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Biomedical subjects

Walter Heindel

Publications and source records attributed to Walter Heindel.

At least 73 records · Page 4Linked to original sources

Metabolic changes after repetitive transcranial magnetic stimulation (rTMS) of the left prefrontal cortex: a sham-controlled proton magnetic resonance spectroscopy (1H MRS) study of healthy brain.

Rapid transcranial magnetic stimulation is being increasingly used in the treatment of psychiatric disorders, especially major depression. However, its mechanisms of action are still unclear. The aim of this study was to assess metabolic changes by proton magnetic resonance spectroscopy following high-frequency rapid transcranial magnetic stimulation (20 Hz), both immediately after a single session and 24 h after a series of five consecutive sessions. Twelve healthy volunteers were enrolled in a prospective single-blind, randomized study [sham (n = 5) vs. real (n = 7)]. Three brain regions were investigated (right, left dorsolateral prefrontal cortex, left anterior cingulate cortex). A single as well as a series of consecutive rapid transcranial magnetic stimulations affected cortical glutamate/glutamine levels. These effects were present not only close to the stimulation site (left dorsolateral prefrontal cortex), but also in remote (right dorsolateral prefrontal cortex, left cingulate cortex) brain regions. Remarkably, the observed changes in glutamate/glutamine levels were dependent on the pre-transcranial magnetic stimulation glutamate/glutamine concentration, i.e. the lower the pre-stimulation glutamate/glutamine level, the higher the glutamate/glutamine increase observed after short- or long-term stimulation (5 days). In general, the treatment was well tolerated and no serious side-effects were reported. Neither transient mood changes nor significant differences in the outcome of a series of neuropsychological test batteries after real or sham transcranial magnetic stimulation occurred in our experiment. In summary, these data indicate that rapid transcranial magnetic stimulation may act via stimulation of glutamatergic prefrontal neurons.

Adult↗

Evaluation of global left ventricular myocardial function with electrocardiogram-gated multidetector computed tomography: comparison with magnetic resonance imaging.

RATIONALE AND OBJECTIVES: Electrocardiogram-gated 3D volume data from multidetector computed tomography coronary angiography (MDCT-CA) enable image reconstruction in any phase of the cardiac cycle. The objective was to determine left ventricular (LV) function parameters by MDCT in comparison to cine magnetic resonance imaging (MRI). METHOD: Thirty patients with known or suspected coronary artery disease (CAD) underwent MDCT-CA. From multiplanar reformations in short axis orientation end-diastolic and end-systolic LV volumes (LVEDV, LVESV) were determined to calculate LV stroke volume and ejection fraction (LVSV, LVEF) and compared with MRI measurements. RESULTS: LVEDV (147 +/- 27 mL) and LVESV (65 +/- 22 mL) determined by MDCT correlated well to the respective MRI measurements (LVEDV 133 +/- 27 mL, r = 0.80, P < 0.001; LVESV 48 +/- 19 mL, r = 0.89, P < 0.001). LVSV (MDCT 82 +/- 15 mL; MRI 85 +/- 17 mL; r = 0.77, P < 0.001) and LVEF (MDCT 56 +/- 9%; MRI 65 +/- 8%; r = 0.85, P < 0.001) showed a good correlation as well. LVEF was significantly underestimated by MDCT (-8.5 +/- 4.7%, P < 0.001). CONCLUSIONS: Initial experience in patients evaluated for CAD shows that spiral MDCT studies may provide LV functional data in good correlation to Cine MRI.

Adult↗

Improved coronary artery stent visualization and in-stent stenosis detection using 16-slice computed-tomography and dedicated image reconstruction technique.

OBJECTIVE: The aim of this study was to compare the visualization of different coronary artery stents and the detectability of in-stent stenoses during 4-slice and 16-slice computed tomography (CT) angiography in a vessel phantom. MATERIAL AND METHODS: Ten coronary stents were introduced in a coronary artery vessel phantom (plastic tubes with an inner diameter of 3 mm, filled with iodinated contrast material diluted to 220 Hounsfiled Units [HU], surrounded by oil [60 HU]). CT scans were obtained perpendicular to the stent axes on a 4-slice scanner (detector collimation 4x1 mm; table feed 1.5 mm/rotation, mAs 300, kV 120, medium-smooth kernel) and a 16-slice scanner (detector collimation 12x0.75 mm; table feed 2.8 mm/rotation, mAs 370, kV 120, reconstruction with a standard and an optimized sharp kernel). Longitudinal multiplanar reformations were evaluated regarding visible lumen diameters and intraluminal attenuation values. Additionally, the stents were scanned with the same parameters after implantation of 60% stenoses (HU 30). RESULTS: Using the same medium-smooth kernel reconstruction with 4-slice and 16-slice CT, there was a slight increase in the average visible lumen area (26% versus 31%) and less increase of average intraluminal attenuation values (380 HU versus 349 HU). Significant improvement of lumen visualization (54%, P<0.01) and attenuation values (250, P<0.01) was observed for the 16-slice scans using the sharp kernel reconstruction. In-stent stenoses could be more reliably identified (or ruled out) by 16-slice CT and sharp reconstruction kernel when compared with the other 2 methods. CONCLUSION: 16-slice CT using a dedicated sharp kernel for image reconstruction facilitates improved visualization of coronary artery stent lumen and detection of in-stent stenoses.

Coronary Angiography↗

CT colonography: Protocol optimization with multi-detector row CT--study in an anthropomorphic colon phantom.

PURPOSE: To determine optimal detector collimation, section thickness, and tube current for multi-detector row computed tomography (CT) colonography. MATERIALS AND METHODS: An anthropomorphic colon phantom with simulated polyps of varying size (2, 6, 8, 10, and 12 mm) was examined by using multi-detector row CT with varying combinations of detector collimation (4 x 1.0 mm and 4 x 2.5 mm), dose per section (10, 20, 40, 60, 80, 100, and 140 mAs), and section thickness/reconstruction interval (1.25/0.6, 2.0/1.0, 3.0/1.0, and 5.0/2.0 mm). Polyp depiction, longitudinal polyp distortion, and presence of rippling artifacts were assessed on reformatted three-dimensional endoluminal images by three reviewers. RESULTS: Longitudinal distortion and rippling artifacts increased with increasing section thickness and use of broader detector collimation. Polyps 8 mm or larger were depicted with any combination of section thickness, detector collimation, and tube current. Depiction of polyps 6 mm or smaller depended on the detector collimation/reconstructed section thickness and was rated optimal for the 4 x 1.0-mm detector collimation with a section thickness of 1.25 mm. This was also observed for low-dose protocols. Polyps 6 mm or smaller that were not detected with 3-mm section thickness and 4 x 2.5-mm detector collimation were detected with 1.25-mm section thickness and 10 mAs. CONCLUSION: A narrow detector collimation with thin-section imaging (4 x 1.0-mm detector collimation, 1.25-mm section thickness) is a prerequisite for low-dose (10-mAs) multi-detector row CT colonography.

Artifacts↗

Performance of a flat-panel detector in the detection of artificial erosive changes: comparison with conventional screen-film and storage-phosphor radiography.

The purpose of this study was to compare a large-area, direct-readout, flat-panel detector system with a conventional screen-film system, a storage-phosphor system, and a mammography screen-film system with regard to the detection of artificial bone erosions simulating rheumatoid disease, and to assess its diagnostic performance with decreasing exposure dose. Six hundred forty regions were defined in 160 metacarpophalangeal and proximal interphalangeal joint specimens from 20 monkey paws (4 regions per joint). Artificial bone erosions were created in 320 of these 640 regions. Specimens were enclosed in containers filled with water to obtain absorption and scatter radiation conditions similar to those of a human hand. Imaging was performed using a flat-panel system, a speed class 200 screen-film system, a mammography screen-film system, and a storage-phosphor system under exactly matched conditions. Different exposure doses equivalent to speed classes of S=100, 200, 400, 800, 1600, and 3200 were used. In all images the presence or absence of a lesion was assessed by three radiologists using a five-level confidence scale. Receiver operating characteristic (ROC) analysis was performed for a total of 21,120 observations (1920 for each imaging modality and exposure level) and diagnostic performance estimated by the area under the ROC curve (A(z)). The significance of differences in diagnostic performance was tested with analysis of variance. The ROC analysis showed A(z) values of 0.809 (S=200), 0.768 (S=400), 0.737 (S=800), 0.710 (S=1600), and 0.685 (S=3200) for the flat-panel system, 0.770 for the speed class 200 screen-film system, 0.781 (S=200), 0.739 (S=400), 0.724 (S=800), 0.680 (S=1600) for the storage-phosphor system, and 0.798 for the mammography screen-film system. Analysis of variance showed significant differences between different combinations of imaging modalities and exposure doses ( p<0.05). The diagnostic performance of the flat-panel detector system is superior to that of a screen-film system and a storage-phosphor system for the detection of erosive lesions at clinical exposure settings (S=200). Using the flat-panel system the exposure dose can be reduced by 50% to obtain a diagnostic performance comparable to a speed class 200 screen-film system.

Animals↗

Neurotrophic effects of electroconvulsive therapy: a proton magnetic resonance study of the left amygdalar region in patients with treatment-resistant depression.

Negatively balanced neurotrophic factors may be important in precipitating clinical depression. Recently, it has been reported that antidepressant therapy may exert positive neurotrophic effects. The aim of this study was to detect probable neurotrophic changes during electroconvulsive therapy (ECT). For this purpose, N-acetylaspartate (NAA), an amino acid exclusively located in neurons, and other brain metabolites such as glutamine/glutamate (Glx), choline (Cho), and creatine (Cr) were measured in patients by localized proton magnetic resonance spectroscopy. A total of 28 severely depressed patients (DSM-IV) were enrolled, and the left amygdalar region was investigated by proton STEAM spectroscopy before and after unilateral ECT. The results were compared with 28 age- and gender-matched controls using nonparametric paired and unpaired tests. A significant increase in NAA was observed only in ECT responders (n=14; p=0.019). Five out of 14 nonresponders to ECT monotherapy were remeasured following a clinical improvement after continued ECT combined with antidepressants and were then found also to present a significant increase in NAA. In all successfully treated patients, parallel observations, that is, increased levels, were made for Glx, whereas Cho and Cr were unchanged. In conclusion, our preliminary finding of increased NAA concentrations after successful ECT may indicate a probable neurotrophic effect of ECT.

Adult↗

Imaging of coronary artery stents using multislice computed tomography: in vitro evaluation.

The aim of this study was to evaluate imaging features of different coronary artery stents during multislice CT Angiography (MSCTA). Nineteen stents made of varying material (steel, nitinol, tantalum) and of varying stent design were implanted in plastic tubes with an inner diameter of 3 mm to simulate a coronary artery. The tubes were filled with iodinated contrast material diluted to 200 Hounsfield units (HU), closed at both ends and positioned in a plastic container filled with oil (-70 HU). The MSCT scans were obtained perpendicular to the stent axes (detector collimation 4x1 mm, table feed 2 mm/rotation, 300 mAs, 120 kV). Axial images and multiplanar reformations were evaluated regarding artifact size, lumen visibility, and intraluminal attenuation values. Artifacts characterized by artifactual thickening of the stent struts leading to apparent reduction in the lumen diameter and increased intraluminal attenuation values were observed in all cases. The stent lumen was totally obscured in the Wiktor stent, the Wallgraft stent, and the Nir Royal stent. Partial residual of the stent lumen could be visualized in all other utilized stent products (artificial lumen reductions ranged from 62% in the V-Flex stent to 94% in the Bx Velocity stent). Parts of the stent lumen can be visualized in most coronary artery stents; however, detectability of in-stent stenoses remains to be evaluated for each stent type.

Artifacts↗

Value of 1.0- M gadolinium chelates: review of preclinical and clinical data on gadobutrol.

Several preclinical and clinical studies with the first commercially available highly concentrated Gd-chelate gadobutrol (1 mol/l) are reviewed. Physicochemical, pharmacological, and pharmacokinetic properties, safety analysis, as well as experimental and clinical efficacy studies are highlighted in comparison with 0.5- M Gd-chelates. The 1-mol gadobutrol has been proven to be safe in an examined dose range from 0.04 up to 0.5 mmol/kg body weight (b.w.). Even in patients with chronic renal impairment, including hemodialysis, gadobutrol can safely be applied at doses up to 0.3 mmol/kg b.w. For contrast-enhanced MRI in the equilibrium phase, efficacy data analysis shows comparable results to other commercially available extracellular Gd-chelates with lower Gd-concentrations (0.5 M). Studies focused on the potential benefit of a tighter bolus, such as brain perfusion imaging using T2*-effects, document the superiority of a highly concentrated Gd contrast agent. For contrast-enhanced MRA, clinical studies are still ongoing; therefore, the ultimate potential of a more compact bolus, using 1- M Gd-chelates, for contrast-enhanced MRI, has still to be analyzed, especially for time-resolved magnetic resonance angiography.

Animals↗

Phosphorus-31 MR spectroscopy of normal adult human brain and brain tumours.

Localized phosphorus-31 MR spectra were obtained in vivo in a large series of normal human brain tissue specimens of healthy volunteers (n=36) and various brain tumours (n=52). Tumour types examined included grade II and grade III gliomas (n=15 and n=1, respectively), glioblastomas (n=16) and meningeomas (n=12). An additional eight tumours were analysed during chemo- or radiotherapy. Spectra were acquired using a modified ISIS pulse sequence with a repetition time of 3 s. Voxel sizes ranged from 56 to 129 ml. The spectra were evaluated using a least-square variable projection (VARPRO) fitting procedure in the time domain, which allows semi-quantitative determination of relative metabolite concentrations. The measurements in normal cerebrum of healthy volunteers revealed the following results of metabolite signal intensity ratios: pH 7.04 (+/- 0.01), PCr/alpha-ATP 0.51 (+/- 0.03), P(i)/alpha-ATP 0.17 (+/-0.02), PCr/P(i) 2.09 (+/-0.12), PDE/alpha-ATP 3.65 (+/-0.13) and PME/alpha-ATP 0.41 (+/-0.04). Meningiomas showed the most obvious changes when compared with normal brain tissue. They are characterized by an alkaline environment (pH 7.16 +/- 0.03; p<0.005), a decrease in the phosphocreatine peak (p<0.0001) and significantly decreased phosphodiesters (p<0.0001). Glioblastomas also showed alkalization (pH 7.12 +/- 0.02; p<0.001) and a decrease in PDE/alpha-NTP (p<0.05), but no significant changes in PCr/alpha-NTP or PCr/Pi. In gliomas with low malignancy, less distinct changes could be detected with slight alkalization (pH 7.09 +/- 0.02; p<0.05) and more than a two-fold reduction in the PDE/alpha-NTP ratio (p<0.05). The spectra of brain tumours during chemo- and radiotherapy indicated clear but inconsistent influence of the therapy.

Adolescent↗

Coronary magnetic resonance angiography for assessment of the stent lumen: a phantom study.

PURPOSE: To evaluate the feasibility of visualizing the stent lumen using coronary magnetic resonance angiography in vitro. MATERIAL AND METHODS: Nineteen different coronary stents were implanted in plastic tubes with an inner diameter of 3 mm. The tubes were positioned in a plastic container filled with gel and included in a closed flow circuit (constant flow 18 cm/sec). The magnetic resonance images were obtained with a dual inversion fast spin-echo sequence. For intraluminal stent imaging, subtraction images were calculated from scans with and without flow. Subsequently, intraluminal signal properties were objectively assessed and compared. RESULTS: As a function of the stent type, various degrees of in-stent signal attenuation were observed. Tantalum stents demonstrated minimal intraluminal signal attenuation. For nitinol stents, the stent lumen could be identified, but the intraluminal signal was markedly reduced. Steel stents resulted in the most pronounced intraluminal signal voids. CONCLUSIONS: With the present technique, radiofrequency penetration into the stents is strongly influenced by the stent material. Thesefindings may have important implicationsforfuture stent design and stent imaging strategies.

Blood Vessel Prosthesis Implantation↗

Performance of a flat-panel detector in detecting artificial bone lesions: comparison with conventional screen-film and storage-phosphor radiography.

PURPOSE: To compare a large-area direct-readout flat-panel detector system with a conventional screen-film system and a storage-phosphor system in detecting small artificial osseous lesions simulating osteolytic disease and to assess diagnostic performance with decreasing exposure dose. MATERIALS AND METHODS: Artificial lesions (0.5-3.0 mm) were created in 100 of 200 predefined regions in 20 porcine femoral specimens. Specimens were enclosed in containers filled with water to create absorption and scatter radiation conditions comparable with those in a human extremity. Imaging was performed with a flat-panel detector system, a conventional screen-film system, and a storage-phosphor system. Levels of exposure equivalent to speed classes 400, 800, 1600, and 3200 were used. In all images, the presence or absence of a lesion was assessed by three radiologists using a five-point confidence scale. Receiver operating characteristic (ROC) analysis was performed for 4,800 observations (600 for each imaging modality and exposure level) and diagnostic performance estimated with the area under the ROC curve (A(z)). The significance of differences in diagnostic performance was tested with analysis of variance. RESULTS: ROC analysis showed A(z) values of 0.820 (speed class 400), 0.780 (class 800), 0.758 (class 1600), and 0.676 (class 3200) for the flat-panel detector; 0.761 (class 400), 0.725 (class 800), and 0.662 (class 1600) for the storage-phosphor system; and 0.788 (class 400) for the conventional screen-film system. The A(z) value for the flat-panel detector at speed class 400 was significantly higher than that for all other systems (P <.05). A(z) values for the speed class 400 screen-film system and flat-panel detector system at speed class 800 were not significantly different. CONCLUSION: The flat-panel detector has diagnostic performance superior to that of conventional screen-film and storage-phosphor radiography for detecting small artificial osseous lesions at clinical exposure settings. With the flat-panel detector, exposure dose can be reduced by 50% to obtain diagnostic performance comparable with that of a conventional speed class 400 screen-film system.

Animals↗

Screening for early lung cancer with low-dose spiral CT: prevalence in 817 asymptomatic smokers.

PURPOSE: To present prevalence screening data from a nonrandomized screening trial by using low-dose computed tomography (CT) and a simple algorithm based on the size and attenuation of detected nodules to guide diagnostic work-up. MATERIALS AND METHODS: Eight hundred seventeen asymptomatic volunteers (age range, 40-78 years; median age, 53 years; median tobacco consumption, 45 pack-years) underwent spiral low-dose CT of the chest without contrast material enhancement. We regarded all noncalcified pulmonary nodules greater than 10 mm in diameter as potentially malignant and recommended histologic examination or follow-up after 3, 6, 12, and 24 months to exclude growth. For noncalcified pulmonary nodules of 10 mm or smaller, repeat low-dose CT was recommended to exclude growth. RESULTS: In 43% (350 of 817) of individuals, 858 noncalcified pulmonary nodules were found. Thirty-two nodules in 29 subjects were larger than 10 mm. Biopsy of 15 lesions revealed lung cancer in 12 lesions in 11 subjects (prevalence for all ages, 1.3% [11 of 817 subjects]; >50 years of age, 2.1% [11 of 519 subjects]; >60 years of age, 3.9% [eight of 206 subjects]), with a high proportion of early tumor stages (seven tumors, stage I; two, stage II; and three, stage III); three lesions were benign. In 17 nodules larger than 10 mm, follow-up with low-dose CT for a minimum of 24 months did not demonstrate growth. CONCLUSION: Lung cancer screening with low-dose CT demonstrated a prevalence of asymptomatic cancers in 1.3% of a smoking population, including a high proportion of early tumor stages and a 20% (three of 15) rate of invasive procedures for benign lesions.

Adult↗

Noninvasive grading of untreated gliomas: a comparative study of MR imaging and 3-(iodine 123)-L-alpha-methyltyrosine SPECT.

PURPOSE: To compare the accuracy of magnetic resonance (MR) imaging scores with that of 3-(iodine 123)-L-alpha-methyltyrosine ((123)I-IMT) single photon emission computed tomography (SPECT) in the noninvasive grading of untreated gliomas. MATERIALS AND METHODS: The study comprised 15 patients with low-grade gliomas (grades I-II, according to World Health Organization criteria) and 33 patients with high-grade gliomas (grades III-IV). The lesions were evaluated by using an MR imaging score based on nine criteria. The (123)I-IMT uptake was quantified as the ratio between the amino acid uptake in the tumor and that in the contralateral hemisphere. To test for potentially significant differences in diagnostic performance between contrast material-enhanced MR imaging and (123)I-IMT SPECT, binormal receiver operating characteristic curves were fitted to the data and compared by using the area test. RESULTS: The accuracy of MR imaging in the noninvasive grading of untreated gliomas was higher than that of (123)I-IMT SPECT (88% vs 79%). However, the difference in diagnostic performance was not significant on the basis of findings at receiver operating characteristic analysis (P >.2). Neither MR imaging nor (123)I-IMT SPECT allowed differentiation between high-grade gliomas (grades III and IV). CONCLUSION: Although (123)I-IMT uptake is significantly higher in high-grade gliomas than in low-grade gliomas, the performance of (123)I-IMT SPECT adds little to the accuracy of determining tumor grade when MR imaging is performed.

Adult↗

MOSAIC: Multimodal Stroke Assessment Using Computed Tomography: novel diagnostic approach for the prediction of infarction size and clinical outcome.

BACKGROUND AND PURPOSE: With new CT technologies, including CT angiography (CTA), perfusion CT (PCT), and multidetector row technique, this method has regained interest for use in acute stroke assessment. We have developed a score system based on Multimodal Stroke Assessment Using CT (MOSAIC), which was evaluated in this prospective study. METHODS: Forty-four acute stroke patients (mean age, 63.8 years) were enrolled within a mean of 3.0+/-1.9 hours after symptom onset. The MOSAIC score (0 to 8 points) was generated by results of the 3 sequential CT investigations: (1) presence and amount of early signs of infarction on noncontrast CT (NCCT; 0 to 2 points), (2) stenosis (>50%) or occlusion of the distal internal carotid or middle cerebral artery on CTA (0 to 2 points), and (3) presence and amount of reduced cerebral blood flow on 2 adjacent PCT slices (0 to 4 points). The predictive value of the MOSAIC score was compared with each single CT component with respect to the final size of infarction and the clinical outcome 3 months after stroke by use of the modified Rankin Scale (mRS) and the Barthel Index (BI). RESULTS: Among the CT components, PCT showed the best correlation to infarction size (r=0.75) and clinical outcome (r=0.60 to 0.62) compared with NCCT (r=0.43 to 0.58) and CTA (r=0.47 to 0.71). The MOSAIC score showed consistently higher correlation factors (r=0.67 to 0.78) and higher predictive values (0.73 to 1.0) than all single CT components with respect to outcome measures. A MOSAIC score <4 predicted independence with 89% to 96% likelihood (mRS </=2, BI >/=90); a MOSAIC score <5 predicted fair outcome with 96% to 100% likelihood (mRS </=3, BI >/=60). CONCLUSIONS: The MOSAIC score based on multidetector row CT technology is superior to NCCT, CTA, and PCT in predicting infarction size and clinical outcome in hyperacute stroke.

Acute Disease↗

Perivascular inflammatory reaction to a Hemobahn stent-graft: diagnosis with 3D MR angiography.

PURPOSE: To present a rare perivascular inflammatory reaction to a commercially produced polytetrafluoroethylene-covered stent and demonstrate the utility of 3-dimensional (3D) magnetic resonance angiography (MRA) in the diagnosis of this phenomenon. CASE REPORT: Three weeks after percutaneous deployment of a Hemobahn stent-graft to treat a high-grade stenosis and aneurysm of the proximal left superficial femoral artery (SFA), a 70-year-old diabetic man developed fever, pain, and local swelling of the left thigh. Venous thrombosis was excluded by ultrasound imaging; a normal flow profile was seen in the left common and superficial femoral arteries. Blood analysis found elevated inflammatory markers. MRA revealed extensive soft-tissue edema and perivascular contrast enhancement around the left SFA, but the stent-graft was patent. The clinical symptoms resolved within 7 days after initiation of anti-inflammatory therapy. Follow-up MRA scans demonstrated significantly reduced inflammatory reaction over the next few months. CONCLUSIONS: Symptomatic perivascular inflammatory soft-tissue response to a stent-graft can be diagnosed with MR imaging studies.

Aged↗

Using highly concentrated gadobutrol as an MR contrast agent in patients also requiring hemodialysis: safety and dialysability.

OBJECTIVE: The purpose of our study was to assess the safety and dialysability of gadobutrol, a new, electrically neutral, and highly concentrated MR contrast agent, in patients who require hemodialysis. SUBJECTS AND METHODS: Eleven patients with end-stage renal failure who required ongoing hemodialysis were enrolled in our prospective study. Gadobutrol (1 mol/L) was injected IV at randomly assigned doses of either 0.1 or 0.3 mmol of gadolinium per kilogram of body weight for contrast-enhanced MR imaging. Hematology, clinical chemistry, and vital signs were closely monitored at baseline and during an observation period of 120 hr after the IV injection of gadobutrol. To calculate the dialysability, blood samples were drawn before and after each of three hemodialysis sessions. Additional arterial and venous blood sampling was performed during the first hemodialysis session after 30 and 90 min. RESULTS: No gadobutrol-related changes in hematology, clinical chemistry, or vital signs were detected at either dose level during the observation period. The mean and the standard deviation for the eliminated fraction of gadobutrol was 68.2% +/- 12.7% after a 3-hr hemodialysis session using a 1.2 m(2) low-flux polysulfone membrane. After three consecutive hemodialysis sessions, the total amount of gadobutrol eliminated increased to 98.0% +/- 1.8%. The mean clearance rates of gadobutrol were 126.1 +/- 17.8 mL/min and 126.6 +/- 24.5 mL/min at 30 and 90 min, respectively. CONCLUSION: Gadobutrol is effectively removed by three hemodialysis sessions using a low-flux polysulfone membrane. Our study documents initial evidence that gadobutrol can be used safely in hemodialysis patients.

Adult↗