiology, Emory University School of Medicine and Children’s Healthcare of Atlanta, Atlanta, Georgia; Congenital Heart Institute of Florida, University of South Florida St. Petersburg, St. Petersburg, Florida; and Department of Anesthesia, Stanford University Medical Center, Stanford, California
A new multisite registry for congenital cardiac anesthesia patients has now been incorporated into The Society of Thoracic Surgeons Congenital Heart Surgery Database. This new registry, “The Joint Congenital Cardiac Anesthesia Society–Society of Thoracic Surgeons Congenital Cardiac Anesthesia Database,” is part of the Congenital Cardiac Anesthesia Society’s commitment to patient care and research on outcomes improvement. This report will review the planning and funding of the initial start-up as well as the data elements being used in the registry. Patients in the registry include not only cardiac surgical patients but also those with congenital heart disease undergoing procedures in locations other than the operating room, including in the cardiac catheterization laboratory,
intensive care unit, general operating room, and radiology suite. Initial results from the first data harvests are reported, including site participation, patient population submitted, and adverse outcomes observed. These initial results validate the concept and serve as a benchmark for further development and implementation of the registry. Because of the relative infrequency of anesthesia-related events in this low-volume procedure, a multisite data harvest is the most reasonable approach to capture a sufficient number of patient encounters in a timely manner to support outcomes analysis, quality assessment, and quality improvement.
I
sia practice and outcomes [1–3]. Before the CCAS-STS database was created, there were no multicenter prospective registries specifically geared toward the highly specialized field of congenital cardiac anesthesia.
Address correspondence to Dr Vener, Baylor College of Medicine, Texas Children’s Hospital, Pediatric Cardiovascular Anesthesia, WT 17417B, Houston, TX 77030; e-mail:
[email protected].
© 2012 by The Society of Thoracic Surgeons Published by Elsevier Inc
Development This initiative was presented to the STS Congenital Heart Surgery Database (STS-CHSDB) Taskforce at the 2005 Annual STS Meeting in Tampa after approval by the CCAS Board of Directors. Subsequent discussions between STS and CCAS led to a contract being executed between the two organizations that formalized the relationship in 2009. As of 2011, the STS-CHSDB currently has 103 participants who are “practice groups of cardiothoracic surgeons” or individual cardiothoracic surgeons. These 103 participants include 100 of the 125 programs that provide congenital pediatric cardiac surgery services in the United States, as well as 3 of the 8 Canadian programs [4]. This registry has now served as the source data for numerous publications in the surgical literature, covering
An Appendix for this article is available in the Auxiliary Annals section of the STS website: http://www. sts.org/annals-thoracic-surgery/auxiliary-annals.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2012.06.070
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n 2005 The Congenital Cardiac Anesthesia Society (CCAS) was formed in partnership with the Society of Pediatric Anesthesia. Information about these societies is available at http://www.pedsanesthesia.org/ccas and http://www.pedsanesthesia.org, respectively. As one of its primary goals, the CCAS is committed to developing a data registry of anesthetic care for patients with congenital and pediatric cardiac disease. It was determined that the most cost-efficient and time-efficient manner to develop the desired registry was to partner with The Society of Thoracic Surgeons (STS). Multicenter anesthesia outcomes databases are still very early in their development and use. The Center for Perioperative Outcomes Research at the University of Michigan has developed a Multicenter Perioperative Outcomes Group that relies on anesthesia departments with automated record keeping systems to download their deidentified data into a data warehouse that can then be “mined” to determine correlates between intraoperative management and physiologic variables and outcomes. The American Society of Anesthesiology has sponsored the development of the Anesthesiology Quality Institute’s National Anesthesia Clinical Outcomes Registry, also using similar automated data dumps to aggregate enormous amounts of information on anesthe-
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Table 1. Charter Sponsoring Institutions ● ● ● ● ● ● ● ● ● ● ●
Children’s Healthcare of Atlanta, Atlanta, Georgia Children’s Hospital Boston, Boston, Massachusetts Children’s Hospital of Denver, Denver, Colorado Children’s Hospital of Los Angeles, Los Angeles, California Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania Cleveland Clinic Foundation, Cleveland, Ohio Miami Children’s Hospital, Miami, Florida Morgan Stanley Children’s Hospital at Columbia University, New York City, New York The Congenital Heart Institute of Florida (CHIF) and Saint Joseph’s Children’s Hospital of Tampa, Tampa, Florida Texas Children’s Hospital, Houston, Texas University of Virginia, Charlottesville, Virginia
everything from specific case management approaches to the effect of genetic and noncardiac congenital abnormalities on outcomes [5–7].
Project Funding
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The initial cost to the CCAS of developing the data elements and incorporating them into the STS-CHSDB was approximately $60,000. The expenses were supported by voluntary donations from the institutions listed in Table 1. According to the agreement with the STS, it was determined that the fee for submitting anesthesia data and receiving back the anesthesia report would be $3,000 per year per site, regardless of the number of anesthesia cases submitted or number of participant anesthesiologists at each site. This fee structure is different from that used by the STS for its surgical case data, which is a combination of a fixed fee per participant of $1,000.00 plus a per-case fee of $1.00 for each submission. The difference in fee schedules was negotiated this way because there are typically significantly more anesthesiologists providing cardiac anesthesia at a given institution than surgeons. In addition, the CCAS wished to encourage the enrollment of congenital cardiac patients whose procedures were done in locations other than the cardiac operating room, such as in the general operating rooms (for noncardiac operations), the cardiac catheterization laboratory, radiology suites, and other locations. Children with cardiac disease undergoing anesthesia are a higher-risk population, especially for procedures outside of the operating room environment, and CCAS members felt that it was important to capture the care of these patients beyond the cardiac operating rooms [8 –11]. For the first time, the STS has agreed to enroll cases involving noncardiac surgeons because the care of congenital cardiac surgical patients reaches throughout the hospital, and one of the common denominators in the care of these patients is the anesthesia team. However, for a program to participate in the joint CCAS-STS Congenital Cardiac Anesthesia Database, the program must participate in the STS-CHSDB. Each anesthesiologist submitting cases is required to be a signatory on the
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business contracts with the sites to make the transmission of data compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Development of the Anesthesia Module for STS-CHSDB The CCAS Database Committee solicited input from the congenital cardiac anesthesia community about data points to be included in the registry. Anesthesia-related data include information about multiple domains, including the provider(s), preoperative medications, intraoperative monitoring and management, transfusion data, and immediate postoperative disposition and status. Anesthesia-related complications are separate from the surgical complications listed in the surgeon’s portion of the database. The anesthesia fields are listed in Appendices A and B (Appendices for this article are available in the Auxiliary Annals section of the STS website: http:// www.sts.org/auxiliaryannals/Vener-2012-94-6-2159Appendix-A.doc and http://www.sts.org/auxiliaryannals/ Vener-2012-94-6-2159-Appendix-B.doc). The anesthesia database shares the remainder of the data fields with the surgeons, including demographics, diagnosis, and procedures. The full STS-CHSDB specifications are available online through the STS. The surgical and anesthesia data fields are revised and updated on a triennial basis, with the newest changes effective on January 1, 2013.
Multidisciplinary Input There has been a tremendous effort by an international group of congenital cardiac surgeons, cardiologists, and anatomists to develop consistent diagnostic and procedural nomenclature for congenital cardiac disease. Multiple publications in the surgical and cardiology literature describe the work of this group in coordinating the nomenclature associated with all of the various congenital cardiac lesions and procedures [12–15]. This work has taken place in forums over the last decade and has resulted in the creation of the International Pediatric and Congenital Cardiac Code (IPCCC), which is now the standard nomenclature for congenital cardiac malformations and related procedures. These codes are available online (www.ipccc.net) at no charge for incorporation into all of the various databases and registries currently active or in development worldwide. The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease brings together surgeons, anesthesiologists, cardiologists, intensive care physicians, perfusionists, nurses, health care administrators, and government representatives from around the world who care for patients with congenital heart disease [15]. This group has been working toward the development of core data sets that can be shared across specialties and international borders. Another goal of this group has been the development of common nomenclature related to patient outcomes and complications [13, 14, 16]. Just as it is critical for all the involved groups to have a common diagnostic and procedural nomenclature, the definitions for various adverse events must be standardized so that
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outcomes may be comparable across different institutions in the United States and worldwide [17, 18].
Table 3. Society of Thoracic Surgeons–Congenital Cardiac Anesthesia Society Participating Centers
Unique Patient Identifier
Size
The STS-CHSDB has also developed a unique patient identifier algorithm based on Private Health Information (PHI) data such as the patient’s name, date of birth, Social Security number (where applicable), and maternal name. The use of this identifier potentially allows for tracking a given patient across multiple locations and is critical to the development of long-term outcomes analysis independent of a specific site. Linkage to administrative databases such as the Social Security Master Death File or state mortality files is also possible through the use of deterministic and probabilistic matching with this information [19, 20]. Transmission of PHI to an outside institution requires the approval and cooperation of a local Institutional Review Board and is made legal by the presence of signed business contracts as mentioned above. Although site-dependent, it might be necessary to obtain specific written consent from families to include PHI in their data submission and not all hospitals or review boards have agreed to this process. Duke University’s Institutional Review Board, which covers the research activity of Duke Clinical Research Institute (DCRI), has reviewed the ongoing submission of protected data and found it to be within the guidelines outlined by HIPAA-related law, as has outside counsel consulted by STS [21]. Commercial vendors supporting the STS-CHSDB have included functionality in their software to remove or deidentify records before transmission for those programs unwilling or unable to share PHI due to privacy concerns. The STS has already begun the process of linking the STS Adult Cardiac Surgery Database clinical with administrative databases with great success [19]. Because of the nature of congenital heart surgery, where a patient may be cared for at multiple institutions over a span of years, clinical–administrative linkage may help determine true long-term morbidity and mortality [22].
Small (⬍125 CPB cases) Medium (126–250 CPB cases) Large (251–500 CPB cases) Very large (⬎501 CPB cases)
Research Research on data collected through the STS-CHSDB is open to participating centers. Data requests can be submitted through a “minor” or “major” request to the STS. “Minor” data requests involve analyses that are performed for an individual institution without plans for publication and without multivariate modeling and are vetted by one of the authors (J.J.), in his role as Chair of Table 2. Society of Thoracic Surgeons–Congenital Cardiac Anesthesia Society Participants by United States Census Region Region Northeast Midwest South West
No. 5 6 14 5
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No. 11 9 4 3
CPB ⫽ cardiopulmonary bypass.
the STS-CHSDB Access and Publications Committee. “Major” data requests include any request that involves modeling or generation of data that may lead to a presentation or publication and are evaluated for approval by the entire STS-CHSDB Access and Publications Committee. Any information gleaned from a STS Database that is submitted for publication must be vetted by the STS Access and Publications Committee before submission. As part of the agreement between the STS and the CCAS, at least one representative from the CCAS serves on this STS-CHSDB Access and Publications Committee to provide input on anesthesia-related questions or publications.
Results of the First Data Harvests Data entry into the Joint CCAS-STS Congenital Cardiac Anesthesia Database was begun in January 2010. The first results of these efforts were reported to the participating centers in August 2011, and the aggregate results of the Spring 2012 harvest, representing now 24 months of data collection, were made available to the authors of this report in May 2012. Eighteen centers submitted at least part of the anesthesia data elements in the first 12-month harvest, and this number has now increased to 29 centers. These sites are widespread geographically (Table 2) and in center size, as determined by the number of cardiopulmonary bypass cases performed (Table 3). The Spring 2012 harvest had 20,226 independent records Table 4. Case Volume Reported by Case Type From January 1, 2010 Through December 31, 2011 Case Type Surgery, total CPB No CPB Support devices (VAD, ECMO) Cardiology Diagnostic Interventional Electrophysiology Othera
No. (% of Total) (N ⫽ 20,226) 13,796 (68.2) 10,029 (72.7) 3,227 (23.4) 540 (3.9) 3,354 (16.6) 615 (18.3) 1,665 (49.6) 1,074 (32.0) 3,076 (15.2)
a Includes thoracic, noncardiac nonthoracic, intensive care unit, and radiology.
CPB ⫽ cardiopulmonary bypass; ECMO ⫽ extracorporeal membrane oxygenation; VAD ⫽ ventricular assist device.
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Table 5. Case Volume Reported by Patient Age at Procedure Date (All Cases) From January 1, 2010 Through December 31, 2011 STS Age Category Neonates (0 to 30 days) Infant (31 days to 1 year) Child (⬎1 year to ⬍18 years) Adult (⬎18 years)
No. (% of Total) (N ⫽ 20,226) 3,662 (18.1) 5,669 (28.0) 8,371 (41.4) 1,459 (7.2)
STS ⫽ The Society of Thoracic Surgeons.
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submitted. Table 4 illustrates the breakdown of cases by case type. Analysis of the data is limited to basic percentages only because the quality of data collection and submission is felt to be incomplete at this time; for example, some centers may have only entered the demographic information and procedure without completing the remainder of the data. Other centers, however, have been far more comprehensive in their data entry and harvesting, and their feedback reports are consequently more valuable for internal analysis, outcomes assessment, and quality improvement. Table 5 demonstrates the demographic breakdown of the cases submitted grouped by age, and Table 6 illustrates the stratification of surgical cases by the five Society of Thoracic Surgeons–European Association for Cardio-Thoracic Surgery (STAT) Congenital Heart Surgery Mortality Categories, which has been previously described elsewhere [23]. The anesthesia data are summarized in subsections, some of which include preoperative, intraoperative, and postoperative medications, monitoring modalities (arterial and central venous catheter presence and location and use of neuromonitoring), and time to extubation. Anesthesia-related adverse events are reported in Table 7. They are typically recognized intraoperatively with relatively few exceptions. Although each complication is defined in the data specifications, there remains a certain element of subjectivity in applying them. In many cases there are not objective elements to measure and define in the anesthesia-related complications. In addition, postoperative complications might not be recognized or reported back to the database, including episodes of intraoperative awareness or longer-term complications of intubation such as subglottic stenosis. Anesthesia follow-up typically does not occur after the first 24 to 48 hours postoperatively unless there is a specific concern.
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recording the medications used. As more anesthesia programs implement electronic anesthesia records, it might be possible to develop electronic data transfers into the appropriate harvesting software, similar to the approach taken by the Multicenter Perioperative Outcomes Group and the Anesthesia Quality Institute [2, 3]. It is unlikely that this will be realized in the near term, however, due to the complexity and expense of the programming required to filter the data into the various STS-approved vendors for relatively few cases.
Cost Structure The cost for anesthesia participation can be broken down into the direct expenses, such as the $3000 annual participation fee, and the indirect expenses. The latter include the costs associated with data entry by the combination of physicians, nurses, perfusionists, or research personnel. These costs vary between institutions depending on the model used for data entry. It is unlikely that additional personnel would be added solely for the anesthesia portion of the database, but a portion of existing personnel time may need to be allocated to accomplish the data harvest, entry, and audit process. Although not insignificant, in many instances this may just be reallocation of existing expenditures and not new expenses. In the event of a complex data analysis request requiring significant programming and multivariate analysis, DCRI has the option of charging the STS or the requesting institution a supplemental fee to be negotiated between the DCRI and the requesting agency. As part of the original agreement with the STS and DCRI, it was agreed that these fees would typically be covered by the annual anesthesia fee. To date, no supplemental charges have been generated or assessed for anesthesia data. Minor data requests are not typically charged any handling or programming fees.
Comment The STS-CCAS collaboration is the first attempt to report back to anesthesia providers what is happening nationwide and the outcomes specifically related to anesthesia care in these critically ill patients. The data generated at each site always belong to that location and may be used for internal quality assurance projects, tracking case Table 6. Society of Thoracic Surgeons–European Association for Cardio-Thoracic Surgery EACTS “STAT” Complexity Score for Congenital Cardiovascular Surgical Patients From January 1, 2010 Through December 31, 2011
Future Registry Developments Work has already begun on the next update of the STS-CHSDB and the Joint CCAS-STS Congenital Cardiac Anesthesia Database. New data specifications will be implemented on January 1, 2013. One area of discussion being reviewed is whether to approach medication listings as specific drugs or as broader drug classifications. Specific drug listings provide more data points but may come at the expense of fewer participants accurately
Category Category 1 Category 2 Category 3 Category 4 Category 5 Not assigned
No. (% of Total) (N ⫽ 13,256) 2,559 (19.3) 3,777 (28.5) 1,822 (13.7) 3,172 (23.9) 580 (4.4) 1,346 (10.2)
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Table 7. Adverse Events Reported From January 1, 2010 Through December 31, 2011 Adverse Event No adverse events reported Any adverse event reported Dental Injury Respiratory Arrest Difficult Intubation/Reintubation Stridor/Subglottic Stenosis Inadvertent Extubation Endotracheal Tube Migration/Malposition Airway Injury Arrhythmia–CVL related Myocardial Injury–CVL related Vascular Compromise–CVL related Pneumothorax–CVL related Vascular Access Hematoma Inadvertent Arterial Puncture Intravenous/Intraarterial Air Embolus Bleeding–Regional Anesthesia Site Inadvertent Intrathecal Puncture–Regional Local Anesthetic Toxicity–Regional Neurologic Injury–Regional Anaphylaxis/Anaphylactoid Reaction Non-allergic Drug Reaction Medication Administration (Wrong Drug) Medication Dosage (Wrong Dose) Intraoperative Recall Malignant Hyperthermia Protamine Reaction Cardiac Arrest Unrelated to Surgery Esophageal Bleeding/Rupture–TEE related Esophageal Chemical Burn–TEE related Airway Compromise–TEE related Extubation–TEE related Patient Transfer Event Neurologic Injury–Positioning
Cardiology No. (%)
Totala No. (%)
12,923 333 (2.5) 2 (0.0) 5 (0.0) 47 (0.4) 27 (0.2) 12 (0.1) 8 (0.1) 4 (0.0) 6 (0.0) 0 19 (0.1) 1 (0.0) 80 (0.6) 4 (0.0) 41 (0.3) 1 (0.0) 1 (0.0) 0 0 0 14 (0.1) 8 (0.1) 7 (0.1) 7 (0.1) 1 (0.0) 0 14 (0.1) 17 (0.1) 6 (0.1) 0 16 (0.1) 7 (0.1) 4 (0.0) 7 (0.1)
1,303 19 (1.2) 0 2 (0.2) 3 (0.2) 3 (0.2) 1 (0.1) 2 (0.2) 1 (0.1) 0 0 1 (0.1) 0 1 (0.1) 0 0 0 0 0 0 0 1 (0.1) 0 0 0 0 0 0 4 (0.3) 0 0 0 0 0 0
19,805 421 (2.1) 2 (0.0) 11 (0.1) 66 (0.3) 32 (0.2) 14 (0.1) 10 (0.0) 7 (0.0) 6 (0.0) 0 20 (0.1) 1 (0.0) 87 (0.4) 4 (0.0) 44 (0.2) 1 (0.0) 1 (0.0) 0 0 0 15 (0.1) 13 (0.1) 8 (0.0) 8 (0.0) 1 (0.0) 0 15 (0.1) 40 (0.2) 6 (0.0) 0 28 (0.1) 8 (0.0) 4 (0.0) 11 (0.1)
Includes all cases in database.
CPB ⫽ Cardiopulmonary Bypass;
CVL ⫽ Central Venous Line;
TEE ⫽ Transesophageal Echocardiography.
volumes, or research. Nationally, the data generated are regularly reported back to the CCAS in person at the annual meeting or through the CCAS newsletter. As the quality and quantity of submissions increase, it should be possible to report on such specific items as antifibrinolytic and factor 7a use and dosage, blood transfusions, and potentially, even anesthesia morbidity as a function of patient age or procedural complexity. Despite the success in the number of cases submitted to date, these data represent a very incomplete picture of activity. Anesthesia programs have come “on-line” with their participation at various times throughout the 24 months reported here. In addition, not all anesthesia elements were complete even in submitted records, and each site is still working out the methodology most useful
for its location to accurately and reliably harvest and enter the anesthesia data. Another of the goals of this project is to capture anesthesia-related information on cardiac patients undergoing procedures in locations other than the operating room, where the patients are at particularly high risk [9]. This aspect of the project has yet to be fully realized at many centers because of the manpower and processes involved in capturing and recording these data. The project is still in its infancy, and it is reasonable to expect variations between institutions in the interpretation of the definitions of the fields of data and in efforts to audit the quality of data input. Therefore, considerable caution is advised when reviewing the results of this initial data harvest. As the data registry “matures,” these
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a
CPB/No CPB Case No. (%)
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problems will become less noticeable. It is hoped that in the near future, anesthesia data will undergo external auditing in a manner similar to the process by which the surgical data is now audited. The advantages and disadvantages of ongoing multicenter data collection and analysis compared with singlesite data analysis has been discussed in detail elsewhere [1, 2, 24, 25]. In summary, multisite collection allows for harvesting of enough data points to analyze lowfrequency events, such as morbidity and mortality related to anesthesia, in a contemporaneous manner [8]. Any endeavor such as this will always be susceptible to under-reporting of adverse events and incomplete data entry. However, even taking this into account, the accumulated knowledge base should provide an enormous resource base for research, establish at least minimal baseline outcome results, and help direct future research studies. Previous single-site outcome reports have been limited by the need to extend over significant periods of time, during which treatment modalities and personnel may change significantly [26] For example, Odegard and colleagues [27] published their experience at Children’s Hospital Boston covering the years 2000 to 2005 on 5,213 cardiac surgical cases, while other reports, such as Flick and colleagues [9], extended over 25 years of care, during which dramatic changes occurred in anesthesia training, pharmacology, and monitoring. The advantage of singlecenter studies, however, is that there should be a more consistent quality of data collection as well as personnel involved. In the 24 months of data harvest into the Joint CCAS-STS Database, which by all accounts was incomplete, we included information on 13,796 cardiac surgical procedures, 3,354 cardiology procedures, and 3,076 noncardiovascular surgical cases or procedures. We express our gratitude to the centers that are submitting data to the Joint CCAS-STS Congenital Cardiac Anesthesia Database. This process represents a significant investment of time and effort by a large number of individuals.
References
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1. Freundlich RE, Kheterpal S. Perioperative effectiveness research using large databases. Best Pract Res Clin Anaesthesiol 2011;25:489 –98. 2. Dutton RP, Dukatz A. Quality improvement using automated data sources: The Anesthesia Quality Institute. Anesthesiol Clin 2011;29:439 –54. 3. Ramachandran SK, Kheterpal S. Outcomes research using quality improvement databases: evolving opportunities and challenges. Anesthesiol Clin 2011;29:71– 81. 4. Jacobs ML, Daniel M, Mavroudis C, et al. Report of the 2010 Society of Thoracic Surgeons congenital heart surgery practice and manpower survey. Ann Thorac Surg 2011;92:762– 8. 5. Fudge JC Jr, Li S, Jaggers J, et al. Outcomes in patients with Down syndrome undergoing congenital heart surgery: analysis of a national clinical database. Pediatrics 2010;126: 315–22. 6. Patel A, Hickey E, Mavroudis C, et al. Impact of noncardiac congenital and genetic abnormalities on outcomes in hypoplastic left heart syndrome. Ann Thorac Surg 2010;89: 1805–13.
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7. Johnson JN, Jaggers J, Li S, et al. Center variation and outcomes associated with delayed sternal closure following stage 1 palliation for hypoplastic left heart syndrome. J Thorac Cardiovasc Surg 2010;139:1205–10. 8. Ramamoorthy C, Haberkern CM, Bhananker SM, et al. Anesthesia-related cardiac arrest in children with heart disease: data from the Pediatric Perioperative Cardiac Arrest (POCA) registry. Anesth Analg 2010;110:1376 – 82. 9. Flick RP, Sprung J, Harrison TE, et al. Perioperative cardiac arrests in children between 1988 and 2005 at a tertiary referral center: a study of 92,881 patients. Anesthesiology 2007;106:226 –37. 10. Bhananker SM, Ramamoorthy C, Geiduschek JM, et al. Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest registry. Anesth Analg 2007;105:344 –50. 11. Zgleszewski SE, Graham D, Hickey PR. Anesthesia-related cardiac arrest: five year analysis at an academic pediatric medical center. Anesthesiology 2006;105:A134. 12. Bergersen L, Everett AD, Giroud JM, et al. Report from the International Society for Nomenclature of Paediatric and Congenital Heart Disease: cardiovascular catheterisation for congenital and paediatric cardiac disease (part 1–procedural nomenclature). Cardiol Young 2011;21:252–9. 13. Bergersen L, Giroud JM, Jacobs JP, et al. Report from The International Society for Nomenclature of Paediatric and Congenital Heart Disease: cardiovascular catheterisation for congenital and paediatric cardiac disease (part 2–nomenclature of complications associated with interventional cardiology). Cardiol Young 2011;21:260 –5. 14. Jacobs JP, Benavidez OJ, Bacha EA, Walters HL, Jacobs ML. The nomenclature of safety and quality of care for patients with congenital cardiac disease: a report of the Society of Thoracic Surgeons Congenital Database Taskforce Subcommittee on Patient Safety. Cardiol Young 2008;13(Suppl 2): 81–91. 15. Strickland MJ, Riehle-Colarusso TJ, Jacobs JP, et al. The importance of nomenclature for congenital cardiac disease: implications for research and evaluation. Cardiol Young 2008;18(Suppl 2):92–100. 16. Vener DF, Tirotta CF, Andropoulos D, Barach P. Anaesthetic complications associated with the treatment of patients with congenital cardiac disease: consensus definitions from the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease. Cardiol Young 2008;18(Suppl 2): 271– 81. 17. Jacobs JP, Maruszewski B, Tchervenkov CI, et al. The current status and future direction of efforts to create a global database for the outcomes of therapy for congenital heart surgery. Cardiol Young 2005;15(Suppl 1):190 –7. 18. Jacobs JP, Mavroudis C, Jacobs ML, et al. What is operative mortality? Defining complications in a surgical registry database: A report of the STS congenital databse taskforce and the joint EACTS-STS congenital database committee. Ann Thorac Surg 2006;81:1937– 41. 19. Jacobs JP, Edwards FH, Shahian DM, et al. Successful linking of the Society of Thoracic Surgeons database to Social Security data to examine survival after cardiac operations. Ann Thorac Surg 2011;92:32–7. 20. Dokholyan RS, Muhlbaier LH, Falletta JM, et al. Regulatory and ethical considerations for linking clinical and administrative databases. Am Heart J 2009;157:971– 82. 21. STS database collection of protected health information FAQ for STS database participants. http://www.sts.org/sites/ default/files/documents/pdf/DCRI_FAQ-Technical_Document_ re_Identifiers_in_Database_Final.pdf. Accessed Oct 28, 2011. 22. Pasquali SK, Jacobs JP, Shook GJ, et al. Linking clinical registry data with administrative data using indirect identifiers: implementation and validation in the congenital heart surgery population. Am Heart J 2010;160:1099 –104. 23. O’Brien SM, Clarke DR, Jacobs JP, et al. An empirically based tool for analyzing mortality associated with congen-
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