Investigation of Different Methods of Intraoperative Graft Perfusion Assessment during Kidney Transplantation for the Prediction of Delayed Graft Function: A Prospective Pilot Trial.

Delayed graft function (DGF) after renal transplantation is a relevant clinical problem affecting long-term organ function. The early detection of patients at risk is crucial for postoperative monitoring and treatment algorithms. In this prospective cohort study, allograft perfusion was evaluated intraoperatively in 26 kidney recipients by visual and formal perfusion assessment, duplex sonography, and quantitative microperfusion assessment using O2C spectrometry and ICG fluorescence angiography. The O2C tissue spectrometry device provides a quantitative method of microperfusion assessment that can be employed during kidney transplantation as an easy-to-use and highly sensitive alternative to ICG fluorescence angiography. Intraoperative microvascular flow and velocity in the allograft cortex after reperfusion predicted DGF with a sensitivity of 100% and a specificity of 82%. Threshold values of 57 A.U. for microvascular flow and 13 A.U. for microvascular velocity were identified by an ROC analysis. This study, therefore, confirmed that impairment of microperfusion of the allograft cortex directly after reperfusion was a key indicator for the occurrence of DGF after kidney transplantation. Our results support the combined use of intraoperative duplex sonography, for macrovascular quality control, and quantitative microperfusion assessment, such as O2C spectrometry, for individual risk stratification to guide subsequent postoperative management.

Quantitative Assessment of Intraoperative Laser Fluorescence Angiography With Indocyanine Green Predicts Early Graft Function After Kidney Transplantation.

OBJECTIVE: This study was designed to demonstrate the predictive ability of quantitative indocyanine green (ICG) fluorescence angiography for the short-term postoperative outcome, the occurrence of delayed graft function (DGF), and long-term graft survival. SUMMARY BACKGROUND DATA: DGF is a relevant problem after kidney transplantation; sufficient microperfusion of the allograft is crucial for postoperative organ function. Fluorescence angiography with ICG can serve as an intraoperative quality control of microperfusion. METHODS: This prospective diagnostic study, conducted in 2 German transplantation centers from November 2015 to October 2018, included 128 consecutive kidney transplantations. Intraoperative assessment of the allograft microperfusion was performed by near-infrared fluorescence angiography with ICG; a software was used for quantitative analysis. The associations between perfusion parameters (eg, ICG Ingress) and donor, recipient, peri-procedural, and postoperative characteristics were evaluated. RESULTS: DGF occurred in 23 (24%) kidney recipients from deceased donors. ICG Ingress ( P = 0.0027), donor age ( P = 0.0452), recipient age ( P = 0.0139), and recipient body mass index ( P = 0.0017) were associated with DGF. ICG Ingress correlated significantly with recipient age (r = -0.27662, P = 0.0016), cold and warm ischemia time (r = -0.25204, P = 0.0082; r = -0.19778, P = 0.0283), operating time (r = -0.32208, P = 0.0002), eGFR on postoperative days 1 (r =+0.22674, P = 0.0104) and 7 (r = +0.33189, P = 0.0001). The cutoff value for ICG Ingress was 106.23 AU with sensitivity of 78.3% and specificity of 80.8% ( P < 0.0001) for the prediction of DGF. CONCLUSION: Fluorescence angiography with ICG allows intraoperative quantitative assessment of microperfusion during kidney transplantation. The parameter ICG Ingress reflects recipient and procedure characteristics and is able to predict the incidence of DGF. TRIAL REGISTRATION: Clinicaltrials.gov: NCT-02775838.

Sonographic assessment of pediatric chest wall thickness and width of the intercostal space: correlation with anthropometric data and implications for needle decompression.

BACKGROUND: Emergent needle decompression in children is a rare event for emergency medicine and critical care providers. Hereby, risk of injury of intrathoracic structures is high and knowledge of age-specific values of chest wall thickness and width of the intercostal space (ICS) is crucial to avoid injuries. Investigation of the correlation of chest wall thickness and width of the intercostal space with age and body dimension like weight and height could provide guidance on depth of insertion and choice of the needle. METHODS: We performed a prospective observational clinical trial in a pediatric surgery operating room that included a convenient sample of children aged 0-10 years undergoing elective surgery. Chest wall thickness and width of the intercostal space were measured with ultrasound at 2nd ICS midclavicular line (MCL) and 4th ICS anterior axillary line (AAL). Correlation of these measures with age, height, weight, BMI and Broselow color was calculated. Furthermore, intra-class correlation coefficient was calculated as a measure of reproducibility and the presence of vital structures (e.g., heart, thymus gland, large pulmonary vessels) at the possible insertion sites for needle decompression was investigated. RESULTS: Of 410 potentially eligible patients, 300 were included in the study. Correlation of chest wall thickness was moderate with weight (2nd ICS MCL: r = 0.57; 4th ICS MCL: r = 0.64) and BMI (r = 0.44 and r = 0.6) and was lower with age (r = 0.38 for both intercostal spaces), height (r = 0.42 and r = 0.40) and Broselow color (r = 0.42 and r = 0.38). Correlation of width of the ICS with anthropometric data was generally stronger, with height showing the strongest, albeit not really strong, correlation (r = 0.71 and r = 0.62). Intra-class correlation was excellent with an ICC of 0.93. Vital structures were significantly more often present at 2nd ICS MCL then at 4th ICS AAL (14 vs. 2 patients; p = 0.0042). CONCLUSIONS: Correlation of chest wall thickness and width of the intercostal space with anthropometric data is at most moderate. Insertion depth and width of the intercostal space can therefore not be predicted accurately from anthropometric data. Ultrasound assessment of the thoracic wall appears to be a reliable technique and could therefore assist in reducing the risk of injury and increasing decompression success. Trial registration German clinical trials register, DRKS00014973, Registered February 11th 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014973.

The Keloid Intervention Benefit Inventory 21: A New Assessment Tool for the Quality of Life of Patients with Auricular Keloids.

The assessment of the quality of life (QoL) of patients with chronic diseases before and after medical interventions has gained increasing importance in recent decades. Particularly for patients with visible keloid scars in the head and neck region, standardized measurement tools are either absent or have been shown to be insufficient. The aim of the present study was to create a new standardized questionnaire that is specific to auricular keloid patients and reflects their clinical symptoms and QoL. The Keloid Intervention Benefit Inventory 21 (KIBI-21) questionnaire was developed in two stages. First, a group of experts identified a pool of 26 questions and modified and supplemented the items through a comparison with existing QoL assessments so that they related to keloid-specific clinical symptoms and the QoL of patients with auricular keloids before and after a medical intervention. This questionnaire was distributed to 27 outpatients who had undergone medical interventions for visible auricular keloids. Second, a sequential statistical analysis was conducted. This included a single-item assessment and reduction, analysis for internal consistency, construct validity, and divergence validity as well as a factor analysis. The analyses were performed for the entire questionnaire and for the items in the subcategories General Health, Physical Symptoms, Self-Esteem, and Social Impact. The final version of this newly validated and standardized KIBI questionnaire consisted of 21 items, of which each item was assigned to only one subscale. The questionnaire showed a Cronbach's α of 0.84 with a good internal consistency. In the item correlation validity, strong associations were found in all subscales, except for the Social Impact Subscale. The keloid-specific QoL questionnaire KIBI-21 proved to be a reliable and reproducible instrument to assess the QoL and clinical symptoms in patients suffering from auricular keloids before and after a medical treatment.

Mobility Assessment of the Supraspinatus in a Porcine Cadaver Model Using a Sensor-Enhanced, Arthroscopic Grasper.

Tendon mobility is highly relevant in rotator cuff surgery. Objective data about rotator cuff mobility is rare. Tendon mobility still needs to be evaluated subjectively by the surgeon. This study aims to establish a porcine animal model for mobility analysis of the supraspinatus. In this context, we introduce a sensor-enhanced, arthroscopic grasper (SEAG) suitable for objective intraoperative measurements of tendon mobility in clinical praxis. Tendon mobility of 15 fresh porcine cadaver shoulders with artificial rotator cuff tears was evaluated using the SEAG. Mobility characteristics (load-displacement curves, maximum load, stiffness) were studied and inter- and intraobserver agreement (intraclass correlation coefficient (ICC)) were tested. Factors with a potential adverse effect (plastic deformation and rigor mortis) were also evaluated. All shoulders showed characteristic reproducible load-displacement curves with a nonlinear part at the start, followed by a linear part. Mean maximum load was 28.6 N ± 12.5. Mean stiffness was 6.0 N/mm ± 2.6. We found substantial interobserver agreement (ICC 0.672) and nearly perfect intraobserver agreement (0.944) for maximum load measurement. Inter- (0.021) and intraobserver (0.774) agreement for stiffness was lower. Plastic deformation and rigor mortis were excluded. The animal model demonstrates reliable and in vivo-like measurements of tendon mobility. The SEAG is a reliable tool for tendon mobility assessment.

A quantitative CT parameter for the assessment of pulmonary oedema in patients with acute respiratory distress syndrome.

OBJECTIVES: The aim of this study was to establish quantitative CT (qCT) parameters for pathophysiological understanding and clinical use in patients with acute respiratory distress syndrome (ARDS). The most promising parameter is introduced. MATERIALS AND METHODS: 28 intubated patients with ARDS obtained a conventional CT scan in end-expiratory breathhold within the first 48 hours after admission to intensive care unit (ICU). Following manual segmentation, 137 volume- and lung weight-associated qCT parameters were correlated with 71 clinical parameters such as blood gases, applied ventilation pressures, pulse contour cardiac output measurements and established status and prognosis scores (SOFA, SAPS II). RESULTS: Of all examined qCT parameters, excess lung weight (ELW), i.e. the difference between a patient's current lung weight and the virtual lung weight of a healthy person at the same height, displayed the most significant results. ELW correlated significantly with the amount of inflated lung tissue [%] (p<0.0001; r = -0.66) and was closely associated with the amount of extravascular lung water (EVLW) (p<0.0001; r = 0.72). More substantially than the oxygenation index (PaO2/FiO2) or any other clinical parameter it correlated with the patients' mean SOFA- (p<0.0001, r = 0.69) and SAPS II-Score (p = 0.0005, r = 0.62). Patients who did not survive intensive care treatment displayed higher values of ELW in the initial CT scans. CONCLUSIONS: ELW could serve as a non-invasive method to quantify the amount of pulmonary oedema. It might serve as an early radiological marker of severity in patients with ARDS.

Amplitude-Integrated EEG for Neurological Assessment and Seizure Detection in a German Pediatric Intensive Care Unit.

Objective: The aim of our study was to assess the use of aEEG in our pediatric intensive care unit (PICU), indications for neuromonitoring and its findings, utility for seizure detection, and associations with outcome. Design: We retrospectively analyzed non-neonates who were treated in our PICU and received amplitude-integrated EEG (aEEG). Patients: 27 patients aged between 29 days and 10 0/12 years (median 7.3 months) were included, who received a total of 35 aEEGS. Measurements: aEEG tracings were assessed for background (BG) pattern and its evolution, seizures, and side differences using a visual classification (Hellström-Westas). Clinical data were collected from patients' histories and analyzed for correlation with aEEG findings. Main results: While rare in early years, there was an increase in use over time. Most aEEGs were conducted because of (suspected) seizures or for management of antiepileptic treatment. aEEG had low sensitivity but high specificity for recognition of pathological BG pattern with reference to conventional EEG. Worsening of BG pattern or failure to improve was associated with death. Seizure detection rates by aEEG were higher than by clinical observation, especially for identification of non-convulsive epileptic state (ES). Side differences in aEEG were rare, but if present, they were associated with unilateral brain injury. Conclusions: aEEG is useful for the detection of seizures and ES in pediatric intensive care patients. Abnormal BG pattern and poor evolution of BG are negatively associated with survival. aEEG is a potential supplement to conventional EEG, facilitating long-term surveillance of cerebral function when continuous full-channel EEG is not available. Further investigation is needed.

Red blood cell transfusion probability and associated costs in neurosurgical procedures.

BACKGROUND: The extent of red blood cell units (RBC) needed for different neurosurgical procedures and the time point of their administration are widely unknown, which results in generously cross-matching prior to surgery. However, RBC are increasingly requested in the aging western populations, and blood donations are significantly reduced. Therefore, the knowledge of the extent and time point of administration of RBC is of major importance. METHODS: This is a retrospective single center analysis. The incidence of RBC transfusion during surgery or within 48 h after surgery was analyzed for all neurosurgical patients within 3 years. Costs for cross-matched and transfused RBC were calculated and risk factors for RBC transfusion analyzed. RESULTS: The risk of intraoperative RBC administration was low for spinal and intracranial tumor resections (1.87%) and exceeded 10% only in spinal fusion procedures. This was dependent on the number of fused segments with an intraoperative transfusion risk of > 12.5% with fusion of more than three levels. Multiple logistic regression analysis showed a significantly increased risk for RBC transfusion for female gender (p = 0.006; OR 1.655), higher age (N = 4812; p < 0.0001; OR 1.028), and number of fused segments (N = 737; p < 0.0001; OR 1.433). Annual costs for cross-matching were 783,820.88 USD and for intraoperative RBC administration 121,322.13 USD. CONCLUSIONS: Neurosurgical procedures are associated with a low number of RBC needed intraoperatively. Only elective spine fusion procedures with ≥ 3 levels involved and AVM resections seem to require cross-matching of RBC. The present data may allow changing the preoperative algorithm of RBC cross-matching in neurosurgical procedures and help to save resources and costs.

Is There a Role for Functional MRI for the Assessment of Extracapsular Extension in Prostate Cancer?

BACKGROUND/AIM: Exctracapsular extension (ECE) in prostate cancer has a high impact on treatment decision. MRI might predict presence of ECE non-invasively. PATIENTS AND METHODS: Triplanar T2w-sequences, DWI (diffusion weighted imaging) and DCE (dynamic contrast-enhanced imaging) of 34 patients with PCa were analyzed to prior prostatectomy. Sensitivity (SS) and specificity (SP) of T2w, apparent diffusion coefficient (ADC), plasma flow (PF) and mean transit time (MTT) normalized by PCa/normal tissue ratio for prediction of CI (capsular infiltration)/ECE were determined by area-under-the-receiver-operating-characteristics analysis. RESULTS: SS/SP for detecting ECE was 29/85. AUC (area under the curve) of ECE cases was 0.98/0.92/0.69 (cut-off-ratios 3.2/0.51/0.46), SS 93/100/86% and SP 95/80/50% for PF-/MTT-/ADC-ratios, respectively. PF- and MTT-ratios between CI and without CI/ECE differed significantly (PF, p<0.0001; MTT, p=0.0134) with SS/SP 84/89% for PF and SS/SP 52/100% for MTT-ratios. No significant differences regarding ADC-ratios were identified. CONCLUSION: ECE/CI can be assessed by quantitative DCE analysis with great diagnostic confidence and higher specificity than ADC.

Individual Assessment of Brain Tissue Changes in MS and the Effect of Focal Lesions on Short-Term Focal Atrophy Development in MS: A Voxel-Guided Morphometry Study.

We performed voxel-guided morphometry (VGM) investigating the mechanisms of brain atrophy in multiple sclerosis (MS) related to focal lesions. VGM maps detect regional brain changes when comparing 2 time points on high resolution T1-weighted (T1w) magnetic resonace imaging (MRI). Two T1w MR datasets from 92 relapsing-remitting MS patients obtained 12 months apart were analysed with VGM. New lesions and volume changes of focal MS lesions as well as in the surrounding tissue were identified by visual inspection on colour coded VGM maps. Lesions were dichotomized in active and inactive lesions. Active lesions, defined by either new lesions (NL) (volume increase > 5% in VGM), chronic enlarging lesions (CEL) (pre-existent T1w lesions with volume increase > 5%), or chronic shrinking lesions (CSL) (pre-existent T1w lesions with volume reduction > 5%) in VGM, were accompanied by tissue shrinkage in surrounding and/or functionally related regions. Volume loss within the corpus callosum was highly correlated with the number of lesions in its close proximity. Volume loss in the lateral geniculate nucleus was correlated with lesions along the optic radiation. VGM analysis provides strong evidence that all active lesion types (NL, CEL, and CSL) contribute to brain volume reduction in the vicinity of lesions and/or in anatomically and functionally related areas of the brain.

Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting Stoma: A Multicenter Longitudinal Observational Study.

BACKGROUND: After low anterior resection for rectal cancer, creation of a diverting stoma is recommended. Data on the impact of a diverting stoma on quality of life are conflicting. Optimal timing of stoma closure in the setting of adjuvant chemotherapy is unclear. OBJECTIVE: The purpose of this study was to investigate the impact of a diverting stoma on quality of life in patients undergoing rectal cancer resection before and after stoma closure. Furthermore, the study was conducted to look at the timing of stoma reversal and the potential influence of factors such as adjuvant chemotherapy. DESIGN: This was a longitudinal, observational, multicenter study. SETTINGS: The study was conducted at 17 German colorectal centers. PATIENTS: Patients with rectal cancer who planned for elective curative surgery with creation of temporary diverting stoma were included. MAIN OUTCOME MEASURES: This longitudinal observational study assessed quality of life at 3 occasions using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire/Colorectal Cancer Module before cancer resection, before stoma closure, and 6 months after stoma closure. Furthermore, the timing of stoma closure and continence were evaluated. RESULTS: A total of 120 patients (64% men; mean age, 63.2 ± 11.5 years) were analyzed. Longitudinal global quality of life was not influenced by the presence of a stoma. Several functional and GI symptom scales were markedly impaired after stoma creation. Physical, role functioning, and sexual interest recovered after stoma closure. Social functioning stayed impaired (p < 0.0001). Median time to stoma closure was 5 months (range, 17 days to 18 months). A total of 3.4% of patients had very early stoma closure (within 30 days). Adjuvant chemotherapy delayed stoma closure (median, 5.6 vs 3.4 months without chemotherapy; p = 0.0001). LIMITATIONS: The study was limited by its missing quality-of-life data for sexual function. CONCLUSIONS: The presence of a stoma had a negative impact on social functioning and GI symptoms. However, this had no clinically relevant influence on global quality of life. Time to stoma closure was nearly doubled when patients underwent adjuvant chemotherapy.

VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification.

TRIAL DESIGN: to further validate the FORTA (Fit fOR The Aged) concept, a bicentric randomised, controlled trial was run in two geriatric clinics. METHODS: patients (≥65 years, ≥3 drugs or ≥60 years, ≥6 drugs) with three relevant diseases and hospitalisation for ≥5 days were randomised. In the intervention, but not the control group, a FORTA team instructed ward physicians on FORTA. FORTA is the first positive/negative listing approach labelling medications used to treat chronic illnesses in older patients from A (indispensable), B (beneficial), C (questionable) to D (avoid). The primary end point was the FORTA score: sum of medication errors classified as over-, under- and mistreatment. Consecutive patients were randomised to the intervention and control ward; outcome assessment was blinded. RESULTS: four hundred and nine patients (age 81.5 years, 64% female, hospitalisation 17.4 days) were included. The primary end point was significantly (P < 0.0001) more reduced in the intervention versus control groups (2.7 ± 2.25 versus 1 ± 1.8, mean ± SD, intergroup comparison of admission/discharge differences). Over- and under-treatment scores and use of A (increase) and D (decrease) drugs were significantly improved (P < 0.01). The total number of adverse drug reactions (ADRs) was significantly reduced by FORTA (P < 0.05, number needed to treat is 5). Activities of daily living and renal failure improved significantly (P < 0.05). Blood pressure remained constant in the intervention, but decreased significantly in the control group. CONCLUSION: applying FORTA to hospitalised geriatric patients leads to improvement of medication quality and may improve secondary clinical end points (e.g. ADRs). The concept is amenable to successful communication and implementation. Registration (DRKS-ID): DRKS00000531. FUNDING: DFG-German Research Foundation (WE 1184/15-1).

Bioelectrical impedance analysis in the assessment of pre-eclampsia.

PURPOSE: Aim of this prospective investigation was to assess pre-eclampsia by bioelectrical impedance analysis (BIA). METHODS: A total of 22 pre-eclamptic as well as matched (patients' age, gestational age, parity, gravidity) healthy pregnant women underwent whole body BIA on admission and then, pre-eclamptic patients, every 2 days until childbirth. For all measured BIA single values and their corresponding reference value mean, standard deviation, minimum and maximum were calculated to compare pre-eclamptic women with corresponding reference values. Furthermore a paired t test and an ANOVA of repeated measurements were performed to detect differences of intraindividual measurements. Subsequently an analysis of variance was accomplished to analyse general changes in the course of time of investigated patients, who were measured more than once. RESULTS: Except for the phase angle, BIA parameters of pre-eclamptic women compared to corresponding reference values were significantly different, suggesting an increase of total body water in pre-eclampsia. Repeated measurements did not reveal statistically significant intra- or interindividual differences in the course of time. CONCLUSION: Bioelectrical impedance analysis allows differentiating healthy from pre-eclamptic women. Further investigations are needed to analyse if BIA is capable to serve as a prognostic diagnostic tool in the detection of deterioration of pre-eclampsia.

Effect of time-of-flight technique on the diagnostic performance of 18F-FDG PET/CT for assessment of lymph node metastases in head and neck squamous cell carcinoma.

UNLABELLED: Precise assessment of lymph node metastases is critical to the treatment outcome and overall survival of patients with head and neck squamous cell carcinoma (HNSCC). The purpose of this study was to investigate the effect of time-of-flight (TOF) technique on the diagnostic performance of (18)F-FDG PET/CT for assessment of lymph node metastases in HNSCC patients. METHODS: In 39 patients with an initial diagnosis of HNSCC, preoperative staging (18)F-FDG PET/CT was performed to assess lymph node metastases before surgery and histologic verification. Potential lymph node metastases were evaluated and documented separately for the right and left neck in accordance with the head and neck lymph node level classification. Two experienced readers measured lesion volume and uptake for every PET-positive lymph node. Sensitivity, specificity, image quality, and the PET characterization of the lesion (benign or malignant) were compared between different reconstruction methods (TOF PET and standard high-definition PET) and matrices for both readers. RESULTS: TOF PET significantly increased the maximal standardized uptake value (SUVmax) but had no significant effect on lesion volume. However, a higher SUVmax did not result in a significant increase in small-lesion detection. Sensitivity and image quality were slightly improved with TOF PET but not significantly so. Matrix, on the other hand, had a significant effect on detected lesion numbers, sensitivity, and image quality. CONCLUSION: For preoperative assessment of lymph node metastases in HNSCC, (18)F-FDG PET/CT using TOF technique increases SUVmax in lesions and improves image quality but has no significant impact on small-lesion detectability.

A learning curve assessment of real-time sonoelastography of the prostate.

PURPOSE: To examine how much practice is essential to properly perform real-time sonoelastography (RTE) in the detection of PC. METHODS: RTE of the prostate was performed in 60 PC patients prior to radical prostatectomy (RP). All patients were examined by a novice and an expert observer in a blinded fashion. The novice's results were validated with the results of the expert. Kappa indexes, sensitivities, specificities as well as the duration of the examination were assessed. Learning curves (LC) were obtained by assessment of 16 (LC A) and eight (LC B) prostate sectors. Cochrane-Armitage trend test, Chi(2) test and t test for paired samples were used. RESULTS: For the 16-sector method (LC A), overall sensitivity and specificity were 58.2 and 77.7 % and, for the 8-sector method, 68.3 and 64.5 %, respectively. For LC A, sensitivity rose over the whole study period (p = 0.0055). As a result, no learning plateau was reached. In contrast, a learning plateau with no constant rise in sensitivity (p = 0.4667) was reached for LC B after 30 examined patients. The mean examination time for both observers was 7.9 min (±3.7). CONCLUSIONS: When being trained by an expert examiner, skills in RTE of the prostate can be obtained quickly. Performed by a trained examiner, the examination itself is little time-consuming. Thus, RTE represents a user- and patient-friendly tool that can easily be integrated into the day-to-day practice of urologists.

Consensus validation of the FORTA (Fit fOR The Aged) List: a clinical tool for increasing the appropriateness of pharmacotherapy in the elderly.

BACKGROUND: Multimorbidity and polypharmacy represent a major problem for elderly patients; improvement of medication schemes is important and listing approaches (e.g. Beers list) are considered to be potentially useful. OBJECTIVES: The aim of this study was to perform expert consensus validation of the FORTA (Fit fOR The Aged) List, a drug classification combining positive and negative labelling of drugs chronically prescribed to elderly patients. METHODS: A two-round Delphi procedure was conducted involving 20 experts, 17 geriatric internists and 3 geriatric psychiatrists from Germany and Austria, evaluating the labels assigned to 190 substances or substance groups. These labels ranged from A (indispensable), B (beneficial), C (questionable) to D (avoid), depending on the state of evidence for safety, efficacy and overall age-appropriateness. The experts were also requested to suggest additional substances and indication areas for assessment and possible inclusion in the FORTA List. A weighted (corrected) consensus coefficient was generated for each substance to reflect (1) agreement with the original label, and (2) distribution among raters' labels. RESULTS: The overall consensus for all items and raters was 92% (corrected). For 54/190 items (28.4%), a unanimous response was achieved as to the original author-based FORTA label choice. Twenty-four substances (12.6%) fell short of the consensus cutoff and were re-evaluated in a second round. This yielded confirmation of 171/190, or 90%, of the original author-based FORTA labels. A total of 35 new substances were also accepted for the FORTA List. Drugs used for dementia and dementia syndromes provoked particular response heterogeneity. CONCLUSION: The FORTA List now reflects a wider consensus among experts, increasing its validity for clinical use. It represents a tool to improve the quality of drug prescription in older patients by identifying both inappropriate and omitted drugs, and thus overtreatment and undertreatment. The validation of FORTA's impact on clinical endpoints has yielded promising preliminary results, to be corroborated in ongoing larger trials.

Periodic MRI lung volume assessment in fetuses with congenital diaphragmatic hernia: prediction of survival, need for ECMO, and development of chronic lung disease.

OBJECTIVE: The purpose of the study was to investigate the ability to predict survival, need for extracorporeal membrane oxygenation (ECMO), and incidence of chronic lung disease in patients with congenital diaphragmatic hernia in the context of a classification into three different times of gestation (< 28, 28-32, and > 32 weeks) by assessing the ratio between observed and expected MRI fetal lung volume. MATERIALS AND METHODS: The data analysis included 226 fetuses with congenital diaphragmatic hernia. MRI was performed at different times of gestation with a T2-weighted HASTE sequence. Receiver operating characteristic curve analysis was performed to investigate the prognostic value of assessment of the ratio between observed and expected MRI fetal lung volumes at different stages of fetal growth. RESULTS: For all reviewed times of gestation, the ratio between observed and expected MRI fetal lung volumes had almost equivalent statistically significant differences for neonatal survival (p ≤ 0.0029), need for ECMO therapy (p ≤ 0.0195), and development of chronic lung disease (p ≤ 0.0064). Results with high prognostic accuracy for early and for medium and late times in gestation also were obtained. Receiver operating characteristic analysis showed the highest area under the curve (≥ 0.819) for neonatal survival. CONCLUSION: In patients with congenital diaphragmatic hernia, the relation between observed and expected MRI fetal lung volume is a valuable prognostic parameter for predicting neonatal mortality, morbidity represented by the development of chronic lung disease, and the need for ECMO therapy in early gestation (< 28 weeks) as well as later gestation with no statistically significant differences.

Diagnostic performance and cost effectiveness of measurements of plasma N-terminal pro brain natriuretic peptide in patients presenting with acute dyspnea or peripheral edema.

BACKGROUND: The purpose of this study was to determine the diagnostic power of a newly available assay for amino-terminal pro-brain natriuretic peptide (NT-proBNP) to identify patients with acute heart failure. In addition, the influence of initial NT-proBNP measurements on economic consequences, diagnostic procedures and staff involvement was evaluated. METHODS AND RESULTS: 401 patients presenting with acute dyspnea or peripheral edema in the emergency department were enrolled. NT-proBNP was measured after initial clinical evaluation. Clinical routine care and diagnostic assessment were blinded to NT-proBNP results. Two cardiologists independently validated the period of hospitalization, clinical examinations and medical therapies of each patient considering NT-proBNP results. The median NT-proBNP level among patients with acute congestive heart failure (CHF) (n=122) was 3497 pg/ml as compared to 320 pg/ml in patients without (n=279) (p<0.0001). An NT-proBNP cutoff level <300 pg/ml was optimal to rule out acute CHF (negative predictive value 96%; sensitivity 96%). NT-proBNP >or=300 pg/ml could strongly predict acute CHF when compared to patients' history or physical examination (odds ratio 9.5; p<0.0001) and diagnostic technical findings (odds ratio 14.7; p<0.05). In patients with NT-proBNP<300 pg/ml, 14% of the period of hospitalization could be saved, corresponding to savings of US $481 per patient. In addition, 9% of the number and time of staff involvement of clinical examinations and therapies could be saved, 10% of the costs of clinical examinations. Chest X-rays were saved in 34%, echocardiography in 9%. CONCLUSIONS: Measurement of NT-proBNP leads to multiple saving amounts and optimizes diagnostic pathways and resource allocation.

Watertight dural closure: is it necessary? A prospective randomized trial in patients with supratentorial craniotomies.

OBJECTIVE: The aim of the current study was to prospectively analyze complication rates and costs associated with dural closure in patients undergoing supratentorial craniotomies, randomized for watertight and adaptive dural closures. METHODS: One hundred fifty consecutive patients with supratentorial lesions who were between 18 and 70 years of age were prospectively included. A watertight dural closure was the primary goal (Group A). Whenever this goal could not be achieved, patients were intraoperatively randomized for secondary watertight (Group B) or adaptive dural closure (Group C). Within a follow-up period of 4 weeks, study end points were the occurrence of complications such as subcutaneous fluid collections, impaired wound healing with and without cerebrospinal fluid leakage, and infection. Moreover, we analyzed costs for dural closure for each group separately. RESULTS: Of 150 eligible patients, 13 were excluded according to predefined criteria (Group A, n = 3; Group B, n = 7; Group C, n = 3). From those patients, a primary watertight dural closure could be obtained in 44 (29.4%) patients. A secondary watertight dural closure was performed in 53 (35.3%) patients, and an adaptive dural closure was performed in 53 (35.3%) patients. Complications that were related to dural closure or wound closure were found in 7 patients in Group A, 6 patients in Group B, and 12 patients in Group C (all not significant). The mean total costs, based on time and additional material required in Group A (US $436 +/- 119) or Group B (US $681 +/- 286) were significantly greater compared with adaptive dural closure in Group C (US $213 +/- 142, P < 0.05). CONCLUSION: In supratentorial craniotomies, an adaptive dural closure may represent a safe and cost-effective alternative to watertight dural closure.

Magnetic resonance imaging for assessment of radiofrequency lesions in kidney tissue immediately after ablation: an experimental study.

BACKGROUND AND PURPOSE: Radiofrequency ablation (RFA) is an attractive minimally invasive treatment option for small renal masses. The purpose of this study was to investigate the morphologic imaging appearance of RF lesions immediately after the ablation of kidney tissue using standard clinical MR sequences, as well as to investigate the correlation between MR and gross lesion size. MATERIALS AND METHODS: Ablations were performed 17 times in a standardized model of ex-vivo perfused porcine kidneys using a resistance-controlled RF device (250 W, 470 kHz) and a nonexpandable bipolar applicator inserted into the center of healthy renal parenchyma. The RF current was applied for 9 minutes at 20 W. Imaging was performed after ablation using standard clinical MR sequences: morphologic T(1)/T(2)- weighted images and an isotropic post-contrast T(1) high-resolution measurement (VIBE). Maximum lesion diameters were measured in three directions and were compared with the measurements of the gross lesions. Histologic (hematoxylin + eosin and nicotinamide adenine dinucleotide staining) and statistical analyses were performed. RESULTS: The gross pathologic examination showed a firm, white-yellow ablation zone sharply demarcated from the untreated tissue. The histologic examination confirmed cellular viability outside but not in the treatment zone. The RF lesions were hyperintense on T(1)-weighted images and hypointense on T(2)-weighted images. The lesion size measured in the VIBE images correlated best with the macroscopic lesion size (N = 16). CONCLUSIONS: Morphologic MR T(1) and T(2) sequences of RF lesions immediately after ablation produce reliable and consistent imaging characteristics. The post-contrast, high-resolution sequence (VIBE) enables the extent of the lesion to be determined accurately. The potential uses of this imaging strategy in clinical practise warrant further investigation on human renal-cell carcinoma.