Fontan Circulation and Aortic Stiffness: Insights into Vascular Dynamics and Haemodynamic Interplay.

Increased aortic stiffness predisposes cardiac afterload and influences cardiac function. Congenital heart diseases involving aortic arch malformation and extended cardiovascular surgery, i.e. univentricular heart diseases, can lead to increased aortic stiffness. This study aimed to investigate whether Fontan patients (FO) have increased aortic stiffness within distinct aortic segments, and whether these parameters relate to Fontan-specific haemodynamics. In a prospective case-control study, 20 FO and 49 heart-transplanted control subjects with biventricular circulation underwent invasive cardiac catheterisation. We invasively measured pulse wave velocity (PWV) in the ascending aorta and along the entire aorta. Haemodynamic parameters, including end-diastolic pressure, pulmonary artery pressure, the cardiac index and systemic vascular resistance index were also assessed. FO exhibited significantly higher ascending aorta PWV (aPWV) than controls (FO: 7.2 ± 2.4 m/s|Controls: 4.9 ± 0.7 m/s, p < 0.001) and compared to the inner group central aorta PWV (cPWV; FO: 5.5 ± 1.2 m/s|Controls: 5.3 ± 1.0 m/s). Multivariate analysis confirmed this aPWV elevation in FO even after adjusting for age and BMI. aPWV and cPWV were almost identical within the control group. Correlation analyses revealed associations between cPWV and blood pressure in controls, while correlations were less apparent in FO. We detected no significant association between the aPWV and other haemodynamic parameters in any of our groups. FO exhibit increased aPWV, indicating specific vascular stiffness in the ascending aorta, while their overall aortic stiffness remains comparable to controls. Further research is needed to understand the implications of these findings on Fontan circulation and long-term cardiovascular health. CENTRAL MESSAGE: Fontan patients show increased aortic arch pulse wave velocity, suggesting specific vascular stiffness. PERSPECTIVE STATEMENT: Our study offers rare insights into pulse wave velocity in Fontan patients, highlighting increased arterial stiffness in the aortic arch. Vascular stiffness was particularly increased in the area of surgical reconstruction. This indicates the need for further research on vascular stiffness in Fontan circulation to understand its impact on cardiovascular health. CLINICAL TRIAL REGISTRATION: German clinical trial registration, DRKS00015066.

Step by Step: Evaluation of Cardiorespiratory Fitness in Healthy Children, Young Adults, and Patients with Congenital Heart Disease Using a Simple Standardized Stair Climbing Test.

(1) Background: Cardiorespiratory fitness (CRF) is known to be a prognostic factor regarding long-term morbidity and mortality. This study aimed to develop a standardized Stair Climbing Test (SCT) with a reliable correlation to spiroergometry and the 6MWT which can be used in healthy children as well as patients with congenital heart disease (CHD) and a restricted exercise capacity. (2) Methods: A total of 28 healthy participants aged 10-18 years were included. We tested the individuals' CRF by cardiopulmonary exercise testing (CPET) on a treadmill, the 6MWT, and a newly developed Stair Climbing Test (SCT). For the SCT, we defined a standardized SCT protocol with a total height of 13.14 m to achieve maximal exercise effects while recording time and vital parameters. To compare the SCT, the 6 Min Walking Test, and CPET, we introduced an SCT-Index that included patient data (weight, height) and time. To assess the SCT's feasibility for clinical practice, we also tested our protocol with five adolescents with complex congenital heart disease (i.e., Fontan circulation). (3) Results: A strong correlation was observed between SCT-Index and O2 pulse (r = 0.921; p < 0.001). In addition, when comparing the time achieved during SCT (tSCT) with VO2max (mL/min/kg) and VO2max (mL/min), strong correlations were found (r = -0.672; p < 0.001 and r = -0.764; p < 0.001). Finally, we determined a very strong correlation between SCT-Index and VO2max (mL/min) (r = 0.927; p = <0.001). When comparing the 6MWD to tSCT, there was a moderate correlation (r = -0.544; p = 0.003). It appears to be feasible in patients with Fontan circulation. (4) Conclusions: We were able to demonstrate that there is a significant correlation between our standardized SCT and treadmill CPET. Therefore, we can say that the SCT can be used as an easy supplement to CPET and in certain contexts, it can also be used as a screening tool when CPET is not available. The advantages would be that the SCT is a simple, quick, cost-effective, and reliable standardized (sub)maximal exercise test to evaluate CRF in healthy children on a routine basis. We can even assume that it can be used in patients with congenital heart disease.

Routine follow-up transjugular liver biopsy in Fontan patients: technical considerations and safety of an initial case series and literature review.

Introduction: Patients with Fontan palliation are susceptible to congestive hepatopathy and Fontan-associated liver disease (FALD) because of hemodynamic changes. The staging of liver fibrosis involves various methods, including invasive biopsy. Transjugular liver biopsy (TJLB) offers a less invasive alternative, enhancing liver disease surveillance in routine cardiac catheterization. We detail the technical aspects, share initial outcomes, and discuss existing literature. Methods/results: During routine follow-up cardiac catheterization indicated by hemodynamic or clinical alterations, four patients aged between 16 and 26 years with univentricular Fontan circulation and three patients with biventricular circulation underwent TJLB during routine surveillance catheterization. The examinations were performed under conscious sedation and local anesthesia without general anesthesia. Jugular access was obtained at the site of liver localization, and a 5 F multipurpose catheter was inserted into the liver veins. After hand angiography to delineate the local hepatic venous anatomy, an exchange wire was used to place the bioptome, and three consecutive biopsies were performed. There were no complications, especially perforation or bleeding. The technical success rate was 100%, with all obtained samples appropriate for histopathological diagnostics. The total additional procedure time was less than 20 min. Conclusion: TJLB is an attractive alternative method for obtaining liver specimens in the scope of FALD care. We believe that it should be performed during routine hemodynamic evaluations in Fontan patients and can be performed safely with very low additional time expenditure. As the biopsy site is intravascular, the risk of external bleeding or hematoma is significantly reduced despite the high intrahepatic pressures and the usually impaired coagulation profile in these patients. Based on our initial experience and the lower complication rates compared with other techniques, TJLB should be considered a standard approach in these patients and used more often during the long-term follow-up of Fontan patients. It can be performed in the same setting whenever a hemodynamic assessment of patients with congenital heart defects is required.

Endovascular treatment of a mycotic aneurysm in an immunocompromised child with acute leukemia-case report and review of the literature.

Mycotic aneurysms are dilatations of an artery, a rare but severe complication arising from infectious obliteration of the vessel wall. Thoracic aneurysms often present with unspecific symptoms and multiple diagnostic and therapeutic challenges. In an advanced state, they have an increased risk of perforation and a high mortality rate. The surgical therapeutic approach has a high perioperative complication rate. In this study, we report a case of a thoracic mycotic aortic aneurysm in an immunocompromised pediatric patient caused by Klebsiella pneumoniae bacteremia. A combination of prompt antibacterial treatment and minimally invasive stent implantation showed a good outcome, avoiding possible severe surgical problems.

Transient liver elastography in the follow-up of Fontan patients: results of a nation wide survey in Germany.

Introduction: Fontan-palliated patients are at risk for the development of Fontan-associated liver disease (FALD). Currently, there is no consensus on how to stage FALD. Transient elastography (TE) is a rapid, non-invasive method to assess FALD and liver fibrosis. Method: To assess the availability and conditions of using TE to monitor liver disease in Fontan patients in german centers for pediatric cardiology and to propose the introduction of a standardized national protocol for the monitoring of liver disease, we developed a questionnaire. Results: In total, 95 valid questionnaires were collected. Only 20% of the centers offer the TE investigation directly. Most of the centers transfer the patients to another department or center (40%) or didnt offer TE (40%). In only 2.6% of the centers TE is performed directly by the cardiologist. Most of the centers transfer the patients to a other department. In 29.2% TE is performed only at a certain age of the patients and in 27.7% it is performed if the patients present symptoms of failing Fontan. In only 13.9% of the centers TE is proposed in all the Fontan patients on a routine basis. Most often TE is performed only from the beginning of the adolescence. In the majority of answers it was not known if the patients are fasting for the examination (68%) or not and if the TE examination had to be performed in a specific breathing phase during TE (Inspiration/Expiration, 90%). In the majority, TE is not offered routinely (46.9%). Discussion: To date in Germany, TE is only used in a few numbers of centers specialized in Fontan follow-up. A standardized protocol to use TE is currently not existing. With regard to the feasibility of the examination, it is evident that TE is a quick, cheap and easy method to distinguish between cases with and without progressive FALD. This makes TE a useful and prognostic tool for screening of liver disease and to failing Fontan circulation. Conclusion: We propose a systematic TE evaluation of possible liver congestion and fibrosis, as a part of the routine follow-up of Fontan patients.

Case report: Beneficial long-term effect of the atrial-flow-regulator device in a pediatric patient with idiopathic pulmonary arterial hypertension and recurring syncope.

We report the long-term effect after successfully implanting an 8 mm Atrial-flow-regulator (AFR) device in a 7-year-old girl with idiopathic pulmonary hypertension with persistent syncope under triple therapy with significant improvement after implantation and absence of any further syncope. Early Implantation of the AFR device (Occlutech, Germany) can be efficient and safe interventional therapy option for pulmonary arterial hypertension with a history of syncope.

Vagal Asystoles in a Boy With Prader-Willi Syndrome.

Prader-Willi syndrome (PWS) is a genetic hormonal disorder of the hypothalamic-pituitary-axis resulting in mental retardation, muscle hypotonia, hypogonadism, and hyperphagia leading to significant obesity. Cardiovascular morbidity and mortality in adult patients with PWS is higher than in healthy controls and mainly secondary to massive obesity. In childhood, mortality may result from respiratory or gastrointestinal illnesses. We present a case of a 10-year-old boy with PWS who experienced recurrent and asymptomatic episodes of sinus pauses caused by the ingestion of large gulps of apple juice, which could be provoked and reproduced. The asystoles could not be provoked by any other vagal maneuvers and an initial diagnostic workup revealed no indication for structural heart disease. Because of the asymptomatic character of the asystoles, no treatment was initially provided. When he re-presented 3 months later after a clinically relevant syncope at school, pacemaker therapy was initiated, and he has demonstrated no subsequent sinus pauses or syncopes. Regarding the rising awareness of subtle cardiac alterations including autonomic dysfunction and electrocardiogram changes in young patients with PWS and especially the occurrence of unexplained sudden deaths in childhood that may be precipitated by arrhythmia, we suggest that the utility of periodic screening for arrhythmia risk should be evaluated in children with PWS.

Have we got the optimal treatment for refractory Kawasaki disease in very young infants? A case report and literature review.

A small group of patients with Kawasaki disease (KD) demonstrates resistance to standard therapy, putting them at high risk for an unfavorable prognosis, especially regarding coronary artery aneurysms. Although adding corticosteroids to first-line i.v. immunoglobulins (IVIGs) is considered beneficial, and despite timely treatment initiation, very young infants, in particular, can present an unfavorable clinical course. We report on a 3-month-old boy with a clinically severe KD phenotype involving the early development of giant coronary artery aneurysms. Because of his poor response to the first course of IVIG and prednisolone, we administered infliximab. His clinical condition improved after that, and his temperature dropped. Inflammatory markers however did not recover completely, and he remained subfebrile. In addition, as the coronary artery dimensions deteriorated, a second IVIG course was administered and prednisolone continued at the initial dosage. Although fever and routine inflammatory parameters normalized, close follow-up investigations revealed both still increasing coronary artery dimensions and renewed rise in inflammatory parameters, necessitating two more infliximab administrations in addition to continuous prednisolone. Because of the coronary artery dimensions (left anterior descending artery, 4.9 mm, Z-score 11.1; right coronary artery 5.8 mm, Z-score 15.5), dual platelet inhibitory therapy with ASA and later clopidogrel combined with low-molecular heparin was indicated. Four weeks after his initial KD diagnosis, we detected no renewed increase in inflammatory markers; at that time, we observed a slight reduction in coronary dimensions. In summary, despite timely guideline-fulfilling therapy, the prolonged clinical course of this very young infant with KD entailing the development of giant coronary artery aneurysms makes us question whether this age group may benefit from early, even more intense therapy.

Energy Drinks and Adverse Health Events in Children and Adolescents: A Literature Review.

This review aims to investigate and summarize adverse health events in children and adolescents associated with energy drink (ED) consumption, while also exploring the impact of simultaneous trigger factors and/or preexisting health conditions. We searched the database of PubMed, Cochrane library, and Web of Science for cases associated with ED consumption in minors up to 9 May 2023. The literature written in English met inclusion criteria if patients were <18 years of age and the ED consumption was confirmed. Records, relevant articles, and reports that met all inclusion criteria were fully read by two researchers. In total, 18 cases reporting adverse health events were included. Of those, 45% affected the cardiovascular system, 33% the neuropsychological system, and 22% other organ systems. In 33% of cases, additional triggers were reported. In 44% preexisting health conditions were present. This literature review suggests that ED intake may well be associated with adverse health events in minors. The cardiovascular and the neuropsychiatric systems seem to be predisposed. ED consumption in combination with potential trigger factors or in the presence of preexisting health conditions appears to be critical. To prevent adverse health events in the future, children and adolescents should be informed about risk factors and responsible consumption behaviors.

Energy drinks: effects on pediatric 24-h ambulatory blood pressure monitoring. A randomized trial.

BACKGROUND: Energy drinks (EDs) are popular beverages among minors. To date, clinical studies investigating ED-induced effects on the pediatric cardiovascular system are sparse. This study aimed to investigate the effects of a single, bodyweight-adjusted ED dosage on 24-h ambulatory blood pressure monitoring (ABPM) in healthy children and adolescents. METHODS: This study was a randomized, single-blind, placebo-controlled, crossover clinical trial. Study participants received a single, bodyweight-adjusted ED amount or a placebo drink on 2 consecutive days at similar morning hours. Twenty-four-hour ABPM was assessed via an automated oscillometric blood pressure device after beverage consumption on both study days. RESULTS: A total of 17 healthy children and teenagers (13.90 (12.29-17.89) years) were included in the final analysis. The ED consumption led, compared to the placebo intake, to a significantly higher 24-h systolic (115.90 (110.22-118.04) vs. 110.64 (108.09-115.45) mmHg, p = 0.013) and diastolic blood pressure (66.08 (64.20-68.32) vs. 62.63 (61.40-66.46) mmHg, p = 0.005). CONCLUSIONS: The single, bodyweight-adjusted ED consumption is linked with a significantly higher systolic as well as diastolic 24-h blood pressure in healthy children and adolescents. Minors, particularly those with an increased cardiovascular morbidity, should be discouraged from drinking EDs. IMPACT: Energy drinks (EDs) are consumed by many children and teenagers. While adverse cardiovascular events after ED consumption were reported in the literature, the effects of these beverages on the pediatric 24-h blood pressure profile have not been systematically evaluated yet. In our manuscript, we demonstrate for the first time that acute ED consumption is associated with a significantly higher 24-h systolic blood pressure and diastolic blood pressure in healthy minors.

Oscillometric pulse wave velocity estimated via the Mobil-O-Graph shows excellent accuracy in children, adolescents and young adults: an invasive validation study.

AIMS: Increased arterial stiffness, measured as arterial pulse wave velocity (PWV) is associated with an elevated cardiovascular risk. Although noninvasive PWV measurement methods have been validated by invasive measurement, there is little such data on pediatric patients. The purpose of this study was to 'fill the gap' by validating PWV obtained by Mobil-O-Graph in children, adolescents in comparison to young adults. METHODS: Sixty patients (25 male, mean age 16.6 years; range 3-35 years) were included in this study. Fifty-one patients underwent cardiac catheterization after a heart transplantation (HTX) and nine for interventional atrial septal defect-closure. Specific invasive pulse wave velocities were assessed for the ascending aorta (aPWV) and entire central aorta (cPWV). These invasive PWV results were compared to simultaneously measured brachial cuff readings using Mobil-O-Graph (oPWV) stratified by age in two groups (PEDIATRICS <18 years|ADULTS ≥18 years). RESULTS: Correlation analysis showed a positive linear relation between both invasive PWV measurements and the oPWV in all ages (cPWV/oPWV: r  = 0.417, aPWV/oPWV: r  = 0.628; P  < 0.001). The oPWV data agreed better with the aPWV in mean-value comparisons and correlations with mean difference in PEDIATRICS was 0.41 ±â€Š0.41 m/s (95% confidence interval 0.27-0.55). We also found the cPWV to be faster than the aPWV particularly in adults. In addition, cPWV correlated closer with age ( r  = 0.393, P  < 0.05). CONCLUSION: Estimated oPWV using the Mobil-O-Graph demonstrated excellent accuracy in adults and pediatric patients. Therefore, the Mobil-O-Graph can be implemented as an ambulatory PWV measuring tool for pediatric cardiovascular risk stratification. CLINICAL TRIAL REGISTRATION: German clinical trial registration, DRKS00015066.

Transient Recurrent Laryngeal Nerve Palsy after Interventional Therapy.

BACKGROUND: Hoarseness due to laryngeal nerve injury is a known complication after cardiothoracic surgery involving the aortic arch. However, this complication is only rarely reported after catheter interventions. RESULTS: In this article we present the unusual case of a left-sided vocal cord paralysis in four patients after primary stenting of a re-coarctation, re-dilatation of a stented coarctation, a primary stenting of the left pulmonary artery (LPA), and prestenting for percutaneous pulmonary valve implantation with dilation of the LPA. After implanting bare metal stents, it is common practice, whilst contemplating the diameters of the adjacent structures, to optimize the stent diameter in a two-step procedure and dilate the stent until a maximum diameter is achieved and there is no residual gradient after applying this technique. Four of our patients experienced hoarseness after the intervention and a vocal cord paralysis was diagnosed. Angiography revealed no signs of extravasation or dissection. Clinical symptoms improved over the course of the following 6 months; patients with interventions at the aortic arch showed a complete remission, patients with procedures involving the LPA showed only mild regression of the symptoms. CONCLUSION: To our knowledge, this complication (Ortner's syndrome, cardiovocal syndrome) after such interventions has rarely been reported before. Although a rare complication, the recognition of these symptoms may support colleagues in managing affected patients. In addition, awareness for hoarseness after interventional therapies and systematic screening for this complication might help to identify patients at risk in the future.

Energy Drinks Decrease Left Ventricular Efficiency in Healthy Children and Teenagers: A Randomized Trial.

Background: Minors are considered the main consumer group of energy drinks (EDs). The aim of this study was to investigate the acute effects of ED consumption on left ventricular (LV) hemodynamics and efficiency in healthy children and teenagers. Methods: This study was a randomized, single-blind, placebo-controlled, crossover clinical trial. Study participants consumed a weight-adjusted amount of an ED or a placebo on two consecutive days. LV hemodynamics and efficiency parameters were evaluated non-invasively by generating LV pressure−volume loops (PVLs) through simultaneous echocardiography and blood pressure measurement. Results: A total of 24 children and teenagers (14.90 ± 2.27 years, 13 male) were included in the present study. Conventional echocardiographic parameters of LV function did not show significant differences between both beverage groups. The non-invasive generation of LV PVLs revealed a significantly lower cardiac efficiency 240 min after the ED consumption compared to the placebo intake (140.72 (133.21−149.73) mmHg vs. 135.60 (124.78−140.33) mmHg, p < 0.01). Conclusions: Acute ED consumption is associated with a significantly lower cardiac efficiency in healthy minors. The generation of non-invasive LV PVLs might be beneficial in the assessment of subtle changes in LV efficiency. Further studies need to investigate the influence of chronic ED consumption on LV function and morphology.

Energy Drinks and Their Acute Effects on Arterial Stiffness in Healthy Children and Teenagers: A Randomized Trial.

Adolescents are the main consumer group of energy drinks (ED). Studies suggest that acute ED consumption is associated with increased peripheral blood pressure. Little is known of the ED-induced effects on arterial stiffness. Therefore, this study aimed to investigate the acute effects of ED consumption on arterial stiffness in healthy children and teenagers by conducting a prospective, randomized, single-blind, placebo-controlled, crossover clinical trial. Study participants (n = 27, mean age = 14.53 years) consumed a body-weight-adjusted amount of an ED or a placebo on two consecutive days. Arterial stiffness was evaluated sonographically by two-dimensional speckle tracking of the common carotid artery (CCA) at baseline and up to four hours after beverage consumption. The ED intake led to a significantly decreased peak circumferential strain of the CCA (11.78 ± 2.70% vs. 12.29 ± 2.68%, p = 0.043) compared with the placebo. The results of this study indicate that the acute ED consumption might be associated with increased arterial stiffness in healthy children and teenagers. Minors, particularly those with increased cardiovascular morbidity, should be discouraged from ED consumption.

Energy Drinks: Effects on Blood Pressure and Heart Rate in Children and Teenagers. A Randomized Trial.

Background: The consumption of Energy Drinks (ED) is very popular among children and teenagers. While potential cardiovascular side effects of these beverages are suggested, the acute impact of ED consumption on the pediatric cardiovascular system has not been systematically examined yet. The aim of this study was to investigate the acute effects of ED consumption on blood pressure and heart rate in healthy children and teenagers. Methods: This study was a randomized, single-blind, placebo-controlled, crossover clinical trial. On two consecutive days, the study participants were asked to consume a weight-adjusted amount of an ED (3 mg caffeine per kg of body weight) or a placebo containing a similar amount of sugar but without conventional ED ingredients. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate were measured at the following time points: baseline as well as 30, 60, 120 and 240 min after beverage consumption. Results: In total, 27 healthy children and adolescents (mean age 14.53 ± 2.40 years, 14 male) were included in the present study. Compared to placebo intake, mean SBP was demonstrated to be up to 5.23 mmHg (p < 0.0001) and mean DBP up to 3.29 mmHg (p < 0.001) increased after ED consumption. Prevalence of elevated blood pressure, stage 1 and stage 2 hypertension was higher after ED consumption. Heart rate tended to be lower after ED consumption. Conclusions: The acute ED consumption is associated with a significantly increased SBP and DBP in healthy children and teenagers. Minors, particularly those with pre-existing health conditions, should be discouraged from drinking EDs. Clinical Trial Registration: https://www.drks.de/drks_web/, identifier: DRKS00027580.

Acute phase of Kawasaki disease: a review of national guideline recommendations.

Key aspects of the medical management of Kawasaki disease (KD) are not yet supported by a high evidence level, thus making room for individual recommendations. We performed a structured comparison of existing international KD guidelines to analyze potential differences in the implementation of evidence-based KD recommendations regarding diagnosis and therapy. To identify country-specific guidelines, we took a multilateral approach including a comprehensive PubMed literature, online research, and directly contacting national pediatric associations. We then ran a structured guidelines' analysis and evaluated the diagnostic and therapeutic differences in the context of evidence-based medicine. In this structured guideline analysis, we identified nine national and one European guidelines. According to them all, the diagnosis of KD still relies on its clinical presentation with no reliable biomarker recommended. First-line treatment consistently involves only intravenous immunoglobulin (IVIG) therapy. Recommendations in terms of acetylsalicylic acid, corticosteroids, and additional therapeutic options vary considerably. CONCLUSION: According to all guidelines, KD is diagnosed clinically with some variance in defining incomplete KD and being a non-responder to treatment. First-line treatment consistently includes IVIG. Recommendations for additional therapeutic strategies are more heterogeneous. WHAT IS KNOWN: • The diagnosis of KD relies on the clinical presentation, entailing challenges in timely diagnosis. • Other treatment options then IVIG are not supported by a high evidence level, making room for individual recommendations. WHAT IS NEW: • Definition of incomplete KD and being non-responsive to an initial treatment vary to some extent between the national guidelines. • Only IVIG is consistently proposed throughout all guidelines, further therapeutic recommendations vary between the national recommendations.

Energy Drinks and Their Acute Effects on Heart Rhythm and Electrocardiographic Time Intervals in Healthy Children and Teenagers: A Randomized Trial.

Beyond their effect on blood pressure, the effect of energy drinks on heart rate in children and teenagers has not been evaluated until now. Thus, this study aimed to investigate the acute cardiovascular effects of energy drinks in healthy children and teenagers. Twenty-six children and adolescents (mean age 14.49 years) received a commercially available energy drink (ED) and placebo on two consecutive days based on the maximum caffeine dosage as proposed by the European Food Safety Authority. Heart rhythm and electrocardiographic time intervals were assessed in a prospective, randomized, double-blind, placebo-controlled, crossover clinical study design. ED consumption resulted in a significantly increased number of supraventricular extrasystoles (SVES) compared to the placebo, whereas supraventricular tachycardia or malignant ventricular arrhythmias were not observed. The mean heart rate (HR) was significantly lower following consumption of EDs. In contrast, QTc intervals were not affected by EDs. Being the first of its kind, this trial demonstrates the cardiovascular and rhythmological effects of EDs in minors. Interestingly, EDs were associated with adverse effects on heart rhythm. Whether higher dosages or consumption in children with preexisting conditions may cause potentially harmful disorders was beyond the scope of this pilot study and remains to be determined in future trials. Trial Registration Number (DRKS-ID): DRKS00027580.

Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience.

Background: After encouraging results with the Edwards Sapien and XT valves, this study aimed to review procedural data and early outcomes for the Sapien 3 valves for transcatheter pulmonary valve replacement (TPVR). Methods: We performed a multicenter, retrospective analysis of cases who underwent a Sapien 3 TPVR between 2015 and 2017 in 7 centers in Germany with a follow-up of up to 2 years. Results: 56 patients could be enrolled (weight 58,5 ± 25,0 kg; 53% Tetralogy of Fallot, 45% native RVOT). Most procedures were two-stage procedures (82,1%) with 100% prestenting. Valve sizes were 20 mm (n = 1), 23 mm (n = 15), 26 mm (n = 27), 29 mm (n = 13). Procedural success rate was 96.4%. Two patients underwent surgical valve implantation after balloon rupture during TPVR. Follow-up data were available up to 24-month post TPVR. The rate of patients with ? moderate and severe pulmonary regurgitation decreased to 0% after TPVR, peak systolic gradient decreased from 24,2 (SD±20,9) mmHg to 7,1 mmHg (SD±5,0). There were no endocarditis, severe tricuspid valve impairment or stent fractures. Conclusions: With the Edwards Sapien 3 valve, the patient pool for TPVR can be substantially extended. Continued data collection is necessary to verify long-term results.