Clinical safety evaluation of contrast agents based on real-world evidence.

WHAT IS KNOWN AND OBJECTIVE: This study was aimed at comparing the adverse drug reactions (ADRs) arising from the use of iodinated contrast medium (ICM) and gadolinium-based contrast media (GBCM), and to provide a basis for the clinical selection of contrast media. METHODS: Retrospective data for ADR cases occurring from the use of ICM or GBCM during enhanced scanning in computed tomography and magnetic resonance imaging were collected between June/2013 and May/2020 from Wenling Hospital of Traditional Chinese Medicine. Chi-square tests were performed based on the characteristics of patients and the classification of contrast medium. Bonferroni correction was applied to the statistical analyses with multiple comparisons of proportions. RESULTS: Among 27,328 patients who were subjected to enhanced CT scanning, 207 cases (0.76%) showed ICM-related ADRs. Among 16,381 patients who were subjected to enhanced MRI scanning, 25 cases (0.15%) showed ADRs related to GBCM. The incidence of ADR induced by GBCM was significantly lower than ICM-induced ADR (p < 0.01). There were no significant differences in the incidence among different types of ICM, including ioversol and iodixanol, as well as iodixanol from different manufacturers (p > 0.05). Interestingly, the ADR incidence of ICM seemed to be associated with gender, with a significantly higher incidence in females than in male patients, and it was also associated with the age, with a lower occurrence in older (>44 years) compared to younger patients. WHAT IS NEW AND CONCLUSION: With respect to ADR incidence, the safety profile of ICM of different types and different manufacturers was found to be similar in clinical use, warranting no need of specifically choosing imported or more expensive products. While choosing contrast medium type for clinical use, attention should be paid to certain populations, especially to younger and female patients when the patients are about to undergo a contrast-enhanced examination.

Ethiodized poppyseed oil versus ioversol for image quality and adverse events in hysterosalpingography: a prospective cohort study.

BACKGROUND: This study aimed to investigate the image quality and adverse events (AEs) of ethiodized poppyseed oil (EPO) compared with ioversol as contrast agents in hysterosalpingography (HSG). METHODS: Two hundred twenty-eight patients underwent HSG were consecutively recruited in this prospective cohort study, and were accordingly divided into EPO group (N = 165) and ioversol group (N = 63). The quality of image was assessed according to the European Guidelines on quality criteria for diagnostic radiographic images. AEs during, within 2 h and at 1-month post-HSG were recorded. RESULTS: EPO displayed elevated image quality compared with ioversol including the total image quality score (P < 0.001), the cervical canal display score (P < 0.001), shape and outline of uterus score (P < 0.01), cervical mucosa or folds score (P < 0.001), oviduct isthmus score (P < 0.001), ampulla and fimbriae of oviduct score (P < 0.001) and celiac diffuse image score (P < 0.001). Multivariate linear regression displayed that EPO (P < 0.001) was an independent predictive factor for increased total image quality score. AEs were similar between EPO group and ioversol group during and within 2 h post-HSG (all P > 0.05). However, at 1-month post-HSG, the number of patients had unchanged and faded menstrual blood color decreased but the proportion of patients with deepened menstrual color increased in EPO group compared with ioversol group (P = 0.007). In addition, the number of patients had iodine residue in uterine cavity was elevated in EPO group compared with ioversol group (P < 0.001). CONCLUSION: EPO is more efficient in image quality and equally tolerant compared to ioversol as contrast agents in HSG.

Prospective comparison of gadoxetic acid-enhanced liver MRI and contrast-enhanced CT with histopathological correlation for preoperative detection of colorectal liver metastases following chemotherapy and potential impact on surgical plan.

OBJECTIVE: To prospectively compare the diagnostic performance of gadoxetic acid-enhanced MRI (EOB-MRI) and contrast-enhanced CT (CECT) for preoperative detection of colorectal liver metastases (CRLM) following chemotherapy and to evaluate the potential change in the hepatic resection plan. METHODS: 51 patients with CRLM treated with preoperative chemotherapy underwent liver imaging by EOB-MRI and CECT prospectively. Two independent blinded readers characterized hepatic lesions on each imaging modality using a 5-point scoring system. 41 patients underwent hepatic resection and histopathological evaluation. RESULTS: 151 CRLM were confirmed by histology. EOB-MRI, compared to CECT, had significantly higher sensitivity in detection of CRLM ≤1.0 cm (86% vs. 45.5%; p < 0.001), significantly lower indeterminate lesions diagnosis (7% vs. 33%; p < 0.001) and significantly higher interobserver concordance rate in characterizing the lesions ≤1.0 cm (72% vs. 51%; p = 0.041). The higher yield of EOB-MRI could have changed the surgical plan in 45% of patients. CONCLUSION: Following preoperative chemotherapy, EOB-MRI is superior to CECT in detection of small CRLM (≤1 cm) with significantly higher sensitivity and diagnostic confidence and interobserver concordance in lesion characterization. This improved diagnostic performance can alter the surgical plan in almost half of patients scheduled for liver resection.

Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial.

BACKGROUND: Contrast medium-induced acute kidney injury (CIAKI) is a leading cause of acquired renal impairment. The effects of antioxidants have been conflicting regarding the prevention of CIAKI. We performed a study of vitamin E use to decrease CIAKI in patients undergoing elective coronary angiography. METHODS AND RESULTS: In a placebo-controlled randomized trial at 2 centers in Iran, 300 patients with chronic kidney disease-defined as estimated glomerular filtration rate <60 mL/min per 1.73 m(2)-were randomized 1:1 to receive 0.9% saline infusion 12 hours prior to and after intervention combined with 600 mg vitamin E 12 hours before plus 400 mg vitamin E 2 hours before coronary angiography or to receive placebo. The primary end point was the development of CIAKI, defined as an increase ≥0.5 mg/dL or ≥25% in serum creatinine that peaked within 72 hours. Based on an intention-to-treat analysis, CIAKI developed in 10 (6.7%) and 21 (14.1%) patients in the vitamin E and placebo groups, respectively (P=0.037). Change in white blood cell count from baseline to peak value was greater in the vitamin E group compared with the placebo group (-500 [-1500 to 200] versus 100 [-900 to 600]×10(3)/mL, P=0.001). In multivariate analysis, vitamin E (odds ratio 0.408, 95% CI 0.170-0.982, P=0.045) and baseline Mehran score (odds ratio 1.257, 95% CI 1.007-1.569; P=0.043) predicted CIAKI. CONCLUSIONS: Prophylactic short-term high-dose vitamin E combined with 0.9% saline infusion is superior to placebo for prevention of CIAKI in patients undergoing elective coronary angiography. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02070679.

Chemoembolization for hepatocellular carcinoma: 1-month response determined with apparent diffusion coefficient is an independent predictor of outcome.

PURPOSE: To evaluate the predictive utility of apparent diffusion coefficient (ADC) changes at diffusion-weighted (DW) magnetic resonance (MR) imaging 1 month after transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) compared with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, European Association for the Study of the Liver (EASL) criteria, and modified RECIST (mRECIST). MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained for this prospective study. Thirty-eight patients with inoperable HCC underwent 1.5-T MR imaging, including DW imaging, before and 1 month after TACE. Responses 1 month after TACE were assessed with the ADC change relative to baseline (ADC ratio), RECIST, EASL criteria, and mRECIST. Eight patients underwent transplantation 4 months after TACE, allowing the association between response and histopathologic necrosis ratio to be determined. In 30 patients, Kaplan-Meier and log-rank tests were used to correlate the response variables with progression-free and overall survival. RESULTS: Median progression-free survival (PFS) was 5 months, and overall survival was 17.5 months. Survival analyses showed significant effects of pretreatment α-fetoprotein level (P = .03) and ADC ratio (P < .0001) on PFS and substantial effects of mRECIST, RECIST, and EASL criteria (.05 < P < .1). ADC ratio was a significant predictor of 5-month PFS (P < .001), with an accuracy of 93.3% compared with 53.3% with mRECIST and EASL criteria and 66.7% with RECIST. No response variables correlated with overall survival. Only the ADC ratio was significantly associated with histopathologic tumor necrosis (P = .03). CONCLUSION: The ADC ratio 1 month after TACE was an independent predictor of PFS, which showed stronger association with tumor response than did RECIST, EASL criteria, or mRECIST.

Distal limb desensitisation following analgesia of the digital flexor tendon sheath in horses using four different techniques.

REASONS FOR PERFORMING STUDY: Controversy exists about the desensitisation obtained after diagnostic analgesia of the digital flexor tendon sheath (DFTS) during lameness examinations. OBJECTIVES: To determine whether DFTS analgesia results in inadvertent desensitisation of the palmar/plantar digital nerves and whether this depends on the injection technique used. STUDY DESIGN: Crossover experimental study. METHODS: The DFTS of 9 horses were injected with local anaesthetic solution and radiodense contrast medium using one of the following techniques: Proximal (at lateral proximal recess of the DFTS), Axial (axial to the lateral proximal sesamoid bone), Base (at base of the lateral proximal sesamoid bone), and Distal (at palmar/plantar mid-pastern). In total, 72 injections were performed. Skin desensitisation at the heel bulbs was tested with a dynamometer before and at 15, 30, 90 and 120 min after injection. RESULTS: Overall, complete desensitisation of a heel bulb at one or more time points after injection occurred in 22 limbs (30.6%). An additional 7 limbs were partially desensitised. Complete skin desensitisation occurred in 10, 3, 4 and 5 limbs using the Proximal, Axial, Base and Distal techniques respectively. Significant differences between techniques were only found at T30. The probability of skin desensitisation at the heel bulbs was 4 times higher when using the Proximal compared with the Axial and Base techniques in the forelimbs, and 3 times higher compared with the Axial and Distal techniques in the hindlimbs. Skin desensitisation nearly always occurred exclusively on the lateral heel bulb. Bilateral desensitisation only occurred in 5 limbs. CONCLUSIONS: Anaesthesia of the palmar/plantar digital nerves with distal limb desensitisation often occurs after DFTS analgesia. A higher chance of desensitisation exists when injecting the proximal DFTS recess. It is advisable to verify skin sensitivity at the heel bulbs after DFTS analgesia to avoid false interpretations about the origin of pain causing lameness.

Does enteral contrast increase the accuracy of appendicitis diagnosis?

BACKGROUND: Several approaches traditionally have helped opacify the bowel when computed tomography (CT) is used to diagnose appendicitis. With the development of multidetector row CT (MDCT), the need for enteral contrast agents is less obvious. Purpose The objective of this study was to evaluate retrospectively the accuracy of MDCT demonstration of appendicitis using enteral contrast agents. METHODS: We reviewed radiologic reports of all 246 adult patients with suspected appendicitis who underwent 16-slice MDCT during 2005-2006 at our department. The use of enteral contrast agents and the route of administration were documented by one investigator. A radiologist evaluated whether the responses in the reports were consistent with diagnosis of appendicitis. The accuracy of the radiologic reports was assessed using the results of surgery, histopathology and 3 to 21 months of follow-up. RESULTS: Of patients studied, 14.6% received no enteral contrast agent, 8.5% received both oral contrast and rectal contrast (enema), 46.7% received oral contrast and 30.1% received rectal contrast enemas. The accuracies for the CT diagnosis of appendicitis with different combinations of agents ranged from 95% to 100%, with no significant difference among groups. CONCLUSION: Our study shows that the accuracy for diagnosis of appendicitis by abdominal 16-slice MDCT is high regardless of enteral contrast use. Therefore, further use of enteral contrast agents for CT diagnosis of appendicitis in adults cannot be recommended.

Jugular versus subclavian totally implantable access ports: catheter position, complications and intrainterventional pain perception.

PURPOSE: To determine the safest and most tolerable method for totally implantable access ports (TIAPs) particularly in regard to patient's pain perception and catheter-related complications. MATERIALS AND METHODS: From January 2007 to October 2008 a subcutaneous TIAP (Bardport, Bard Access System, UT, USA) was implanted in 138 oncological patients (60 male, 78 female; 18-85 years old; mean age of 56 ± 6 years) by experienced interventional radiologists. 94 TIAP were implanted through the subclavian vein (subclavian group) and 44 TIAP were implanted through the internal jugular vein (jugular group). Intrainterventional pain perception (visual analogue scale from 1 to 10), postinterventional catheter tip migration and radiation dose were documented for each method and implantation side and differences were compared with Wilcoxon t-test. For ordinal variables, comparison of two groups was performed with the Fisher's exact test. RESULTS: No severe periinterventional complication occurred. Inadvertent arterial punctures without serious consequences were reported in one case for the jugular group versus four cases in the subclavian group. Significantly (p<0.05) lower pain perception, radiation dose and tip migration rate were observed in the jugular group. Catheter occlusions occurred in 4% (n=4) of the subclavian group versus 2% (n=1) of the jugular group. The corresponding values for vein thrombosis and catheter dislocation were 3% (n=3) and 1% (n=1) in the subclavian group, while none of those complications occurred in the jugular group. CONCLUSION: Both techniques, the TIAP implantation via fluoroscopy-guided subclavian vein puncture and via ultrasound-guided jugular vein puncture, are feasible and safe. Regarding intrainterventional pain perception, radiation dose, postinterventional catheter tip position and port function the jugular vein puncture under ultrasound guidance seems to be advantageous.

Caudate lobe hepatocellular carcinoma treated with selective chemoembolization.

PURPOSE: To analyze the clinical outcomes of chemoembolization for solitary caudate lobe hepatocellular carcinoma (HCC) found at initial presentation. MATERIALS AND METHODS: This retrospective study was approved by the institutional review board; the requirement for informed patient consent was waived. From July 1998 to June 2009, 40 patients (28 men, 12 women; mean age, 57 years) found to have a single HCC lesion in the caudate lobe at initial presentation were treated with chemoembolization and evaluated for overall survival and progression-free survival. Multivariate analyses for potential clinical and radiologic factors were performed by using the Cox proportional hazard model. RESULTS: Selective chemoembolization via the caudate artery was achieved in 34 (85%) patients. Overall survival rates at 1, 2, 3, 4, and 5 years were 92%, 79%, 65%, 56%, and 56%, respectively. Selective chemoembolization of the caudate artery was a critically important factor in longer overall survival (hazard ratio, 0.091; 95% confidence interval [CI]: 0.021, 0.389; P < .001), and portal vein tumor thrombosis (hazard ratio, 31.25; 95% CI: 4.88, 200.1; P < .001) and multiple tumor-feeding vessels (hazard ratio, 6.87; 95% CI: 1.47, 32.1; P = .014) were significant factors in shorter overall survival. Selective chemoembolization of the caudate artery was also a significant factor in longer progression-free survival (hazard ratio, 0.278; 95% CI: 0.10, 0.76; P = .013). CONCLUSION: Selective chemoembolization via the caudate artery is possible in most patients with caudate lobe HCC and a critical factor in longer overall survival and longer progression-free survival.

Calculation of glomerular filtration rate in conscious rats by the use of a bolus injection of iodixanol and a single blood sample.

INTRODUCTION: To establish a simple and convenient procedure for the determination of glomerular filtration rate (GFR) in conscious rats, we developed a single-blood-sample method, in contrast to the conventional three-sample method, using a bolus injection of the nonionic contrast medium iodixanol. METHODS: Iodixanol was intravenously administered at 1500 mg I/kg to healthy or renal-impaired rats, and blood was collected 60, 120, and 180 min later. Serum iodixanol concentrations were measured by HPLC, and serum urea nitrogen (UN) and creatinine concentrations were determined as renal function tests. RESULTS: In rats subjected to 1/2 and 3/4 nephrectomies, GFR values decreased significantly without and with increases in serum UN and creatinine concentrations, respectively. In rats treated subcutaneously with gentamicin sulfate (GM) at 80 mg/kg/day or puromycin aminonucleoside (PAN) at 15 mg/kg/day for 10 consecutive days, the GFR values decreased or showed a tendency to decrease before increases in serum UN and creatinine concentrations. Accordingly, when the GFR decreased to more than 60% of the basal value, serum UN or creatinine concentrations became elevated. The GFR values obtained from the three-sample method were closely correlated (r=0.83) with those calculated from the estimated distribution volume (V) and serum iodixanol concentration 120 min after iodixanol injection in the single-blood-sample method in which serum iodixanol concentrations ranged between 20 and 250 microg I/mL. DISCUSSION: These results suggest that the single-blood-sample method with a bolus injection of iodixanol, allowing for the repeated use of the same animals, is an expedient procedure without ensuring accurate urine collection.

Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies.

BACKGROUND: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. METHODS AND RESULTS: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group). CONCLUSIONS: The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.

Pneumatosis cystoides intestinalis: imaging findings with colonoscopy correlation.

We report on a case of pneumatosis cystoides intestinalis in a 32-year-old woman affected by coeliac disease with stool cultures positive for salmonella. After plain film of the abdomen, patient underwent computed tomography and magnetic resonance colonography studies that demonstrated numerous, diffuse bubblelike intramural gas collections into the ascending, transverse and descending colonic wall. CT and MR findings were correlated with colonoscopy.

Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial.

OBJECTIVES: This study sought to compare the nephrotoxicity of iodixanol and ioxaglate in patients with renal impairment undergoing coronary angiography. BACKGROUND: Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than low-osmolar contrast media (LOCM) in high-risk patients. METHODS: In a prospective, randomized trial in 300 adults with creatinine clearance (CrCl) < or =60 ml/min, patients received either iodixanol or ioxaglate and underwent coronary angiography with or without percutaneous coronary intervention. The primary end point was the incidence of contrast-induced nephropathy (CIN) (an increase in serum creatinine [SCr] > or =25% or > or =0.5 mg/dl [> or =44.2 mumol/l]). The incidence of CIN in patients with severe renal impairment at baseline (CrCl <30 ml/min) or diabetes and in those receiving large doses (> or =140 ml) of contrast medium was also determined. RESULTS: The incidence of CIN was significantly lower with iodixanol (7.9%) than with ioxaglate (17.0%; p = 0.021), corresponding to an odds ratio (OR) of CIN of 0.415 (95% confidence interval [CI] 0.194 to 0.889) for iodixanol. The incidence of CIN was also significantly lower with iodixanol in patients with severe renal impairment (p = 0.023) or concomitant diabetes (p = 0.041), or in patients given > or =140 ml of contrast media (p = 0.038). Multivariate analysis identified use of ioxaglate (OR 2.65, 95% CI 1.11 to 6.33, p = 0.028), baseline SCr, mg/dl (OR 2.0, 95% CI 1.04 to 3.85, p = 0.038), and left ventricular ejection fraction, % (OR 0.97, 95% CI 0.94 to 0.99, p = 0.019) as independent risk factors for CIN. CONCLUSIONS: The IOCM iodixanol was significantly less nephrotoxic than ioxaglate, an ionic, dimeric LOCM. (The RECOVER Trial; http://clinicaltrials.gov; NCT00247325).

Contrast medium concentration in epithelial mucosal cells after colonic instillation of lodixanol: a semiquantitative study indicating the route of permeation.

RATIONALE AND OBJECTIVES: Studies have shown that water-soluble radiographic contrast media may be useful as intestinal permeability probes. The current study was undertaken to provide information about the route by which such a permeability probe crosses the mucosal epithelium. MATERIALS AND METHODS: The authors administered 3 mL of iodixanol (iodine, 320 mg/mL) by means of an enema into the colons of (a) rats with experimental colitis induced 14 days earlier and (b) normal rats. At various intervals after the enema, laparotomy was performed and the colon was identified and longitudinally split immediately before cryofixation, without prior interruption of circulation. Freeze-dried cryosections were studied by means of electron microscopy and x-ray microanalysis. RESULTS: Approximately equal concentrations of iodine were found intracellularly and between the epithelial cells of the colonic mucosa. Ninety percent of analyzed cells had a normal sodium-potassium ratio and low levels of intracellular chlorine, indicating intact cell membranes. Nevertheless, many of these cells, in specimens from both normal rats and rats with colitis, contained high intracellular iodine concentrations. CONCLUSION: The transcellular route seems to be at least as important as the paracellular route for permeation of the highly water-soluble molecule iodixanol through the mucosal epithelium of both normal and inflamed rat colon. This finding may contradict previous findings in other water-soluble substances.

Hypoperfusion in the renal outer medulla after injection of contrast media in rats.

PURPOSE: The effect on regional renal blood was studied after injection of nonionic iso-osmolar iotrolan or ionic high-osmolar iothalamate. MATERIAL AND METHODS: Laser-Doppler flowmetry was used to measure outer medullary (OMBF) and superficial cortical blood flow (CBF) simultaneously in anesthetized rats. Iotrolan (320 mOsm/kg H2O) was injected i.v. at a dose of 600 mg I/kg b.w. (normal dose) over 2 min or 1,600 (high dose) mg I/kg b.w. over 2 or 8 min. Iothalamate (2,580 mOsm/kg H2O) was injected i.v. at a dose of 1,600 (high dose) or 2,900 (extremely high dose) mg I/kg b.w. over 2 min. RESULTS: At the normal dose and 2-min injection of iotrolan, OMBF was reduced by 25+/-9% over 20 min. The high dose of iotrolan injected over 8 min resulted in a reduction in OMBF slightly smaller (17+/-9%) than that induced by the normal dose but lasting longer (30 min). Compared to the normal dose, the high dose and fast (2 min) injection of iotrolan resulted in a greater and more prolonged decrease in OMBF (32+/-6% lasting 50 min). After the high dose of iothalamate (1,600 mg I/kg) there was a decrease in OMBF by 21+/-6%, lasting 30 min. An extremely high dose (2,900 mg I/kg b.w.) gave a heterogeneous response with a mean increase in OMBF of 48+/-24% occurring 60 min after the injection. CONCLUSION: Iso-osmolar and high-osmolar contrast media (CM), at normal and high doses, decrease OMBF, while an extremely high dose of iothalamate may result in an increase. The depression of outer medullary perfusion may have implications for CM-induced acute renal failure in view of the vulnerability of this region to a decrease in oxygen tension.

A new liposomal contrast medium for CT of the liver. An imaging study in a rabbit tumour model.

A new type of liposomal liver-specific contrast medium was studied in an experimental tumour model. Rabbits were inoculated with VX2-carcinoma directly in the liver of laparotomy. CT studies were carried out 14 days after inoculation. The liver-specific contrast medium consisted of a suspension of liposomes in a 100 mg I/ml iodixanol solution, with equal amounts of encapsulated and nonencapsulated iodixanol. It was administered at a dose of 200 mg I/kg. The contrast of normal liver tissue to tumorous tissue was significantly increased by contrast medium administration, the increase being largest 10 min after injection.

Cardiac hemodynamic effects of iodixanol, iopamidol, and ioxaglate following left coronary injections in anesthetized dogs.

RATIONALE AND OBJECTIVES: Iodixanol, a dimeric, nonionic X-ray contrast medium, has been formulated at 320 mg iodine per milliliter and supplemented with Na+, Ca2+, and Cl- to produce an osmolality that approximates that of plasma. We compared the effects of left main coronary artery injections of iodixanol, ioxaglate, and iopamidol on cardiac mechanical function in dogs. METHODS: Six mixed-breed dogs were anesthetized and prepared for recordings for electrocardiogram, aortic and left ventricular pressures, and the first derivative of left ventricular pressure, dP/dt. The test solutions and saline were injected into the left coronary artery in a randomized order. The series of four injections were repeated three times in each animal for a total of 12 injections per dog. RESULTS: Iodixanol caused significantly lower (p < .05) reduction in peak left ventricular pressure (-1.7 +/- 0.9% vs -0.7 +/- 2.0%), in diastolic aortic pressure (-1.3 +/- 1.1% vs -9 +/- 1.3%), and in left ventricular dP/dt (0.3 +/- 1.3% vs -13.2 +/- 2.4%) than did ioxaglate. Iodixanol also produced smaller cardiovascular effects than did iopamidol, but the differences were not statistically significant. Injections of both iopamidol and ioxaglate caused significant decreases from baseline parameter values; however, the changes with iodixanol were not significant. CONCLUSION: The isotonic formulation of iodixanol caused smaller cardiovascular hemodynamic effects than did iopamidol and ioxaglate and may offer increased safety in patients with severe cardiac disease.

[Clinical tolerability of ioversol 300 in brain computed tomography]. / Tolérance clinique de l'ioversol 300 en tomodensitométrie cérébrale.

Ioversol 300 (Optiray 300) is a new low-osmolality contrast medium. Optiray 300 was used in 92 patients for CT examination of the brain, to assess its clinical tolerance. Adverse reactions, when sensations of heat were neglected, were observed in 15% of the patients. All the adverse reactions, either observed by the radiologist or pointed out by the patient, have spontaneously disappeared without medical treatment and did not require hospitalization. Anaphylactoid phenomena were not observed. Optiray 300 appears as a well suited contrast medium for CT scan of the brain especially in patients with contrast medium high risk.

Ioversol in intravenous excretory urography. Evaluation of radiographic quality, patient tolerance and safety in four clinical studies.

Three randomized, parallel group, double-blind clinical trials (Study A, B and C) and one open-label, noncomparative clinical trial (Study D) were performed in adult patients to evaluate the radiographic quality, patient tolerance and safety of Optiray 300 (ioversol) in intravenous excretory urography. Comparative agents were iohexol (Study A and C) and iopamidol (Study B). Regarding the radiographic quality ioversol provided a statistically significant better ureter opacification (p = 0.029) compared to iohexol (Study A). In comparison to iopamidol (Study B) the mean degree of certainly with respect to the investigator's urogram-based diagnoses was statistically significant higher (p = 0.025) for ioversol. In these two studies the enhancement quality of regions visualized was higher in the ioversol groups than in the control groups. Regions investigated were: parenchyma, calyces, pelvis, ureters and the bladder. Ioversol, iohexol and iopamidol were found to be statistically comparable with regard to safety and patient tolerance. The results of these studies demonstrate that ioversol is an effective, well tolerated and safe contrast agent for intravenous excretory urography.

[Evaluation of efficacy and tolerability of ioversol in intravenous urography]. / Evaluation de l'efficacité et de la tolérance du ioversol en urographie intraveineuse.

In an open clinical trial, 100 patients have been injected with ioversol (Optiray 350) during an IVP performed for various indications. This low osmolality contrast medium, which is remarkably hydrophilic, has exhibited a safety of use and image quality which were quite satisfactory.