Postoperative radiological assessment of the mastoid facial canal in cochlear implant patients in correlation with facial nerve stimulation.

OBJECTIVES: To correlate the radiological assessment of the mastoid facial canal in postoperative cochlear implant (CI) cone-beam CT (CBCT) and other possible contributing clinical or implant-related factors with postoperative facial nerve stimulation (FNS) occurrence. METHODS: Two experienced radiologists evaluated retrospectively 215 postoperative post-CI CBCT examinations. The mastoid facial canal diameter, wall thickness, distance between the electrode cable and mastoid facial canal, and facial-chorda tympani angle were assessed. Additionally, the intracochlear position and the insertion angle and depth of electrodes were evaluated. Clinical data were analyzed for postoperative FNS within 1.5-year follow-up, CI type, onset, and causes for hearing loss such as otosclerosis, meningitis, and history of previous ear surgeries. Postoperative FNS was correlated with the measurements and clinical data using logistic regression. RESULTS: Within the study population (mean age: 56 ± 18 years), ten patients presented with FNS. The correlations between FNS and facial canal diameter (p = 0.09), wall thickness (p = 0.27), distance to CI cable (p = 0.44), and angle with chorda tympani (p = 0.75) were statistically non-significant. There were statistical significances for previous history of meningitis/encephalitis (p = 0.001), extracochlear-electrode-contacts (p = 0.002), scala-vestibuli position (p = 0.02), younger patients' age (p = 0.03), lateral-wall-electrode type (p = 0.04), and early/childhood onset hearing loss (p = 0.04). Histories of meningitis/encephalitis and extracochlear-electrode-contacts were included in the first two steps of the multivariate logistic regression. CONCLUSION: The mastoid-facial canal radiological assessment and the positional relationship with the CI electrode provide no predictor of postoperative FNS. Histories of meningitis/encephalitis and extracochlear-electrode-contacts are important risk factors. KEY POINTS: • Post-operative radiological assessment of the mastoid facial canal and the positional relationship with the CI electrode provide no predictor of post-cochlear implant facial nerve stimulation. • Radiological detection of extracochlear electrode contacts and the previous clinical history of meningitis/encephalitis are two important risk factors for postoperative facial nerve stimulation in cochlear implant patients. • The presence of scala vestibuli electrode insertion as well as the lateral wall electrode type, the younger patient's age, and early onset of SNHL can play important role in the prediction of post-cochlear implant facial nerve stimulation.

Rituximab plus leflunomide in rheumatoid arthritis: a randomized, placebo-controlled, investigator-initiated clinical trial (AMARA study).

OBJECTIVE: To investigate the efficacy and safety of rituximab + LEF in patients with RA. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled phase 3 trial, patients with an inadequate response to LEF who had failed one or more DMARD were randomly assigned 2:1 to i.v. rituximab 1000 mg or placebo on day 1 and 15 plus ongoing oral LEF. The primary efficacy outcome was the difference between ≥50% improvement in ACR criteria (ACR50 response) rates at week 24 (P ≤ 0.025). Secondary endpoints included ACR20/70 responses, ACR50 responses at earlier timepoints and adverse event (AE) rates. The planned sample size was not achieved due to events beyond the investigators' control. RESULTS: Between 13 August 2010 and 28 January 2015, 140 patients received rituximab (n = 93) or placebo (n = 47) plus ongoing LEF. Rituximab + LEF resulted in an increase in the ACR50 response rate that was significant at week 16 (32 vs 15%; P = 0.020), but not week 24 (27 vs 15%; P = 0.081), the primary endpoint. Significant differences favouring the rituximab + LEF arm were observed in some secondary endpoints, including ACR20 rates from weeks 12 to 24. The rituximab and placebo arms had similar AE rates (71 vs 70%), but the rituximab arm had a higher rate of serious AEs (SAEs 20 vs 2%), primarily infections and musculoskeletal disorders. CONCLUSION: The primary endpoint was not reached, but rituximab + LEF demonstrated clinical benefits vs LEF in secondary endpoints. Although generally well tolerated, the combination was associated with additional SAEs and requires monitoring. TRIAL REGISTRATION: EudraCT: 2009-015950-39; ClinicalTrials.gov: NCT01244958.

Radiohistologic Comparison Study of Temporal Bone Specimens After Cochlear Implant Electrode Array Insertion: Is Cone-Beam CT Superior to MDCT?

OBJECTIVE. The purpose of this article is to evaluate subjective image quality and diagnostic accuracy to determine cochlear implant (CI) electrode position in a temporal bone (TB) specimen on cone-beam CT (CBCT) versus MDCT. MATERIALS AND METHODS. In this retrospective study, two radiologists independently reviewed CBCT (96-kV and 120-kV settings) and MDCT images of 20 TB specimens after electrode implantation. Qualitative evaluation of bone structures of the otic capsule, inner and outer cochlear wall, osseous spiral lamina, electrode position relative to the osseous spiral lamina, visualization of single electrode contacts on the array, metal artifacts, and overall image quality was performed using a five-point scale. Intracochlear electrode position was subsequently correlated with histologic examination. RESULTS. Radiologic assessment of bone structures of the otic capsule, the cochlear wall (except the outer part), osseous spiral lamina, electrode position, visualization of single electrode contacts on the array, metal artifacts, and overall image quality were significantly higher in CBCT compared with MDCT (maximum p = .04). No significant differences were found between CBCT at 96 kV and 120 kV (minimum p = .21). The intracochlear electrode position with histologic correlation was correctly diagnosed in 100% and 97.5% of specimens on 120-kV and 96-kV CBCT, respectively, whereas 77.5% were correctly assessed using MDCT. CONCLUSION. The data suggest that CBCT shows a higher diagnostic accuracy in TB specimen imaging after CI compared with MDCT, in particular to determine the intracochlear localization of the implant.

Antimicrobial Susceptibility and Phylogenetic Relations in a German Cohort Infected with Mycobacterium abscessus.

Mycobacterium abscessus is a highly antibiotic-resistant opportunistic pathogen causing clinically challenging infections in patients with preexisting lung diseases or under immunosuppression. Hence, reliable antibiotic susceptibility data are required for effective treatment. Aims of this study were to investigate (i) the congruence of genotypic and phenotypic antimicrobial susceptibility testing, (ii) the relationship between resistance profile and clinical course, and (iii) the phylogenetic relations of M. abscessus in a German patient cohort. A total of 39 isolates from 29 patients infected or colonized with M. abscessus underwent genotypic and phenotypic drug susceptibility testing. Clinical data were correlated with susceptibility data. Phylogenetic analysis was performed by means of whole-genome sequencing (WGS) and single-nucleotide polymorphism (SNP) analysis. Macrolide resistance was mainly mediated by functional Erm(41) methyltransferases (T28 sequevars) in M. abscessus subsp. abscessus (n = 25) and M. abscessus subsp. bolletii (n = 2). It was significantly associated with impaired culture conversion (P = 0.02). According to the core SNP phylogeny, we identified three clusters of closely related isolates with SNP distances below 25. Representatives of all circulating global clones (Absc. 1, Absc. 2, and Mass. 1) were identified in our cohort. However, we could not determine evidence for in-hospital interhuman transmission from clinical data. In our patient cohort, we identified three M. abscessus clusters with closely related isolates and representatives of the previously described international clusters but no human-to-human in-hospital transmission. Macrolide and aminoglycoside susceptibility data are critical for therapeutic decision-making in M. abscessus infections.

The prophylactic use of a topical scar gel containing extract of Allium cepae, allantoin, and heparin improves symptoms and appearance of cesarean-section scars compared with untreated scars.

BACKGROUND: Abdominal Cesarean sections (C-sections) are frequently associated with an increased risk of excessive or unpleasant scarring. A topical scar gel containing extract of Allium cepae, allantoin and heparin (Contractubex®; Merz Pharmaceuticals GmbH, Germany), has shown efficacy in improving the appearance of various scar types. OBJECTIVE: To investigate the efficacy of the topical scar gel, Contractubex, in the early treatment of C-section scars. MATERIALS & METHODS: A total of 61 females, aged ≥18 years, who had given birth by elective C-section for the first time within the last 5-10 days, were included in this prospective, randomized, single-center study. Patients were advised to apply the topical scar gel twice daily (treatment group), or received no treatment (control group). Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment tool comprised of a Patient Scale and an Observer Scale. RESULTS: Analysis revealed a significant change in the POSAS Patient Scale total score, with a 14.2% improvement in the treatment group compared with a decline of similar magnitude (-14.8%) in the control group at week 6. Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color (13.6% vs -18.5%, respectively, P=0.0284), stiffness (12.5% vs -34.6%, respectively, P=0.0029), and irregularity (29.4% vs -46.2%, respectively, P=0.0140) after 6 weeks of treatment. No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel, although there was a strong overall trend in favor of the treatment group. No significant adverse events were observed during the study. CONCLUSION: Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color, stiffness and irregularity of C-section scars.

Effect of 2D vs. 3D laparoscopy on postoperative complications and operation time in a propensity-score-matched real-world data analysis.

BACKGROUND: Postoperative complication rates using 3D visualization are rarely reported. The primary aim of our study is to detect a possible advantage of using 3D on postoperative complication rates in a real-world setting. METHOD: With a sample size calculation for a medium effect size difference that 3D reduces significantly postoperative complications, data of 287 patients with 3D visualization and 832 with 2D procedure were screened. The groups underwent an exact propensity score-matching to be comparable. Comprehensive complication index (CCI) for every procedure was calculated and Operation Time was determined. RESULTS: Including 1078 patients in the study, 213 exact propensity score-matched pairs could finally be established. Concerning overall CCI (3D: 5.70 ± 13.63 vs. 2D: 3.37 ± 9.89; p = 0.076) and operation time (3D: 103.98 ± 93.26 min vs. 2D: 88.60 ±6 9.32 min; p = 0.2569) there was no significant difference between the groups. CONCLUSION: Our study shows no advantage of 3D over 2D laparoscopy regarding postoperative complications in a real-world setting, the second endpoint operation time, too, was not influenced by 3D overall.

Evaluating a Clinical Pathway in Laparoscopic Cholecystectomy: Effective in Reducing Complications? A Propensity Score Matching Analysis.

BACKGROUND: Care pathways are primarily aimed at decreasing length of hospital stay (LOS) and preventing unnecessary costs while maintaining or improving the quality of care. In laparoscopic cholecystectomy, there is insufficient evidence for proving an impact upon postoperative complications. METHODS: In this retrospective study, logistic regression was used to calculate a propensity score, and, after carrying out 1:1 nearest-neighbor matching, 296 patients were analyzed in both groups with regard to postoperative complications using the Clavien-Dindo classification system as a primary aim. In addition, secondary aims were LOS, compliance to care, and deviation from the care pathway with respect to patient discharge. Relative risk of the primary outcome was calculated and compared with the e-value as sensitivity testing approach. RESULTS: Due to the mandatory part of the care pathway, patient record compliance was 100%. Deviation from the care pathway with respect to the planned patient discharge on postoperative day 2 was noted in 16% of the cases. After adjustment for potential factors, the relative risk when comparing Clavien-Dindo complication grades 0 versus 1-4 is 1.64 (95% CI 0.87-3.11), which did not reach significance (p = 0.127). After matching, LOS lasted 3.69 days without and 3.26 days with the care pathway, respectively. CONCLUSIONS: Against the background of already implemented structured standard operation procedures, a care pathway is not able to reduce postoperative complications. Nevertheless, we consider our clinical pathway a highly valuable tool for the interdisciplinary management of patient hospitalization under the supervision of experienced specialized surgeons.

Risk factors and outcomes associated with the carriage of tigecycline- and vancomycin-resistant Enterococcus faecium.

OBJECTIVES: Vancomycin-resistant E. faecium (VRE) is a common cause of healthcare-associated infections. The emergence of VRE with tigecycline resistance (TVRE) is increasing but its impact on patient outcome is still not well defined. This study aimed to assess risk factors for the acquisition of TVRE and of patient outcomes associated with TVRE carriage/infection. METHODS: At the University Hospital Frankfurt, we conducted a matched pair TVRE-VRE analysis to identify risk factors for TVRE carriage. Bed-to-bed contacts and potential transmission routes were reconstructed. TVRE were whole-genome sequenced to confirm suspected transmission events and to identify tigecycline resistance mechanisms. RESULTS: 76 TVRE cases were identified between 02/2014-04/2017 and compared to VRE colonized or infected controls. TVRE carriage was associated with exposure to tigecycline, an increased rate of bloodstream infections (BSI) with VRE or Candida spp., and higher mortality. Whole-genome sequencing-based analysis of 24 TVRE provided evidence for transmissions of TVRE, also across different wards. CONCLUSIONS: Tigecycline exposure is the main risk factor for TVRE carriage. VRE/TVRE- and Candida-BSI are associated with worse clinical outcome. Hospital transmission of TVRE may occur despite strict contact precautions, whereas both antimicrobial stewardship and infection control interventions are of high importance to prevent emergence and spread of TVRE.

Disseminated disease due to non-tuberculous mycobacteria in HIV positive patients: A retrospective case control study.

INTRODUCTION: Disseminated infection due to non-tuberculous mycobacteria has been a major factor of mortality and comorbidity in HIV patients. Until 2018, U.S. American guidelines have recommended antimycobacterial prophylaxis in patients with low CD4 cell counts, a practice that has not been adopted in Europe. This study aimed at examining the impact of disseminated NTM disease on clinical outcome in German HIV patients with a severe immunodeficiency. MATERIALS AND METHODS: In this retrospective case control study, HIV patients with disseminated NTM disease were identified by retrospective chart review and matched by their CD4 cell counts to HIV patients without NTM infection in a 1:1 alocation. Primary endpoints were mortality and time to first rehospitalisation. In addition, other opportunistic diseases, as well as antimycobacterial and antiretroviral treatments were examined. RESULTS: Between 2006 and 2016, we identified 37 HIV patients with disseminated NTM disease. Most of them were suffering from infections due to M. avium complex (n = 31, 77.5%). Time to event analysis showed a non-significant trend to higher mortality in patients with disseminated NTM disease (p = 0.24). Rehospitalisation took place significantly earlier in patients with disseminated NTM infections (median 40.5 days vs. 109 days, p<0.0001). CONCLUSION: In this retrospective case control study, we could demonstrate that mortality is not significantly higher in HIV patients with disseminated NTM disease in the ART era, but that they require specialised medical attention in the first months following discharge.

Comparative analysis of phenotypic and genotypic antibiotic susceptibility patterns in Mycobacterium avium complex.

OBJECTIVE: Phenotypic (Sensititre Myco, pDST) and genotypic drug susceptibility testing (GenoType NTM DR, gDST) in M. avium complex (MAC) have become available as standardized assays, but comparable data is needed. This study aimed to investigate the phenotypic and genotypic drug susceptibility patterns in MAC clinical isolates. METHODS: Overall, 98 isolates from 85 patients were included. pDST and gDST were performed on all isolates and results compared regarding specificity and sensitivity using pDST as a reference method. The impact of drug instability on pDST results was studied using a biological assay over 14 days. In addition, the evolution of antimicrobial resistance was investigated in sequential isolates of 13 patients. RESULTS: Macrolide resistance was rare, 1.2% (95% CI 0.7-7.3) of isolates in the base cohort. No aminoglycoside resistances were found, but 14.1% of the studied isolates (95% CI 7.8-23.8) showed intermediate susceptibility. The GenoType NTM DR identified two out of four macrolide-resistant isolates. Antibiotic stability was demonstrated to be poor in rifampicin, rifabutin, and doxycycylin. CONCLUSIONS: pDST results in NTM for unstable antibiotics must be interpreted with care. A combination of pDST and gDST will be useful for the guidance of antimicrobial therapy in MAC-disease.