The utility of Prostar XL percutaneous vascular closure device after stent-graft implantation for infrarenal abdominal aortic aneurysms

Introduction. Over time, endovascular techniques of abdominal aortic aneurysm repair became the principal methods of treatment of this potentially fatal disease. Currently, endovascular aneurysm repair (EVAR) constitutes an effective alternative to open surgery, also in cases of aneurysm rupture. Low degree of invasiveness is the main advantage of this method. Introduction of a system enabling percutaneous stent-graft implantation appears to be the next step in the development of endovascular AAA surgery. Aim of the study is to evaluate the Prostar XL® closure device with regard to clinical effectiveness, safety, cost-effectiveness. Material and methods. The study included 100 patients (from January 2013 to December 2015) subject to endovascular abdominal aortic aneurysm repair in the infrarenal region of the aorta with the application of the Prostar Xl® closure device. Most patients were operated under epidural anaesthesia. Local anaesthesia (1% Lidocaine) was used in 36 patients due to comorbidities. A possible application of the closure system depended on a preoperative assessment of common femoral arteries using ultrasonography. Presence of atherosclerotic plaque on the anterior wall of the vessel disqualified the patient from percutaneous endovascular aneurysm repair (PEVAR). The main part of the procedure consisted of stent-graft implantation into the abdominal aortic aneurysm. In the final stage, puncture site on the anterior wall of common femoral arteries was closed using previously placed sutures of the Prostar XL system. The wound in the inguinal region was closed with a skin suture. Results. The analysis of obtained results demonstrated significantly shorter mean hospitalization times in patients treated with PEVAR compared to EVAR. Low rates and types of observed complications in the study group (PEVAR) compared to the control group (EVAR) are strongly in favour the percutaneous technique (PEVAR) of endovascular aortic abdominal aneurysm repair in the infrarenal region of the aorta, confirming its minimally invasive character

An empathy level in students starting nursing studies as a valid skill of therapeutic communication

Empatia należy do kluczowych umiejętności interpersonalnych niezbędnych w komunikacji terapeutycznej i zapewnieniu pacjentom wysokiej jakości opieki. Stąd zdaniem autorów ważne jest, aby studenci rozpoczynający studia w dyscyplinach medycznych charakteryzowali się wyjściowo względnie wysokim poziomem tej umiejętności i rozwijali ją podczas studiów. Celem prezentowanej pracy była ocena poziomu empatii u studentów rozpoczynających naukę na wydziale pielęgniarstwa. Aby ocenić poziom empatii, dokonano porównania poziomu empatii między grupą 64 studentów pierwszego roku Pielęgniarstwa Collegium Medicum Uniwersytetu Jagiellońskiego oraz równie liczną grupą studentów pierwszego roku Turystyki i Rekreacji na Uniwersytecie Ekonomicznym w Krakowie. Jako narzędzie badawcze wykorzystano Indeks Reaktywności Interpersonalnej (IRI) autorstwa M.H Davisa. Wyniki badań nie potwierdziły hipotezy, że osoby wybierające studia o profilu medycznym charakteryzują się znacząco wyższym poziomem empatii od studentów turystyki i rekreacji. Co więcej w obu grupach zaobserwowano jedynie średni poziom IRI - empatii całkowitej. W grupie studentów turystyki i rekreacji ujawniono nieco wyższą intensywność komponentu empatii o nazwie fantazja (różnica była statystycznie znacząca). Uzyskane wyniki dowodzą, że w trakcie kształcenia studentów wydziału pielęgniarskiego, należy zwrócić szczególną uwagę na rozwój empatii, zwłaszcza jego komponentu poznawczego, w postaci umiejętności przyjmowania cudzego punktu widzenia (perspektywy pacjenta).Empathy belongs to pivotal interpersonal skills necessary for therapeutic communication and provision of patients with high quality care. Hence, according to the authors of the present work, it is valid that the students following degree programs in medical disciplines were characterized by a relatively high level of this skill, and also that they developed it during their studies. The aim of the presented work was the assessment of the empathy level in the students starting education in the nursing faculty. To assess the empathy level, the comparison was carried out between a group of 64 first-year students of nursing in the Jagiellonian University Medical College and an equally numerous group of first-year students of tourism and recreation in the Cracow University of Economics. As a research tool, the Interpersonal Reactivity Index (IRI) was used. The results of the research did not confirm the hypothesis that students choosing studies of medical profile have higher empathy level than students of tourism and recreation. In both groups an average level of entire empathy was observed, wherein the students of tourism revealed slightly higher intensity of fantasy (the difference was statistically significant). The obtained results prove that during education of the students of the nursing faculty, attention should be paid to the development of empathy, especially its cognitive component in the form of the skill of reception of someone else’s perspective (the patient’s perspective)

Is the merA gene sufficient as a molecular marker of mercury bacterial resistance?

Gene encoding mercuric ion reductase, merA is a crucial component of the mer operon for reduction of nonorganic mercury ions into less toxic form. The merA gene or its fragments are commonly used as a molecular marker of bacterial resistance to mercury. In this study, it was tested whether the merA gene can be considered as a molecular marker of mercury bacterial resistance. For this purpose, the presence of the mer operon in bacteria isolated from the microbiota of Tussilago farfara L. growing in post-industrial mercury-contaminated and non-contaminated areas was verified by merA gene identification. Mercury resistance was determined by analyzing the bacterial growth parameters in standard Luria-Bertani (LB) medium with mercury concentration of 0.01% (w/v) and in medium without mercury addition. The results obtained showed that the merA gene was present in all T. farfara L. bacterial isolates growing in both mercury-contaminated and noncontaminated soils, however, only the isolates from mercury-contaminated areas were able to grow under mercury conditions. Although merA is commonly regarded as a molecular marker of bacterial mercury resistance, results of our research indicate the need for a verification of that statement/thesis and further investigation of bacterial mercury resistance to indicate other its key markers, structures, or mechanisms

Results of endovascular treatment of iliac and femoral symptomatic lesions. Identification of re-intervention risk factors

Introduction. The aim of the study was to assess a presence of peripheral arterial disease risk factors in patients with symptomatic femoral and iliac lesions treated with use of Jaguar and Supera nitinol stents and to estimate potential relation between these factors and reintervention rate. Material and methods. The study group consisted of 60 patients between 46 and 85 years of age who presented with typical symptoms of intermittent claudication or critical limb ischemia and underwent percuta­neous transluminal angioplasty with stenting. We examined and divided group into two subgroups — patients who experienced or did not experience need of reintervention in treated lesion. Results. During the follow-up 24 (40%) of patients underwent reintervention in treated artery due to re­current symptoms of disease. Need of target lesion revascularization occurred more frequent in patients with hypertension (OR = 2.5), patient older than 68 (OR = 1.75) and smokers (OR = 1.75). Patency of all three arteries below knee protected from reintervention. Conclusions. Jaguar and Supera self-expanding nitinol stents has several advantages and its use were char­acterized by high procedural success and moderate frequency of reintervention correlated to some clinical findings like hypertension. Further studies are necessary to estimate factors disturbing and interfering with long-term patency.Introduction. The aim of the study was to assess a presence of peripheral arterial disease risk factors in patients with symptomatic femoral and iliac lesions treated with use of Jaguar and Supera nitinol stents and to estimate potential relation between these factors or some angiographical conditions and reintervention rate. Material and methods. The study group consisted of 60 patients between 46 and 85 years of age who presented with typical symptoms of intermittent claudication or critical limb ischemia and underwent percutaneous transluminal angioplasty with stenting using Supera or Jaguar self-expanding nitinol stent. We examined and divided group into two subgroups – patients who experienced or didn’t experience need of reintervention in treated lesion.Results. In 33 patients (55%) nitinol stent Jaguar and in 27 patients (45%) Supera were implanted. During the follow-up 24 of patients (40%) underwent reintervention in treated artery due to recurrent symptoms of disease. Need of target lesion revascularization occurred more frequent in patients with hypertension (OR=2,5), patient older than 68 (OR=1,75) and smokers (OR=1,75). Patency of all three arteries below knee protected from reintervention. Diabetes mellitus type 2, chronic kidney disease, kind or size of implanted stent and antiplatelet therapy model didn’t determine a need of reintervention. Conclusions. Jaguar and Supera self-expanding nitinol stents has several andvantages and its use were characterized by high procedural success and moderate frequency of reintervention correlated to some clinical findings like hypertension. Further studies are necessary to estimate factors disturbing and interfering with long-term patency

Wyniki leczenia wemurafenibem chorych na zaawansowanego czerniaka w ramach programu lekowego w Polsce

Introduction. Melanoma is a heterogeneous group of tumours with poor prognosis if the disease is metastatic. More than half of patients with melanoma of the skin have detectable mutations in the BRAF gene. Vemurafenib is the BRAF kinase inhibitor used in the treatment of patients with advanced melanoma with the BRAF mutation. This improves time to progression-free survival and overall survival in patients with this diagnosis. The aim of the study was to analyse the results of treatment and safety of vemurafenib in patients treated during the Polish drug programme. Materials and methods .Between October 2013 and April 2015 a total of 189 patients were treated, 90 women and 99 men, who had previously been diagnosed with unresectable/metastatic melanoma with BRAF V600 mutation. Patients received vemurafenib in 960 mg dose twice per day. The estimated progression-free survival, overall survival and adverse events were assessed. For the survival analysis the Kaplan-Meier method and log-rank test (log-rank) for multi-factor analysis were used. Results. In the first evaluation of the effectiveness of treatment, 8 patients (4.3%) had a complete response, 75 patients (39.7%) partial response, 62 patients (32.8%) had stable disease, and 44 patients (23.2%) had progression of the disease. The disease was controlled in 76.7% of patients. After progression during the therapy with vemurafenib 27% of the patients received subsequent lines of systemic therapy. Twenty-eight patients received chemotherapy and 22 patients immunotherapy with ipilimumab. During the last analysis dated 5 September 2015, the median observation time for still living patients was 8 months (range 3–26). Median progression-free survival was 6.7 months. The median overall survival was 12 months. 146 patients (77%) had adverse events, mostly in the form of dermal toxicity of Grades 1 and 2. Thirty-two patients (17%) presented with side effects of the 3rd and 4th grades of toxicity. Two patients had to stop the treatment due to the toxicity. There were no deaths reported due to the toxicity of treatment. Conclusions. The multicentre analysis confirmed the efficacy and safety of vemurafenib in routine clinical practice in a heterogeneous group of advanced melanomas with BRAF mutation. We confirmed the importance of the known prognostic factors for overall survival in this group of patients, such as lactate dehydogenaze activity (LDH) and ECOG performance status. The current survival of patients with the metastatic melanomas with BRAF mutations are longer than those observed in historical groups.  Wstęp. Czerniak należy do heterogennej grupy nowotworów o bardzo złym rokowaniu w przypadku rozsiewu choroby. U ponad połowy chorych na czerniaka skóry stwierdza się obecność mutacji w obrębie genu BRAF. Wemurafenib jest inhibitorem kinazy BRAF stosowanym w leczeniu chorych na zaawansowanego czerniaka z mutacją BRAF, który poprawia u nich czas przeżycia wolny od progresji choroby oraz przeżycia całkowitego. Celem pracy jest analiza wyników leczenia oraz bezpieczeństwa terapii wemurafenibem u chorych leczonych w ramach programu lekowego w Polsce. Materiały i metody. W okresie od października 2013 do kwietnia 2015 roku leczonych było 189 chorych (90 kobiet i 99 mężczyzn) z rozpoznaniem nieresekcyjnego/przerzutowego czerniaka z mutacją BRAF V600. Chorzy otrzymywali wemurafenib w dawce wyjściowej 960 mg dwa razy na dobę. Oceniano czas wolny od progresji choroby, czas przeżycia całkowitego oraz monitorowano działania niepożądane. Do analizy przeżycia użyto metody Kaplana-Meiera oraz testu logarytmicznego rang (log-rank) dla analiz dwuczynnikowych. Wyniki. W pierwszej ocenie skuteczności leczenia u 8 chorych (4,3%) stwierdzono całkowitą odpowiedź, u 75 chorych (39,7%) częściową odpowiedź, u 62 chorych (32,8%) stabilizację choroby, a u 44 chorych (23,2%) progresję choroby. Kontrolę choroby wykazano u 76,7% chorych. Po progresji w trakcie terapii wemurafenibem 27% chorych otrzymało kolejne linie leczenia systemowego — 28 chorych chemioterapię, 22 chorych ipilimumab. Podczas ostatniej analizy z dnia 5 września 2015 mediana czasu obserwacji dla żyjących chorych wyniosła 8 miesięcy (zakres 3–26). Mediana przeżycia wolnego od progresji wyniosła 6,7 miesiąca. Mediana czasu całkowitego przeżycia wyniosła 12 miesięcy. U 146 chorych (77%) stwierdzono działania niepożądane, głównie pod postacią toksyczności skórnej w stopniu 1. i 2., u 32 chorych (17%) objawy uboczne w 3.–4. stopniu toksyczności. U dwóch chorych zakończono leczenie z powodu toksyczności. Nie było zgonów spowodowanych toksycznością leczenia. Wnioski. Przeprowadzona analiza wieloośrodkowa potwierdziła skuteczność i bezpieczeństwo leczenia wemurafenibem w rutynowej praktyce klinicznej w heterogennej grupie zaawansowanych czerniaków z obecnością mutacji BRAF. Potwierdzono wagę znanych czynników prognostycznych dla całkowitego przeżycia w tej grupie chorych, takich jak aktywność dehydrogenazy mleczanowej (LDH) i wyjściowy stan sprawności wg ECOG. Obecne przeżycia chorych w grupie przerzutowych czerniaków z mutacją BRAF są dłuższe niż obserwowane w próbach historycznych.

Robust ecological analysis of camera trap data labelled by a machine learning model

1. Ecological data are collected over vast geographic areas using digital sensors such as camera traps and bioacoustic recorders. Camera traps have become the standard method for surveying many terrestrial mammals and birds, but camera trap arrays often generate millions of images that are time‐consuming to label. This causes significant latency between data collection and subsequent inference, which impedes conservation at a time of ecological crisis. Machine learning algorithms have been developed to improve the speed of labelling camera trap data, but it is uncertain how the outputs of these models can be used in ecological analyses without secondary validation by a human. 2. Here, we present our approach to developing, testing and applying a machine learning model to camera trap data for the purpose of achieving fully automated ecological analyses. As a case‐study, we built a model to classify 26 Central African forest mammal and bird species (or groups). The model generalizes to new spatially and temporally independent data (n = 227 camera stations, n = 23,868 images), and outperforms humans in several respects (e.g. detecting ‘invisible’ animals). We demonstrate how ecologists can evaluate a machine learning model's precision and accuracy in an ecological context by comparing species richness, activity patterns (n = 4 species tested) and occupancy (n = 4 species tested) derived from machine learning labels with the same estimates derived from expert labels. 3. Results show that fully automated species labels can be equivalent to expert labels when calculating species richness, activity patterns (n = 4 species tested) and estimating occupancy (n = 3 of 4 species tested) in a large, completely out‐of‐sample test dataset. Simple thresholding using the Softmax values (i.e. excluding ‘uncertain’ labels) improved the model's performance when calculating activity patterns and estimating occupancy but did not improve estimates of species richness. 4. We conclude that, with adequate testing and evaluation in an ecological context, a machine learning model can generate labels for direct use in ecological analyses without the need for manual validation. We provide the user‐community with a multi‐platform, multi‐language graphical user interface that can be used to run our model offline.Additional co-authors: Cisquet Kiebou Opepa, Ross T. Pitman, Hugh S. Robinso

Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food-A first step in an initiative to better inform patients and avoid fatal allergic reactions : A GA(2)LEN position paper

Background Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as "may contain traces of" is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement "this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product" for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.Peer reviewe

Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food—A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA²LEN position paper

Background: Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as "may contain traces of" is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods: MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results: In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion: Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement "this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product" for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged