Evaluation of a Video-Based Education Intervention for Parents of Children Undergoing Fontan Surgery: A Cluster Randomized Controlled Trial.

Background: Fontan surgery is performed at 2-4 years of age and is the third planned surgical intervention for children with a univentricular heart. Major challenges for children and parents after Fontan include (a) psychological distress, (b) prolonged pleural drainage, and (c) the need for postoperative anticoagulation. The aim of this study was to evaluate a pre-Fontan video-based intervention for parents to address these challenges. Methods: This study is a single-centre mixed-methods cluster randomized controlled trial. The intervention consisted of 3 brief whiteboard videos offered online from preadmission clinic to 1 month postoperatively. The parent's State Trait Anxiety Inventory score and the child's Post Hospital Behaviour Questionnaire score were measured 1 week and 1 month postoperatively. Semistructured interviews were conducted to obtain parental feedback on the videos. Results: We enrolled 26 children (13 female patients; 16 intervention group) and 1 parent per child. Mean State Trait Anxiety Inventory scores were similar between groups at both 1 week (52.8 vs 55.5, P = 0.25) and 1 month postoperatively (50.9 vs 53.9, P = 0.25). Post Hospital Behaviour Questionnaire scores were in the maladaptive range but did not differ between groups. Parents agreed or strongly agreed that the videos were helpful but should be provided earlier in the preoperative process. The main value of the videos was recognized as being a method for standardizing information provided to parents. Conclusions: A video-based education intervention did not impact State Trait Anxiety Inventory or Post Hospital Behaviour Questionnaire scores. However, the majority of parents agreed that the videos were helpful.

Contexte: L'opération de Fontan est réalisée à l'âge de 2 à 4 ans et constitue la troisième intervention chirurgicale planifiée chez les enfants qui présentent un ventricule unique. Les enfants et leurs parents font face à des défis importants après une opération de Fontan, dont a) la détresse psychologique, b) le drainage pleural prolongé et c) la nécessité de recourir à une anticoagulothérapie après la chirurgie. Notre étude visait à évaluer une intervention éducative préopératoire sous forme de vidéos présentées aux parents afin de leur permettre de mieux relever ces défis. Méthodologie: Nous avons mené un essai monocentrique à méthodes mixtes et à répartition aléatoire par grappes avec groupe témoin. L'intervention éducative consistait en une série de trois courtes vidéos sur tableau blanc disponibles en ligne à partir de la consultation clinique de préadmission et jusqu'à un mois après la chirurgie. Les scores des parents à l'inventaire d'anxiété situationnelle et de trait d'anxiété (State Trait Anxiety Inventory) et les scores des enfants à l'évaluation du comportement suivant l'hospitalisation (Post Hospital Behaviour Questionnaire) ont été mesurés une semaine et un mois après l'opération. Des entrevues semi-dirigées ont été réalisées afin de recueillir les commentaires des parents au sujet des vidéos. Résultats: Nous avons recruté 26 enfants (dont 13 filles; 16 enfants ont été affectés au groupe d'intervention éducative) et un parent pour chacun des enfants. Les scores moyens obtenus au State Trait Anxiety Inventory étaient comparables entre les deux groupes une semaine (52,8 vs 55,5, p = 0,25) et un mois (50,9 vs 53,9, p = 0,25) après l'opération. Les scores obtenus au Post Hospital Behaviour Questionnaire se situaient dans la fourchette des comportements mésadaptés, mais ne différaient pas entre les groupes. Les parents étaient d'accord ou fortement d'accord pour dire que les vidéos étaient utiles, mais qu'elles auraient dû être offertes plus tôt dans le processus préopératoire. La valeur principale des vidéos était selon eux qu'il s'agissait d'un moyen d'uniformiser l'information transmise aux parents. Conclusions: Une intervention éducative sous forme de vidéos n'a pas eu d'incidence sur les scores obtenus au State Trait Anxiety Inventory ou au Post Hospital Behaviour Questionnaire. Toutefois, la majorité des parents ont trouvé que les vidéos étaient utiles.

Accuracy and Precision of Point-of-Care International Normalized Ratio in Patients With Liver Disease.

OBJECTIVE: To determine if the CoaguChek XS Pro Point-of-Care (POC) device can accurately and precisely measure the international normalized ratio (INR) compared with the gold standard laboratory INR in pediatric and adult patients with liver disease. METHODS: This prospective cohort study included 15 pediatric patients without liver disease, 13 pediatric patients with liver disease, and 17 adult patients with liver disease. The accuracy of the POC INR values was determined using the correlation and Bland-Altman limits of agreement. The accuracy of the coagulometer INR was assessed by calculating the proportion of POC INR measurements that were ≤15% of their corresponding laboratory INR. RESULTS: A comparison of INR measurements showed an excellent correlation in pediatric patients without liver disease ( r = 0.82), pediatric patients with liver disease ( r = 0.89), and adult patients with liver disease ( r = 0.96). Fourteen (93%) POC INR values were ≤15% in pediatric patients without liver disease from its paired laboratory INR. All 13 paired measurements were ≤15% in pediatric patients with liver disease. In adult patients with liver disease, 12 (71%) POC INR values were ≤15% of their paired laboratory INR. CONCLUSIONS: In patients with liver disease, the CoaguChek XS Pro provides an accurate measure of the INR compared to laboratory INR measurements.

Prospective Exploratory Experience With Bivalirudin Anticoagulation in Pediatric Extracorporeal Membrane Oxygenation.

OBJECTIVES: Objective of this study was to determine if bivalirudin resulted in less circuit interventions than unfractionated heparin. A secondary objective was to examine associations between bivalirudin dose and partial thromboplastin time, international normalized ratio, and activated clotting time. DESIGN: Prospective observational. SETTING: Medical-surgical and cardiac PICUs. PATIENTS: Neonatal and pediatric extracorporeal membrane oxygenation patients who received bivalirudin anticoagulation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Twenty extracorporeal membrane oxygenation runs in 18 patients used bivalirudin; 90% were venoarterial. Median (interquartile range) age was 4.5 months (1.6-35 mo). Thirteen patients (72%) had an underlying cardiac diagnosis. Of the 20 runs using bivalirudin, 16 (80%) were initially started on unfractionated heparin and transitioned to bivalirudin due to ongoing circuit thrombosis despite therapeutic anti-Xa levels (n = 13), ongoing circuit thrombosis with unfractionated heparin greater than or equal to 40 U/kg/hr (n = 2), or absence of increase in ACT after bolus of 100 U/kg of unfractionated heparin and escalation of unfractionated heparin infusion (n = 1). Initial bivalirudin dose ranged from 0.2 to 0.5 mg/kg/hr; no bolus doses were used. Median (range) bivalirudin dose was 0.9 mg/kg/hr (0.15-1.6 mg/kg/hr). Median (interquartile range) time on extracorporeal membrane oxygenation was 226.5 hours (150.5-393.0 hr) including 84 hours (47-335 hr) on bivalirudin. Nonparametric results are as follows: the rate of circuit intervention was significantly lower in patients on bivalirudin than on unfractionated heparin (median [interquartile range]: 0 [0-1] and 1 [1-2], respectively; Wilcoxon p = 0.0126). Bivalirudin dose was correlated to PTT (rs = 0.4760; p < 0.0001), INR (rs = 0.6833; p < 0.0001), and ACT (rs = 0.6161; p < 0.0001). Four patients had a significant bleeding complication on bivalirudin. Survival to hospital discharge was 56%. CONCLUSIONS: Bivalirudin appears to be a viable option for systemic anticoagulation in pediatric extracorporeal membrane oxygenation patients who have failed unfractionated heparin, but questions remain namely its optimal monitoring strategy. This pilot study supports the need for larger prospective studies of bivalirudin in pediatric extracorporeal membrane oxygenation, particularly focusing on meaningful monitoring variables.

Successful Treatment of Pediatric Ventricular Assist Device Thrombosis.

Pump thrombosis represents a significant cause of morbidity and mortality in patients on continuous flow ventricular assist devices (CF-VAD). Pump thrombosis in the pediatric CF-VAD population has been reported between 11% and 44%, with the largest reported series from the PediMACS registry reporting a rate of approximately 15%. We report our early experience with four pediatric patients who developed pump thrombosis on a CF-VAD. Our limited experience suggests that the treatment of pediatric VAD thrombosis can be approached with similar principles to the adult population. Our current strategy includes:i. Initiating treatment with bivalirudin for an isolated rise in lactate dehydrogenase (LDH) with no corresponding rapid rise in plasma-free hemoglobin which may prevent further progression.ii. Treatment with a low-dose systemic tissue plasminogen activator (TPA) protocol as opposed to targeted therapy via catheter intervention if bivalirudin fails.iii. If there are concerns with respect to the impact of hemolysis on kidney function or the patient is close to a previous surgery, device exchange can be considered.The balance between achieving appropriate anticoagulation/antiplatelet therapy in the face of bleeding/hemorrhagic complications remains a challenge. There is a need for larger studies in the pediatric population to outline an algorithm for the definitive management of VAD thrombosis.

Prospective Side by Side Comparison of Outcomes and Complications With a Simple Versus Intensive Anticoagulation Monitoring Strategy in Pediatric Extracorporeal Life Support Patients.

OBJECTIVES: A continuous infusion of unfractionated heparin is the most common anticoagulant used for pediatric patients on extracorporeal life support. The objective of this study was to compare extracorporeal life support complications and outcomes between two large-volume pediatric extracorporeal life support centers that use different anticoagulation strategies. DESIGN: Prospective, observational cohort study. SETTING: The University of Michigan used simple anticoagulation monitoring, whereas the University of Alberta used an intensive anticoagulation monitoring strategy. PATIENTS: Pediatric patients on extracorporeal life support. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was major bleeding per extracorporeal life support run defined as bleeding that was retroperitoneal, pulmonary, or involved the CNS; bleeding greater than 20 mL/kg over 24 hours; or bleeding that required surgical intervention. Secondary outcomes measured were patient thrombosis per run, circuit thrombosis per run, and survival to hospital discharge per patient. Eighty-eight patients (95 runs) less than 18 years old were enrolled at the two centers over 2 years. The two centers enrolled different extracorporeal life support populations; University of Alberta enrolled more postcardiac surgical patients (74% vs 47%; p = 0.005). The indication for extracorporeal life support support also varied by center (p = 0.04). The two centers used similar proportions of VA extracorporeal life support (p = 0.3). Median (interquartile range) unfractionated heparin doses were similar between University of Michigan and University of Alberta, 30 (21-34) U/kg/hr and 26 (22-31) U/kg/hr, p value equals to 0.3, respectively. Median (interquartile range) antifactor Xa was lower in the University of Michigan cohort (0.23 [0.19-0.28] vs 0.41 [0.36-0.46] U/mL; p < 0.001). There was no significant difference in major bleeding (15% University of Michigan vs 21% University of Alberta; p = 0.6) or in patient thromboses (18% University of Michigan vs 13% University of Alberta; p = 0.5). There was no significant difference in survival to hospital discharge (University of Michigan 63% vs University of Alberta 73%; p = 0.1). CONCLUSIONS: Although this prospective cohort study compared different pediatric extracorporeal life support populations, the results did not identify a significant difference in outcomes between simple and intensive anticoagulation monitoring strategies.

Defining Optimal Brain Health in Adults: A Presidential Advisory From the American Heart Association/American Stroke Association.

Cognitive function is an important component of aging and predicts quality of life, functional independence, and risk of institutionalization. Advances in our understanding of the role of cardiovascular risks have shown them to be closely associated with cognitive impairment and dementia. Because many cardiovascular risks are modifiable, it may be possible to maintain brain health and to prevent dementia in later life. The purpose of this American Heart Association (AHA)/American Stroke Association presidential advisory is to provide an initial definition of optimal brain health in adults and guidance on how to maintain brain health. We identify metrics to define optimal brain health in adults based on inclusion of factors that could be measured, monitored, and modified. From these practical considerations, we identified 7 metrics to define optimal brain health in adults that originated from AHA's Life's Simple 7: 4 ideal health behaviors (nonsmoking, physical activity at goal levels, healthy diet consistent with current guideline levels, and body mass index <25 kg/m2) and 3 ideal health factors (untreated blood pressure <120/<80 mm Hg, untreated total cholesterol <200 mg/dL, and fasting blood glucose <100 mg/dL). In addition, in relation to maintenance of cognitive health, we recommend following previously published guidance from the AHA/American Stroke Association, Institute of Medicine, and Alzheimer's Association that incorporates control of cardiovascular risks and suggest social engagement and other related strategies. We define optimal brain health but recognize that the truly ideal circumstance may be uncommon because there is a continuum of brain health as demonstrated by AHA's Life's Simple 7. Therefore, there is opportunity to improve brain health through primordial prevention and other interventions. Furthermore, although cardiovascular risks align well with brain health, we acknowledge that other factors differing from those related to cardiovascular health may drive cognitive health. Defining optimal brain health in adults and its maintenance is consistent with the AHA's Strategic Impact Goal to improve cardiovascular health of all Americans by 20% and to reduce deaths resulting from cardiovascular disease and stroke by 20% by the year 2020. This work in defining optimal brain health in adults serves to provide the AHA/American Stroke Association with a foundation for a new strategic direction going forward in cardiovascular health promotion and disease prevention.

Coagulopathy in Children With Liver Disease.

It was thought that a high international normalized ratio predicted bleeding in patients with chronic liver disease (CLD) and patients were "autoanticoagulated." Contrary to this belief, while patients with CLD experienced bleeding, they also developed thromboses. In the last decade, the prevailing literature challenged the idea that an elevated international normalized ratio increased bleeding risk. The global assays of coagulation such as thromboelastography (TEG)/rotational thromboelastometry and thrombin generation assays provide additional insight into coagulation processes. It has become apparent that a parallel reduction of procoagulant and anticoagulant factors leave patients in a new "balanced" state, albeit a fragile one, where the balance can be easily disrupted. The inherent differences in coagulation between children and adults such as differences in levels of procoagulant and anticoagulant factors, underlying liver disease, and the paucity of studies in children make extrapolation of these findings to the pediatric population problematic. Ultimately, this is an area that requires further investigation to avoid inappropriate use of blood products and medication.

The Impact of Central Venous Catheters on Pediatric Venous Thromboembolism.

The use of central venous catheters (CVCs) in children is escalating, which is likely linked to the increased incidence of pediatric venous thromboembolism (VTE). In order to better understand the specific risk factors associated with CVC-VTE in children, as well as available prevention methods, a literature review was performed. The overall incidence of CVC-VTE was found to range from 0 to 74%, depending on the patient population, CVC type, imaging modality, and study design. Throughout the available literature, there was not a consistent determination regarding whether a particular type of central line (tunneled vs. non-tunneled vs. peripherally inserted vs. implanted), catheter material, insertion technique, or insertion location lead to an increased VTE risk. The patient populations who were found to be most at risk for CVC-VTE were those with cancer, congenital heart disease, gastrointestinal failure, systemic infection, intensive care unit admission, or involved in a trauma. Both mechanical and pharmacological prophylactic techniques have been shown to be successful in preventing VTE in adult patients, but studies in children have yet to be performed or are underpowered. In order to better determine true CVC-VTE risk factors and best preventative techniques, an increase in large, prospective pediatric trials needs to be performed.

Immunizations in Children Requiring Warfarin Therapy.

Children with conditions requiring chronic warfarin therapy have increased. The importance of receiving immunizations in this population is magnified due to potential weakness in their immune response. There is concern about immunizing on therapeutic anticoagulation due to risk of hematomas and the influence of vaccine on warfarin metabolism. This study evaluated the influence of vaccines on warfarin effect as measured by the International Normalized Ratio and the clinically relevant hematomas or bruising postimmunization. There were no clinically relevant negative outcomes postimmunizations. This study demonstrates that immunizations may be safely administered to children receiving therapeutic warfarin therapy.

Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape: A Conference Report From the American Heart Association Data Summit 2015.

BACKGROUND: A 1.5-day interactive forum was convened to discuss critical issues in the acquisition, analysis, and sharing of data in the field of cardiovascular and stroke science. The discussion will serve as the foundation for the American Heart Association's (AHA's) near-term and future strategies in the Big Data area. The concepts evolving from this forum may also inform other fields of medicine and science. METHODS AND RESULTS: A total of 47 participants representing stakeholders from 7 domains (patients, basic scientists, clinical investigators, population researchers, clinicians and healthcare system administrators, industry, and regulatory authorities) participated in the conference. Presentation topics included updates on data as viewed from conventional medical and nonmedical sources, building and using Big Data repositories, articulation of the goals of data sharing, and principles of responsible data sharing. Facilitated breakout sessions were conducted to examine what each of the 7 stakeholder domains wants from Big Data under ideal circumstances and the possible roles that the AHA might play in meeting their needs. Important areas that are high priorities for further study regarding Big Data include a description of the methodology of how to acquire and analyze findings, validation of the veracity of discoveries from such research, and integration into investigative and clinical care aspects of future cardiovascular and stroke medicine. Potential roles that the AHA might consider include facilitating a standards discussion (eg, tools, methodology, and appropriate data use), providing education (eg, healthcare providers, patients, investigators), and helping build an interoperable digital ecosystem in cardiovascular and stroke science. CONCLUSION: There was a consensus across stakeholder domains that Big Data holds great promise for revolutionizing the way cardiovascular and stroke research is conducted and clinical care is delivered; however, there is a clear need for the creation of a vision of how to use it to achieve the desired goals. Potential roles for the AHA center around facilitating a discussion of standards, providing education, and helping establish a cardiovascular digital ecosystem. This ecosystem should be interoperable and needs to interface with the rapidly growing digital object environment of the modern-day healthcare system.

Current quality of cardiovascular prevention for Million Hearts: an analysis of 147,038 outpatients from The Guideline Advantage.

BACKGROUND: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years. The degree to which outpatient providers are controlling risk factors has not been fully described. METHODS: We examined adherence to the Million Hearts clinical quality measures using The Guideline Advantage, a nationwide quality improvement program for outpatient care. Specifically, we determined the proportion of patients with (1) ischemic vascular disease who were prescribed an antiplatelet drug; (2) hypertension whose blood pressure was controlled; (3) diabetes mellitus whose most recent low-density lipoprotein cholesterol level was <100 mg/dL; and 4) a tobacco use screening and who received a smoking cessation intervention as needed. RESULTS: From January 1, 2010, to March 31, 2012, there were 147,038 patients enrolled from 25 US practices. At the practice level, antiplatelet prescription ranged from 50.0% to 82.3% (median 71.9%, interquartile range [IQR] 66.7-82.1), hypertension control ranged from 48.6% to 75.3% (median 66.6%, IQR 60.1-70.9), hyperlipidemia control among patients with diabetes mellitus ranged from 53.3% to 100.0% (median 75.8%, IQR 65.8-83.0), and tobacco use screening and intervention ranged from 31.0% to 98.8% (median 79.8%, IQR 72.0-83.2). Black and people of color races were associated with a lower likelihood of blood pressure control and cholesterol control. Female gender was associated with a lower likelihood of antiplatelet prescription and cholesterol control. CONCLUSIONS: Compliance with quality measures for the Million Hearts initiative varies widely and is notable for racial and gender disparities. Our findings identify multiple opportunities to improve the quality of cardiovascular prevention.

Antithrombin concentrate in pediatric patients requiring unfractionated heparin anticoagulation: a retrospective cohort study.

OBJECTIVE: To describe antithrombin levels, altered unfractionated heparin effect (anti-factor Xa activity and activated partial thromboplastin time), and adverse effects post administration of a single high dose of antithrombin concentrate. DESIGN: Retrospective review. PATIENTS: Infants and children with antithrombin levels less than 50% and a subtherapeutic unfractionated heparin effect. SETTING: Quaternary care children's hospital with a dedicated anticoagulation program. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A single high dose of antithrombin concentrate was administered. Antithrombin level, anti-factor Xa, and activated partial thromboplastin times were measured post antithrombin concentrate infusion and daily until stable. One hundred twenty-one patients received 246 doses of antithrombin. Patients were described using two cohorts based on the ability to obtain exact heparin doses. Cohort 1 included all patients between January 2004 and May 2008 when complete heparin dosing was unavailable. Cohort 2 included patients from May 2008 to May 2011 when heparin dose was available. Median age and weight were 3.7 months and 4.1 kg. Mean antithrombin concentrate dose was 222 IU/kg. Mean antithrombin level increased from 0.39 to 1.20 U/mL following antithrombin concentrate administration. In cohort 2, unfractionated heparin doses to achieve a target anti-factor Xa activity pre-post antithrombin concentrate were 28 and 19 U/kg/hr, respectively, for children 12 months old or younger and 25 and 19 U/kg/hr, respectively, for children older than 12 months. There were no hemorrhagic, thrombotic, or allergic events within 1 week of antithrombin concentrate administration. CONCLUSIONS: This is the largest study of antithrombin concentrate evaluation in children. Administration of antithrombin concentrate increases anti-factor Xa activity with lower administered unfractionated heparin doses.

Administration of antithrombin concentrate in infants and children on extracorporeal life support improves anticoagulation efficacy.

Unfractionated heparin (UFH) is required in children on extracorporeal life support (ECLS) to maintain circuit patency. When high-dose UFH is inadequate to maintain an anticoagulant effect, the addition of antithrombin concentrate (ATC) is considered. The objective of this study was to review clinical experience giving 1,000 units (U) of ATC to patients on ECLS and UFH anticoagulation. Specifically, antithrombin (AT) levels pre- and post-administration of high-dose ATC, estimation of the efficacy of high-dose ATC administration as measured by the level of anticoagulation, and the incidence of adverse effects were determined. A retrospective chart review of all infants and children on ECLS who received ATC between June 2008 and May 2011 at Stollery Children's Hospital, Edmonton, Canada, was performed. A total of 78 doses of ATC were administered to 36 patients with a median age of 2.9 months (interquartile range, 0.6-12.6) on ECLS. Mean dose of ATC was 241 U/kg (95% confidence interval, 199-283). Mean AT level pre- and post-administration was 0.40 and 0.93 U/ml, respectively. Mean anti-Xa level pre- and post-AT administration was 0.23 and 0.41 U/ml, respectively. There were no associated acute adverse events. The administration of high-dose ATC decreases UFH dose requirements.