The Use of the “Preclosure” Technique for Antegrade Aspiration Thrombectomy with Large Catheters in Acute Limb Ischemia

Purpose

This study was designed to assess retrospectively short- and mid-term outcomes of the use of a suture-mediated closure device to close the antegrade access in patients undergoing percutaneous aspiration thrombectomy with large catheters for acute leg ischemia.

Methods

Between November 2005 and February 2010, a suture-mediated active closure system (ProGlide^® 6F, Abbott) was placed before arterial sheath (mean 9 F, range 6–12 F) introduction in 101 patients (74 men, 73 %, mean age 70.1 ± 12.6 years standard deviation). Data regarding mortality, complications, and factors contributing to vascular complications at the access site was collected for 6 month after the intervention to detect device-related problems. As a coincidence, 77 patients had follow-up visits for a duplex ultrasound.

Results

There were a total of 19 vascular complications (19 %) at the puncture site, all of which were of hemorrhagic nature and none of which consisted of vessel occlusion. Two major outcome complications (2 %) occurred. A retroperitoneal hematoma and a serious inguinal bleeding required additive treatment and did not result in permanent sequelae. Nine cases involved death of which eight were not attributable to the closure and one remained unclear. Successful closure was achieved in 95 patients (94 %); additional manual compression was sufficient in the majority of the remaining patients. Numerous factors contributing to vascular complications were encountered.

Conclusions

With acceptable short- and mid-term outcomes, the “preclose” technique can be a reliable option for the closure of a large antegrade femoral access even for patients at a high risk of vascular complications, such as those undergoing aspiration thrombectomy.     

Comparison of Ultrasound-Accelerated versus Pigtail Catheter–Directed Thrombolysis for the Treatment of Acute Massive and Submassive Pulmonary Embolism

Purpose

To compare the technical and clinical effectiveness of ultrasound-accelerated endovascular thrombolysis (USAT) versus pigtail catheter–directed thrombolysis (PCDT) for the treatment of acute pulmonary embolism (PE).

Laceration of the Common Femoral Artery Following Deployment of the StarClose™ Vascular Closure System

StarClose is a novel arterial closure device which achieves hemostasis, following arteriotomy, via a nitinol clip deployed on the outer arterial wall. Since its introduction to the market, several studies have shown StarClose to be both safe and effective, with few major complications encountered. We report a case of common femoral artery laceration following deployment of the StarClose vascular closure system. We conclude that the injury occurred secondary to intravascular misplacement of the nitinol clip.     

Is the Use of Fullerene in Photodynamic Therapy Effective for Atherosclerosis?

The purpose of this study was to evaluate Fullerene as a therapeutic photosensitizer in the treatment of atherosclerosis. An atherosclerotic experimental rabbit model was prepared by causing intimal injury to bilateral external iliac arteries using balloon expansion. In four atherosclerotic rabbits and one normal rabbit, polyethylene glycol-modified Fullerene (Fullerene-PEG) was infused into the left external iliac artery and illuminated by light emitting diode (LED), while the right external iliac artery was only illuminated by LED. Two weeks later, the histological findings for each iliac artery were evaluated quantitatively and comparisons were made among atherosclerotic Fullerene+LED artery (n = 4), atherosclerotic light artery (n = 4), normal Fullerene+LED artery (n = 1), and normal light artery (n = 1). An additional two atherosclerotic rabbits were studied by fluorescence microscopy, after Fullerene-PEG-Cy5 complex infusion into the left external iliac artery, for evaluation of Fullerene-PEG incorporated within the atherosclerotic lesions. The degree of atherosclerosis in the atherosclerotic Fullerene+LED artery was significantly (p < 0.05) more severe than that in the atherosclerotic LED artery. No pathological change was observed in normal Fullerene+LED and LED arteries. In addition, strong accumulation of Fullerene-PEG-Cy5 complex within the plaque of the left iliac artery of the two rabbits was demonstrated, in contrast to no accumulation in the right iliac artery. We conclude that infusion of a high concentration of Fullerene-PEG followed by photo-illumination resulted not in a suppression of atherosclerosis but in a progression of atherosclerosis in experimental rabbit models. However, this intervention showed no adverse effects on the normal iliac artery.     

Characterization of microRNA expression profiles in blood and saliva using the Ion Personal Genome Machine® System (Ion PGM™ System)

MicroRNA (miRNA) expression profiling is gaining interest in the forensic community because the intrinsically short fragment and tissue-specific expression pattern enable miRNAs as a useful biomarker for body fluid identification. Measuring the quantity of miRNAs in forensically relevant body fluids is an important step to screen specific miRNAs for body fluid identification. The recent introduction of massively parallel sequencing (MPS) has the potential for screening miRNA biomarkers at the genome-wide level, which allows both the detection of expression pattern and miRNA sequences. In this study, we employed the Ion Personal Genome Machine^® System (Ion PGM™ System, Thermo Fisher) to characterize the distribution and expression of 2588 human mature miRNAs (miRBase v21) in 5 blood samples and 5 saliva samples. An average of 1,885,000 and 1,356,000 sequence reads were generated in blood and saliva respectively. Based on miRDong, a Perl-based tool developed for semi-automated miRNA distribution designations, and manually ascertained, 6 and 19 miRNAs were identified respectively as potentially blood and saliva-specific biomarkers. Herein, this study describes a complete and reliable miRNA workflow solution based on Ion PGM™ System, starting from efficient RNA extraction, followed by small RNA library construction and sequencing. With this workflow solution and miRDong analysis it will be possible to measure miRNA expression pattern at the genome-wide level in other forensically relevant body fluids.     

Cost-effectiveness and economic impact of the KineSpring® Knee Implant System in the treatment for knee osteoarthritis

Purpose

To investigate the cost-effectiveness and economic impact of the KineSpring System in the treatment for knee osteoarthritis in Germany.

Methods

Functional outcome scores of the general German population and knee osteoarthritis (OA) patients under surgical treatments (HTO, UKA and TKA), conservative treatments and treatment with the KineSpring System were used to derive the utility scores for each group. Quality-adjusted life years (QALYs) of each group were estimated using the utility scores. Finally, cost-utility analysis was performed using cost and QALYs data. The economic impact of knee OA in Germany was assessed in terms of annual total direct cost and indirect cost, total diseased population and potential QALYs saved with the KineSpring System.

Results

Assuming the durability of 10 years, the cost-utility ratio of the KineSpring System, surgical treatments and conservative treatments compared to no treatment in 2012 was €3,402/QALY, €4,899/QALY and €9,996/QALY, respectively. With even a lesser durability of 5 years, the cost-utility ratio of the KineSpring System maintained superiority over surgical treatments and conservative treatments (€7,327/QALY, €9,706/QALY and €10,467/QALY, respectively). The KineSpring System is a highly cost-effective alternative for knee osteoarthritis compared with the current accepted cost-effective threshold (willingness to pay) of $50,000 US/QALY gained. Our models suggest KineSpring System, if adapted widely could save up to 2.0 ± 0.07 million QALY assuming it has a 5-year durability and save up to 3.9 ± 0.1 million QALY assuming it has a 10-year durability.

Conclusion

An economic advantage for using the KineSpring System over other surgical and conservative treatments in knee OA patients in Germany is suggested by our model. According to currently accepted cost-effectiveness guidelines, the KineSpring Knee Implant System for knee OA is a cost-effective strategy.

Level of evidence

Cost-effectiveness analysis, Level III.     

WiiFit™ Plus balance test scores for the assessment of balance and mobility in older adults

The Nintendo Wii? is becoming an increasingly popular technology for the training and assessment of balance in older adults. Recent studies have shown promising results for its use in fall prevention. However, it is not clear how scores on the WiiFit? balance games relate to current standardized tests of balance and mobility. The purpose of this study was to evaluate the relationship between WiiFit? Plus balance tests, and standardized tests of older adult fitness, balance, mobility, self-reported balance confidence, and visual attention and processing. Results from 34 older adult participants indicate that WiiFit? balance tests do not correlate well with standardized functional balance, mobility and fitness tests. However, the Wii balance score, as measured by the Basic Balance Test of the WiiFit?, does correlate with visual processing speed as measured by the Useful Field of View (UFOV^®) test. These results indicate that WiiFit? balance tests may provide advantageous information supplementary to information obtained through standard functional mobility and balance tests; however, caution should be used when using the WiiFit? balance tests in isolation. Further research is necessary as these technologies become widely used in clinical and home settings for balance training and assessment.     

Developmental validation of the Microreader™ RM-Y ID System: a new rapidly mutating Y-STR 17-plex system for forensic application

International Journal of Legal Medicine - Y-chromosomal short tandem repeats (Y-STRs) are widely applied to evolutionary, genealogical, and kinship analyses of male linages in forensic studies, but...     

Effects of Acute γ-irradiation on the Development of the Thymus in Embryos and Fry of Oryzias Latipes

An automated variant the of micronucleus assay for erythrocytes in mouse peripheral blood has recently been developed. The flow-cytometric technique used allows very large numbers of erythrocytes to be analysed with a relatively small effort. Here we report the potential of this method to detect a response to extended low-dose-rate exposure to γ-irradiation. The mice were irradiated with a ¹³⁷Cs source at a dose rate of 4·8 cGy/day for 26 days. Sampling was continued for another 39 days after irradiation. Elevated frequencies compared with the control group were found at days 2, 9 and 20 after the start of the irradiation for micronucleated polychromatic erythrocytes, and at days 9, 20, 29, 42, 51 and 65 for micronucleated normochromatic erythrocytes.     

Ureteric Embolization for Lower Urinary Tract Fistulae: Use of Two Amplatzer Vascular Plugs and N-Butyl Cyanoacrylate Employing the “Sandwich” Technique

Purpose

This study describes and evaluated the effectiveness of occluding distal ureters in the clinical setting of urinary vaginal (vesicovaginal or enterovesicovaginal) fistulae utilizing a new technique which combines Amplatzer vascular plugs and N-butyl cyanoacrylate.

Materials

This is a retrospective study (January 2007–December 2010) of patients with urinary-vaginal fistulae undergoing distal ureter embolization utilizing an Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique. An 8–12–mm type-I or type-II Amplatzer vascular plug was delivered using the sheath and deployed in the ureter distal to the pelvic brim. Instillation of 0.8–1.5 cc of N-butyl cyanoacrylate into ureter proximal to the Amplatzer plug was performed. This was followed by another set of 8–12-mm type-I or type-II Amplatzer vascular plugs in a technique referred to as the “sandwich technique.”

Results

Five ureters in three patients were occluded utilizing the above-described technique during the 4-year study period. Mean maximum size Amplatzer used per ureter was 10.8 mm (range, 8–12). One ureter required three Amplatzer plugs and the rest required two. Two patients (3 ureters) were clinically successful with complete resolution of symptoms in 36–48 h. The third patient (2 ureters) was partly successful and required a second Amplatzer- N-butyl cyanoacrylate sandwich technique embolization. The mean clinical follow-up was 11.3 months (range, 1.7–29.2).

Conclusions

The Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique for occluding the distal ureter is safe and effective with a quick (probably due to the N-butyl cyanoacrylate) and durable (probably due to the Amplatzer plugs) clinical response.     

The Use of the D-STAT® Dry Bandage for the Control of Vascular Access Site Bleeding: A Multicenter Experience in 376 Patients

Multiple topical hemostats have been approved for control of surface bleeding from vascular access sites. The majority of these devices, however, have few clinical data supporting their use. This study was conducted to assess the efficacy and safety of the new commercially available D-Stat Dry hemostatic bandage compared to standard care manual compression. A prospective, randomized, multicenter trial was conducted in patients undergoing diagnostic cardiac catheterization or peripheral angiography utilizing femoral artery access. Subjects were randomized to either the D-Stat Dry bandage as an adjunct to manual compression or manual compression alone. Primary end points were time-to-hemostasis (TTH) and major complications. Secondary end points included minor complications, patient satisfaction, time-to-ambulation (TTA), and time-to-discharge (TTD). Three hundred seventy-six subjects (189 control, 187 investigational) with similar baseline characteristics participated in the study. The mean age was 61.5 years, with a male predominance of 58%. TTH was significantly lower in the investigational group (7.8 vs. 13.0 min; p = 0.001). No difference in major complication rates was observed between the groups. The mean TTA (investigational, 392 min, vs. control, 415 min; p = 0.023) and patient satisfaction significantly favored the investigational group (p = 0.025). No difference in TTD or the rate of minor complications was observed. This study demonstrates that in the aforementioned population, the D-Stat Dry bandage is safe and effective in reducing both TTH and TTA and results in improved patient satisfaction.     

Population data of the AmpFlSTR® NGM™ loci in South Portuguese population

Allele frequencies and other relevant forensic parameters for 15 loci studied with AmpFlSTR(R) NGM™ kit were calculated in a population of individuals residing in the south of Portugal. Blood stain samples were obtained from a total of 452 unrelated individuals involved in paternity testing casework. The kit has five loci – D10S1248, D22S1045, D2S441, D1S1656 and D12S391 not present in any other kit used in our laboratory (Powerplex 16 System and Identifiler Plus). In our laboratory, this new kit is used as a screening tool to solve deficient cases as fatherless paternity test, and to help in paternity investigations with only one genetic incompatibility after the use of routine seventeen loci. Furthermore, this five loci included in the European Standard Set are also recommended by the European Network of Forensic Science Institutes “ENFSI” and the European DNA Profiling group “EDNAP”. These studies are necessary to calculate statistical forensic parameters such as power of discrimination, power of exclusion, minimum allele frequency. Statistical parameters such as heterozigoty, homozigoty and combined power of exclusion were determinated. This kind of study is part of the Quality Program for Certificated Forensic Laboratories.     

Acute abdominal pain: Is there a potential role for MRI in the setting of the emergency department in a patient with renal calculi?

Acute flank pain is a frequent clinical presentation encountered in emergency departments, and a work-up for obstructive urolithiasis in this setting is a common indication for computed tomography (CT). However, imaging alternatives to CT for the evaluation of renal colic are warranted in some clinical situations, such as younger patients, pregnancy, patients that have undergone multiple prior CT exams and also patients with vague clinical presentations. MRI, although relatively insensitive for the direct detection of urinary calculi, has the ability to detect the secondary effects of obstructive urolithiasis. Using rapid, single shot T2-weighted sequences without and with fat saturation provides an abdominopelvic MR examination that can detect the sequelae of clinically active stone disease, in addition to alternate inflammatory processes that may mimic the symptoms of renal colic. In addition, MR nephro-urography (MRNU) has the ability to provide quantitative analysis of renal function that has the potential to direct clinical management in the setting of obstructing calculi. This review describes the potential utility and limitations of MRI in the emergency setting for diagnosing causes of flank pain and renal colic, particularly in patients with unusual presentations or when an alternative to CT may be warranted.     

Internal validation of the GlobalFiler™ Express PCR Amplification Kit for the direct amplification of reference DNA samples on a high-throughput automated workflow

The GlobalFiler™ Express PCR Amplification Kit uses 6-dye fluorescent chemistry to enable multiplexing of 21 autosomal STRs, 1 Y-STR, 1 Y-indel and the sex-determining marker amelogenin. The kit is specifically designed for processing reference DNA samples in a high throughput manner. Validation studies were conducted to assess the performance and define the limitations of this direct amplification kit for typing blood and buccal reference DNA samples on various punchable collection media. Studies included thermal cycling sensitivity, reproducibility, precision, sensitivity of detection, minimum detection threshold, system contamination, stochastic threshold and concordance. Results showed that optimal amplification and injection parameters for a 1.2 mm punch from blood and buccal samples were 27 and 28 cycles, respectively, combined with a 12 s injection on an ABI 3500xL Genetic Analyzer. Minimum detection thresholds were set at 100 and 120 RFUs for 27 and 28 cycles, respectively, and it was suggested that data from positive amplification controls provided a better threshold representation. Stochastic thresholds were set at 250 and 400 RFUs for 27 and 28 cycles, respectively, as stochastic effects increased with cycle number. The minimum amount of input DNA resulting in a full profile was 0.5 ng, however, the optimum range determined was 2.5–10 ng. Profile quality from the GlobalFiler™ Express Kit and the previously validated AmpFlSTR® Identifiler® Direct Kit was comparable. The validation data support that reliable DNA typing results from reference DNA samples can be obtained using the GlobalFiler™ Express PCR Amplification Kit.     

Testing the Ion AmpliSeq™ HID Y-SNP Research Panel v1 for performance and resolution in admixed South Americans of haplogroup Q

Y haplogroups, defined by Y-SNPs, allow the reconstruction of the human Y chromosome genealogy, which is important for population, evolutionary and forensic genetics. In this study, Y-SNPs were typed and haplogroups inferred with the MPS Ion AmpliSeq™ HID Y-SNP Research Panel v1, as a high-throughput approach. Firstly, the performance of the panel was evaluated with different DNA input amounts, reagent volumes and cycle numbers. DNA-inputs from 0.5 to 1 ng generated the most balanced read depth. Combined with full reagent and 19 cycles, this offered the highest number of amplicons with a sequencing read depth of at least 20 reads. Secondly, the sub-haplogroups of 182 admixed South Americans and Greenlanders belonging to haplogroup Q were inferred and tested for potential improvement in resolution. Most samples were assigned to lineage Q-M3 with some samples assigned to lineages upstream (Q-M346, L56, L57; Q-L331, L53; Q-L54; Q-CTS11969, CTS11970) or parallel (Q-L330, L334; Q-Z780/M971) to Q-M3. Only one sample was assigned to a downstream lineage (Q-Z35615, Z35616). Most individuals of haplogroup Q with NAM ancestry could neither be distinguished from each other, nor from half of the Greenlandic samples. Typing additional, known SNPs within lineage Q-M3, Z19483 and SA05, increased the resolution of predicted haplogroups. The search for novel variants in the sequenced regions allowed the detection of 42 variants and the subdivision of lineage Q-M3 into new subclades. The variants found in six of these subclades were exclusive to certain South American countries. In light of the limited differentiation of haplogroup Q samples, the additional information on known or novel SNPs disclosed in this study when using MPS Ion AmpliSeq™ HID Y-SNP Research Panel v1 should be included in the Yleaf software, to increase the differentiation of lineage Q-M3.     

Performance and concordance of the ForenSeq™ system for autosomal and Y chromosome short tandem repeat sequencing of reference-type specimens

Though the utility of next-generation sequencing (NGS) technologies for forensic short tandem repeat (STR) typing has been evident for several years, commercially available assays and software solutions developed specifically to meet forensic needs have only recently become available. One of these, the ForenSeq™ DNA Signature Prep Kit (Illumina, Inc.) sequences 27 autosomal STR (aSTR) and 24 Y chromosome STR (Y-STR) loci (concurrent with additional nuclear markers) per multiplexed sample, with automated secondary and tertiary analyses of the data accomplished via the associated ForenSeq™ Universal Analysis Software (UAS). In this study we investigated the performance of the ForenSeq system for aSTR and Y-STR typing by examination of 151 sample libraries developed from high quality DNAs amplified at the target 1 ng template. Utilizing PCR Primer Mix B, greater than 99.5% of aSTR loci and 97.0% of Y-STR loci were recovered when 42 or fewer sample libraries were pooled for sequencing. A direct comparison of UAS developed fragment length results to capillary electrophoresis (CE) based data identified only two allele call discrepancies when no UAS quality flag was triggered. Review of the ForenSeq data indicated that most samples with total sequence read counts exceeding 40,000 could be interpreted to develop nearly complete aSTR genotypes or Y-STR haplotypes. However, markers D22S1045 and DYS392 produced poor or inconsistent results even when sample read counts were greater than 85,000. Excluding these two loci, analyst-interpreted aSTR and Y-STR ForenSeq profiles were 99.96% and 100% concordant, respectively, with CE data. In addition to demonstrating concordance on par with other CE kit to kit comparisons, the results from this study will assist laboratories seeking to develop workflows for high volume processing and analysis of aSTRs and Y-STRs from reference-type specimens using the ForenSeq system.     

An evaluation of the PowerSeq™ Auto System: A multiplex short tandem repeat marker kit compatible with massively parallel sequencing

Capillary electrophoresis (CE) and multiplex amplification with fluorescent tagging have been routinely used for STR typing in forensic genetics. However, CE-based methods restrict the number of markers that can be multiplexed simultaneously and cannot detect any intra-repeat variations within STRs. Several studies already have indicated that massively parallel sequencing (MPS) may be another potential technology for STR typing. In this study, the prototype PowerSeq™ Auto System (Promega) containing the 23 STR loci and amelogenin was evaluated using Illumina MiSeq. Results showed that single source complete profiles could be obtained using as little as 62 pg of input DNA. The reproducibility study showed that the profiles generated were consistent among multiple typing experiments for a given individual. The mixture study indicated that partial STR profiles of the minor contributor could be detected up to 19:1 mixture. The mock forensic casework study showed that full or partial profiles could be obtained from different types of single source and mixture samples. These studies indicate that the PowerSeq Auto System and the Illumina MiSeq can generate concordant results with current CE-based methods. In addition, MPS-based systems can facilitate mixture deconvolution with the detection of intra-repeat variations within length-based STR alleles.     

Management of Acute Contrast Reactions—Understanding Radiologists' Preparedness and the Efficacy of Simulation-Based Training in Canada

Purpose

Acute radiologic emergencies, primarily severe contrast reactions, are rare but life-threatening events. Given a generalized paucity of formalized or mandated training, studies have shown that radiologists and trainees perform poorly when acutely managing such events. Moreover, skill base, knowledge, and comfort levels precipitously decline over time given the infrequent occurrence of these events during one's daily practice.The primary aim of this study was to assess radiologists' preparedness for managing acute radiologic emergencies and to determine the efficacy of a high-fidelity simulation based training model in an effort to provide a rationale for similar programs to be implemented on a provincial or national level.