Clinical evaluation of a dose management system-integrated 3D skin dose map by comparison with radiochromic films.

OBJECTIVES: To validate the performance of an automatic tool to estimate a patient's peak skin dose (PSD) and a skin dose map from data collected by a radiation dose management system (RDMS) during interventional procedures. METHODS: In total, 288 eligible consecutive patients undergoing abdominopelvic embolisation or planned coronary angioplasty using radiochromic films were screened between June 2018 and March 2019. For 98 included patients, PSD was measured using radiochromic films (PSDFilm) and computed by RDMS (PSDRDMS) using one flat and two anthropomorphic phantoms. Statistical concordance between PSDFilm and PSDRDMS was computed with Lin's concordance correlation coefficient and clinical concordance with the Bland and Altman graphic; values were compared using the paired Mann-Whitney-Wilcoxon test. RESULTS: In total, 190/288 patients were excluded and 98 patients were analysed (69 men, mean age 66 ± 14 years). The PSDFilm median (1st; 3rd quartile) was 0.59 Gy (0.40; 1.08). PSDRDMS was 0.62 Gy (0.43; 1.22) for the flat phantom and 0.62 Gy (0.42; 1.19) for anthropomorphic phantoms. The concordance between PSDFilm and PSDRDMS was good for both phantoms (flat: 0.94 [0.91; 0.95]; anthropomorphic 0.94 [0.91; 0.96]). Compared with the values of PSDFilm, the values of PSDRDMS were significantly increased by 5% (- 4%; 16%) for flat phantom (p = 0.001) and 7% (- 6%; 22%) for anthropomorphic phantoms (p = 0.002) for vascular procedures and 9% (- 4%; 26%, p = 0.01) and 6% (- 4%; 23%, p = 0.02) for cardiac procedures, respectively. Dose map representations matched for most patients. The gaps identified were due to table displacement during fluoroscopy events and the use of a wedge filter. CONCLUSIONS: The RDMS skin dose map tool allowed the computation of the PSD and skin dose distribution for all patients with fewer constraints than radiochromic films. However, the computed PSD was overestimated, increasing the number of patients requiring follow-up. KEY POINTS: • A good concordance correlation was identified between the peak skin dose (PSD) values measured with radiochromic films and estimated with the radiation dose management system (RDMS) skin dose map tool. • Differences were related to table displacement during fluoroscopy events and the use of a wedge filter, which are not accounted in the Digital Imaging and Communications in Medicine Radiation Dose Structured Reports. • For all procedures, the estimated PSDs were significantly higher than the measured PSDs by 5% (- 4%; 18%) for flat phantom (p < 0.001) and 6% (- 5%; 22%) for anthropomorphic phantoms (p < 0.001).

The Björk-Shiley convexo-concave heart valve experience from the perspective of the supervisory panel.

The 20-year activities of a medical supervisory panel appointed under the terms of a settlement agreement of the Bowling v. Pfizer class action suit involving the Björk-Shiley convexo-concave (BSCC) heart valve are detailed. Of approximately 86,000 valves implanted, catastrophic failure of the valve was reported in 663 patients from 1978 to 2012. In 1994, a 7-member medical panel consisting of cardiologists, cardiovascular surgeons, epidemiologists, and a nontechnical chairman was appointed by the federal court. The panel collected clinical and manufacturing data, supported epidemiologic studies assessing risk factors for valve fracture, and developed guidelines for payment for explanting potentially defective valves in patients. Three sets of guidelines, based on comparisons of estimated risks of valve fracture versus risks of valve replacement surgery, were issued by the panel to help guide patients and their physicians in decisions about explanting valves. In addition, the panel supported research directed at identifying valves at risk for outlet strut fracture. The primary techniques evaluated included analyzing acoustic signals from the valves, imaging valves for potential cracks in the struts, and structural analyses of Björk-Shiley convexo-concave valves, but none proved applicable for large-scale surveillance of the patient population. The panel also became a patient advocate and acted as an intermediary between the manufacturer and the attorneys initiating the legal settlement. The panel's experiences may help inform future strategies for guideline development for other medical devices or procedures involving risk-benefit comparisons.

Synthetic hydrogel scaffold is an effective vehicle for delivery of INFUSE (rhBMP2) to critical-sized calvaria bone defects in rats.

Medtronic's INFUSE Bone Graft provides surgeons with a potent tool for stimulating bone formation. Current delivery vehicles that rely on Absorbable Collagen Sponges (ACS) require excessive quantities of the active ingredient in INFUSE, recombinant human Bone Morphogenic Protein-2 (rhBMP2), to achieve physiologically relevant concentrations of the growth factor, driving up the cost of the product and increasing the likelihood of undesirable side effects in neighboring tissues. We demonstrate that a simple light-mediated, thiol-ene chemistry can be used to create an effective polymer delivery vehicle for rhBMP2, eliminating the use of xenographic materials and reducing the dose of rhBMP2 required to achieve therapeutic effects. Comprised entirely of synthetic components, this system entraps rhBMP2 within a biocompatible hydrogel scaffold that is degraded by naturally occurring remodeling enzymes, clearing the way for new tissue formation. When tested side-by-side with ACS in a critical-sized bone defect model in rats, this polymeric delivery system significantly increased bone formation over ACS controls.

White matter microstructure and cognition in non-neuropsychiatric systemic lupus erythematosus.

OBJECTIVE: This study examined white matter (WM) structural and metabolic alterations in relation to cognition in patients with non-neuropsychiatric systemic lupus erythematosus (non-NPSLE). BACKGROUND: SLE can produce cognitive impairment even without overt neuropsychiatric features, but the pathogenesis of this dysfunction is not well understood. Our preliminary study of non-NPSLE found evidence correlating cognitive impairment with increased choline/creatine (Ch/Cr) in frontal lobe WM. METHODS: Subjects included 60 non-NPSLE patients and 24 controls. Magnetic resonance imaging and magnetic resonance spectroscopy were performed, and a battery of neuropsychologic tests was administered. Structural and metabolic measures were analyzed and correlated with neuropsychologic data. RESULTS: No significant differences were found in total brain, gray matter, and WM volumes, or in frontal WM N-acetylaspartate/Cr, but the non-NPSLE group had significantly increased Ch/Cr in frontal WM. A WM cognitive score (WMCS) that included the Paced Auditory Serial Addition Task, Letter Fluency, and Animal Naming was found to correlate with total WM volume, and lower WMCS correlated with higher left frontal WM Ch/Cr. CONCLUSIONS: Non-NPSLE patients had frontal WM metabolic changes that correlated with cognitive impairment, whereas no cerebral atrophy or WM axonal damage was evident. These data confirm and extend our previous observations supporting the role of microstructural WM changes in the cognitive impairment of non-NPSLE patients. The data also suggest that the WMCS may be sensitive to cognitive dysfunction from myelin damage that develops before axonal injury.

Identification of fibers at risk for degeneration by diffusion tractography in patients at high risk for MS after a clinically isolated syndrome.

PURPOSE: Focal inflammatory/demyelinating lesions are thought to be the source of Wallerian degeneration or other injury to local, transiting fiber tracts in the brain or spinal cord in multiple sclerosis (MS). A methodology is established to isolate connections between focal demyelinating lesions and intersecting fibers to permit explicit analyses of the pathology of secondary fiber injury distant from the focal lesion. MATERIALS AND METHODS: A strategy is described and feasibility demonstrated in three patients with a clinically isolated syndrome and positive MRI (at high risk for MS). The strategy utilizes streamtube diffusion tractography to identify neuronal fibers that intersect a focal lesion and pass through a region of interest, in this case the corpus callosum, where distal (to focal lesion) interrogation can be accomplished. RESULTS: A sizeable fraction of the normal appearing white matter (NAWM) in the early stages of disease can be defined in the corpus callosum, which is distinctive in that this tissue connects to distant demyelinating lesions. CONCLUSION: The new class of tissue called fibers-at-risk for degeneration (FAR) can be identified and interrogated by a variety of quantitative MRI methodologies to better understand neuronal degeneration in MS.

Multiple sclerosis pathology in the normal and abnormal appearing white matter of the corpus callosum by diffusion tensor imaging.

Lesions in the corpus callosum in multiple sclerosis (MS) include those that are hyperintense on T2-weighted images, which can be either focal (isolated) or connected, but there is evidence that the corpus callosum, similar to other white matter regions, contains normal appearing white matter (NAWM) which is abnormal based on quantitative MR methodologies. In this pilot study, diffusion tensor based measures were determined in corpus callosum from 10 patients with MS and 12 age and gender matched controls. T2-hyperintense lesions were carefully segmented out from normal appearing corpus callosum to minimize contamination of the NAWM fraction with these lesions. The orientationally averaged diffusion coefficient was increased and the fractional anisotropy reduced in the NAWM fraction of the MS patients. These results confirm prior studies which suggest that pathology in the NAWM occurs independent of focal MS lesions, and are not likely the result of sample contamination through or across slices. This injury to the NAWM may be the result of focal, microscopic T2-invisible lesions and/or secondary degeneration related to distant lesions whose related fibres cross the corpus callosum.

Neurobiology of smooth pursuit eye movement deficits in schizophrenia: an fMRI study.

OBJECTIVE: Smooth pursuit eye movements are abnormal in patients with schizophrenia. The investigators used functional magnetic resonance imaging (fMRI) to compare brain hemodynamic response during a smooth pursuit eye movement task in patients with schizophrenia and healthy comparison subjects. METHOD: Fourteen patients with schizophrenia and 14 healthy comparison subjects performed a smooth pursuit eye movement task while undergoing 1.5-T fMRI. Echo-planar images from the blocked design were evaluated with both a whole-brain random-effects analysis and a region-of-interest analysis. Smooth pursuit deficits were assessed outside the fMRI apparatus by using infrared oculography and were assessed during scanning by evaluating echo-planar time-series data from the eyes. RESULTS: Compared to the healthy subjects, the patients with schizophrenia exhibited greater activity in both posterior hippocampi and the right fusiform gyrus during smooth pursuit eye movements. The region-of-interest analysis revealed subtle activity deficits in frontal and occipital regions in the patients with schizophrenia. Smooth pursuit deficits in the subjects with schizophrenia included lower gain (eye velocity relative to target velocity) and a higher percentage of total eye movements due to anticipatory saccades, compared with the healthy subjects. CONCLUSIONS: The observed group differences are consistent with evidence for diminished inhibitory function in the hippocampus as well as for a disturbance in a frontotemporal network subserving smooth pursuit eye movements in schizophrenia.

Pulmonary immunoglobulin responses to Streptococcus pneumoniae are altered but not reduced in human immunodeficiency virus-infected Malawian adults.

We tested the hypothesis that human immunodeficiency virus (HIV)-infected adults have a specific defect in anti-pneumococcal capsular polysaccharide (Pn-specific) immunoglobulin (Ig) in fluid obtained from the lower respiratory tract. Higher levels of total IgG and IgM were present in bronchoalveolar lavage samples from HIV-infected subjects than in those from HIV-uninfected subjects. Pn-specific IgG and IgM in bronchoalveolar lavage samples were not significantly different between HIV-infected and -uninfected subjects. After pneumococcal infection, HIV-infected patients had higher bronchoalveolar lavage levels of Pn-specific IgG than HIV-infected patients without recent infection (geometric means, 387 vs. 30 ng/mL, P=.001).

Thin-section CT findings in flock worker's lung, a work-related interstitial lung disease.

PURPOSE: To characterize the thin-section computed tomographic (CT) features of flock worker's lung (FWL) and to determine whether these features may be used to distinguish workers with FWL from flock workers who do not fulfill diagnostic criteria for FWL. MATERIALS AND METHODS: Thin-section CT images obtained in 43 flock workers (including 11 with FWL) were reviewed independently by radiologists blinded to occupational and clinical details. CT features recorded included ground-glass opacities, consolidation, micronodules, reticular abnormality, and septal thickening. Thirty-five of the CT scans (including nine obtained in patients with FWL) were also studied by using quantitative image analysis. The Student t test was used to compare mean lung attenuation between the workers with FWL and those without it. RESULTS: Every patient with FWL and 19 (59%) of the 32 exposed flock workers who did not meet criteria for the disease had an abnormal thin-section CT scan. The most common findings in FWL were ground-glass opacities and micronodules. Quantitative analysis showed a mean lung attenuation of -736.4 HU in patients with FWL, compared with -775.0 HU in workers without the disease (P <.05). CONCLUSION: While ground-glass opacities, micronodules, or both were found in all cases of FWL, these abnormalities were also present in a substantial proportion of symptomatic flock workers who did not satisfy current criteria for FWL. Although nonspecific, these findings should suggest the diagnosis of FWL in exposed individuals.

Monitoring eye movements during fMRI tasks with echo planar images.

Verifying task compliance during functional magnetic resonance imaging (fMRI) experiments is an essential component of experimental design. To date, studies of oculomotor tasks such as smooth pursuit eye movements have either measured task performance outside the magnet and assumed similar performance during functional neuroimaging, or have used MR-compatible eye movement recording devices, which can be costly and technically difficult to use. We describe a simple method to visualize and quantify eye movements during an imaging experiment using the gradient echo images. We demonstrate that local eye movements will influence whole-head motion correction procedures, resulting in inaccurate movement parameters and potentially lowering the sensitivity to detect activations.