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Background: This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children's consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from research interviews and observations in two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families' informed consent to surgery. Results: The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices. Conclusion: We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children's rights. [ABSTRACT FROM AUTHOR]

This discussion paper considers how seldom recognised theories influence clinical ethics committees. A companion paper examined four major theories in social science: positivism, interpretivism, critical theory and functionalism, which can encourage legalistic ethics theories or practical living bioethics, which aims for theory–practice congruence. This paper develops the legalistic or living bioethics themes by relating the four theories to clinical ethics committee members' reported aims and practices and approaches towards efficiency, power, intimidation, justice, equality and children's interests and rights. Different approaches to framing ethical questions are also considered. Being aware of the four theories' influence can help when seeking to understand and possibly change clinical ethics committee routines. The paper is not a research report but is informed by a recent study in two London paediatric cardiac units. Forty-five practitioners and related experts were interviewed, including eight members of ethics committees, about the work of informing, preparing and supporting families during the extended process of consent to children's elective heart surgery. The mosaic of multidisciplinary teamwork is reported in a series of papers about each profession, including this one on bioethics and law and clinical ethics committees' influence on clinical practice. The qualitative social research was funded by the British Heart Foundation, in order that more may be known about the perioperative views and needs of all concerned. Questions included how disputes can be avoided, how high ethical standards and respectful cooperation between staff and families can be encouraged, and how minors' consent or refusal may be respected, with the support of clinical ethics committees. [ABSTRACT FROM AUTHOR]

The success of cardiac surgery has transformed the prospects of children with congenital heart disease with over 90% now surviving to adulthood. The early pioneering surgeons took on significant risk, whilst current surgical practice emphasises safety and consistency. In this article we review important British contributions to the field and consider challenges for the future, specifically how to better manage and reduce the adverse sequelae of congenital cardiac surgery by continuing to innovate safely. [ABSTRACT FROM AUTHOR]

The question posed in the title of this article is: “Congenital Heart Surgery Databases Around the World: Do We Need a Global Database?” The answer to this question is “Yes and No”! Yes - we need to create a global database to track the outcomes of patients with pediatric and congenital heart disease. No–we do not need to create a new “global database.” Instead, we need to create a platform that allows for the linkage of currently existing continental subspecialty databases (and continental subspecialty databases that might be created in the future) that will allow for the seamless sharing of multi-institutional longitudinal data across temporal, geographical, and subspecialty boundaries. This review article will achieve the following objectives: (A) Consider the current state of analysis of outcomes of treatments for patients with congenitally malformed hearts. (B) Present some principles that might make it possible to achieve life-long longitudinal monitoring and follow-up. (C) Describe the rationale for the creation of a Global Federated Multispecialty Congenital Heart Disease Database. (D) Propose a methodology for the creation of a Global Federated Multispecialty Congenital Heart Disease Database that is based on linking together currently existing databases without creating a new database. To perform meaningful multi-institutional analyses, any database must incorporate the following six essential elements: (1) Use of a common language and nomenclature. (2) Use of a database with an established uniform core dataset for collection of information. (3) Incorporation of a mechanism to evaluate the complexity of cases. (4) Implementation of a mechanism to assure and verify the completeness and accuracy of the data collected. (5) Collaboration between medical and surgical subspecialties. (6) Standardization of protocols for life-long longitudinal follow-up. Analysis of outcomes must move beyond recording 30-day or hospital mortality, and encompass longer-term follow-up, including cardiac and non-cardiac morbidities, and importantly, those morbidities impacting health-related quality of life. Methodologies must be implemented in our databases to allow uniform, protocol-driven, and meaningful long-term follow-up. We need to create a platform that allows for the linkage of currently existing continental subspecialty databases (and continental subspecialty databases that might be created in the future) that will allow for the seamless sharing of multi-institutional longitudinal data across temporal, geographical, and subspecialty boundaries. This “Global Federated Multispecialty Congenital Heart Disease Database” will not be a new database, but will be a platform that effortlessly links multiple databases and maintains the integrity of these extant databases. Description of outcomes requires true multi-disciplinary involvement, and should include surgeons, cardiologists, anesthesiologists, intensivists, perfusionists, neurologists, educators, primary care physicians, nurses, and physical therapists. Outcomes should determine primary therapy, and as such must be monitored life-long. The relatively small numbers of patients with congenitally malformed hearts requires multi-institutional cooperation to accomplish these goals. The creation of a Global Federated Multispecialty Congenital Heart Disease Database that links extant databases from pediatric cardiology, pediatric cardiac surgery, pediatric cardiac anesthesia, and pediatric critical care will create a platform for improving patient care, research, and teaching related to patients with congenital and pediatric cardiac disease. [Copyright &y& Elsevier]

Background: Surgery for congenital heart disease (CHD) has changed considerably during the last three decades. The results of primary repair have steadily improved, to allow treating almost all patients within the pediatric age; nonetheless an increasing population of adult patients requires surgical treatment. The objective of this study is to present the early surgical results of patients who require surgery for CHD in the adult population within a multicentered European study population. Methods: Data relative to the hospital course of 2,012 adult patients (age ≥18 years) who required surgical treatment for CHD from January 1, 1997 through December 31, 2004 were reviewed. Nineteen cardiothoracic centers from 13 European countries contributed to the data collection. Results: Mean age at surgery was 34.4 ± 14.53 years. Most of the operations were corrective procedures (1,509 patients, 75%), followed by reoperations (464 patients, 23.1%) and palliative procedures (39 patients, 1.9%). Six hundred forty-nine patients (32.2%) required surgical closure of an isolated ostium secundum atrial septal defect. Overall hospital mortality was 2%. Preoperative cyanosis, arrhythmias, and NYHA class III-IV, proved significant risk factors for hospital mortality. Follow-up data were available in 1,342 of 1,972 patients (68%) who were discharged home. Late deaths occurred in 6 patients (0.5%). Overall survival probability was 97% at 60 months, which is higher for corrective procedures (98.2%) if compared with reoperations (94.1%) and palliations (86.1%). Conclusions: Surgical treatment of CHD in adult patients, in specialized cardiac units, proved quite safe, beneficial, and low-risk. [Copyright &y& Elsevier]

Background: After utilizing separate congenital databases in the early 1990s, the Society of Thoracic Surgeons (STS) and the European Association for Cardio-Thoracic Surgery (EACTS) collaborated on several joint database initiatives. Methods: In 1998, the joint EACTS-STS International Congenital Heart Surgery Nomenclature and Database Project Committee was created and a common nomenclature and common core minimum database dataset were adopted and published by the STS and the EACTS. In 1999, the joint EACTS-STS Aristotle Committee was created and the Aristotle Score was adopted and published as a method to provide complexity adjustment for congenital heart surgery. Collaborative efforts involving the EACTS and STS are underway to develop mechanisms to verify data completeness and accuracy. Results: Since 1998, this nomenclature, database, and methodology of complexity adjustment have been used by both the STS and EACTS to analyze outcomes of over 40,000 patients. A huge amount of data have been generated which allow comparison of practice patterns and outcomes analysis between Europe and North America. The aggregate data from the first 5 years of data collection not only make for interesting comparison but also allow examination of regional difference in practice patterns. For example, in the EACTS, out of 4,273 neonates, 885 (20.7%) underwent arterial switch procedures and 297 (6.95%) underwent Norwood stage 1 procedures. In the STS, out of 3,988 neonates, 472 (11.8%) underwent arterial switch procedures and 575 (14.4%) underwent Norwood stage 1 procedures. Conclusions: This analysis of the EACTS-STS multi-institutional outcomes database confirms that in both Europe and North America, case complexity and mortality is highest among neonates, then infants, and then children. Regional differences in practice patterns are demonstrated, with the overall goal being the continued upgrade in the quality of surgery for congenital heart disease worldwide. [Copyright &y& Elsevier]

Background: The analysis of the second harvest (1998–2001) of the Society of Thoracic Surgeons Congenital Heart Surgery Database included the first attempt by the STS to apply a complexity-adjustment method to evaluate congenital heart surgery results. Methods: This data harvest represents the first STS multiinstitutional experience with software utilizing the international nomenclature and database specifications adopted by the STS and the European Association for Cardio-Thoracic Surgery (April 2000 Annals of Thoracic Surgery) and the first STS Congenital Database Report incorporating a methodology facilitating complexity adjustment. This methodology, allowing for complexity adjustment, gives each operation a basic complexity score (1.5 to 15) and level (1 to 4) based upon the work of the EACTS-STS Aristotle Committee, a panel of 50 expert surgeons. The complexity scoring, based on the primary procedure (from the EACTS-STS International Nomenclature Procedures Short List), estimates complexity through three factors: mortality potential, morbidity potential, and technical difficulty. Results: This STS harvest includes data from 16 centers reporting 12,787 cases, with discharge mortality known for 10,246 cases. The basic complexity score has been applied to the outcomes analysis of these cases and a new equation has been proposed to evaluate one aspect of performance: Aristotle Performance Index = Outcome × Complexity = (Survival) × (Mean Complexity Score) Conclusions: The complexity analysis represents a basic complexity-adjustment method to evaluate surgical results. Complexity is a constant precise value for a given patient at a given point in time; performance varies between centers. Future STS congenital data harvests will incorporate a second step, the Comprehensive Aristotle Score, utilizing additional patient specific complexity modifiers to allow a more precise complexity adjustment. [Copyright &y& Elsevier]

Purpose: We describe the methods we have used to employ digital video techniques in the teaching of surgery for congenital heart disease.Description: This paper describes the hardware and software required to initiate and utilize digital video in surgery for congenital heart defects. Images are collected through a headlight camera and stored on standard digital-video camera tape. Tapes are catalogued using a purpose built database, linked to the hospital data system, and employing the European Pediatric Codes coding system for diagnostic and procedural coding. This permits keyword as well as patient-based searches. Master tapes are then digitally edited using proprietary software to create for example teaching tapes or to explain the operation to the family of the patient.Evaluation: Eighty percent of the procedures performed by one surgeon (M.J.E.) during the last year have been recorded in this way.Conclusions: A working digital archive of pediatric cardiac surgical procedures has been created. Database links to hospital systems create the opportunity for linking full, visual records of procedures to be retained in an electronic patient record. [Copyright &y& Elsevier]

Background: The balance between systemic oxygen consumption (&Vdot;O2) and delivery (DO2) is impaired after cardiopulmonary bypass (CPB) and is related to systemic inflammatory response syndrome. We sought to assess &Vdot;O2 and DO2 and their relationship with proinflammatory cytokines after CPB with the use of modified ultrafiltration (MUF) in infants.Methods: Sixteen infants, aged 1–11.5 months (median, 6.3 months), undergoing hypothermic CPB with MUF were studied during the first 12 hours after arrival in the intensive care unit (ICU). The central temperature was maintained at 36.8–37.1°C using external cooling or warming. &Vdot;O2 was continuously measured using respiratory mass spectrometry. Arterial blood samples for the tumor necrosis factor (TNF), interleukin-6 (IL-6), and interleukin-8 (IL-8) were taken and DO2 was calculated using the Fick principle on arrival at the ICU, and 2, 4, 8, and 12 hours postoperatively. Cytokines were additionally measured after induction of anesthesia and at the end of MUF.Results: &Vdot;O2 significantly decreased by 18.8% during the study period. DO2 was depressed throughout this period and reached a nadir at 8 hours (357.1 ± 136.2 ml · min-1 · m-2). The decrease in cytokines was accompanied with the decrease in &Vdot;O2 despite varied relationships between the levels of each of the cytokines and &Vdot;O2 measurements.Conclusions: Our data indicate an unusual continuous decrease in &Vdot;O2 during the first 12 hours after CPB in infants. Control of body temperature to maintain euthermia in addition to the use of MUF may be beneficial to the balance between &Vdot;O2 and DO2 in the early postoperative period. [Copyright &y& Elsevier]

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Uhl''s anomaly is a rare condition and surgical techniques are few and have had variable success. We present a novel and successful surgical technique to treat this difficult condition. [Copyright &y& Elsevier]

Slide tracheoplasty has become the preferred technique for repair of long-segment congenital tracheal stenosis with complete tracheal rings. Complex morphological subtypes require technical modifications, which we present as follows. [Copyright &y& Elsevier]

The first report of The Society of Thoracic Surgeons (STS) National Congenital Heart Surgery Database in 1998 reported the clinical features of 18 congenital heart categories. The report provided a significant amount of important information and also highlighted the strengths and weaknesses of the existing database. Following this report the STS Congenital Heart Surgery Committee in cooperation with the European Association of Cardio-Thoracic Surgery and the European Congenital Heart Surgeons Foundation initiated the International Congenital Heart Surgery Nomenclature and Database Project. The goal was to begin the standardization of nomenclature reporting strategies and establish the foundations for an international congenital heart surgery database. The first report of the International Congenital Heart Surgery Nomenclature Project was published in The Annals of Thoracic Surgery in April 2000. The current report outlines modifications to the minimum dataset as well as the diagnoses and procedure short lists. Plans for the next STS National Congenital Heart Surgery Database harvest are also presented. [Copyright &y& Elsevier]

Abstract: Objective: The Aristotle Score has been proposed as a measure of ‘complexity’ in congenital heart surgery, and a tool for comparing performance amongst different centres. To date, however, it remains unvalidated. We examined whether the Basic Aristotle Score was a useful predictor of mortality following open-heart surgery, and compared it to the Risk Adjustment in Congenital Heart Surgery (RACHS-1) system. We also examined the ability of the Aristotle Score to measure performance. Methods: The Basic Aristotle Score and RACHS-1 risk categories were assigned retrospectively to 1085 operations involving cardiopulmonary bypass in children less than 18 years of age. Multiple logistic regression analysis was used to determine the significance of the Aristotle Score and RACHS-1 category as independent predictors of in-hospital mortality. Operative performance was calculated using the Aristotle equation: performance=complexity×survival. Results: Multiple logistic regression identified RACHS-1 category to be a powerful predictor of mortality (Wald 17.7, p <0.0001), whereas Aristotle Score was only weakly associated with mortality (Wald 4.8, p =0.03). Age at operation and bypass time were also highly significant predictors of postoperative death (Wald 13.7 and 33.8, respectively, p <0.0001 for both). Operative performance was measured at 7.52units. Conclusions: The Basic Aristotle Score was only weakly associated with postoperative mortality in this series. Operative performance appeared to be inflated by the fact that the overall complexity of cases was relatively high in this series. An alternative equation (performance=complexity/mortality) is proposed as a fairer and more logical method of risk-adjustment. [Copyright &y& Elsevier]

In 1998, the first report of the Society of Thoracic Surgery (STS) National Congenital Heart Surgery Database reported the clinical features of 18 congenital heart categories. The report provided a significant amount of important information and also highlighted the strengths and weaknesses of the existing database. Following this report, the STS Congenital Heart Surgery Committee, in cooperation with the European Association of Cardio-Thoracic Surgery and the European Congenital Heart Surgeons Foundation, initiated the International Congenital Heart Surgery and Nomenclature Database Project. The goal was to begin the standardization of nomenclature and reporting strategies and establish the foundations for an international congenital heart surgery database. The first report of the International Congenital Heart Surgery Nomenclature Project was published in the Annals of Thoracic Surgery in April 2000. The current report outlines modifications to the minimal dataset, as well as the diagnosis and procedure short lists. [Copyright &y& Elsevier]

Abstract: Objective: We introduced a fast-track program for our cardiac operations requiring adjustment in anaesthesia techniques to facilitate rapid extubation and discharge from the intensive care unit (ICU). Our objective was to investigate the quality of analgesia in fast-track paediatric cardiac patients. Methods: We performed a retrospective review of the records of all patients who were fast-tracked in our institution between January 2006 and January 2007. Data collected included surgical procedure, anaesthesia technique, intra-operative opioids, ventilation time, intensive care stay, postoperative morphine consumption, pain scores, patient-controlled analgesia/nurse-controlled analgesia (PCA/NCA) duration, supplemental analgesia and incidence of vomiting. Results: Fifty-four patients were studied, with a median age of 5.6 years (8 months–18 years), median weight 15.6kg (range: 6.4–101kg), median intensive care unit (ICU) ventilation time 1.1h (range: 0–8h) and median ICU stay of 4.1h (1–52h). All patients received intra-operative fentanyl, median dose of 16.8mcgkg−1 (range: 15–20mcgkg−1). Twenty-three children received a bolus of morphine intra-operatively median dose of 102mcgkg−1 (range: 50–170mcgkg−1). Those patients who did not receive a morphine bolus intra-operatively, received a 100mcgkg−1 loading dose of morphine in the ICU. Twenty-four patients received intravenous paracetamol intra-operatively and five patients were given both paracetamol and diclofenac. Twenty-five children were not given either paracetamol or diclofenac intra-operatively. During the postoperative period, all patients received morphine by infusion administered via either PCA (18%) or NCA)(73%). The median PCA/NCA infusion time was 28.9h. Forty-eight patients received paracetamol and non-steroidal analgesics postoperatively, either diclofenac or ibuprofen. Five patients received only paracetamol and only one patient required no supplemental analgesia. The bedside nurse reported the pain scores on an hourly basis on a 10-point visual analogue score where 0=no pain and 10=strongest pain. Pain scores showed that most patients after day 0 (which was the day of surgery) had only mild pain. Conclusions: Our data showed that our program achieves high-quality analgesia in fast-track paediatric cardiac patients. [Copyright &y& Elsevier]

Abstract: Objective: Fast-track patient pathways for cardiac surgery are used in adult practice and by necessity is a mainstay in the developing world. We aimed to introduce a fast-track protocol for uncomplicated paediatric open-heart surgery cases and to subsequently review the results of this change in practice. Methods: A fast-track protocol co-ordinated by the Advanced Nurse Practitioners was introduced in January 2006 for children aged over 6 months undergoing uncomplicated open-heart procedures. We conducted a review of prospectively collected data on all included patients. The setting was a tertiary paediatric cardiac surgical centre in the UK. The outcome measures for audit were: patient fitness to leave the intensive care unit (ICU) on the day of surgery and hospital length of stay. Results: Included children had a mean age 6 (standard deviation (SD) 4.9) years and mean weight 22.7 (SD 17.6) kg. Of the 194 patients included, 153 (79%) were fit to leave the ICU on the day of surgery. Patients undergoing surgery for ventricular septal defect: odds ratio (OR) 2.8 (95% CI: 1.2–5.6) P =0.01 and left ventricular outflow tract obstruction: OR 5.5 (95% CI: 1.4–21.2) P =0.01, were more likely to be unfit than atrial septal defect and right ventricular outflow tract obstruction. Patients undergoing surgery in the afternoon were more likely to be unfit than those undergoing surgery in the morning: OR 2.3 (95% CI: 1.2–4.8) P =0.03. No relationship was found between age or weight and fitness to fast track. Median length of hospital stay for the whole cohort was 3 (range: 2–11) days. After adjustment for case mix, there was significant evidence that length of hospital stay reduced as experience with the protocol increased over the series of patients RC −0.02 (95% CI: −0.01 to −0.03) P <0.01. Conclusion: A fast-track programme can be implemented safely and effectively if the appropriate support including a step-down ward area is put in place. Greater experience with this type of protocol leads to reductions in the length of hospital stay for children aged over 6 months undergoing uncomplicated open-heart surgery. Fast-track cases should be performed in the morning. [Copyright &y& Elsevier]

Summary: Objective: To review our strategy for the treatment of patients with Type IV laryngotracheoesophageal cleft—a very rare congenital malformation. Methods: Retrospective review of nine cases of Type IV laryngotracheoesophageal cleft managed between October 1994 and January 2004 at Great Ormond Street Hospital for Children, London. Results: Three children were not operated upon (Group A) because of serious co-morbidity and parental decision not to opt for repair; they died at the ages of 2, 7 and 14 days, respectively. Six cases were repaired (Group B) at ages ranging from 2 to 53 days, all using an anterior cervico-thoracic approach. Two cases were operated upon using conventional ventilation, three using cardiopulmonary bypass and one using extracorporeal membrane oxygenation. There was no intra-operative mortality. The number of operative and diagnostic procedures varied from 4 to 37. Two operated cases expired at the ages of 11 days and 25 months; both were operated upon using cardiopulmonary bypass and had significant cardiac co-morbidity. Post-operative microlaryngoscopy and bronchoscopy showed dehiscence in the cleft repair ranging from 1mm to 2cm in five cases. This was observed at the distal end in three patients and just below the vocal cords in two cases. Three cases underwent further repair which was successful. The most recent case repaired using extracorporeal membrane oxygenation required less heparin when compared with those done on cardiopulmonary bypass and had the best post-operative result. Two patients were finally decannulated. The total duration of diagnostic and operative procedures ranged from 9 to 26h and 30min. The hospital stay in the operated cases varied from 9 days to 2 years 2 months 3 days, and their ICU stay ranged from 9 days to 10 months 7 days. All four of our patients with clefts which ended above the carina are alive after multiple repairs whereas all five cases with clefts extending all the way to the carina died (repair was attempted in two). Conclusion: Early diagnosis and repair are essential for successful treatment of Type IV laryngotracheoesophageal clefts. We believe it is best to repair this defect via an anterior cervico-thoracic approach, with or without a median sternotomy, and extracorporeal membrane oxygenation is now our preferred method of gas exchange during such repair. The longest Type IV clefts extending all the way to the carina have the worst prognosis. The decision to operate or not should be based upon the associated co-morbidity and fully informed parental choice, since treatment entails significant morbidity and mortality. [Copyright &y& Elsevier]

Abstract: Objective: The aim of this study was to develop a graphical method of risk-stratified outcome analysis in paediatric cardiac surgery to provide a means of continuous, prospective performance monitoring and allow real-time detection of change in outcomes. Methods: Risk-adjusted survival following open-heart surgery was prospectively measured over a 15-month period (n =460). Outcomes were charted using variable life-adjusted display (VLAD) charts, which indicate the cumulative difference in observed minus expected survival against the cumulative number of cases performed. Risk stratification was based on RACHS-1 (risk adjustment in congenital heart surgery) risk category and age at surgery, using our previously published risk model. The probability of deviation in performance from the expected baseline level was determined using a mathematical model. Results: By the end of the series, observed survival (443/460=96.3%) exceeded that predicted by the risk model (434.5/460=94.5%), equivalent to a one-third reduction in expected mortality. Mathematical modelling indicated a 1–5% likelihood that this difference would have occurred by random variation alone, suggesting the outcomes represented genuine improvement. Conclusions: VLAD charts provide an effective, easily visualised display of surgical performance and can be applied to paediatric cardiac surgery. Early detection of change, whether improvement or deterioration, is important for ongoing quality assurance within a cardiac surgery programme. [Copyright &y& Elsevier]

Background: More children are coming to heart transplantation on extracorporeal membrane oxygenation (ECMO), or inotropic support and/or with renal impairment. The use of basiliximab, a chimeric monoclonal antibody against CD25 (interleukin 2 receptor alfa) has not been previously reported in critically ill pediatric heart transplant recipients. Basiliximab has potential advantages in the treatment of patients with renal impairment. Methods: Basiliximab was provided to 29 patients (median age 7.8 years; range 0.4–16 years) on ECMO, with renal impairment or receiving intravenous inotropes at transplantation. Children normally received 2 doses on Day 0 and Day 4 after transplantation. Calcineurin inhibitor was provided in low dose or withheld altogether in patients with renal impairment. Flow cytometry was used to monitor CD25. Results: At transplantation, 11 patients were prescribed cyclosporine; the remaining 18 received tacrolimus. All but 4 patients had subtherapeutic levels of calcineurin inhibitor in the first postoperative week. Excluding these 4, there were 19 patients who had more than 4 consecutive doses of calcineurin inhibitor canceled in the first week (median 8 doses; range 3–40 doses). A total of 71 surveillance biopsies were performed, and 4 episodes of severe acute rejection occurred in the first 6 months. In all but one child, the glomerular filtration rate had returned to, or improved on baseline measurement by 1 month after transplantation. Infections rates were low and acceptable. CD25 was undetectable at first assessment, and in all but 1 patient (on ECMO) for at least 2 to 3 weeks thereafter. There were no adverse effects. Conclusions: Basiliximab was well tolerated in this group of very ill children. In children with pre- or postoperative renal dysfunction, where doses of calcineurin inhibitor were low or canceled, basiliximab was associated with a low incidence of rejection. Posttransplant ECMO may reduce the efficacy of basiliximab. These preliminary results are encouraging and now need confirmation in a large, randomized trial. [Copyright &y& Elsevier]

Objective: The aims of this study were to identify independent risk factors for mortality following paediatric open-heart surgery and to develop risk models for use in clinical audit based on identified risk factors. The study also tests the validity of the recently proposed Risk Adjustment in Congenital Heart Surgery (RACHS-1) method of risk stratification [J Thorac Cardiovasc Surg 123 (2002) 110] as applied to open-heart operations. Methods: A multiple logistic regression analysis was performed on all patients less than 18 years of age undergoing open-heart surgery at a single institution over a 3-year period. Preoperative and operative variables included for analysis were age at operation, weight, sex, American Society of Anaesthesiology (ASA) grade, RACHS-1 risk category, preoperative haemoglobin, bypass time, temperature, cross-clamp time, circulatory arrest time, blood transfusion on bypass and surgeon. The outcome measure was in-hospital death. Results: 1085 consecutive open-heart cases were identified. There were 51 in-hospital deaths (4.7%). Variables identified as being independently significant risk factors for in-hospital death were age (P=0.0002), RACHS-1 risk category (P<0.0001) and bypass time (P<0.0001). Based on these three variables, a risk model was constructed to predict mortality. The area under the receiver-operating-characteristic (ROC) curve for this model was 0.86. A second model was constructed ignoring bypass time. In this model, the significance of the ‘preoperative’ risk factors was P=0.0003 for age and P<0.0001 for RACHS-1 risk category. The area under the ROC curve was 0.81 for the second model. Conclusions: This study identifies age at operation, RACHS-1 risk category and bypass time as highly significant risk factors for mortality after paediatric open-heart surgery. It validates the RACHS-1 risk stratification method as applied to the subset of open-heart surgery, whilst accepting the limitations of such a system. The risk models formulated permit risk prediction and allow for analysis of surgical results. Such risk-adjustment is important when assessing performance and comparing outcomes amongst individuals or institutions. [Copyright &y& Elsevier]

Objective: The analysis of the second harvest of the STS Congenital Heart Surgery Database produced meaningful outcome data and several critical lessons relevant to congenital heart surgery outcomes analysis worldwide. Methods: This data harvest represents the first STS multi-institutional experience with software utilizing the nomenclature and database requirements adopted by the STS and EACTS (April 2000 Annals of Thoracic Surgery). Members of the STS Congenital Heart Committee analyzed the STS data. Results: This STS harvest includes data from 16 centers (12787 cases, 2881 neonates, 4124 infants). In 2002, the EACTS reported similar outcome data utilizing the same database definitions (41 centers, 12736 cases, 2245 neonates, 4195 infants). Lessons from the analysis include: (1) Death must be clearly defined. (2) The Primary Procedure in a given operation must be documented. (3) Inclusionary and exclusionary criteria for all diagnoses and procedures must be agreed upon. (4) Missing data values remain an issue for the database. (5) Generic terms in the nomenclature lists, that is terms ending in Not Otherwise Specified (NOS), are redundant and decrease the clarity of data analysis. (6) Methodology needs to be developed and implemented to assure and verify data completeness and data accuracy. ‘Operative Mortality’ and ‘Mortality Assigned to this Operation’ were defined by the STS and EACTS; these definitions were not utilized uniformly. ‘Thirty Day Mortality’ was problematic because some centers did not track mortality after hospital discharge. Only ‘Mortality Prior to Discharge’ was consistently reported. Designation of Primary Procedure for a given operation determines its location for analysis. Until Complexity Scores lead to automated methodology for choosing the Primary Procedure, the surgeon must designate the Primary Procedure. Inclusionary and exclusionary criteria for all diagnoses and procedures have been developed in an effort to define acceptable concomitant diagnoses and procedures for each analysis. Improvements in data completeness can be achieved using a variety of techniques including developing more functional techniques of data entry at individual institutions and software improvements. Future versions of the STS Congenital Database will request that the coding of diagnoses and procedures avoid the terms ending in NOS. Conclusions: Lessons from this data harvest should improve congenital heart surgery outcome analysis. [Copyright &y& Elsevier]