Computer-aided detection of breast carcinoma in standard mammographic projections with digital mammography

Purpose

A retrospective evaluation of the ability of computer-aided detection (CAD) ability to identify breast carcinoma in standard mammographic projections.

Materials and methods

Forty-five biopsy proven lesions in 44 patients imaged digitally with CAD applied at examination were reviewed. Forty-four screening BIRADS^® category 1 digital mammography examinations were randomly identified to serve as a comparative normal/control population. Data included patient age; BIRADS^® breast density; lesion type, size, and visibility; number, type, and location of CAD marks per image; CAD ability to mark lesions; needle core and surgical pathologic correlation.

Results

The CAD lesion/case sensitivity of 87% (n = 39), image sensitivity of 69% (n = 31) for mediolateral oblique view and 78% (n = 35) for the craniocaudal view was found. The average false positive rate in 44 normal screening cases was 2.0 (range 1–8). The 2.0 figure is based on 88 reported false positive CAD marks in 44 normal screening exams: 98% (n = 44) lesions proceeded to excision; initial pathology upgraded at surgical excision from in situ to invasive disease in 24% (n = 9) lesions.

Conclusion

CAD demonstrated potential to detect mammographically visible cancers in standard projections for all lesion types.     

Intra- and inter-individual variation of BIS-index® and Entropy® during controlled sedation with midazolam/remifentanil and dexmedetomidine/remifentanil in healthy volunteers: an interventional study

Introduction

We studied intra-individual and inter-individual variability of two online sedation monitors, BIS^® and Entropy^®, in volunteers under sedation.

Methods

Ten healthy volunteers were sedated in a stepwise manner with doses of either midazolam and remifentanil or dexmedetomidine and remifentanil. One week later the procedure was repeated with the remaining drug combination. The doses were adjusted to achieve three different sedation levels (Ramsay Scores 2, 3 and 4) and controlled by a computer-driven drug-delivery system to maintain stable plasma concentrations of the drugs. At each level of sedation, BIS^® and Entropy^® (response entropy and state entropy) values were recorded for 20 minutes. Baseline recordings were obtained before the sedative medications were administered.

Results

Both inter-individual and intra-individual variability increased as the sedation level deepened. Entropy^® values showed greater variability than BIS^® values, and the variability was greater during dexmedetomidine/remifentanil sedation than during midazolam/remifentanil sedation.

Conclusions

The large intra-individual and inter-individual variability of BIS^® and Entropy^® values in sedated volunteers makes the determination of sedation levels by processed electroencephalogram (EEG) variables impossible. Reports in the literature which draw conclusions based on processed EEG variables obtained from sedated intensive care unit (ICU) patients may be inaccurate due to this variability.

Trial registration

clinicaltrials.gov Nr. NCT00641563.     

Monitoring Dynamic Interactions Between Breast Cancer Cells and Human Bone Tissue in a Co-culture Model

Purpose

Bone is a preferential site of breast cancer metastasis, and models are needed to study this process at the level of the microenvironment. We have used bioluminescence imaging (BLI) and multiplex biomarker immunoassays to monitor dynamic breast cancer cell behaviors in co-culture with human bone tissue.

Procedures

Femur tissue fragments harvested from hip replacement surgeries were co-cultured with luciferase-positive MDA-MB-231-fLuc cells. BLI was performed to quantify breast cell proliferation and track migration relative to bone tissue. Breast cell colonization of bone tissues was assessed with immunohistochemistry. Biomarkers in co-culture supernatants were profiled with MILLIPLEX^® immunoassays.

Results

BLI demonstrated increased MDA-MB-231-fLuc cell proliferation (p?<?0.001) in the presence vs. absence of bones and revealed breast cell migration toward bone. Immunohistochemistry illustrated MDA-MB-231-fLuc cell colonization of bone, and MILLIPLEX^® profiles of culture supernatants suggested breast/bone crosstalk.

Conclusions

Breast cell behaviors that facilitate metastasis occur reproducibly in human bone tissue co-cultures and can be monitored and quantified using BLI and multiplex immunoassays.     

Antipsychotic-induced priapism in an HIV patient: a cytochrome P450-mediated drug interaction

Background

With upwards of 48% of human immunodeficiency virus (HIV)-infected persons having a probable psychiatric disorder, the possibility of cross-class drug interactions causing adverse effects or fatalities exists.

Aims

This report discusses an emergent case of low-flow priapism caused by an interaction between a previously prescribed combination protease inhibitor (PI) and newly added antipsychotic medications.

Methods

A 50-year-old HIV-positive man on highly active antiretroviral therapy (HAART), including the combination PI, lopinavir/ritonavir (Kaletra^®), experienced an episode of priapism hours after beginning two new antipsychotic medications. Quetiapine (Seroquel^®) and perphenazine (Trilafon^®) were added to treat a diagnosed schizoaffective disorder.

Results

The patient presented to the emergency department complaining of a constant, painful erection lasting approximately 42 h. Treatment with intracavernous ephedrine, irrigation, and aspiration helped achieve detumescence.

Conclusion

This case displays the immediate and detrimental effects due to the addition of antipsychotic medications to previously altered cytochrome P450 (CYP450) enzyme levels. The inhibition of CYP450 enzymes 3A4 and 2D6 by the combination PI, lopinavir/ritonavir, was likely the major culprit in causing greater than expected free levels of perphenazine and quetiapine resulting in priapism.     

Monitoring Tumor Response with Radiolabeled Nucleoside Analogs in a Hepatoma-Bearing Mouse Model Early After Doxisome® Treatment

Purpose

This study aims to demonstrate that 3′-deoxy-3′-¹⁸F-fluorothymidine (¹⁸F-FLT) positron emission tomography (PET) is a promising modality for noninvasively monitoring the therapeutic efficacy of Doxisome^® in a subcutaneous hepatoma mouse model.

Procedures

Male BALB/c nu/nu mice were inoculated with HepG2 hepatoma xenograft in the right flank. Doxisome^® (5 mg/kg, three times a week for 2 weeks) was intravenously administrated for treatment. ¹⁸F-FLT-microPET, biodistribution studies, and immunohistochemistry of Ki-67 were performed.

Results

A significant difference (p?<?0.05) in tumor volume was observed on day 5 between treated and control groups. The tumor-to-muscle ratio derived from ¹⁸F-FLT-PET and ¹²³I-ICdR-microSPECT images of Doxisome^®-treated mice dropped from 12.55?±?0.76 to 3.81?±?0.31 and from 2.48?±?0.42 to 1.59?±?0.08 after a three-dose treatment, respectively, while that of the control group remained steady. The retarded proliferation rate of treated xenograft was confirmed by Ki-67 immunohistochemistry staining.

Conclusions

This study clearly demonstrated that Doxisome^® is an effective anti-cancer drug against the growth of HepG2 hepatoma and that ¹⁸F-FLT-PET could provide early information of tumor response during treatment.     

Fully Automated Radiosynthesis of 2-[18F]Fludarabine for PET Imaging of Low-Grade Lymphoma

Purpose

An efficient and fully automated radiosynthesis of 2-[¹⁸F]fluoro-9-β-d-arabinofuranosyl-adenine (2-[¹⁸F]fludarabine, [¹⁸F]-5) based on a GE TRACERlab? FX-FN module has been developed.

Procedures

A 2-nitro purine derivative 3 was developed as precursor for labeling with fluorine-18. The radiosynthesis of [¹⁸F]-5 was performed in two steps in a single reactor with an intermediary purification on Sep-Pak® silica which involved the addition of a three-way valve on the original module. After hydrolysis, [¹⁸F]-5 was purified by semi-preparative high-pressure liquid chromatography (HPLC) and a quality control was established.

Results

The labeling precursor 3 was obtained in 45 % overall yield. Nucleophilic substitution with K¹⁸F/K_2.2.2 afforded protected 2-[¹⁸F]fludarabine ([¹⁸F]-4) in 73?±?4 % , radiochemical yield (decay corrected to the end of bombardment (EOB)) and based on the initial [¹⁸F]F^? activity. An aqueous ammonia/methanol solution was used for the deprotection reaction and gave the desired [¹⁸F]-5 in 67?±?3 % yield after 20 min at 70 °C based on HPLC profile.

Conclusions

The process afforded pure 2-[¹⁸F]fludarabine in 48?±?3 % yield (decay corrected to the EOB) in 85 min, with a specific activity of 310?±?72 GBq/μmol at the end of synthesis (EOS) and a radiochemical purity up to 99 %.     

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS©) in the management of chemotherapy-related toxicity

Objectives

To evaluate the impact of a mobile phone-based, remote monitoring, advanced symptom management system (ASyMS^©) on the incidence, severity and distress of six chemotherapy-related symptoms (nausea, vomiting, fatigue, mucositis, hand–foot syndrome and diarrhoea) in patients with lung, breast or colorectal cancer.

Design

A two group (intervention and control) by five time points (baseline, pre-cycle 2, pre-cycle 3, pre-cycle 4 and pre-cycle 5) randomised controlled trial.

Setting

Seven clinical sites in the UK; five specialist cancer centres and two local district hospitals.

Participants

One hundred and twelve people with breast, lung or colorectal cancer receiving outpatient chemotherapy.

Interventions

A mobile phone-based, remote monitoring, advanced symptom management system (ASyMS^©).

Main outcome measures

Chemotherapy-related morbidity of six common chemotherapy-related symptoms (nausea, vomiting, fatigue, mucositis, hand–foot syndrome and diarrhoea).

Results

There were significantly higher reports of fatigue in the control group compared to the intervention group (odds ratio?=?2.29, 95%CI?=?1.04 to 5.05, P?=?0.040) and reports of hand–foot syndrome were on average lower in the control group (odds ratio control/intervention?=?0.39, 95%CI?=?0.17 to 0.92, P?=?0.031).

Conclusion

The study demonstrates that ASyMS^© can support the management of symptoms in patients with lung, breast and colorectal cancer receiving chemotherapy.     

Quantitative Evaluation of Ultrasound-Mediated Cellular Uptake of a Fluorescent Model Drug

Purpose

This study aims to quantitatively analyze cellular uptake following local ultrasound (US)-mediated cell permeabilization.

Procedures

A 2 μM cell-impermeable dye Sytox Green was co-injected with 3?×?10⁷ microbubbles in the presence of C6 rat glioblastoma cell monolayer in total volume of 10 ml. A 5.8-mm diameter mono-element US transducer was positioned at a distance of 8 mm to the Opticell® membrane. Acoustical pressure of pulsed US was varied from 0.62 MPa peak-to-peak (p-p) to 1.25 MPa p-p. Large field of view (FOV?=?15?×?15 mm) 22?×?22 mosaic acquisitions were done under epifluorescence Leica DMR microscope and analyzed in Metamorph software to evaluate cell density as well as model drug uptake percentage.

Results

The size of acoustical field of the transducer closely matches the spatial pattern of the model drug internalized into the cells by US. Maximum of uptake percentage (42?±?15 %) was found at 0.88 MPa p-p.

Conclusions

Spatial aspect of US-mediated model drug uptake has been quantitatively evaluated on adherent cells using robust 2D-mapping approach.     

Three-dimensional prediction of free-flap volume in autologous breast reconstruction by CT angiography imaging

Purpose

   The diagnostic use of computer tomography angiography (CTA) to identify perforating blood vessels for abdominal free-flap breast reconstruction was extended to estimate the three-dimensional (3D) preoperative flap volume and to compare it with the real intraoperative flap weights in order to (1) evaluate the accuracy of CTA-based 3D flap volume prediction, and (2) to analyze abdominal tissue estimation for required breast volume reconstruction.

Methods

   Preoperative CTA was performed in 54 patients undergoing unilateral breast reconstruction with a free, deep, inferior epigastric artery perforator flap. 3D flap volumes ( \(\hbox {cm}^{3}\) ) based on CTA data were calculated and compared with the actual intraoperative flap weight (g). In addition, a breast volume to flap volume ratio was calculated to analyze whether the estimated 3D abdominal flap volume would match that of the breast to be removed.

Results

   40 CTA data sets (74.1 %) fulfilled the technical requirements for a reliable determination of flap volume. 3D CTA flap volume prediction showed no relevant differences to the actual flap weight (p = 0.44) and high correlations (r = 0.998, \(p < 0.001\) ), allowing a prediction accuracy within 0.29 \(\pm \) 3.0 % (range: from \(-\) 8.77 to 5.67 %) of the real flap weight. Significantly larger flap volumes were harvested compared with the actually required breast volumes ( \(p < 0.001\) ), leading to an average of 21 % of the remnant flap tissue potentially being discarded.

Conclusions

   CTA-based 3D flap volume prediction provides accurate preoperative guidelines concerning the needed amount of abdominal tissue that can be harvested to achieve acceptable symmetry.     

A micrometer-sized ultrasound contrast agent with nanometer-scale polygonal patterning surfaces

Purpose

To develop a smaller micro-sized bubble ultrasound contrast agent which composed of an insoluble, less-dense, self-assembled surfactant with a condensed crystallized nanometer-scale polygonal patterning surface.

Methods

The microbubble was prepared by high-shear mixing a mixture of sucrose esters, glucose sugar, and water. The coulter counter was used to measure the size and concentration of the microbubble. Surface patterns of the microbubble were determined using vitrified samples under cryo-transmission electron microscopy. Myocardial contrast effects of six normal dog’s myocardium were assessed.

Results

The diameter of the developed microbubble was smaller than Sonovue^®. Direct imaging of cryo-transmission electron microscopy revealed that the developed microbubble has a nanometer-scale polygonal surface pattern. Both the developed microbubble and Sonovue^® effectively enhanced the myocardial contrast. The difference in the peak video intensity, the longevity of the contrast effect, and time-to-peak interval between both microbubbles were not statistically significant (NS).

Conclusion

The microbubble with nanometer-scale polygonal patterning surfaces is a feasible and promising contrast agent for the ultrasound imaging.     

Uncommon delayed and late complications after percutaneous left atrial appendage closure with Amplatzer® Cardiac Plug

Aims

Percutaneous left atrial appendage closure with Amplatzer^® Cardiac Plug (St. Jude Medical Inc.) for the prevention of stroke in patients with atrial fibrillation is rapidly propagating. We sought to provide additional safety data.

Methods and results

We have screened our database of patients having been treated with Amplatzer^® Cardiac Plug and found 3 cases with uncommon complications that have not been reported previously. One patient experienced an embolisation of the occluder about 12 months after implantation that potentially resulted from mismatch of occluder size and landing zone. Another patient developed cardiac tamponade 9 days after implantation. This case of delayed effusion was probably not a result of interventional trauma, but might have been provoked by scratching of the inner pericardial membrane. A third patient developed a large thrombus in the left atrium which was considered to be caused by injury of the endothelial wall during implantation. The first two cases could be treated by a percutaneous procedure, the last case by cardiac surgery without any sequelae.

Conclusions

Complications after left atrial appendage closure not related to a device-related thrombus can occur later after implantation. With appropriate percutaneous or surgical management these complications can be handled without sequelae.     

A Comparison Between Rheological Properties of Intra-articular Hyaluronic Acid Preparations and Reported Human Synovial Fluid

Introduction

This study aims to compare the properties of currently available intra-articular hyaluronate (IA-HA) products widely available in the USA to those of healthy knee synovial fluid with respect to their bulk rheological properties. We hypothesize that products would have differing rheological properties, with some more closely resembling the properties and physiological aspects of healthy joint fluid HA.

Methods

We obtained reported HA product molecular weights, as well as measurements of the presence of cross-linking, zero shear rate viscosity, shear thinning ratio, and crossover frequency for the following IA-HA products available in the USA: Euflexxa^®, Orthovisc^®, Supartz^®, Monovisc^®, Synvisc^®, Synvisc-One^®, Gel-One^®, and Hyalgan^®.

Results

Differences were seen between the study products across all of the investigated parameters. Hyalgan, Supartz, Orthovisc, and Euflexxa had a linear chain structure, while Synvisc, Synvisc-One, and Monovisc were cross-linked in structure. Molecular weight, shear rates, and crossover frequencies ranged widely across tested products, with values ranging from below to above those reported for healthy knee synovial fluid HA. When compared to healthy knee parameter values reported within the current literature, observed parameters for Euflexxa and Orthovisc were typically seen to be the most similar to healthy knee synovial fluid. When comparing Euflexxa and Orthovisc directly, Euflexxa was more often similar to the properties of healthy knee synovial fluid with respect to the observed parameters of molecular structure, shear rates, and crossover frequency.

Conclusion

Available IA-HA products vary with respect to molecular weight, presence of cross-linking, shear rate dependency of viscosity, and crossover frequency. Since IA-HA treatment for osteoarthritis aims to restore synovial fluid back to original HA property characteristics, using HA supplements resembling healthy synovial fluid is a logical approach. Our findings demonstrate that Euflexxa is the most similar to healthy synovial fluid with respect to molecular structure, shear rates, and crossover frequency.

Funding

Ferring Pharmaceuticals, Inc.

     

Beeinflussung muskulärer Gesichtsschmerzen durch Botulinumtoxin A

Objective

Can chronic pain of the masticatory muscles be positively affected by low dose injection of botulinum toxin (BTX-A)?

Methods

Twenty patients suffering chronic myofacial pain were questioned and examined after injection of 25–50 U Dysport^® into the affected muscles over a period of 8 weeks.

Results

Four weeks after injection of BTX-A patients reported a significant reduction of pain (p <0.001, paired t-test. Power of performed test with alpha 0.050:1.000). Then the pain remained constant over the next 4 weeks. Concurrently a significant increase of mandubular range of movement was observed (p <0,05, Wilcoxon signed rank test).

Conclusions

Even though lacking placebo control the findings suggest that patients suffering chronic myofacial pain may benefit from injection of low dose BTX-A into the affected muscles.     

Zarzio<Superscript>®</Superscript>, biosimilar of filgrastim,in prophylaxis of chemotherapy-induced neutropenia in routine practice: a French prospective multicentric study

Purpose

Chemotherapy-induced neutropenia is a serious and potentially life-threatening consequence of cancer treatment. Prophylactic treatment with granulocyte-colony stimulating factor (G-CSF) decreases the incidence of febrile neutropenia, the rate of hospitalization, and the use of antibiotics in patients at risk. The aim of this study was to assess efficacy, safety, and use of Zarzio^®—biosimilar of Neupogen^® (G-CSF; filgrastim)—in prophylaxis of chemotherapy-induced neutropenia in current practice in cancer patients.

Methods

We conducted an observational, prospective, longitudinal, and multicentric study in France. The incidence of neutropenia was evaluated at each cycle of chemotherapy.

Results

One hundred eighty-four patients (women, 64.7 %; mean age, 61.7 years) with solid tumor (89.7 %; breast cancer, 50.5 %) or non-Hodgkin lymphoma (10.3 %) were included. The risk of febrile neutropenia based on chemotherapy regimen was >20 % for 32.1 % of patients. No case of febrile neutropenia was reported. Neutropenia was the cause of hospitalization and/or antibiotic therapy in 10 patients. The most frequent adverse events related to Zarzio^® were pain, in particular bone pain. No serious adverse event related to Zarzio^® was reported.

Conclusion

The results obtained in real-life conditions confirm that Zarzio^® is efficient and well tolerated in cancer patients.

     

Pivotal Bioequivalence Study of Clopacin<Superscript>®</Superscript>, a Generic Formulation of Clopidogrel 75 mg Film-Coated Tablets

Introduction

Clopacin^® (Acino Pharma AG) is a proprietary, besylate salt and lactose-free formulation of the widely-used anti-platelet treatment, clopidogrel. This study aimed to evaluate the bioequivalence of Clopacin^® with the originator as reference drug, using a guideline-compliant trial design: open-labeled, randomized, single-dose (clopidogrel 75 mg tablet), two-period, crossover trial in 48 healthy male volunteers, with a 7 day wash-out period.

Methods

Plasma samples were collected at intervals and extracted before quantifying clopidogrel concentrations using a fully validated LC–MS/MS method. Bioequivalence of Clopacin^® and the reference drug was established by comparison of the primary pharmacokinetic parameters, C _max, AUC_0–t, and AUC_0–∞.

Results

The parameter values were similar for the two products (analysis of variance) and provided Clopacin/reference ratios (least squares means) of >90% and 90% confidence intervals (CIs 84.64–105.50%, 90.43–111.22%, 88.75–110.71%, respectively) that were well within the limits set for defining bioequivalence, according to international guidelines. The respective Clopacin^® and reference drug values for mean time to maximal plasma clopidogrel concentration (t _max) were 0.83 and 0.91 h, and for terminal elimination half-life were 3.99 and 3.51 h. The intra-subject coefficients of variability for maximal plasma clopidogrel concentration (C _max), area under the plasma clopidogrel concentration versus time curve, at 48 h (AUC_0–t) and extrapolated to infinity (AUC_0–∞) were 32.2%, 30.2%, and 28.9% (least square means), respectively, and the respective power values were 99.5%, 97.1%, and 95.3%.

Conclusion

This bioequivalence study provided robust clopidogrel pharmacokinetic data that established the bioequivalence of Clopacin^® and the reference originator drug.

Funding

Acino Pharma AG (formerly Cimex AG)

     

Reduction of health risk factors through an adapted physical activity program in patients with breast cancer

Purpose

After a breast cancer diagnosis, patients are at high risk of reducing their physical activity and gaining weight. Lack of physical activity and weight gain are known negative but modifiable prognostic factors. An observational study of a 3-month adapted physical activity (APA) program was performed to assess its effectiveness in improving physical activity level and reducing risk factors related to health during or after breast cancer treatments.

Method

Height, weight, and waist circumference (WC) were measured at the beginning and end of the 26-session program. Body mass index (BMI) and WC to height ratio (WHtR) were calculated. Physical activity profile, aerobic capacity, and usual average daily energy expenditure were estimated. Median values were compared using nonparametric tests.

Results

Sixty-one (61) voluntary breast cancer patients attended 80 % of the sessions. At baseline, median (minimum–maximum) BMI was 23.3 (16.1–36.8)?kg.m^?2 and WC and WHtR showed metabolic risks. After 3 months, anthropometric data remained stable. Moderate physical activity significantly improved (+13 min/day) and sedentary tended to decrease (?18 min/day).

Conclusion

A 3-month APA program allows patients to limit risk factors related to health such as physical inactivity and metabolic risks. This study reinforces the need to promote physical activity as early as possible in cancer patients' care.     

Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry

Objective

To examine the prevalence and impact of concomitant coronary artery disease (CAD) on short-term outcome after transcatheter aortic valve implantation (TAVI).

Background

The prevalence of CAD in patients undergoing surgical aortic valve replacement is estimated at 30–50?% and its presence increases procedural risk. The prevalence and impact of CAD on outcome after TAVI are not well defined.

Methods

We analyzed 1,382 patients enrolled in the German TAVI registry; the majority (81?%) received the Medtronic CoreValve. The presence of coronary lesions with ≥50?% stenosis on pre-TAVI angiography defined the existence of concomitant CAD.

Results

859 patients (62.2?%) had concomitant CAD, of which 534 (62.3?%) had multi-vessel and 83 (9.7?%) left main disease. Patients with CAD were younger (81.5?±?6.1 vs. 82.1?±?6.3?years, p?<?0.05), more commonly males (49.4 vs. 30.0?%, p?<?0.0001) and diabetics (36.9 vs. 31.2?%, p?<?0.05), and had a worse Canadian Cardiovascular Society angina class at baseline compared to patients with no CAD. During TAVI patients with CAD more often required additional coronary intervention and had longer procedures, but procedural success rates were similar (97.1 vs. 97.7?%). Crude in-hospital mortality was higher in patients with CAD (10.0 vs. 5.5?%, OR 1.90, 95?% CI 1.23–2.93), but this was not significant after adjustment for confounders (adjusted OR 1.41, 95?% CI 0.85–2.33). Both groups had significant improvement in 30-day symptoms and quality of life.

Conclusion

The prevalence of CAD in contemporary TAVI patients is high. Its presence characterizes a high-risk population and is associated with increased crude short-term mortality, largely explained by co-morbidities, but does not limit functional improvement after TAVI.     

Tacrolimus-eluting carbon-coated stents versus sirolimus-eluting stents for prevention of symptom-driven clinical end points

Background

Coating of stents has been shown to minimize the interactions between platelets, stent surface and vascular response following stent implantation. The aim of our study was to compare the tacrolimus-eluting carbon-coated JANUS^® stent with sirolimus-eluting CYPHER^® stent for the prevention of symptom-driven clinical end points in a real world clinical setting.

Methods

This prospective registry with a follow-up period of 24 months was conducted in 90 consecutive patients undergoing coronary artery stenting receiving CYPHER^® (n = 48) or JANUS^® (n = 42) stents. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction and target vessel revascularisation, and the secondary end point was clinically driven in-stent restenosis.

Results

The primary combined endpoint occurred in 38% of patients (n = 16) in the JANUS^® group compared to 10% (n = 5) in the CYPHER^® group. The relative risk increase of the composite end point was therefore 63% higher in patients receiving JANUS^® stents compared to the CYPHER^® stents (crude HR = 1.63, 95% CI = 1.17–2.28, p = 0.004; adjusted HR = 1.79, CI = 1.26–2.55, p = 0.001). Interestingly, 75% of events in the JANUS^® group occurred during the first 6 months after stent implantation. Similarly, the rate of clinically driven in-stent restenosis was higher in patients receiving JANUS^® stent (n = 10, 2%) compared to the CYPHER^® stent (n = 2, 4%). Concordantly, the relative risk for clinically driven in-stent restenosis was 81% higher in the JANUS^® group compared to the CYPHER^® group (crude HR = 1.81, 95% CI = 1.08–3.02, p = 0.02; adjusted HR = 2.24, CI = 1.26–3.96, p = 0.006).

Conclusion

The use of tacrolimus-eluting carbon coated JANUS^® stent was associated with worse clinical outcome compared to the sirolimus-eluting CYPHER^® stent in clinical routine use.     

Test-retest reliability of stride time variability while dual tasking in healthy and demented adults with frontotemporal degeneration

Background

Although test-retest reliability of mean values of spatio-temporal gait parameters has been assessed for reliability while walking alone (i.e., single tasking), little is known about the test-retest reliability of stride time variability (STV) while performing an attention demanding-task (i.e., dual tasking). The objective of this study was to examine immediate test-retest reliability of STV while single and dual tasking in cognitively healthy older individuals (CHI) and in demented patients with frontotemporal degeneration (FTD).

Methods

Based on a cross-sectional design, 69 community-dwelling CHI (mean age 75.5 ± 4.3; 43.5% women) and 14 demented patients with FTD (mean age 65.7 ± 9.8 years; 6.7% women) walked alone (without performing an additional task; i.e., single tasking) and while counting backward (CB) aloud starting from 50 (i.e., dual tasking). Each subject completed two trials for all the testing conditions. The mean value and the coefficient of variation (CoV) of stride time while walking alone and while CB at self-selected walking speed were measured using GAITRite^® and SMTEC^® footswitch systems.

Results

ICC of mean value in CHI under both walking conditions were higher than ICC of demented patients with FTD and indicated perfect reliability (ICC > 0.80). Reliability of mean value was better while single tasking than dual tasking in CHI (ICC = 0.96 under single-task and ICC = 0.86 under dual-task), whereas it was the opposite in demented patients (ICC = 0.65 under single-task and ICC = 0.81 under dual-task). ICC of CoV was slight to poor whatever the group of participants and the walking condition (ICC < 0.20), except while dual tasking in demented patients where it was fair (ICC = 0.34).

Conclusions

The immediate test-retest reliability of the mean value of stride time in single and dual tasking was good in older CHI as well as in demented patients with FTD. In contrast, the variability of stride time was low in both groups of participants.     

The usefulness of a computer-aided diagnosis scheme for improving the performance of clinicians to diagnose non-mass lesions on breast ultrasonographic images

Purpose

The purpose of this study was to evaluate the usefulness of a computer-aided diagnosis (CAD) scheme for improving the performance of clinicians to diagnose non-mass lesions appearing as hypoechoic areas on breast ultrasonographic images.

Methods

The database included 97 ultrasonographic images with hypoechoic areas: 48 benign cases [benign lesion with benign mammary tissue or fibrocystic disease (n = 20), fibroadenoma (n = 11), and intraductal papilloma (n = 17)] and 49 malignant cases [ductal carcinoma in situ (n = 17) and invasive ductal carcinoma (n = 32)]. Seven clinicians, three expert breast surgeons, and four general surgeons participated in the observer study. They were asked their confidence level concerning the possibility of malignancy in all 97 cases with and without the use of the CAD scheme. Receiver operating characteristic (ROC) analysis was performed to evaluate the usefulness of the CAD scheme.

Results

The areas under the ROC curve (AUC) improved for all observers when they used the CAD scheme and increased from 0.649 to 0.783 (P = 0.0167). Notably, the AUC for the general surgeon group increased from 0.625 to 0.793 (P = 0.045).

Conclusions

This study showed that the performance of clinicians to diagnose non-mass lesions appearing as hypoechoic areas on breast ultrasonographic images was improved by the use of a CAD scheme.