Long-term feasibility of the new sutureless excimer laser-assisted non-occlusive anastomosis clip in a pig model.

BACKGROUND: High flow bypass surgery can be a last resort procedure for patients suffering from complex neurovascular pathology. Temporary occlusion of a recipient artery in these patients could result in debilitating neurological deficits. We developed a sutureless, mechanical anastomotic connection device, the SELANA clip (Sutureless Excimer Laser-Assisted Non-occlusive Anastomosis clip: SEcl). In the present study, we aim to determine the long-term non-inferiority of the SEcl technique compared with historical data of the conventional ELANA anastomosis technique. METHODS: A total of 18 SEcl bypasses were created on the carotid artery in a porcine model in 6 different survival groups. Mean application times, flap retrieval rates, hemostasis, patency, flow, endothelialization, and remodeling were assessed. RESULTS: The mean application time of the SEcl anastomoses was 15.2 ± 9.6 min, which was faster compared with the conventional ELANA anastomoses. The flap retrieval rate of the SEcl anastomoses was 86% (32/37). Direct hemostasis was achieved in 89% (33/37) SEcl anastomoses. Patency in all surviving animals was 94% (17/18). Bypass flow after six months was 156.5 ± 24.7 mL/min. Full endothelialization of the SEcl pins was observed after 3 weeks. CONCLUSION: The SEcl technique is not inferior to the ELANA technique regarding patency, flap retrieval rate, flow, and endothelialization. On the basis of a significantly shorter application time and superior hemostasis, the SEcl technique could be preferable over the ELANA technique. A pilot study in patients is a logical next step based on our current results.

Feasibility of the new sutureless excimer laser-assisted non-occlusive anastomosis clip in a rabbit model.

BACKGROUND: The excimer laser-assisted non-occlusive anastomosis (ELANA) technique facilitates the construction of anastomoses without temporary occlusion of the recipient artery. Experiments aimed at simplifying the technique eventually resulted in a sutureless ELANA slide (SEsl) anastomosis. After the first clinical use, new insights lead to the application of a clip at the back of the device, the SELANA clip (SEcl). The SEcl offers a distinct advantage over the SEsl since no sealant is necessary. In this study, we determine the feasibility of the SEcl anastomosis in an in vivo rabbit model. METHODS: 15 SEcl anastomoses and 15 conventional ELANA anastomoses were created on the abdominal aorta in 5 rabbits. Mean application times, flap retrieval rates, hemostasis, and burst pressures were assessed. RESULTS: The mean application time of the SEcl anastomoses was 11.4 min versus 39.0 min for the ELANA anastomoses (mean difference, 27.6 min; 95% CI, 20.6-34.7). The flap retrieval rate of the SEcl anastomoses (14/15) was not inferior to the flap retrieval rate of the ELANA anastomoses (13/15). Direct hemostasis was achieved in 13/15 (87%) SEcl anastomoses and in 14/15 (94%) ELANA anastomoses. All SEcl anastomoses were resistant to provoked pressures until 250 mmHg. CONCLUSION: The SEcl anastomosis is technically feasible in in vivo experiments. Mean application time, flap retrieval rate, hemostasis, and burst pressure are not inferior to the conventional ELANA anastomosis. Further long term experiments should be performed to assess safety, patency, and reendothelialization.

Preclinical success but clinical failure of the sutureless excimer laser-assisted non-occlusive anastomosis (SELANA) slide.

BACKGROUND: The excimer laser-assisted non-occlusive anastomosis (ELANA) has been developed for intracranial bypass without the need for temporary recipient occlusion. We designed and tested a sutureless variant of the ELANA-the SELANA slide (SEsl). OBJECTIVE: This study aims to evaluate the SEsl preclinical results and describe its first clinical application. METHODS: First, in a cadaver study, 28 SEsl anastomoses were compared with 28 ELANA anastomoses. Second, in an acute rabbit model, 90 SEsl anastomoses were compared with 30 ELANA anastomoses. Finally, in a surviving pig model, 38 SEsl bypasses were created. To evaluate the clinical efficacy of the SEsl, we then treated one patient with a giant, right-sided middle cerebral artery (MCA) aneurysm with an intracranial-intracranial SEsl bypass and parent vessel occlusion. RESULTS: In preclinical studies, the SEsl anastomosis was shown to be equivalent or superior to the ELANA in terms of associated ease, patency, and bleeding complications. However, clinical application in rigid and arteriosclerotic receiving arteries was problematic. Although bypass creation and aneurysm occlusion were technically successful and the patient was postoperatively well, a pseudoaneurysm formed postoperatively at the internal carotid artery anastomosis and bled. Subsequent treatment failed and the patient did not survive. CONCLUSION: The SEsl showed promising preclinical results across three models. However, in its present form, it is not suitable for clinical application. TRIAL NUMBER: IRB UMCU 10/154.

Daily lives of residents with dementia in nursing homes: development of the Maastricht electronic daily life observation tool.

BACKGROUND: Daily life is a dynamic and multidimensional concept, for which appropriate assessment tools are lacking. This study describes the development of the Maastricht Electronic Daily Life Observation tool (MEDLO-tool), a freely accessible, easy to use, electronic observation tool to assess relevant daily life aspects for nursing home residents with dementia. METHODS: (1) Determining relevant aspects of daily life for nursing home residents with dementia based on a literature search and expert interviews; (2) pilot testing observation procedures and operationalizations of the aspects of daily life; and (3) exploring inter-rater reliability and feasibility of the tool in a nursing home facility with 16 residents (56% female, mean age: 77). RESULTS: The following aspects of daily life are assessed with the MEDLO-tool: (1) activity (activity performed by resident, engagement in this activity, and the degree of physical effort); (2) physical environment (location of the resident and interaction with the physical environment); (3) social interaction (the level and type of social interaction, and with whom this social interaction took place); and (4) emotional well-being (mood and agitation). Each aspect of daily life is observed and scored using standardized scoring options. Agreement on the aspects is high with an average absolute agreement of 86%. Users of the MEDLO-tool indicated that it was feasible in practice and contained clear operationalization of the aspects of daily life. CONCLUSIONS: The MEDLO-tool is a promising tool to gain real time insight into the aspects of the daily lives of nursing home residents with dementia.

Living at the farm, innovative nursing home care for people with dementia - study protocol of an observational longitudinal study.

BACKGROUND: In nursing home care, new care environments directed towards small-scale and homelike environments are developing. The green care farm, which provides 24-h nursing home care for people with dementia, is one such new care environment. Knowledge is needed on the relation between environmental features of green care farms such as nature, domesticity and offering care in small groups and the influence on the daily lives of residents. The aim of this study is to explore (1) the daily lives of residents, (2) the quality of care and (3) the experiences of caregivers on green care farms compared with other nursing home care environments. METHODS/DESIGN: An observational longitudinal study including a baseline and a six-month follow-up measurement is carried out. Four types of nursing home care environments are included: (1) large scale nursing home ward, (2) small scale living facility on the terrain of a larger nursing home (3) stand-alone small scale living facility and (4) green care farm. Quality of care is examined through structure, process and outcome indicators. The primary outcome measure is the daily life of residents, assessed by ecological momentary assessments. Aspects of daily life include (1) activity (activity performed by the resident, the engagement in this activity and the degree of physical effort); (2) physical environment (the location of the resident and the interaction with the physical environment); (3) social environment (the level and type of social interaction, and with whom this social interaction took place) and (4) psychological well-being (mood and agitation). In addition, social engagement, quality of life, behavioral symptoms and agitation are evaluated through questionnaires. Furthermore, demographics, cognitive impairment, functional dependence and the severity of dementia are assessed. Semi-structured interviews are performed with caregivers regarding their experiences with the different nursing home care environments. DISCUSSION: This is the first study investigating green care farms providing 24-h nursing home care for people with dementia. The study provides valuable insight into the daily lives of residents, the quality of care, and the experiences of caregivers at green care farms in comparison with other nursing home care environments including small-scale care environments and large scale nursing home wards.

Gagging Problem Assessment: a re-evaluation.

The Gagging Problem Assessment (GPA) is an instrument to evaluate dental gagging. Although the GPA seemed to be reliable and valid in a pilot study, a replication study with more subjects was needed. Based on the pilot study, the number of items was reduced, resulting in the revised version of the GPA (GPA-R). The aims of this study were to replicate the reliability of the GPA-R and to investigate the correlation between dental gagging and general anxiety. Dental gagging patients (n = 59) were compared with a control group (n = 17) at t0 and 3 weeks later. The 'gagging group' also filled in the SCL-90 anxiety scale. Gagging-specific homogenous domains and internal consistency were determined. Stability and distinguishing capacity of the GPA-R were assessed. SCL-90-Anxiety scores were compared with standard values in a non-clinical population. The GPA-R patient part was able to reliably discriminate between the absence or the presence of dental gagging. However, the reliability of the GPA-R-dentist part was insufficient. The GPA-R seems to be sensitive to subtle differences in acts of the dentists. To overcome these problems, more detailed and explicit instructions on how to use the GPA-R should be formulated and more specific gagging stimuli should be included. The 'gagging group' reported 'fear of choking' significantly more often than the control group (P = 0·008). This finding might be important for the treatment of dental gagging. Considering the outcome of our study, development of a new diagnostic gagging tool needs another approach that focuses on gagging severity.

Persistent 400,000-year variability of Antarctic ice volume and the carbon cycle is revealed throughout the Plio-Pleistocene.

Marine sediment records from the Oligocene and Miocene reveal clear 400,000-year climate cycles related to variations in orbital eccentricity. These cycles are also observed in the Plio-Pleistocene records of the global carbon cycle. However, they are absent from the Late Pleistocene ice-age record over the past 1.5 million years. Here we present a simulation of global ice volume over the past 5 million years with a coupled system of four three-dimensional ice-sheet models. Our simulation shows that the 400,000-year long eccentricity cycles of Antarctica vary coherently with δ(13)C data during the Pleistocene, suggesting that they drove the long-term carbon cycle changes throughout the past 35 million years. The 400,000-year response of Antarctica was eventually suppressed by the dominant 100,000-year glacial cycles of the large ice sheets in the Northern Hemisphere.

Unification of trap-limited electron transport in semiconducting polymers.

Electron transport in semiconducting polymers is usually inferior to hole transport, which is ascribed to charge trapping on isolated defect sites situated within the energy bandgap. However, a general understanding of the origin of these omnipresent charge traps, as well as their energetic position, distribution and concentration, is lacking. Here we investigate electron transport in a wide range of semiconducting polymers by current-voltage measurements of single-carrier devices. We observe for this materials class that electron transport is limited by traps that exhibit a gaussian energy distribution in the bandgap. Remarkably, the electron-trap distribution is identical for all polymers considered: the number of traps amounts to 3 × 10(23) traps per m(3) centred at an energy of ~3.6 eV below the vacuum level, with a typical distribution width of ~0.1 eV. This indicates that the electron traps have a common origin that, we suggest, is most likely related to hydrated oxygen complexes. A consequence of this finding is that the trap-limited electron current can be predicted for any polymer.

Left Shift 1+ flag for the detection of band neutrophils: interlaboratory variations and recommendations for the routine laboratory.

INTRODUCTION: Microscopic differential analysis of leukocytes is a time-consuming activity for routine diagnostic laboratories. The criteria used to decide whether a manual differential should be performed should therefore be as strict as possible. The goal of this investigation was to give recommendations for the use of the left shift (LS) 1+ flag, which signals the presence of band neutrophils. METHODS: The LS1+ flag of the ADVIA 120 and 2120 hematology analyzers was evaluated in 6 peripheral hospital laboratories in the Netherlands. In 2683 samples with exclusively a LS1+ flag, the percentage of band neutrophils were determined microscopically. A set of photographs of neutrophils were used to examine the differences between laboratories in the assessment of band cells. RESULTS: In 18% of all samples with only a LS1+ flag, 5% or more band neutrophils were found. However, this percentage differed greatly between laboratories, as did the proportion of samples that received a LS1+ flag. Several factors were found to influence the amount and accuracy of the LS1+ alarm, i.e. band neutrophil counting by microscopists, specificity of request for leukocyte differentials, percentage of general practitioners requesting a leukocyte differential, and sample storage. Based on these findings, a number of recommendations were formulated. CONCLUSION: Critical control of the factors influencing the LS1+ flag can significantly decrease the number of microscopic samples to be reviewed and may be valuable for every laboratory performing routine differentials, using any type of hematology analyzer.

Towards sutureless non-occlusive cerebral revascularization.

Sutureless vascular anastomoses have been the subject of extensive research for decades. In neurosurgery the need for a safe and fast technique is high, because temporary occlusion of cerebral arteries may rapidly lead to brain ischemia. Conventional sutured anastomoses have always been the golden standard. Limited working space and difficult suturing techniques were reasons to find alternatives. Many artificial devices to create anastomoses have been engineered over the years like tissue sealants, clips and automated suturing sets with variable success. For all previous options, temporary occlusion of the recipient artery was necessary. The Excimer Laser Assisted Non-Occlusive Anastomosis (ELANA) technique™ facilitates the construction of an end-to-side anastomosis without temporary occlusion of the recipient artery using a platinum ring and a laser. However, the technical challenge of intracranial micro-sutures remained. Experiments using less sutures eventually resulted in a sutureless ELANA (SELANA) anastomosis. After in vitro and in vivo experiments, the SELANA slide was considered feasible for intracranial use although some concrete improvements, like the inclusion of a clip at the back of the device, were needed. Therefore, the development of an ideal sutureless anastomosis is still ongoing. This process is an evolution rather than a revolution.

Hepatic epithelioid haemangioendothelioma: challenges in diagnosis and management.

BACKGROUND: Hepatic epithelioid haemangioendothelioma (HEH) is a rare, low grade malignant neoplasm of endothelial origin which is difficult to diagnose and has a variable outcome. We review five HEH cases from our centre with the aim of identifying clinical predictors of outcome and various therapeutic options. METHODS: A search was made on the WA Liver Transplant registry for cases with histologically confirmed HEH. Their medical records were reviewed. A literature search was conducted through Medline using terms to compare the results from this series with those of other series. RESULTS: Five patients were identified to have HEH. The mean age was 44.2years (range 34-53years). Four of five patients presented with dyspepsia and two patients had clinical evidence of portal hypertension with ascites. Two patients had radiologically diffuse disease and three patients had discrete nodular liver involvement. The mean duration from presentation of symptoms to diagnosis of HEH was 26.8months. Liver transplantation was performed in one patient with diffuse HEH who is alive with no disease recurrence at 3years. Three patients with radiologically stable disease followed with 6monthly surveillance imaging are currently alive and well. The median survival of all five patients was 5years (range 1.5-16years) at the time of follow up. CONCLUSIONS: These results support the role of surveillance alone for patients with focal and radiologically stable disease. Patients with diffuse HEH with hepatic decompensation should be considered for transplantation. However, numbers are small and an international registry is required to make firm comparisons.

[Prevalence of dental disorders in 483 horses and ponies]. / De prevalentie van gebitsafwijkingen bij 483 paarden en pony's.

Prevalence of dental disorders in 483 horses and ponies Five equine veterinarians working at three equine referral hospitals examined the oral cavity of 483 horses and ponies prior to surgery, to gain information about the prevalence of common dental disorders in the horse. A thorough examination, using hands/fingers, a full-mouth speculum, a dental mirror and a good light source, is essential to detect such disorders. Many horses examined needed dental attention even though there were no problems with mastication or riding. The most detected abnormalities were sharp enamel points on the buccal side of the upper arcade and the lingual side of the lower arcade, and hooks at 106/206 and 311/411. Regular dental care would improve the condition and welfare of horses.

Identification of serosal invasion and extramural venous invasion on review of Dukes' stage B colonic carcinomas and correlation with survival.

AIMS: To determine whether serosal invasion (SI) and/or extramural venous invasion (VI) could be more frequently identified on review of Dukes' stage B colonic carcinoma resection specimens and whether the revised findings correlated with clinical outcome. METHODS AND RESULTS: The original histology slides from 82 patients with Dukes' stage B colonic carcinoma were reviewed specifically to identify tumours showing SI and/or VI. All tumours were initially reported to be negative for both pathological parameters. The selected cases included 35 patients who died of carcinoma within 5 years of surgery and 47 patients with a minimum of 5-years' postoperative survival. The review was blinded to the original histopathology reports and to clinical follow-up data. SI and/or VI were identified in 26 cases (32%). Fourteen of 18 patients with SI, 8/12 patients with VI and all four patients with both adverse histological features died of carcinoma. CONCLUSIONS: Review of routinely sampled and stained colonic carcinoma resection specimens increased the proportion of cases classified as positive for SI and/or VI. The revised assessment correlated with patient outcome. Reliable identification of these features may permit stratification of high-risk patients with Dukes' stage B colonic cancer who could benefit from adjuvant treatment.

An integrated and sensitive detection platform for magneto-resistive biosensors.

A compact biosensor platform with giant magneto-resistive (GMR) sensors suited for the detection of superparamagnetic nanoparticle labels is presented. The platform consist of disposable biosensor cartridges and an electronic reader, which enables quantitative detection with high analytical performance, combined with robustness, ease of use and at low cost. In order to optimise the signal-to-noise ratio (SNR), magnetic labels are excited at high frequency. Wires, integrated in the silicon of the sensor chip are used to generate a well-defined magnetic field on the sensor surface, thus removing the need for mechanical alignment with external apparatus. A signal modulation scheme is applied to obtain optimal detection accuracy. The platform is scalable and can be adapted according to application-specific requirements. Experimental results indicate that three beads of 300 nm diameter can be detected on a sensor surface of 1500 microm2 for a measurement time of 1s.

Population-based study of prognostic factors in stage II colonic cancer.

BACKGROUND: Adjuvant chemotherapy in stage II colorectal cancer may be considered for patients whose tumours have poor prognostic features. The aim of this study was to evaluate the prognostic significance of commonly reported clinical and pathological features of stage II colonic cancer. METHODS: A population-based observational study of all patients with stage II colonic cancer diagnosed in the state of Western Australia from 1993 to 2003 was performed. A total of 1306 patients treated by surgery alone were identified, with a median follow-up of 59 (range 0-145) months. RESULTS: Multivariable analysis revealed that the only independent prognostic factors for disease-specific survival were stage T4 (hazard ratio (HR) 1.75 (95 per cent confidence interval (c.i.) 1.32 to 2.32); P < 0.001) and vascular invasion (HR 1.63 (95 per cent c.i. 1.15 to 2.30); P < 0.001). In younger patients (aged 75 years or less), who are more likely to be considered for chemotherapy, these two features showed independent prognostic significance but with higher HR values (1.96 for stage T4 and 2.73 for vascular invasion). Stage T4 and/or the presence of vascular invasion identified a 'poor' prognostic group, comprising 26.6 per cent of younger patients and with a 5-year survival rate of 71.2 per cent. The remaining 'good' prognostic group had a survival rate of 84.3 per cent at 5 years' follow-up. CONCLUSION: This study highlights the importance of accurate pathological assessment of tumour stage and vascular invasion for the prognostic stratification of patients with stage II colonic cancer. The results provide clarification of guidelines for the management of stage II disease in relation to recommendations for chemotherapy.

The prevalence of bother, acceptance, and need for help in men with erectile dysfunction.

INTRODUCTION: Apart from knowledge on the prevalence of erectile dysfunction (ED), for clinical reasons it is important to obtain information on concern or bother and need for help. However, information is lacking on men with ED who need help but do not seek medical attention. Thus, this study aimed to assess the distribution of bother, acceptance, and need for help in men with ED, and assess characteristics of patients with ED in need for help but not receiving medical attention for ED. METHODS: A total of 5,721 men aged 18 years and older and registered in 12 general practices in the middle of the Netherlands were sent a questionnaire by mail about sexual problems, ED, need for help, and medical attention. Out of 2,117 questionnaires that were returned, 1,481 were completed on ED, bother, and need for help. RESULTS: The prevalence of ED (according to World Health Organization definition) in the 1,481 men was 14.2%. Of these men 67.3% were bothered, 68.7% did not accept ED, and 85.3% wanted help. Surprisingly, 41.9% of men who denied a need for help were bothered and 19.4% did not accept ED. Only 10.4% of men with ED received any medical care. Bother in men with ED was related to increasing age (decreasing above 60 years). Compared with men who already received help for ED, men who wanted help but did not receive it more often suffered from diabetes, neurological problems, and various cardiovascular problems. On the other hand, history of myocardial infarction increased the chance of getting adequate medical attention for ED. CONCLUSIONS: The majority of men with ED are concerned or bothered and perceive a need for help. Most of them do not receive any medical attention. These men are characterized by chronic medical conditions, visiting the physician's office regularly for their medical condition.

Impact of various questionnaires on the prevalence of erectile dysfunction. The ENIGMA-study.

The prevalence estimates of erectile dysfunction (ED) vary considerably across studies. These differences may be attributed to used definitions of ED. Quantitative data on the effect of different definitions of ED on the prevalence are lacking, because precise information on the used definition and questionnaire is often absent. Aim of this study was to quantify the effect of using different questionnaires for ED on the prevalence estimates. In all, 5721 mail surveys on sexual problems and ED were sent to all men (aged >18 y) in 12 general practices in the middle of the Netherlands of which 2117 were completed. The questionnaire contained Enigma (WHO), International Index of Erectile Function (IIEF), Cologne Erectile Inventory (KEED) and one question (Boxmeer, Krimpen). The prevalence of ED based on the various questionnaires and the effect of these questionnaires on risk factor relationships was compared. IIEF gave the highest age specific and overall ED prevalence, KEED the lowest. The difference in prevalence was 16.8%. The agreement (kappa coefficient) between the various ED definitions varied from 0.52 (IIEF & KEED) to 0.95 (Enigma & Boxmeer). The number of risk factor relations were similar for the Dutch studies, reduced for the IIEF and KEED. This study provides evidence that differences in questionnaires to assess ED have a considerable effect on the (age specific) prevalence estimates and little on the risk factor relations. The number of questions of the survey appears not to be responsible for differences in the prevalence of ED and risk factor relations, however they affect the response rate. Uniform use is strongly recommended, since a 'golden standard' for ED assessment (by questionnaire) is lacking. A short questionnaire with one or two questions is recommended for example the one from the Boxmeer-study. These data may be used to adjust (age-specific) prevalence rates comparing ED prevalence in the open population across studies.

Erectile dysfunction in primary care: prevalence and patient characteristics. The ENIGMA study.

The availability of adequate treatment for erectile dysfunction (ED) triggers studies into the prevalence of ED in the general population. Yet, previous studies showed different prevalence estimates partly due to differences in patient selection, in (unclear) definitions of ED and in assessment. ENIGMA has been designed to study the prevalence of ED in the general population of The Netherlands, using the WHO definition with a description of the way of assessment. In all, 5721 mail surveys were sent to all men, aged 18 y and older in 12 general practices in The Netherlands. A total of 5601 were included in the study and 2117 (38%) were completed. A total of 38% of the men reported to have ever had some kind of erectile problem. The prevalence of ED was 17% (6% mild, 4% moderate and 7% complete). Age, diabetes, cardiovascular diseases, penile disorders, irradiation in the pelvic region, relational problems, fear for failure, surmenage, medication use and regular consumption of alcohol were independently related to ED. Men with ED were less content with their (sexual) life and had less confidence in sexual performance. Presence of ED was negatively related to affected happiness in life. ED is commonly found in men and is related to age, medication, comorbidity and lifestyle factors. Men with ED perceive a lower quality of (sex)life. Doctors should be aware of the presence of ED and its consequences in patients.