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Background: EXCOR ventricular assist device (VAD) is the gold standard circulatory support for children with end-stage heart failure. Until recently, the only available driving unit was the stationary Ikus. This study (NCT04634708) investigates the impact of the novel mobile EXCOR Active driving unit on patients’ mobility and the quality of life (QoL) of their families. Methods: Children on EXCOR VAD support with the Ikus who were mobilizable outside the hospital room were eligible for the prospective study. Patients remained on Ikus for 7 days, then switched to Excor Active, and were observed for another 45 days. The end-points were the rates of clinically relevant device exchanges (i.e., exchanges that could raise safety concerns for the patient) and successful patient outcomes, respectively. QoL of patients’ families was recorded through 2 validated questionnaires: the Pediatric Quality of Life Inventory Family Impact Module and Depression, Anxiety and Stress Scale 21. Patients’ mobility and activity levels were monitored through diary entries. Results: A total of 24 patients were enrolled of which 23 patients completed the study. No clinically relevant device exchanges occurred and there was a successful outcome in 22/23 (95.7%) patients. Changing from the Ikus to the EXCOR Active improved QoL as seen in family impact total score (from 53.8 ± 19.8-66.5 ± 20.8, p = 0.005) and mental health (depression: moderate to mild, stress moderate to normal, both p

IntroductionCardiopulmonary bypass (CPB) causes coagulopathy, increasing the risk of postoperative bleeding and mortality. The underlying causes of post-CPB coagulopathy and the factors associated with its occurrence are not yet fully understood. This study assesses platelet and fibrinogen concentration and function following CPB in children with congenital heart diseases (CHD).MethodsWe analyzed prospective data from 104 patients aged 0–16 years who underwent CPB surgery for CHD. Blood samples were collected before surgery and within 30 min of CPB completion. In addition to usual coagulation tests, functional analyses were performed using point of care systems with thromboelastometry and impedance aggregometry.ResultsPlatelet count, fibrinogen concentration, and platelet and fibrinogen activities significantly decreased after CPB. The duration of CPB was directly associated with a reduction in platelet count and fibrinogen level (r = −0.38, p

Objectives In trials of acute severe infections or inflammations frequent administration of non-randomised treatment (ie, intercurrent event) in response to clinical events is expected. These events may affect the interpretation of trial findings. Swissped-RECOVERY was set up as one of the first randomised controlled trials worldwide, investigating the comparative effectiveness of anti-inflammatory treatment with intravenous methylprednisolone or intravenous immunoglobulins in children and adolescents with Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS). We present one approach towards improving the interpretation of non-randomised treatment in a randomised controlled trial.Design This is a pre-planned ancillary analysis of the Swissped-RECOVERY trial, a randomised multicentre open-label two-arm trial.Setting 10 Swiss paediatric hospitals (secondary and tertiary care) participated.Participants Paediatric patients hospitalised with PIMS-TS.Interventions All patient-first intercurrent events, if applicable, were presented to an independent adjudication committee consisting of four international paediatric COVID-19 experts to provide independent clinical adjudication to a set of standardised questions relating to whether additional non-randomised treatments were clinically indicated and disease classification at the time of the intercurrent event.Results Of 41 treatments in 75 participants (24/41 (59%) and 17/41 (41%) in the intravenous methylprednisolone and immunoglobulin arms of the trial, respectively), two-thirds were considered indicated. The most common treatment (oral glucocorticoids, 14/41, 35%) was mostly considered not indicated (11/14, 79%), although in line with local guidelines. Intercurrent events among patients with Shock-like PIMS-TS at baseline were mostly considered indicated. A significant proportion of patients with undifferentiated PIMS-TS at baseline were not attributed to the same group at the time of the intercurrent event (6/12 unchanged, 4/12 Kawasaki disease-like, 2/12 Shock-like).Conclusion The masked adjudication of intercurrent events contributes to the interpretation of results in open-label trials and should be incorporated in the future.Trial registration numbers SNCTP000004720 and NCT 04826588.

Fontan physiology creates a chronic state of decreased cardiac output and systemic venous congestion, leading to liver cirrhosis/malignancy, protein-losing enteropathy, chylothorax, or plastic bronchitis. Creating a fenestration improves cardiac output and relieves some venous congestion. The anatomic connection of the thoracic duct to the subclavian-jugular vein junction exposes the lymphatic system to systemic venous hypertension and could induce plastic bronchitis. To address this complication, two techniques have been developed. A surgical method that decompresses the thoracic duct by diverting the innominate vein to the atrium, and a percutaneous endovascular procedure that uses a covered stent to create an extravascular connection between the innominate vein and the left atrium. We report a novel variant transcatheter intervention of the innominate vein turn-down procedure without creating an extravascular connection in a 39-month-old patient with failing Fontan circulation complicated by plastic bronchitis and a 2-year post-intervention follow-up.

IntroductionThis systematic review aimed to evaluate the quality of clinical practice guidelines (CPGs) and recommendations for managing pain, sedation, delirium, and iatrogenic withdrawal syndrome in pediatric intensive care (PICU). The objectives included evaluating the quality of recommendations, synthesizing recommendations, harmonizing the strength of the recommendation (SoR) and the certainty of evidence (CoE), and assessing the relevance of supporting evidence.MethodsA comprehensive search in four electronic databases (Medline, Embase.com, CINAHL and JBI EBP Database), 9 guideline repositories, and 13 professional societies was conducted to identify CPGs published from January 2010 to the end of May 2023 in any language. The quality of CPGs and recommendations was assessed using the AGREE II and AGREE-REX instruments. Thematic analysis was used to synthesize recommendations, and the GRADE SoR and CoE harmonization method was used to interpret the credibility of summary recommendations.ResultsA total of 18 CPGs and 170 recommendations were identified. Most CPGs were of medium-quality, and three were classified as high. A total of 30 summary recommendations were synthesized across each condition, focused on common management approaches. There was inconsistency in the SoRs and CoE for summary recommendations, those for assessment showed the highest consistency, the remaining were conditional, inconsistent, inconclusive, and lacked support from evidence.ConclusionThis systematic review provides an overview of the quality of CPGs for these four conditions in the PICU. While three CPGs achieved high-quality ratings, the overall findings reveal gaps in the evidence base of recommendations, patient and family involvement, and resources for implementation. The findings highlight the need for more rigorous and evidence-based approaches in the development and reporting of CPGs to enhance their trustworthiness. Further research is necessary to enhance the quality of recommendations for this setting. The results of this review can provide a valuable foundation for future CPG development.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=274364, PROSPERO (CRD42021274364).

BackgroundPain, sedation, delirium, and iatrogenic withdrawal syndrome are conditions that often coexist, algorithms can be used to assist healthcare professionals in decision making. However, a comprehensive review is lacking. This systematic review aimed to assess the effectiveness, quality, and implementation of algorithms for the management of pain, sedation, delirium, and iatrogenic withdrawal syndrome in all pediatric intensive care settings.MethodsA literature search was conducted on November 29, 2022, in PubMed, Embase, CINAHL and Cochrane Library, ProQuest Dissertations & Theses, and Google Scholar to identify algorithms implemented in pediatric intensive care and published since 2005. Three reviewers independently screened the records for inclusion, verified and extracted data. Included studies were assessed for risk of bias using the JBI checklists, and algorithm quality was assessed using the PROFILE tool (higher % = higher quality). Meta-analyses were performed to compare algorithms to usual care on various outcomes (length of stay, duration and cumulative dose of analgesics and sedatives, length of mechanical ventilation, and incidence of withdrawal).ResultsFrom 6,779 records, 32 studies, including 28 algorithms, were included. The majority of algorithms (68%) focused on sedation in combination with other conditions. Risk of bias was low in 28 studies. The average overall quality score of the algorithm was 54%, with 11 (39%) scoring as high quality. Four algorithms used clinical practice guidelines during development. The use of algorithms was found to be effective in reducing length of stay (intensive care and hospital), length of mechanical ventilation, duration of analgesic and sedative medications, cumulative dose of analgesics and sedatives, and incidence of withdrawal. Implementation strategies included education and distribution of materials (95%). Supportive determinants of algorithm implementation included leadership support and buy-in, staff training, and integration into electronic health records. The fidelity to algorithm varied from 8.2% to 100%.ConclusionsThe review suggests that algorithm-based management of pain, sedation and withdrawal is more effective than usual care in pediatric intensive care settings. There is a need for more rigorous use of evidence in the development of algorithms and the provision of details on the implementation process.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021276053, PROSPERO [CRD42021276053].

Reversible cerebral vasoconstriction syndrome (RCVS) is a vascular disease characterized by diffuse transient vasoconstriction and vasodilatation of the cerebral arteries. It is commonly associated with recurrent severe acute headaches with or without focal neurological deficits due to hemorrhages, infarcts, and even posterior reversible encephalopathy syndrome. The optimal management of acute neurologic deficits caused by RCVS is still uncertain. Calcium channel blockers (CCBs) such as nimodipine or verapamil have been reported to be effective in adult series. Intra-arterial injection of nimodipine, verapamil, and milrinone has recently been demonstrated to be safe and effective for treating severe segmental vasoconstriction in adults. CCBs are the most used treatment in the available pediatric literature. Intra-arterial vasodilators have been reported in some rare pediatric reports with more severe diseases, but their utility is still under investigation. We report a case of a 12-year-old girl who underwent a severe course of RCVS complicated by multiple cerebral infarcts, treated by several sessions of intra-arterial vasodilators infusion.

Colchicine poisoning is associated with a poor prognosis, especially when leading to shock and multi-organ failure, and management is limited to supportive care, including multiple-dose activated charcoal. At therapeutic concentrations, colchicine elimination occurs mainly through hepatic metabolism and involves an enterohepatic circulation, with a small contribution of renal elimination (10–30%). Colchicine toxicokinetics is however rarely described, especially in children. We present the case of a 4-year-old patient who survived a severe iatrogenic colchicine intoxication with a dose of 0.5 mg/kg. She developed multi-organ failure and shock, but recovered after receiving aggressive resuscitation, including extracorporeal life support. Close monitoring of colchicine blood levels showed a plateau for 6 days, indicating impeded elimination resulting from liver failure. We observed no significant clearance from renal replacement therapy, nor activated charcoal, during this period. Extracorporeal life support may play a supportive role in the management of severe colchicine poisoning. However, extracorporeal techniques do not seem to improve colchicine elimination.