Expert Panel Recommendations for a Standardized Ambulatory Glucose Profile Report for Connected Insulin Pens.

BACKGROUND: Connected insulin pens capture data on insulin dosing/timing and can integrate with continuous glucose monitoring (CGM) devices with essential insulin and glucose metrics into a single platform. Standardization of connected insulin pen reports is desirable to enhance clinical utility with a single report. METHODS: An international expert panel was convened to develop a standardized connected insulin pen report incorporating insulin and glucose metrics into a single, clinically useful report. An extensive literature review and identification of examples of current connected insulin pen reports was performed serving as the basis for creation of a draft of a standardized connected insulin pen report. The expert panel participated in three virtual standardization meetings and online surveys. RESULTS: The AGP Report: Connected Insulin Pen brings all clinically relevant CGM-derived glucose and connected insulin pen metrics into a single simplified two-page report. The first page contains the time in ranges bar, summary of key insulin and glucose metrics, the ambulatory glucose profile (AGP) curve, and detailed basal (long-acting) insulin assessment. The second page contains the bolus (mealtime and correction) insulin assessment periods with information on meal timing, insulin-to-carbohydrate ratio (ICR), average bolus insulin dose and number of days with bolus doses recorded. The report's second page contains daily glucose profiles with an overlay of the timing and amount of basal and bolus insulin administered. CONCLUSION: The AGP Report: Connected Insulin Pen is a standardized clinically useful report that should be considered by companies developing connected pen technology as part of their system reporting/output.

A new recumbirostran 'microsaur' from the lower Permian Bromacker locality, Thuringia, Germany, and its fossorial adaptations.

Several recumbirostran 'microsaurs' are known from early Permian sites across Germany, including the Tambach Formation in Thuringia, central Germany. The only 'microsaur' thus far described from the Tambach Formation was the ostodolepid recumbirostran Tambaroter carrolli. However, there is also the documented presence of an undescribed recumbirostran 'microsaur' at the well-known Bromacker locality. The Bromacker locality is highly recognized and best known for its very diverse and extremely well-preserved terrestrial tetrapod assemblage combined with the co-occurrence of an exceptional vertebrate ichnofossil record. Here we describe a second new recumbirostran taxon from the Tambach Formation, which is also the first from the Bromacker locality itself. Phylogenetic analysis indicates that the new taxon, Bromerpeton subcolossus gen. et sp. nov., is a brachystelechid recumbirostran, a group also known elsewhere in Germany. The following features differentiate Bromerpeton from the other members of the clade: the presence of 13 maxillary teeth, narrow postorbitals that do not substantially contribute to the postorbital region of the skull, the frontal does not contribute to the orbital margin, and the presence of five manual digits. This new recumbirostran 'microsaur' further adds to the unique ecosystem that is preserved at the Bromacker locality, granting us a better understanding of what was living underfoot the larger more well-known animals at the locality. Likewise, it expands our understanding of the evolution of recumbirostran 'microsaurs', especially with regards to digit and limb reduction within the clade.

Spontaneous resolution of an intrapericardial thrombus as a complication of pericardiocentesis in a neonate.

We present the case of a premature neonate with pericardial effusion secondary to extravasation of total parenteral nutrition from a mispositioned/migrated umbilical venous catheter. Emergency pericardiocentesis was complicated by an intrapericardial thrombus, which was managed conservatively with spontaneous resolution within 24 hours. This case illustrates that the rare complication of an intrapericardial thrombus after pericardiocentesis can be successfully managed conservatively with close monitoring in haemodynamically stable paediatric patients.

Roadmap to the Effective Use of Continuous Glucose Monitoring in Primary Care.

Diabetes technology has undergone a remarkable evolution in the past decade, with dramatic improvements in accuracy and ease of use. Continuous glucose monitor (CGM) technology, in particular, has evolved, and coevolved with widely available consumer smartphone technology, to provide a unique opportunity to both improve management and decrease the burden of management for populations across nearly the entire spectrum of people living with diabetes. Capitalizing on that opportunity, however, will require both adoption of and adaptations to the use of CGM technology in the broader world of primary care. This article focuses on mechanisms to expand pathways to optimized glycemic management, thereby creating a robust roadway capable of improving care across broad populations managed in primary care settings. Recent expansions in access to devices combined with improved mechanisms for data access at the time of primary care visits and improved training and evolving systems of support within primary care, hold potential to improve glycemic management in diabetes across the health care spectrum.

Long-term follow-up of atrioventricular valve function in Fontan patients: effect of atrioventricular valve surgery.

OBJECTIVES: The aim of this study was to evaluate the relationship between atrioventricular valve and ventricular function in Fontan survivors, including the effect of atrioventricular valve surgery. METHODS: Analysis focused on transplant-free survival and the need for atrioventricular valve surgery in single ventricle patients after Fontan completion. Longitudinal echocardiographic examination of long-term valve and ventricular function was performed. RESULTS: Fontan completion was performed in 113 patients, having a right univentricular morphology in 33.6%, a left ventricle morphology in 62.8% and ambiguous in 3.6%. Perioperative mortality was 2.7% (n = 3). Within a median follow-up of 16.3 years (interquartile range 10.6-23.6), transplant-free survival was 96.1 ± 1.9% and 90.4 ± 5.8% at 10-25 years. Twenty AV valve procedures were performed in 14 (12.4%) children, respectively, pre-Fontan (n = 10), per-Fontan (n = 8) and post-Fontan (n = 2), resulting in a cumulative incidence of AV valve surgery is 5.7 ± 2.2% and 12.3 ± 3.2% at 1-5 years. Atrio-ventricular valve function deteriorated over time [hazard ratio (HR) 1.112, 95% confidence interval (CI) 1.089-1.138, P < 0.001], without difference for valve morphology (P = 0.736) or ventricular dominance (P = 0.484). AV valve dysfunction was greater in patients requiring AV valve surgery (HR 20.383, 95% CI 6.223-36.762, P < 0.001) but showed a comparable evolution since repair to those without valve surgery (HR 1.070, 95% CI 0.987-1.160, P = 0.099). Progressive time-related ventricular dysfunction was observed (HR 1.141, 95% CI 1.097-1.182, P < 0.001), significantly less in left ventricle-dominance (HR 0.927, 95% CI 0.860-0.999, P = 0.047) but more after AV valve surgery (HR 1.103, 95% CI 1.014-1.167, P = 0.022). CONCLUSIONS: In a homogeneously treated Fontan population, 25-year transplant-free survival is encouraging. Atrio-ventricular valve surgery was necessary in 12.4%, resulting mostly in a durable valve function. However, a slow time-related decline of atrioventricular valve function as of ventricular function is worrisome, evoking a role for additional heart failure therapy.

Failure of Tricuspid Annuloplasty for Functional Tricuspid Regurgitation: Impact of Patient's Body Size.

Tricuspid repair is recommended for significant functional tricuspid regurgitation (FTR) or tricuspid annulus (TA) dilation, based on TA >40 mm or >21 mm/m². The concordance between both TA dimensions related to the patient's body size has not been investigated. Patients who underwent rigid ring tricuspid annuloplasty for FTR between 2009 and 2017 were included. Assuming equality between both TA diameter criteria, patients were divided per body surface area (BSA): group 1 = BSA ≤1.9 m² and group 2 = BSA >1.9 m². The primary outcome was TR recurrence at 5 years. Tricuspid annuloplasty was performed in 186 patients (group 1: 130 patients [69.9%]; group 2: 56 patients [30.1%]). Group 1 comprised more female (70.8% to 23.2%, p <0.001) and older patients (77.1 ± 9.3 years; 74.2 ± 8.2 years, p = 0.048). Group 1 had a smaller absolute TA diameter (group 1: 45.3 ± 5.2 mm; group 2: 48.2 ± 5.6 mm, p <0.001), whereas the indexed TA size was inversely higher (group 1: 26.3 ± 3.4 mm/m²; group 2: 24.2 ± 2.7 mm/m², p <0.001). The tenting height was comparable (group 1: 7.8 ± 3.0 mm; group 2: 8.0 ± 2.7 mm, p = 0.714). The median ring size was 30 (interquartile range 28 to 32) and 32 (interquartile range 30 to 34) for groups 1 and 2, respectively (p <0.001). TR recurrence at 5 years was noticed in 20.2% and 6.5% of group 1 and 2 (p = 0.035). Indexed TA diameter (hazard ratio 1.43, 95% confidence interval 1.10 to 1.87, p = 0.008) and tenting height (hazard ratio 5.52, 95% confidence interval 1.87 to 14.57, p = 0.002) were independent predictors of TR recurrence. In conclusion, when the absolute TA diameter is used as the primary criterion, smaller patients are at a higher risk for TR recurrence by having a proportionally larger TA at the time of repair. An individualized approach guided by patient's body size might be more appropriate to indicate FTR correction to adjust for the annuloplasty sizing method.

Biomarkers for the Diagnosis of Heart Failure in People with Diabetes: A Consensus Report from Diabetes Technology Society.

Diabetes Technology Society assembled a panel of clinician experts in diabetology, cardiology, clinical chemistry, nephrology, and primary care to review the current evidence on biomarker screening of people with diabetes (PWD) for heart failure (HF), who are, by definition, at risk for HF (Stage A HF). This consensus report reviews features of HF in PWD from the perspectives of 1) epidemiology, 2) classification of stages, 3) pathophysiology, 4) biomarkers for diagnosing, 5) biomarker assays, 6) diagnostic accuracy of biomarkers, 7) benefits of biomarker screening, 8) consensus recommendations for biomarker screening, 9) stratification of Stage B HF, 10) echocardiographic screening, 11) management of Stage A and Stage B HF, and 12) future directions. The Diabetes Technology Society panel recommends 1) biomarker screening with one of two circulating natriuretic peptides (B-type natriuretic peptide or N-terminal prohormone of B-type natriuretic peptide), 2) beginning screening five years following diagnosis of type 1 diabetes (T1D) and at the diagnosis of type 2 diabetes (T2D), 3) beginning routine screening no earlier than at age 30 years for T1D (irrespective of age of diagnosis) and at any age for T2D, 4) screening annually, and 5) testing any time of day. The panel also recommends that an abnormal biomarker test defines asymptomatic preclinical HF (Stage B HF). This diagnosis requires follow-up using transthoracic echocardiography for classification into one of four subcategories of Stage B HF, corresponding to risk of progression to symptomatic clinical HF (Stage C HF). These recommendations will allow identification and management of Stage A and Stage B HF in PWD to prevent progression to Stage C HF or advanced HF (Stage D HF).

Evaluating student's ability to assess treatment claims: validating a German version of the Claim Evaluation Tools.

BACKGROUND: The Claim Evaluation Tools measure the ability to assess claims about treatment effects. The aim of this study was to adapt the German item sets to the target group of secondary school students (aged 11 to 16 years, grade 6 to 10) and to validate them accordingly. The scale's reliability and validity using Rasch's probabilistic test theory should be determined. METHODS: We conducted a sequential mixed-method study comprising three stages: contextualisation and adaption of the items (stage 1), piloting of the item sets using qualitative interviews (stage 2) and a construct validation by testing the unidimensional Rasch scalability for each item set after data collection in one secondary school in Germany and two secondary schools in Austria. We explored summary and individual fit statistics and performed a distractor analysis (stage 3). RESULTS: Secondary school students (n = 6) and their teachers (n = 5) participated in qualitative interviews in Germany. The qualitative interviews identified the need for minor modifications (e.g. reducing thematic repetitions, changing the order of the items). The data of 598 German and Austrian secondary school students were included to test for Rasch scalability. Rasch analyses showed acceptable overall model fit. Distractor analyses suggested that model fit could be improved by simplifying the text in the scenarios, removing and editing response options of some items. CONCLUSION: After the revision of some items, the questionnaires are suitable to evaluate secondary school students' ability to assess health claims. A future goal is to increase the pool of items being translated and tested.

Anterior and posterior tracheopexy for severe tracheomalacia.

Objectives: Congenital tracheomalacia can be the cause of respiratory failure in young children. Although the indication for surgical treatment has already been discussed vigorously, no clear guidelines about the modality are available. Methods: Through a sternotomy approach, a combination of posterior pexy and anterior tracheopexy using a tailored ringed polytetrafluoroethylene prosthesis is performed. Patient demographic characteristics, as well as operative details and postoperative outcomes, are included in the analysis. Results: Between 2018 and 2022, 9 children underwent the operation under review. All patients showed severe clinical symptoms of tracheomalacia, which was confirmed on bronchoscopy. The median age was 9 months. There was no operative mortality. Eight patients could be weaned from the ventilator. One patient died because of interstitial lung disease with bronchomalacia and concomitant severe cardiac disease. The longest follow-up now is 4 years, and shows overall excellent clinical results, without any reintervention. Conclusions: Surgical treatment of tracheomalacia through a combination of posterior and anterior pexy is feasible, with acceptable short- and midterm results.

Quantification of Pulmonary Artery Configuration after the Arterial Switch Operation: A Pilot Study.

BACKGROUND: The arterial switch operation (ASO) is the preferred treatment for d-transposition of the great arteries (TGA). Freedom from reintervention is mainly determined by the performance of the arterial outflow tracts, with variable incidence of pulmonary artery stenosis (PAS), possibly related to aspects of surgical technique. This pilot study attempts to describe pulmonary artery (PA) configuration through several measurements using three-dimensional data from cardiac magnetic resonance (CMR) imaging and assesses whether PA configuration is associated with PAS. METHODS: A retrospective, single-centre analysis of paediatric patients undergoing CMR after ASO. The geometry of the pulmonary arteries was compared between patients with and without PAS as judged by the CMR report. RESULTS: Among all patients (n = 612) after ASO, 45 patients underwent CMR at a median age of 10 years (3.5-13). Twenty-two (57.9%) had PAS, categorized as mild (n = 1), moderate (n = 19) or severe (n = 2). Eighteen had stenosis on PA branches. Four had MPA stenosis. Comparison between groups with and without PAS revealed no significant differences in neo-aortic to pulmonary angle, MPA to LPA/RPA angle, or bifurcation angle. There was a significant difference in cranial displacement, with more cranial displacement in the group without PAS. However, this group was older, 10.8 (7.3-14.3) years compared to those with PAS, 6.8 (1.5-12.1). CONCLUSIONS: The spectrum of PAS after ASO is heterogenous. This study shows the feasibility of measuring PA configuration in three planes on CMR. There is no correlation between PA configuration and PAS. Therefore, other mechanisms are probably responsible for the occurrence of PAS, rather than the configuration on itself. Further multicentric studies are warranted to confirm the suggested measuring method and assessing the associations with PAS, to eventually advise surgical methodology.

Exploring the Mutational Landscape of Isolated Congenital Heart Defects: An Exome Sequencing Study Using Cardiac DNA.

Congenital heart defects (CHD) are the most common congenital anomalies in liveborn children. In contrast to syndromic CHD (SCHD), the genetic basis of isolated CHD (ICHD) is complex, and the underlying pathogenic mechanisms appear intricate and are incompletely understood. Next to rare Mendelian conditions, somatic mosaicism or a complex multifactorial genetic architecture are assumed for most ICHD. We performed exome sequencing (ES) in 73 parent-offspring ICHD trios using proband DNA extracted from cardiac tissue. We identified six germline de novo variants and 625 germline rare inherited variants with 'damaging' in silico predictions in cardiac-relevant genes expressed in the developing human heart. There were no CHD-relevant somatic variants. Transmission disequilibrium testing (TDT) and association testing (AT) yielded no statistically significant results, except for the AT of missense variants in cilia genes. Somatic mutations are not a common cause of ICHD. Rare de novo and inherited protein-damaging variants may contribute to ICHD, possibly as part of an oligogenic or polygenic disease model. TDT and AT failed to provide informative results, likely due to the lack of power, but provided a framework for future studies in larger cohorts. Overall, the diagnostic value of ES on cardiac tissue is limited in individual ICHD cases.

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): third Paediatric (Paedi-EUROMACS) report.

OBJECTIVES: A third paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. METHODS: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (<19 years of age) performed from 1 January 2000 to 31 December 2020 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. RESULTS: Twenty-five hospitals contributed 537 registered implants in 480 patients. The most frequent aetiology of heart failure was any form of cardiomyopathy (59%), followed by congenital heart disease and myocarditis (15% and 14%, respectively). Competing outcomes analysis revealed that a total of 86% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 21.9% died while on support. At 12 months, 45.1% received transplants, 7.5% were weaned from their device and 20.8% died. The 3-month adverse events rate was 1.59 per patient-year for device malfunction including pump exchange, 0.7 for major bleeding, 0.78 for major infection and 0.71 for neurological events. CONCLUSIONS: The overall survival rate was 79.2% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age; P = 0.01) and lower weight (<20 kg; P = 0.015). Transplant rates at 6 months continue to be low (33.2%).

Impact of mean perfusion pressure and vasoactive drugs on occurrence and reversal of cardiac surgery-associate acute kidney injury: A cohort study.

PURPOSE: Low cardiac output and kidney congestion are associated with acute kidney injury after cardiac surgery (CSA-AKI). This study investigates hemodynamics on CSA-AKI development and reversal. MATERIALS AND METHODS: Adult patients undergoing cardiac surgery were retrospectively included. Hemodynamic support was quantified using a new time-weighted vaso-inotropic score (VISAUC), and hemodynamic variables expressed by mean perfusion pressure and its components. The primary outcome was AKI stage ≥2 (CSA-AKI ≥2) and secondary outcome full AKI reversal before ICU discharge. RESULTS: 3415 patients were included. CSA-AKI ≥2 occurred in 37.4%. Mean perfusion pressure (MPP) (OR 0.95,95%CI 0.94-0.96, p < 0.001); and central venous pressure (CVP) (OR 1.17, 95%CI 1.13-1.22, p < 0.001) are associated with CSA-AKI ≥2 development, while VISAUC/h was not (p = 0.104). Out of 1085 CSA-AKI ≥2 patients not requiring kidney replacement therapy, 76.3% fully recovered of AKI. Full CSA-AKI reversal was associated with MPP (OR 1.02 per mmHg (95%CI 1.01-1.03, p = 0.003), and MAP (OR = 1.01 per mmHg (95%CI 1.00-1.02), p = 0.047), but not with VISAUC/h (p = 0.461). CONCLUSION: Development and full recovery of CSA-AKI ≥2 are affected by mean perfusion pressure, independent of vaso-inotropic use. CVP had a significant effect on AKI development, while MAP on full AKI reversal.

How use of continuous glucose monitoring can address therapeutic inertia in primary care.

A significant proportion of individuals with diabetes have suboptimal glycemic management. Studies have shown that persistent hyperglycemia significantly increases the risks for both acute and long-term microvascular and macrovascular complications of diabetes. A key contributor to suboptimal glycemic management is therapeutic inertia in which clinicians delay intensifying therapy when patients are not meeting their glycemic goals. During the past five years, an increasing number of individuals with type 1 diabetes (T1D) and insulin-treated type 2 diabetes (T2D) have adopted the use of continuous glucose monitoring (CGM) for daily measurement of glucose levels. As demonstrated in numerous clinical trials and real-world observational studies, use of CGM improves glycated hemoglobin (HbA1c) and reduces the occurrence and severity of hypoglycemia. However, for primary care clinicians who are unfamiliar with using CGM, integrating this technology into clinical practice can be daunting. In this article, we discuss the benefits and rationale for using CGM compared with traditional blood glucose monitoring (BGM), review the evidence supporting the clinical value of CGM in patients with T1D and T2D, and describe how use of CGM in primary care can facilitate appropriate and more timely therapy adjustments.

Clipping of an Aortopulmonary Window in a Small Neonate With Bronchial Bleeding: A Simple Solution for a Complex Condition.

Although the conventional treatment of aortopulmonary (AP) window consists of reconstructive surgery with the use of cardiopulmonary bypass (CPB), some conditions like low birth weight or active respiratory tract bleeding may lead to diverting therapeutic options. We present a case of a premature 1.9 kg neonate with severe pulmonary arterial hypertension based on the association of an AP window and large patent ductus arteriosus. Because of intrabronchial hemorrhage, a conservative strategy was chosen excluding the need for heparinization and CPB. Through median sternotomy, the ductus arteriosus and AP window were clipped, effectively occluding both shunts. The postoperative course was uneventful with a rapid decrease of pulmonary artery pressure. Although classical surgical reconstruction is still advocated as primary therapy, this case illustrates the suitability of an alternative approach without the need for CPB and full heparinization in a patient with an increased risk of bleeding complications.