Characteristics and Symptoms of App Users Seeking COVID-19-Related Digital Health Information and Remote Services: Retrospective Cohort Study.

BACKGROUND: Patient-facing digital health tools have been promoted to help patients manage concerns related to COVID-19 and to enable remote care and self-care during the COVID-19 pandemic. It has also been suggested that these tools can help further our understanding of the clinical characteristics of this new disease. However, there is limited information on the characteristics and use patterns of these tools in practice. OBJECTIVE: The aims of this study are to describe the characteristics of people who use digital health tools to address COVID-19-related concerns; explore their self-reported symptoms and characterize the association of these symptoms with COVID-19; and characterize the recommendations provided by digital health tools. METHODS: This study used data from three digital health tools on the K Health app: a protocol-based COVID-19 self-assessment, an artificial intelligence (AI)-driven symptom checker, and communication with remote physicians. Deidentified data were extracted on the demographic and clinical characteristics of adults seeking COVID-19-related health information between April 8 and June 20, 2020. Analyses included exploring features associated with COVID-19 positivity and features associated with the choice to communicate with a remote physician. RESULTS: During the period assessed, 71,619 individuals completed the COVID-19 self-assessment, 41,425 also used the AI-driven symptom checker, and 2523 consulted with remote physicians. Individuals who used the COVID-19 self-assessment were predominantly female (51,845/71,619, 72.4%), with a mean age of 34.5 years (SD 13.9). Testing for COVID-19 was reported by 2901 users, of whom 433 (14.9%) reported testing positive. Users who tested positive for COVID-19 were more likely to have reported loss of smell or taste (relative rate [RR] 6.66, 95% CI 5.53-7.94) and other established COVID-19 symptoms as well as ocular symptoms. Users communicating with a remote physician were more likely to have been recommended by the self-assessment to undergo immediate medical evaluation due to the presence of severe symptoms (RR 1.19, 95% CI 1.02-1.32). Most consultations with remote physicians (1940/2523, 76.9%) were resolved without need for referral to an in-person visit or to the emergency department. CONCLUSIONS: Our results suggest that digital health tools can help support remote care and self-management of COVID-19 and that self-reported symptoms from digital interactions can extend our understanding of the symptoms associated with COVID-19.

American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock.

OBJECTIVES: The American College of Critical Care Medicine provided 2002 and 2007 guidelines for hemodynamic support of newborn and pediatric septic shock. Provide the 2014 update of the 2007 American College of Critical Care Medicine "Clinical Guidelines for Hemodynamic Support of Neonates and Children with Septic Shock." DESIGN: Society of Critical Care Medicine members were identified from general solicitation at Society of Critical Care Medicine Educational and Scientific Symposia (2006-2014). The PubMed/Medline/Embase literature (2006-14) was searched by the Society of Critical Care Medicine librarian using the keywords: sepsis, septicemia, septic shock, endotoxemia, persistent pulmonary hypertension, nitric oxide, extracorporeal membrane oxygenation, and American College of Critical Care Medicine guidelines in the newborn and pediatric age groups. MEASUREMENTS AND MAIN RESULTS: The 2002 and 2007 guidelines were widely disseminated, translated into Spanish and Portuguese, and incorporated into Society of Critical Care Medicine and American Heart Association/Pediatric Advanced Life Support sanctioned recommendations. The review of new literature highlights two tertiary pediatric centers that implemented quality improvement initiatives to improve early septic shock recognition and first-hour compliance to these guidelines. Improved compliance reduced hospital mortality from 4% to 2%. Analysis of Global Sepsis Initiative data in resource rich developed and developing nations further showed improved hospital mortality with compliance to first-hour and stabilization guideline recommendations. CONCLUSIONS: The major new recommendation in the 2014 update is consideration of institution-specific use of 1) a "recognition bundle" containing a trigger tool for rapid identification of patients with septic shock, 2) a "resuscitation and stabilization bundle" to help adherence to best practice principles, and 3) a "performance bundle" to identify and overcome perceived barriers to the pursuit of best practice principles.

An Elevated Low Cardiac Output Syndrome Score Is Associated With Morbidity in Infants After Congenital Heart Surgery.

OBJECTIVES: To evaluate an empirically derived Low Cardiac Output Syndrome Score as a clinical assessment tool for the presence and severity of Low Cardiac Output Syndrome and to examine its association with clinical outcomes in infants who underwent surgical repair or palliation of congenital heart defects. DESIGN: Prospective observational cohort study. SETTING: Cardiac ICU at Seattle Children's Hospital. PATIENTS: Infants undergoing surgical repair or palliation of congenital heart defects. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Clinical and laboratory data were recorded hourly for the first 24 hours after surgery. A Low Cardiac Output Syndrome Score was calculated by assigning one point for each of the following: tachycardia, oliguria, toe temperature less than 30°C, need for volume administration in excess of 30 mL/kg/d, decreased near infrared spectrometry measurements, hyperlactatemia, and need for vasoactive/inotropes in excess of milrinone at 0.5 µg/kg/min. A cumulative Low Cardiac Output Syndrome Score was determined by summation of Low Cardiac Output Syndrome Score on arrival to cardiac ICU, and 8, 12, and 24 hours postoperatively. Scores were analyzed for association with composite morbidity (prolonged mechanical ventilation, new infection, cardiopulmonary arrest, neurologic event, renal dysfunction, necrotizing enterocolitis, and extracorporeal life support) and resource utilization. Fifty-four patients were included. Overall composite morbidity was 33.3%. Median peak Low Cardiac Output Syndrome Score and cumulative Low Cardiac Output Syndrome Score were higher in patients with composite morbidity (3 [2-5] vs 2 [1-3]; p = 0.003 and 8 [5-10] vs 2.5 [1-5]; p < 0.001)]. Area under the receiver operating characteristic curve for cumulative Low Cardiac Output Syndrome Score versus composite morbidity was 0.83, optimal cutoff of greater than 6. Patients with cumulative Low Cardiac Output Syndrome Score greater than or equal to 7 had higher morbidity, longer duration of mechanical ventilation, cardiac ICU, and hospital length of stay (all p ≤ 0.001). After adjusting for other relevant variables, peak Low Cardiac Output Syndrome Score and cumulative Low Cardiac Output Syndrome Score were independently associated with composite morbidity (odds ratio, 2.57; 95% CI, 1.12-5.9 and odds ratio, 1.35; 95% CI, 1.09-1.67, respectively). CONCLUSION: Higher peak Low Cardiac Output Syndrome Score and cumulative Low Cardiac Output Syndrome Score were associated with increased morbidity and resource utilization among infants following surgery for congenital heart defects and might be a useful tools in future cardiac intensive care research. Independent validation is required.

Outcomes Analysis and Quality Improvement in Children With Congenital and Acquired Cardiovascular Disease.

OBJECTIVES: In this review, the current state of outcomes analysis and quality improvement in children with acquired and congenital cardiovascular disease will be discussed, with an emphasis on defining and measuring outcomes and quality in pediatric cardiac critical care medicine and risk stratification systems. DATA SOURCE: MEDLINE and PubMed CONCLUSION: : Measuring quality and outcomes in the pediatric cardiac critical care environment is challenging owing to many inherent obstacles, including a diverse patient mix, difficulty in determining how the care of the ICU team contributes to outcomes, and the lack of an adequate risk-adjustment method for pediatric cardiac critical care patients. Despite these barriers, new solutions are emerging that capitalize on lessons learned from other quality improvement initiatives, providing opportunities to build upon previous successes.

Pediatric Index of Cardiac Surgical Intensive Care Mortality Risk Score for Pediatric Cardiac Critical Care.

OBJECTIVE: Comparison of clinical outcomes is imperative in the evaluation of healthcare quality. Risk adjustment for children undergoing cardiac surgery poses unique challenges, due to its distinct nature. We developed a risk-adjustment tool specifically focused on critical care mortality for the pediatric cardiac surgical population: the Pediatric Index of Cardiac Surgical Intensive care Mortality score. DESIGN: Retrospective analysis of prospectively collected pediatric critical care data. SETTING: Pediatric critical care units in the United States. PATIENTS: Pediatric cardiac intensive care surgical patients. INTERVENTIONS: Prospectively collected data from consecutive patients admitted to ICUs were obtained from The Virtual PICU System (VPS, LLC, Los Angeles, CA), a national pediatric critical care database. Thirty-two candidate physiologic, demographic, and diagnostic variables were analyzed for inclusion in the development of the Pediatric Index of Cardiac Surgical Intensive care Mortality model. Multivariate logistic regression with stepwise selection was used to develop the model. MEASUREMENTS AND MAIN RESULTS: A total of 16,574 cardiac surgical patients from the 55 PICUs across the United States were included in the analysis. Thirteen variables remained in the final model, including the validated Society of Thoracic Surgeons-European Association of Cardio-Thoracic Surgery Congenital Heart Surgery Mortality (STAT) score and admission time with respect to cardiac surgery, which identifies whether the patient underwent the index surgical procedure before or after admission to the ICU. Pediatric Index of Cardiac Surgical Intensive Care Mortality (PICSIM) performance was compared with the performance of Pediatric Risk of Mortality-3 and Pediatric Index of Mortality-2 risk of mortality scores, as well as the STAT score and STAT categories by calculating the area under the curve of the receiver operating characteristic from a validation dataset: PICSIM (area under the curve = 0.87) performed better than Pediatric Index of Mortality-2 (area under the curve = 0.81), Pediatric Risk of Mortality-3 (area under the curve = 0.82), STAT score (area under the curve = 0.77), STAT category (area under the curve = 0.75), and Risk Adjustment for Congenital Heart Surgery-1 (area under the curve = 0.74). CONCLUSIONS: This newly developed mortality score, PICSIM, consisting of 13 risk variables encompassing physiology, cardiovascular condition, and time of admission to the ICU showed better discrimination than Pediatric Index of Mortality-2, Pediatric Risk of Mortality-3, and STAT score and category for mortality in a multisite cohort of pediatric cardiac surgical patients. The introduction of the variable "admission time with respect to cardiac surgery" allowed prediction of mortality when patients are admitted to the ICU either before or after the index surgical procedure.

Vasoactive-inotropic score is associated with outcome after infant cardiac surgery: an analysis from the Pediatric Cardiac Critical Care Consortium and Virtual PICU System Registries.

OBJECTIVE: To empirically derive the optimal measure of pharmacologic cardiovascular support in infants undergoing cardiac surgery with bypass and to assess the association between this score and clinical outcomes in a multi-institutional cohort. DESIGN: Prospective, multi-institutional cohort study. SETTING: Cardiac ICUs at four academic children's hospitals participating in the Pediatric Cardiac Critical Care Consortium during the study period. PATIENTS: Children younger than 1 year at the time of surgery treated postoperatively in the cardiac ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Three hundred ninety-one infants undergoing surgery with bypass were enrolled consecutively from November 2011 to April 2012. Hourly doses of all vasoactive agents were recorded for the first 48 hours after cardiac ICU admission. Multiple derivations of an inotropic score were tested, and maximum vasoactive-inotropic score in the first 24 hours was further analyzed for association with clinical outcomes. The primary composite "poor outcome" variable included at least one of mortality, mechanical circulatory support, cardiac arrest, renal replacement therapy, or neurologic injury. High vasoactive-inotropic score was empirically defined as more than or equal to 20. Multivariable logistic regression was performed controlling for center and patient characteristics. Patients with high vasoactive-inotropic score had significantly greater odds of a poor outcome (odds ratio, 6.5; 95% CI, 2.9-14.6), mortality (odds ratio, 13.2; 95% CI, 3.7-47.6), and prolonged time to first extubation and cardiac ICU length of stay compared with patients with low vasoactive-inotropic score. Stratified analyses by age (neonate vs infant) and surgical complexity (low vs high) showed similar associations with increased morbidity and mortality for patients with high vasoactive-inotropic score. CONCLUSIONS: Maximum vasoactive-inotropic score calculated in the first 24 hours after cardiac ICU admission was strongly and significantly associated with morbidity and mortality in this multi-institutional cohort of infants undergoing cardiac surgery. Maximum vasoactive-inotropic score more than or equal to 20 predicts an increased likelihood of a poor composite clinical outcome. The findings were consistent in stratified analyses by age and surgical complexity.

Creating a standardized process to offer the standard of care: continuous process improvement methodology is associated with increased rates of sperm cryopreservation among adolescent and young adult males with cancer.

BACKGROUND: There is limited literature on strategies to overcome the barriers to sperm banking among adolescent and young adult (AYA) males with cancer. By standardizing our process for offering sperm banking to AYA males before cancer treatment, we aimed to improve rates of sperm banking at our institution. MATERIALS AND METHODS: Continuous process improvement is a technique that has recently been applied to improve health care delivery. We used continuous process improvement methodologies to create a standard process for fertility preservation for AYA males with cancer at our institution. We compared rates of sperm banking before and after standardization. RESULTS: In the 12-month period after implementation of a standardized process, 90% of patients were offered sperm banking. We demonstrated an 8-fold increase in the proportion of AYA males' sperm banking, and a 5-fold increase in the rate of sperm banking at our institution. DISCUSSION: Implementation of a standardized process for sperm banking for AYA males with cancer was associated with increased rates of sperm banking at our institution. This study supports the role of standardized health care in decreasing barriers to sperm banking.

Cardiovascular Dysfunction Criteria in Critically Ill Children: The PODIUM Consensus Conference.

CONTEXT: Cardiovascular dysfunction is associated with poor outcomes in critically ill children. OBJECTIVE: We aim to derive an evidence-informed, consensus-based definition of cardiovascular dysfunction in critically ill children. DATA SOURCES: Electronic searches of PubMed and Embase were conducted from January 1992 to January 2020 using medical subject heading terms and text words to define concepts of cardiovascular dysfunction, pediatric critical illness, and outcomes of interest. STUDY SELECTION: Studies were included if they evaluated critically ill children with cardiovascular dysfunction and assessment and/or scoring tools to screen for cardiovascular dysfunction and assessed mortality, functional status, organ-specific, or other patient-centered outcomes. Studies of adults, premature infants (≤36 weeks gestational age), animals, reviews and/or commentaries, case series (sample size ≤10), and non-English-language studies were excluded. Studies of children with cyanotic congenital heart disease or cardiovascular dysfunction after cardiopulmonary bypass were excluded. DATA EXTRACTION: Data were abstracted from each eligible study into a standard data extraction form, along with risk-of-bias assessment by a task force member. RESULTS: Cardiovascular dysfunction was defined by 9 elements, including 4 which indicate severe cardiovascular dysfunction. Cardiopulmonary arrest (>5 minutes) or mechanical circulatory support independently define severe cardiovascular dysfunction, whereas tachycardia, hypotension, vasoactive-inotropic score, lactate, troponin I, central venous oxygen saturation, and echocardiographic estimation of left ventricular ejection fraction were included in any combination. There was expert agreement (>80%) on the definition. LIMITATIONS: All included studies were observational and many were retrospective. CONCLUSIONS: The Pediatric Organ Dysfunction Information Update Mandate panel propose this evidence-informed definition of cardiovascular dysfunction.

Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Contemporary Organ Dysfunction Criteria: Executive Summary.

Prior criteria for organ dysfunction in critically ill children were based mainly on expert opinion. We convened the Pediatric Organ Dysfunction Information Update Mandate (PODIUM) expert panel to summarize data characterizing single and multiple organ dysfunction and to derive contemporary criteria for pediatric organ dysfunction. The panel was composed of 88 members representing 47 institutions and 7 countries. We conducted systematic reviews of the literature to derive evidence-based criteria for single organ dysfunction for neurologic, cardiovascular, respiratory, gastrointestinal, acute liver, renal, hematologic, coagulation, endocrine, endothelial, and immune system dysfunction. We searched PubMed and Embase from January 1992 to January 2020. Study identification was accomplished using a combination of medical subject headings terms and keywords related to concepts of pediatric organ dysfunction. Electronic searches were performed by medical librarians. Studies were eligible for inclusion if the authors reported original data collected in critically ill children; evaluated performance characteristics of scoring tools or clinical assessments for organ dysfunction; and assessed a patient-centered, clinically meaningful outcome. Data were abstracted from each included study into an electronic data extraction form. Risk of bias was assessed using the Quality in Prognosis Studies tool. Consensus was achieved for a final set of 43 criteria for pediatric organ dysfunction through iterative voting and discussion. Although the PODIUM criteria for organ dysfunction were limited by available evidence and will require validation, they provide a contemporary foundation for researchers to identify and study single and multiple organ dysfunction in critically ill children.

Performance of the Pediatric Index of Mortality 2 for pediatric cardiac surgery patients.

OBJECTIVE: To evaluate the performance of the Pediatric Index of Mortality 2 (PIM-2) for pediatric cardiac surgery patients admitted to the pediatric intensive care unit (PICU). DESIGN: : Retrospective cohort analysis. SETTING: Multi-institutional PICUs. PATIENTS: Children whose PICU admission had an associated cardiac surgical procedure. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Performance of the PIM-2 was evaluated with both discrimination and calibration measures. Discrimination was assessed with a receiver operating characteristic curve and associated area under the curve measurement. Calibration was measured across defined groups based on mortality risk, using the Hosmer-Lemeshow goodness-of-fit test. Analyses were performed initially, using the entire cohort, and then based on operative status (perioperative defined as procedure occurring within 24 hrs of PICU admission and preoperative as occurring >24 hrs from the time of PICU admission). A total of 9,208 patients were identified as cardiac surgery patients with 8,391 (91%) considered as perioperative. Average age of the entire cohort was 3.3 yrs (median, 10 mos, 0-18 yrs), although preoperative children tended to be younger (median, <1 month). Preoperative patients also had longer PICU median lengths of stay than perioperative patients (12 days [1-375 days] vs. 3 days [1-369 days], respectively). For the entire cohort, the PIM-2 had fair discrimination power (area under the curve, 0.80; 95% confidence interval, 0.77-0.83) and poor calibration (p < .0001). Its predictive ability was similarly inadequate for quality assessment (standardized mortality ratio, 0.81; 95% confidence interval, 0.72-0.90) with significant overprediction in the highest-decile risk group. For the subpopulations, the model continued to perform poorly with low area under the curves for preoperative patients and poor calibration for both groups. PIM-2 tended to overpredict mortality for perioperative patients and underpredict for preoperative patients (standardized mortality ratios, 0.69 [95% confidence interval, 0.59-0.78] and 1.48 [95% confidence interval, 1.27-1.70], respectively). CONCLUSIONS: The PIM-2 demonstrated poor performance with fair discrimination, poor calibration, and predictive ability for pediatric cardiac surgery population and thus cannot be recommended in its current form as an adequate adjustment tool for quality measurement in this patient group.

Novel pH1N1 viral cardiomyopathy requiring veno-venous extracorporeal membrane oxygenation.

OBJECTIVE: To report a case of pH1N1 viral infection presenting as heart failure requiring mechanical extracorporeal life support. DESIGN: Case report. SETTING: Pediatric intensive care unit at a regional children's hospital. PATIENT: Obese 15-yr-old boy who presented with pH1N1-related cardiomyopathy and respiratory failure that required extracorporeal membrane oxygenation. INTERVENTIONS: Extracorporeal membrane oxygenation, echocardiography, high-frequency oscillating ventilation. MEASUREMENTS AND MAIN RESULTS: Discovery of severe dilated cardiomyopathy and respiratory failure. CONCLUSIONS: Patients with pH1N1 may present in profound heart failure in addition to respiratory failure. Extracorporeal membrane oxygenation may play an important role in managing these complex patients.

Reducing the incidence of necrotizing enterocolitis in neonates with hypoplastic left heart syndrome with the introduction of an enteral feed protocol.

OBJECTIVE: Neonates with hypoplastic left heart syndrome are prone to gastrointestinal complications, including necrotizing enterocolitis, during initiation or advancement of enteral feeds. A feeding protocol was developed to standardize practice across a multidisciplinary team. The purpose of this study was to examine the impact of a standardized feeding protocol on the incidence of necrotizing enterocolitis and overall postoperative gastrointestinal morbidity. DESIGN: Retrospective case-control study. SETTING: Cardiothoracic intensive care unit of a tertiary care children's hospital. PATIENTS: Ninety-eight neonates with hypoplastic left heart syndrome admitted to the cardiothoracic intensive care unit after first-stage palliation. INTERVENTION: A retrospective chart review was performed. Two groups were analyzed: the preprotocol group (n = 52) was examined from January 2000 through December 31, 2001, and the postprotocol group (n = 46) from February 2002 through December 31, 2003. MEASUREMENTS AND MAIN RESULTS: The incidence of suspected or diagnosed necrotizing enterocolitis as defined by the modified Bell staging criteria was recorded. Data were also collected regarding postoperative day of enteral feed initiation, postoperative day full feeds attained, and postoperative hospital length of stay. Necrotizing enterocolitis was detected in 14 preprotocol (27%) and three postprotocol (6.5%) patients (p < .01). Enteral feeds were initiated later in the postprotocol group (7.5 vs. 5.5 days, p < .001), and number of days to full feeds was also later in the postprotocol group (7 vs. 4 days, p = .02). Hospital length of stay tended to be shorter in the postprotocol group (21.5 vs. 28 days, p = .25). CONCLUSION: Measures directed at reducing the incidence of necrotizing enterocolitis may reduce morbidity in neonates with hypoplastic left heart syndrome and reduce cost by decreasing hospital length of stay. A standardized feeding protocol instituted to address these problems likely contributed to reducing the incidence of necrotizing enterocolitis in this high-risk population.

Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine.

BACKGROUND: The Institute of Medicine calls for the use of clinical guidelines and practice parameters to promote "best practices" and to improve patient outcomes. OBJECTIVE: 2007 update of the 2002 American College of Critical Care Medicine Clinical Guidelines for Hemodynamic Support of Neonates and Children with Septic Shock. PARTICIPANTS: Society of Critical Care Medicine members with special interest in neonatal and pediatric septic shock were identified from general solicitation at the Society of Critical Care Medicine Educational and Scientific Symposia (2001-2006). METHODS: The Pubmed/MEDLINE literature database (1966-2006) was searched using the keywords and phrases: sepsis, septicemia, septic shock, endotoxemia, persistent pulmonary hypertension, nitric oxide, extracorporeal membrane oxygenation (ECMO), and American College of Critical Care Medicine guidelines. Best practice centers that reported best outcomes were identified and their practices examined as models of care. Using a modified Delphi method, 30 experts graded new literature. Over 30 additional experts then reviewed the updated recommendations. The document was subsequently modified until there was greater than 90% expert consensus. RESULTS: The 2002 guidelines were widely disseminated, translated into Spanish and Portuguese, and incorporated into Society of Critical Care Medicine and AHA sanctioned recommendations. Centers that implemented the 2002 guidelines reported best practice outcomes (hospital mortality 1%-3% in previously healthy, and 7%-10% in chronically ill children). Early use of 2002 guidelines was associated with improved outcome in the community hospital emergency department (number needed to treat = 3.3) and tertiary pediatric intensive care setting (number needed to treat = 3.6); every hour that went by without guideline adherence was associated with a 1.4-fold increased mortality risk. The updated 2007 guidelines continue to recognize an increased likelihood that children with septic shock, compared with adults, require 1) proportionally larger quantities of fluid, 2) inotrope and vasodilator therapies, 3) hydrocortisone for absolute adrenal insufficiency, and 4) ECMO for refractory shock. The major new recommendation in the 2007 update is earlier use of inotrope support through peripheral access until central access is attained. CONCLUSION: The 2007 update continues to emphasize early use of age-specific therapies to attain time-sensitive goals, specifically recommending 1) first hour fluid resuscitation and inotrope therapy directed to goals of threshold heart rates, normal blood pressure, and capillary refill 70% and cardiac index 3.3-6.0 L/min/m.

Congenital cardiac surgical complications of the integument, vascular system, vascular-line(s), and wounds: consensus definitions from the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.

A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval. The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease has set forth a comprehensive list of complications associated with the treatment of patients with congenital cardiac disease, related to cardiac, pulmonary, renal, haematological, infectious, neurological, gastrointestinal, and endocrinal systems, as well as those related to the management of anaesthesia and perfusion, and the transplantation of thoracic organs. The objective of this manuscript is to examine the definitions of operative morbidity as they relate specifically to a collection of loosely related topics that include the following groups of complications: 1) Complications of the Integument, 2) Complications of the Vascular System, 3) Complications of the Vascular-Line(s), 4) Complications of Wounds. These specific definitions and terms will be used to track morbidity associated with surgical and transcatheter interventions and other forms of therapy in a common language across many separate databases. As surgical survival in children with congenital cardiac disease has improved in recent years, focus has necessarily shifted to reducing the morbidity of congenital cardiac malformations and their treatment. A comprehensive list of complications is presented. This list is a component of a systems-based compendium of complications that will standardize terminology and thereby allow the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

Neurological 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.

A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval. The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease has set forth a comprehensive list of complications associated with the treatment of patients with congenital cardiac disease, related to cardiac, pulmonary, renal, haematological, infectious, neurological, gastrointestinal, and endocrine systems, as well as those related to the management of anaesthesia and perfusion, and the transplantation of thoracic organs. The objective of this manuscript is to examine the definitions of operative morbidity as they relate specifically to the neurological system. These specific definitions and terms will be used to track morbidity associated with surgical and transcatheter interventions and other forms of therapy in a common language across many separate databases. Although neurological injury and adverse neurodevelopmental outcome can follow procedures for congenital cardiac defects, much of the variability in neurological outcome is now recognized to be more related to patient specific factors rather than procedural factors. Additionally, the recognition of pre and postoperative neurological morbidity requires procedures and imaging modalities that can be resource-intensive to acquire and analyze, and little is known or described about variations in "sampling rate" from centre to centre. The purpose of this effort is to propose an initial set of consensus definitions for neurological complications following congenital cardiac surgery and intervention. Given the dramatic advances in understanding achieved to date, and those yet to occur, this effort is explicitly recognized as only the initial first step of a process that must remain iterative. This list is a component of a systems-based compendium of complications that may help standardize terminology and possibly enhance the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease may be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.

Complications related to the transplantation of thoracic organs: consensus definitions from the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.

A complication is an event or occurrence associated with a disease or a healthcare intervention, which constitutes a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after an intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval. The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease has set forth a comprehensive list of complications associated with the treatment of patients with congenital cardiac disease, related to cardiac, pulmonary, renal, haematological, infectious, neurological, gastrointestinal, and endocrinal systems, as well as those related to the management of anaesthesia and perfusion, and the transplantation of thoracic organs. The objective of this manuscript is to examine the definitions of operative morbidity as they relate specifically to patients who have received transplantation of the heart, heart and lung(s) or lung(s). These specific definitions and terms will be used to track morbidity associated with transplantation in a common language across many separate databases. The complications of transplantation are known risks of congenital cardiac surgery. The purpose of this effort is to propose consensus definitions for post-transplant complications following cardiac surgery so that collection of such data can be standardized. Clinicians caring for patients who have had transplantation of thoracic organs will be able to use this list for databases, quality improvement initiatives, reporting of complications, and comparing treatment strategies.

Databases for assessing the outcomes of the treatment of patients with congenital and paediatric cardiac disease--the perspective of critical care.

The development of databases to track the outcomes of children with cardiovascular disease has been ongoing for much of the last two decades, paralleled by the rise of databases in the intensive care unit. While the breadth of data available in national, regional and local databases has grown exponentially, the ability to identify meaningful measurements of outcomes for patients with cardiovascular disease is still in its early stages. In the United States of America, the Virtual Pediatric Intensive Care Unit Performance System (VPS) is a clinically based database system for the paediatric intensive care unit that provides standardized high quality, comparative data to its participants [https://portal.myvps.org/]. All participants collect information on multiple parameters: (1) patients and their stay in the hospital, (2) diagnoses, (3) interventions, (4) discharge, (5) various measures of outcome, (6) organ donation, and (7) paediatric severity of illness scores. Because of the standards of quality within the database, through customizable interfaces, the database can also be used for several applications: (1) administrative purposes, such as assessing the utilization of resources and strategic planning, (2) multi-institutional research studies, and (3) additional internal projects of quality improvement or research.In the United Kingdom, The Paediatric Intensive Care Audit Network is a database established in 2002 to record details of the treatment of all critically ill children in paediatric intensive care units of the National Health Service in England, Wales and Scotland. The Paediatric Intensive Care Audit Network was designed to develop and maintain a secure and confidential high quality clinical database of pediatric intensive care activity in order to meet the following objectives: (1) identify best clinical practice, (2) monitor supply and demand, (3) monitor and review outcomes of treatment episodes, (4) facilitate strategic healthcare planning, (5) quantify resource requirements, and (6) study the epidemiology of critical illness in children.Two distinct physiologic risk adjustment methodologies are the Pediatric Risk of Mortality Scoring System (PRISM), and the Paediatric Index of Mortality Scoring System 2 (PIM 2). Both Pediatric Risk of Mortality (PRISM 2) and Pediatric Risk of Mortality (PRISM 3) are comprised of clinical variables that include physiological and laboratory measurements that are weighted on a logistic scale. The raw Pediatric Risk of Mortality (PRISM) score provides quantitative measures of severity of illness. The Pediatric Risk of Mortality (PRISM) score when used in a logistic regression model provides a probability of the predicted risk of mortality. This predicted risk of mortality can then be used along with the rates of observed mortality to provide a quantitative measurement of the Standardized Mortality Ratio (SMR). Similar to the Pediatric Risk of Mortality (PRISM) scoring system, the Paediatric Index of Mortality (PIM) score is comprised of physiological and laboratory values and provides a quantitative measurement to estimate the probability of death using a logistic regression model.The primary use of national and international databases of patients with congenital cardiac disease should be to improve the quality of care for these patients. The utilization of common nomenclature and datasets by the various regional subspecialty databases will facilitate the eventual linking of these databases and the creation of a comprehensive database that spans conventional geographic and subspecialty boundaries.

Reclassifying by highest complexity operation rather than first operation influences mortality after pediatric heart surgery.

OBJECTIVE: To evaluate the effect on mortality of reclassifying patients undergoing pediatric heart reoperations of varying complexity by operation of highest complexity instead of by first operation. METHODS: Data from the Virtual Pediatric Systems Database on children aged < 18 years who underwent heart surgery (with or without cardiopulmonary bypass) were included (2009-2015). Only patients who underwent reoperations during the same hospitalization were included. Patients were classified based on the first cardiovascular operation (the index operation), and on the complexity of the operation (the operation with the highest Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery [STAT] mortality category of each hospital admission) performed. RESULTS: Of 51,047 patients (73 centers), 22,393 met inclusion criteria. Using index operation as the classifying operation, the number of patients classified in the STAT 1 category increased by approximately 2.5 times compared with the highest-complexity operation (index, 7,077 and highest complexity, 2,654). In contrast, when the highest-complexity classification was used, we noted an increase in the number of patients in other STAT categories. We also noted higher mortality in all STAT categories when patients were classified by index operation instead of by highest complexity (index vs highest STAT category 1, 0.6% vs 0.2%; category 2, 2.4% vs 0.8%; category 3, 3.1% vs 2.1%; category 4, 5.8% vs 5.6%; and category 5, 16.7% vs 16.5%). CONCLUSIONS: This study demonstrates differences in the reported number of patients and reported mortality in each STAT category among children undergoing various heart reoperations during the same hospitalization by classifying patients based on index operation compared with the operation of highest complexity.

An investigation of Aspergillus cardiac surgical site infections in 3 pediatric patients.

BACKGROUND: Within a 3-month period, 3 pediatric patients at our hospital developed Aspergillus surgical site infections after undergoing cardiac surgery. METHODS: A multidisciplinary team conducted an epidemiologic review of the 3 patients and their infections, operative and postoperative patient care delivery, and routine maintenance of hospital equipment and air-filtration systems and investigated potential environmental exposures within the hospital that may have contributed to the development of these infections. RESULTS: Review of the patients and their infections, operative and postoperative patient care delivery, and routine maintenance did not reveal a source for infection. Inspection of operating room (OR) facilities identified several areas in need of repair. Of the 58 samples of air and equipment exhaust in the ORs and patient care areas, 11 revealed 2 to 4 colony-forming units of various Aspergillus species per cubic meter of air, and the remaining 47 samples were negative for Aspergillus. Eighty-three samples of surfaces and equipment water reservoirs were obtained from the OR and patient care areas. One culture of a soiled liquid nitrogen tank housed between the 2 cardiac ORs revealed 13 colony-forming units of Aspergillus. CONCLUSION: No definitive source was identified, although a soiled liquid nitrogen tank contaminated with Aspergillus and kept near the OR was found and could have been a possible source.