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Background: The study objective was to detect any incidence of aseptic meningitis associated with measles-mumps-rubella (MMR) vaccines that would be considered of public health importance subsequent to the introduction of a new MMR vaccine (Priorix™). Patients and Methods: Adverse drug reaction (ADR) rates were calculated by relating the number of cases to the number of doses of the different MMR vaccines distributed during a 2-year period in Germany. Results: During the 2-year study period 1,575,936 doses of Priorix™ and 1,907,875 doses of other MMR vaccines were distributed in Germany. There were no confirmed cases of aseptic meningitis associated with MMR vaccination during this period. Thus, the ADR rates (rejectable with 5% alpha error) were lower than 1/525,312 for Priorix™ and lower than 1/635,958 for other MMR vaccines. Conclusion: The safety profile of the Priorix™ is similar to that of other MMR vaccines used in Germany. [ABSTRACT FROM AUTHOR]

Focuses on a study which assessed the efficacy of pertussis vaccine after partial and completed primary vaccination series for preventing hospitalizations due to pertussis in Germany. Methodology; Incidence of pertussis in the country; Vaccination status of hospitalized children with pertussis; Effectiveness of the vaccine.

Examines the plasma concentrations of alpha human atrial natriuretic peptide of children with congenital heart pulmonary diseases in Germany. Amino acid composition among humans; Association of bronchopulmonary dysplasia with high atrial pressure and atrial stretching; Use of hormones as a marker for the diagnosis of cardiac and pulmonary diseases.

Background: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications., Methods: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749., Findings: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months., Interpretation: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications., Funding: Medtronic., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

In the summer of 2016, delegates from the German Society of Cardiology (DGK), the German Respiratory Society (DGP), and the German Society of Pediatric Cardiology (DGPK) met in Cologne, Germany, to define consensus-based practice recommendations for the management of patients with pulmonary hypertension (PH). These recommendations were built on the 2015 European Pulmonary Hypertension guidelines, aiming at their practical implementation, considering country-specific issues, and including new evidence, where available. To this end, a number of working groups was initiated, one of which was specifically dedicated to PH associated with left heart disease. In this context, the European Guidelines point out that the drugs currently approved to treat patients with PAH (prostanoids, endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, sGC stimulators) have not sufficiently been investigated in other forms of PH. However, despite the lack of respective efficacy data, an uncritical use of targeted PAH drugs in patients with PH associated with left heart disease is currently observed at an increasing rate. This development is a matter of concern. On the other hand, PH is a frequent problem that is highly relevant for morbidity and mortality in patients with left heart disease. In that sense, the distinction between isolated post-capillary pulmonary hypertension (IpcPH) and combined post- and pre-capillary pulmonary hypertension (CpcPH) and their proper definition may be of particular relevance. The detailed results and recommendations of the working group on PH associated with left heart disease, which were last updated in the spring of 2018, are summarized in this article., (Copyright © 2018. Published by Elsevier B.V.)

Ambulatory blood pressure (BP) and central BP are better predictors for overall cardiovascular risk and mortality than brachial BP. Renal denervation (RDN) has been shown to reduce office brachial and central BP as well as brachial ambulatory BP, but data on central ambulatory BP are limited. Patients (N = 94) with treatment resistant hypertension (TRH) who underwent RDN were included. Ambulatory BP, including central pressures, hemodynamics, and arterial stiffness were measured at baseline and 3, 6, 12 months after RDN by an oscillometric device (MobiloGraph ™ ). At 3, 6, and 12-month follow-ups, brachial ambulatory BP was reduced (P for all < .001). Consistently, central ambulatory BP was reduced (P for all < .001). Ambulatory assessed averaged daytime pulse wave velocity improved after RDN (P < .05). Total vascular resistance decreased (P for all < .01). In patients with TRH, RDN improves brachial and central ambulatory BP, arterial stiffness, and total vascular resistance, indicating an improvement of cardiovascular outcome., (©2018 Wiley Periodicals, Inc.)

Arterial hypertension is a major risk factor for cardiovascular mortality and remains insufficiently controlled in Germany. The sham controlled Symplicity HTN-3 trial did meet its primary safety endpoint but failed to meet its primary efficacy endpoint. Renal denervation can not replace established, well-proven therapies. It can only be used in selected truly resistant hypertensive patients as an additive approach and should be performed by specialized centers only. Randomized controlled trials are needed to further evaluate renal denervation., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: Marfan syndrome (MFS) is a genetic disorder of the connective tissue. Aortic root dilation is a main criterion of the Ghent Nosology. Dural ectasia and the presence of mitral valve prolapse (MVP) contribute to its systemic score. The purpose of this study was to investigate the frequency of dural ectasia and its correlation with cardiovascular manifestations in a pediatric study population., Patients and Methods: 119 pediatric patients with confirmed or suspected MFS were examined in the local Marfan Clinic. 31 children with MFS who underwent magnetic resonance imaging (MRI) were included. Each patient was evaluated according to the Ghent nosology. Echocardiography was used to measure the aortic root diameter and assess the presence of MVP and mitral regurgitation. Z-scores were calculated for the evaluation of the aortic root diameters. MRI was performed to determine the dural sac ratio (DSR)., Results: The prevalence of dural ectasia was 90.3 %, of aortic root dilation 32.2 %, of MVP 64.5 % and of mitral regurgitation 51.6 %. DSR at L5 correlated with the intraindividual z-scores (slope, 3.62 ± 1.5 [0.56; 6.68]; r = 0.17; p = 0.02; F = 5.84). Z-scores ≥ 2 were accompanied by dural ectasia in 100 %, MVP in 95 % and mitral regurgitation in 100 % of cases. MVP was accompanied by mitral regurgitation in 70 % of cases., Conclusion: As the examined cardiac manifestations show a coincidence with dural ectasia in 95 - 100 % of cases, MRI for diagnostic dural sac imaging should be reserved for MFS suspicions with the absence of those manifestations in order to establish the diagnosis according to the Ghent criteria. Thus, the present study supports the recent downgrading of dural ectasia to a contributor to the systemic score., (© Georg Thieme Verlag KG Stuttgart · New York.)

The 2009 European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension (PH) have been adopted for Germany. While the guidelines contain detailed recommendations regarding pulmonary arterial hypertension (PAH), they contain only a relatively short paragraph on other, much more frequent forms of PH including PH owing to left heart disease. The guidelines point out that the drugs currently used to treat patients with PAH (prostanoids, endothelin receptor antagonists and phosphodiesterase type 5 inhibitors) have not been sufficiently investigated in other forms of PH. However, despite the lack of respective efficacy data an uncritical use of targeted PAH drugs in patients with PH associated with left heart disease is currently observed at an increasing rate. This development is a matter of concern. On the other hand, PH is a frequent problem that is highly relevant for morbidity and mortality in patients with left heart disease. It that sense, the practical implementation of the European Guidelines in Germany requires the consideration of several specific issues and already existing novel data. This requires a detailed commentary to the guidelines, and in some aspects an update already appears necessary. In June 2010, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany. This conference aimed to solve practical and controversial issues surrounding the implementation of the European Guidelines in Germany. To this end, a number of working groups was initiated, one of which was specifically dedicated to PH due to left heart disease. This commentary describes in detail the results and recommendations of the working group which were last updated in October 2011., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: Improved survival after Norwood stage 1 palliation is giving more patients the opportunity to reach stage 2 palliation; thus, more patients are exposed to the risk of interstage death., Methods: A single-center review of patients who underwent stage 1 palliation from January 1998 to December 2007 (n = 58) was performed. Pulmonary blood flow was established either by a modified Blalock-Taussig-shunt (mBTS, n = 33) or a right ventricle-to-pulmonary artery conduit (RVPAC, n = 25)., Results: Hospital, interstage, and 1-year survival was not significantly different between groups. However, Kaplan-Meier survival analysis reflected a significantly higher survival probability for RVPAC patients until the age of 120 days (RVAPC, 92% ± 5% [standard error of the mean]; 95% confidence interval, 82 to 100; mBTS, 63% ± 9%; 95% confidence interval, 48 to 82; p = 0.01). During a 1-year follow-up, all 11 nonsurvivors with mBTS died at an age younger than 120 days, including 2 patients with early stage 2 palliation. In contrast, besides 2 early deaths, all RVPAC patients (n = 5) showed later attrition at an age older than 120 days while awaiting stage 2 palliation. Interstage death occurred significantly later among RVPAC patients (RVPAC, 146 ± 60 days versus mBTS, 81 ± 23 days; p = 0.01). After stage 2 palliation, all patients with RVPAC survived, including 7 patients with surgery at an age younger than 120 days. All interstage and late deaths were related to compromising cardiac lesions with no statistical difference between groups., Conclusions: After Norwood stage 1 palliation, survival was improved with RVPAC for the first 4 months. However, a loss of the favorable primary outcome was present by delaying stage 2 palliation beyond the age of 120 days. Progressive volume load as a result of conduit regurgitation may play a crucial role for later attrition. Residual lesions should be addressed early to preserve cardiac function., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The 2009 European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension (PH) have been adopted for Germany. Invasive hemodynamic data obtained by right heart catheterization are essential to confirm the diagnosis, test vasoreactivity, assess severity and guide therapy in PH patients. The definition of PH is resting on a mean pulmonary artery pressure ≥ 25 mm Hg obtained by right heart catheterization. Furthermore, a pulmonary capillary wedge pressure > 15 mm Hg excludes pre-capillary PH. Vasoreactivity testing is part of the diagnostic work-up in pulmonary arterial hypertension. Recent data on the use of inhaled iloprost update these guidelines and are of special importance due to the frequent diagnostic use of iloprost in Germany. Other aspects of invasive hemodynamic data in certain PH subgroups as well as their measurement and interpretation in children are discussed. Several aspects of right heart catheterization in PH justify a detailed commentary, and in some areas an update already appears necessary. In June 2010, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Paediatric Cardiology (DGPK) was held in Cologne, Germany. This conference aimed to solve practical and controversial issues surrounding the implementation of the European Guidelines in Germany. To this end, a number of working groups were initiated, one of which was specifically addressing the invasive hemodynamic evaluation of patients with PH. This commentary summarizes the results and recommendations of this working group., (© Georg Thieme Verlag KG Stuttgart · New York.)

The 2009 European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension have been adopted for Germany. While the guidelines contain detailed recommendations regarding pulmonary arterial hypertension (PAH), they contain only a relatively short paragraph on other, much more frequent forms of PH such as PH due to left heart disease. Despite the lack of data, targeted PAH treatments are increasingly being used for PH associated with left heart disease. This development is of concern. On the other hand, PH is a frequent problem that is highly relevant for morbidity and mortality in patients with left heart disease, so that it may be speculated whether selected patients may benefit from targeted PH therapy. It that sense, the practical implementation of the European Guidelines in Germany requires the consideration of several specific issues and already existing novel data. This requires a detailed commentary to the guidelines, and in some aspects an update already appears necessary. In June 2010, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany. This conference aimed to solve practical and controversial issues surrounding the implementation of the European Guidelines in Germany. To this end, a number of working groups was initiated, one of which was specifically dedicated to PH due to left heart disease. This commentary summarizes the results and recommendations of this working group., (© Georg Thieme Verlag KG Stuttgart · New York.)

For the prevention of pertussis and invasive Haemophilus influenzae type b (Hib) infections, each with a peak for mortality and serious complications in the first year of life, early vaccination is important and needs adequate monitoring. In a 1999 national coverage survey the timing of uptake of these vaccines in German children was therefore assessed conventionally at defined age thresholds and with a new adaptation of the Kaplan-Meier (KM) method estimating immunization uptake over time by 1 minus the survival function s(t). Only 6% and 9% of children were vaccinated against pertussis and Hib in accordance with the national recommended primary vaccination schedule. Coverage levels for the primary vaccination course of 50% and 90% were attained for pertussis after 6.6 and 16.3 months respectively and for Hib after 7.0 and 24.3 months. These estimates were only possible with the KM method which proved useful to monitor vaccination programmes and will allow the comparison of vaccination uptake in different populations.

Background: Since 1996 in Germany primary infant immunization against Haemophilus influenzae has been most commonly given in the form of diphtheria-tetanus toxoids-acellular pertussis/H. influenzae type b (DTaP/Hib) or diphtheria-tetanus toxoids-acellular pertussis (-inactivated poliovirus)/H. influenzae type b (DTaP-IPV/Hib) combination vaccines. These combination vaccines elicit lower anti-Hib antibody concentrations than the equivalent Hib conjugate administered as a separate injection, but the clinical relevance of this phenomenon is unknown., Methods and Findings: To assess the impact of DTaP/Hib combination vaccines on the incidence of invasive Hib disease in Germany, two independent surveillance systems, one hospital- and one laboratory-based, were used during 1998 and 1999 for detection of cases. Vaccination histories of all cases detected were obtained by telephone contact with parents or health care providers. During the 2-year study period invasive H. influenzae disease in the <5-year age group continued to fall, with a mean annual incidence of 1.01/100 000 children. National vaccination coverage rates revealed that only 70% of children given DTaP/Hib or DTaP-IPV/Hib received the recommended three doses in their first year of life, but the overall effectiveness of these vaccines was high at 97.5% (95% confidence interval, 96.3 to 98.4) for those who had received at least one dose. In subjects who received the full 3-dose schedule, effectiveness was 98.8% (95% confidence interval, 98.2 to 99.3)., Conclusion: Although it is well-documented that DTaP/Hib vaccines elicit lower anti-Hib titers than separate vaccines, such combinations are effective in reducing the incidence of invasive H. influenzae type b disease.

Between 1 November 1993 and 31 October 1996, admissions to paediatric departments for Bordetella pertussis complications were reported to a nationwide, hospital-based active surveillance system. The case definition included pertussis complicated by pneumonia, apnoea requiring assisted ventilation, seizures, encephalopathy or a combination of these. Two hundred sixteen cases of pertussis complications were registered. 57.4% of them were in infants, 50.9% of them less than 6 months old. There were five deaths, three previously healthy children died. At the time of hospital admission, 106 cases would have been eligible for at least three doses of pertussis vaccine, only four (3.8%) had received the recommended number of immunisations. From the second quarter of 1995, the reported number of cases declined. The decrease coincides with an improvement of pertussis vaccination coverage between 1992 and 1995 due to an increased use of acellular vaccines. The reduction of complicated pertussis was observed even in age-groups too young for the recommended vaccinations. The observed decrease could be due to the increase in vaccination coverage with interruption of the chain of transmission to the younger age-groups, to a cyclic decrease in pertussis cases, or to a combination of both. Continued surveillance will provide information on the epidemiological trend of hospitalisations for pertussis complications in the first European country to have introduced vaccination with acellular vaccines on a large scale.