Comparison of molding helmet therapy versus natural course in twins with nonsynostotic head deformation.

This observational study aims to compare the effectiveness of helmet therapy versus natural course in twin siblings suffering from nonsynostotic head deformations. A retrospective analysis of all twin couples treated with helmet therapy between March 2009 and May 2017 at an orthopedic hospital was conducted. Inclusion criteria were me if only one twin received helmet therapy. The other twin acted as control. A classification for different head shapes was used. A total of 61 twin couples was included. Change in outcome parameters of helmet therapy and natural course differed significantly: cranial vault asymmetry (CVA) -0.66 cm vs. -0.04 cm, cranial vault asymmetry index (CVAI) -5.35% vs. -0.51% (both p < 0.001), cephalic index (CI) -3.10% vs. -1.91% (p = 0.006). Helmet therapy showed a success rate (CI < 90% and CVAI ≤7% or better) of 63.6% vs. 21.1% in children with natural course (p = 0.002). Within the limitations of the study it seems that the results of this retrospective, single-center study confirm that helmet therapy to be a reliable treatment for mild to severe positional head deformation.

Rationale and design of the DIGIT-HF trial (DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure): a randomized, double-blind, placebo-controlled study.

AIMS: Despite recent advances in the treatment of chronic heart failure (HF), mortality and hospitalizations still remain high. Additional therapies to improve mortality and morbidity are urgently needed. The efficacy of cardiac glycosides - although regularly used for HF treatment - remains unclear. DIGIT-HF was designed to demonstrate that digitoxin on top of standard of care treatment improves mortality and morbidity in patients with HF and a reduced ejection fraction (HFrEF). METHODS: Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF) ≤ 40%, or patients in NYHA functional class II and LVEF ≤ 30% are randomized 1:1 in a double-blind fashion to treatment with digitoxin (target serum concentration 8-18 ng/mL) or matching placebo. Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline. A total of 2190 eligible patients will be included in this clinical trial (1095 per group). All patients receive standard of care treatment recommended by expert guidelines upon discretion of the treating physician. The primary outcome is a composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first). Key secondary endpoints are all-cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF. CONCLUSION: The DIGIT-HF trial will provide important evidence, whether the cardiac glycoside digitoxin reduces the risk for all-cause mortality and/or hospital admission for worsening HF in patients with advanced chronic HFrEF on top of standard of care treatment.

Outcome analysis of molding helmet therapy using a classification for differentiation between plagiocephaly, brachycephaly and combination of both.

PURPOSE: The incidence of positional head deformation has increased during the last decades. Helmet therapy has been proved to be a reliable method for the treatment of nonsynostotic skull deformities. Until today, a simple classification to differentiate between different head shapes has not been established. MATERIALS AND METHODS: We suggest a classification system to group patients with plagiocephaly, brachycephaly, and a combination of both, using two simple values: cranial vault asymmetry (CVA), and cephalic index (CI). We further analyzed a study population of 1050 children treated with molding helmets to identify prognostic variables for better outcome within our proposed classification. RESULTS: In all, 736 patients were male (70.10%) and 314 patients were female (29.90%). Mean improvement of cranial vault asymmetry index (CVAI) ranged from 2.94% to 7.08% (CVA 0.37 cm-0.86 cm) in subgroups of patients defined by classification and severity of deformation. In patients with brachycephaly, CI improved from 4.17% to 8.22%. Duration of therapy differed from 21 weeks to 24 weeks. Children aged 6 months or less showed greater improvement and shorter duration of therapy compared to older patients. In addition to early onset of therapy, classification and severity of deformation were significantly associated with a reduction of the deformation under therapy. There were distinct differences in outcomes between different head shapes. CONCLUSION: Helmet therapy should be initiated early. Our analysis suggests that the proposed classification correctly identifies patients whose deformation is reduced under therapy. LEVEL OF EVIDENCE: III.

Evaluation of CT vascularization patterns for survival prognosis in patients with hepatocellular carcinoma treated by conventional TACE.

PURPOSE: Transarterial chemoembolization (TACE) is an established treatment for intermediate stage hepatocellular carcinoma (HCC). The aim of this retrospective study was to evaluate the power of lesion vascularization criteria based on computed tomography for prognosis of overall survival before initiation of treatment. METHODS: A total of 59 patients with intermediate stage HCC treated with TACE as first-line treatment were retrospectively evaluated. TACE procedures were performed using doxorubicin, cisplatin, and lipiodol. Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) were used to determine the initial tumor response. Four vascularization patterns (VP) of the largest target lesion (homogeneous vascularization [VP1], homogeneous vascularization with additional arterial hypervascularization [VP2], heterogeneous vascularization with [VP3] and without zones of hypervascularization [VP4]) were assessed prior to the first TACE and correlated to survival. RESULTS: Kaplan-Meier analysis yielded a median overall survival of 608 days (standard error [SE], 120.5 days). Survival analysis showed significant differences depending on the vascularization patterns (P = 0.012; hazard ratio, 0.327): patients with homogeneously vascularized lesions (VP1, VP2) had a median overall survival of 1091 days (SE, 235.5 days). Patients with heterogeneous vascularization of the lesion (VP3 and VP4) showed a median overall survival of 508 days (SE, 113.9 days). CONCLUSION: The vascularization pattern of the largest HCC lesion is helpful for survival prognosis under TACE treatment and therefore has the potential to be used as an additional parameter for treatment stratification.

Neurological Manifestations of Mycoplasma pneumoniae Infection in Hospitalized Children and Their Long-Term Follow-Up.

Objective In this retrospective study, we aimed to assess frequency, types, and long-term outcome of neurological disease during acute Mycoplasma pneumoniae (M. pneumoniae) infection in pediatric patients. Materials and Methods Medical records of patients hospitalized with acute M. pneumoniae infection were reviewed. Possible risk factors were analyzed by uni- and multivariate regression. Patients with neurological symptoms were followed up by expanded disability status score (EDSS) and the cognitive problems in children and adolescents (KOPKJ) scale. Results Out of 89 patients, 22 suffered from neurological symptoms and signs. Neurological disorders were diagnosed in 11 patients: (meningo-) encephalitis (n = 6), aseptic meningitis (n = 3), transverse myelitis (n = 1), and vestibular neuritis (n = 1), 11 patients had nonspecific neurological symptoms and signs. Multivariate logistic regression identified lower respiratory tract symptoms as a negative predictor (odds ratio [OR] = 0.1, p < 0.001), a preexisting immune deficit was associated with a trend for a decreased risk (OR = 0.12, p = 0.058). Long-term follow-up after a median of 5.1 years (range, 0.6-13 years) showed ongoing neurological deficits in the EDSS in 8/18, and in the KOPKJ in 7/17. Conclusion Neurological symptoms occurred in 25% of hospitalized pediatric patients with M. pneumoniae infection. Outcome was often favorable, but significant sequels were reported by 45%.