The conventional protocol vs. a protocol including illumination with a fabric-based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, noninferiority clinical study.

BACKGROUND: Topical photodynamic therapy (PDT) using methyl aminolaevulinate is a noninvasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The most widely used, conventional protocol in Europe includes illumination with a red-light lamp. This illumination commonly causes pain, and patients often cannot complete the treatment. OBJECTIVES: The aims of this paper are twofold. The first aim is to introduce a novel protocol, the Phosistos protocol (P-PDT), which includes illumination with a fabric-based biophotonic device. The second and major aim is to assess the noninferiority, in terms of efficacy for PDT of AK, of P-PDT compared with the conventional protocol (C-PDT). METHODS: A randomized, controlled, multicentre, intraindividual clinical study was conducted. Forty-six patients with grade I-II AK of the forehead and scalp were treated with P-PDT on one area (280 AK lesions) and with C-PDT on the contralateral area (280 AK lesions). The primary end point was the lesion complete response (CR) rate at 3 months, with an absolute noninferiority margin of -10%. Secondary end points included pain scores, incidence of adverse effects and cosmetic outcome. RESULTS: Three months following treatment, the lesion CR rate of P-PDT was noninferior to that of C-PDT (79·3% vs. 80·7%, respectively; absolute difference -1·6%; one-sided 95% confidence interval -4·5% to infinity). The noninferiority of P-PDT to C-PDT in terms of the lesion CR rate remained at the 6-month follow-up (94·2% vs. 94·9%, respectively; absolute difference -0·6%; one-sided 95% confidence interval -2·7% to infinity). Moreover, the pain score at the end of illumination was significantly lower for P-PDT than for C-PDT (mean ± SD 0·3 ± 0·6 vs. 7·4 ± 2·3; P < 0·001). CONCLUSIONS: P-PDT is noninferior to C-PDT in terms of efficacy for treating AK of the forehead and scalp and resulted in much lower pain scores and fewer adverse effects. What's already known about this topic? Topical photodynamic therapy using methyl aminolaevulinate is effective for treating actinic keratosis. In Europe, the conventional protocol involves illumination with a red-light lamp. Unfortunately, pain is often experienced by patients undergoing this protocol. An alternative protocol that uses daylight illumination has recently been shown to be as effective as the conventional protocol while being nearly painless. However, this alternative protocol can be conducted only in suitable weather conditions. What does this study add? The Phosistos protocol is demonstrated to be as effective as the conventional protocol, nearly as painless as the daylight protocols and suitable year round for treatment of actinic keratosis.

Real-life evaluation of the treatment of actinic keratoses by textile photodynamic therapy (FLUXMEDICARE® device).

INTRODUCTION: Actinic keratoses (AK) are a common precancerous skin condition in dermatology practice. Photodynamic therapy (PDT) with ALA or MAL is an effective but painful treatment of fields of cancerization particularly when conventional illumination sources and irradiation rates are used. Two prior studies showed that illumination with textile PDT was not inferior to conventional PDT. FLUXMEDICARE® (FLX-PDT) is the first medical device marketed with textile based lighting . We performeda real-life study to evaluate efficacy and tolerance of this device. METHODS: We carried out a single-center retrospective study. We collected data from patients treated with FLX-PDT with MAL for AKs localized on scalp and temples between November 2018 and November 2019. The primary endpoint was complete clearance rate (CR) at 3 months-follow up. RESULTS: Data of 39 patients were reviewed in the study, with a total of 417 AKs. The CR rate was 72.6 % (95 %CI 67.9-77.0) at 3 months-follow up and 67.5 % (95 %CI 61.2-73.3) at 6 months-follow up. The median pain felt during the session was 0 and there wasn't erythema after the session for 64.1 %. CONCLUSION: Our real-life study confirms efficacy and safety of textile PDT by FLUXMEDICARE device in the treatment of scalp and temples AKs, with excellent tolerance and minimal pain reported.

Association of transcription factor 7-like 2 gene (TCF7L2) polymorphisms with stress-related hyperglycaemia (SRH) in intensive care and resulting outcomes: The READIAB study.

OBJECTIVE: The study aimed to evaluate the impact of the single nucleotide polymorphism (SNP) rs7903146 on the transcription factor 7-like 2 (TCF7L2) gene in stress-related hyperglycaemia (SRH), defined as blood glucose≥11mmol/L in at least two blood samples during the first 3 days in the intensive care unit (ICU), and on 28-day and 1-year mortality, and incidence of type 2 diabetes (T2D) at 6 months and 1 year in patients hospitalized in the ICU. METHODS: This prospective observational (non-interventional) multicentre READIAB study, carried out during 2012-2016 in six French ICUs, involved adult patients admitted to ICUs for at least two organ failures; patients admitted for<48h were excluded. During the 3-day ICU observational period, genetic testing, blood glucose values and insulin treatment were recorded. MAIN RESULTS: The association of rs7903146 with SRH was assessed using logistic regression models. Cox proportional hazards regression models assessed the associations between rs7903146 and mortality and between SRH and mortality, both at 28 days and 1 year. A total of 991 of the 1000 enrolled patients were included in the READIAB-G4 cohort, but 242 (24.4%) had preexisting diabetes and were excluded from the analyses. SRH occurred within the first 3 days in the ICU for one-third of the non-diabetes patients. The association between the rs7903146 polymorphism and SRH did not reach significance (P=0.078): OR(peroneTcopy): 1.24, 95% CI: 0.98-1.58. A significant association was found between rs7903146 and 28-day mortality after adjusting for severity scores (P=0.026), but was no longer significant at 1 year (P=0.61). At 28 days, mortality was increased in patients with SRH (HR: 2.09, 95% CI: 1.43-3.06; P<0.001), and remained significant at 1 year after adjusting for severity scores (HR: 1.73, 95% CI: 1.32-2.28; P<0.001). On admission, non-diabetes patients with SRH had a higher incidence of T2D at 6 months vs. those without SRH (16.0% vs. 7.6%, RR: 2.11, 95% CI: 1.07-4.20; P=0.030). At 1 year, these figures were 13.4% vs. 9.2%, RR: 1.45, 95% CI: 0.71-2.96; P=0.31). Moreover, the rs7903146 polymorphism was not significantly associated with T2D development at either 6 months (P=0.72) or 1 year (P=0.64). CONCLUSION: This study failed to demonstrate any significant association between rs7903146 and SRH. Nevertheless, the issue remains an important challenge, as SRH may be associated with increased rates of both mortality and T2D development.

[Alexithymia and psoriasis: a case-control study of 53 patients]. / Alexithymie et psoriasis : étude cas-témoin à propos de 53 patients.

INTRODUCTION: Alexithymia was originally defined as the inability to recognize and verbalize emotions. It is characterized by an emptiness of feelings, poverty of imagination or of a life fantasy and difficulties in communicating with other people, as well as lack of positive emotions and a high prevalence of negative emotions. Its presence has been incriminated in the genesis and in the maintenance of various psychosomatic pathologies. Psoriasis, a frequent dermatitis, is classified among psychosomatic pathologies. In fact, the psychological dimension seems important, either in the appearance of the illness, in its evolution or in its prognosis. AIMS OF THE STUDY: Estimate the prevalence of alexithymia among patients with psoriasis. Study the relationship between them. PATIENTS' CHARACTERISTICS: Fifty-three patients with psoriasis consulted the Dermatology Department of the Hedi Chaker University Hospital, in Sfax, Tunisia. Patients' mean age was 42 years (min: 18 years; max: 76 years). The majority was married (58%), coming from middle to low social economic status (86%), and having a primary or secondary school level (84%). Psoriasis was vulgar for 47 patients (89%) and pustular for the others (11%). METHODOLOGY: We built a case-control study of 53 patients with psoriasis. The control group was formed of 53 subjects without psoriasis and paired according sex, age and school level. We evaluated psoriasis severity using the Psoriasis Area and Severity Index (PASI), a standardised instrument permitting assessment of the global severity of psoriasis. A cut off of 12 was used to diagnose severe psoriasis. Alexithymia was assessed with the 20-item version of the Toronto Alexithymia Scale (TAS-20). This instrument has shown to be the best validated instrument for measuring alexithymia. A cut off of 61 was used to diagnose alexithymia. Sociodemographical and clinical data were assessed by a questionnaire that was filled in by the doctor conducting the study. All analyses were performed using the SPSS version 11.0 and with a 95% confidence interval. Differences in groups were tested using student's independent t-test, and Chi-square. RESULTS: The mean score of alexithymia for the patients was 56 (E: 12.1). The mean score of alexithymia for the control group was 45 (E: 9.6). Thirty-nine decimal six percent (n: 21) of patients and 13.2% (n: 7) of controls exhibited alexithymia. Our results confirm the high prevalence of alexithymia among patients with psoriasis (39.6%) compared to controls (13.2%) (p: 0.0002, RR: 3.4). A stress factor was present before the apparition of psoriasis in half of the cases. Psoriasis was severe in 50% of cases. Women with psoriasis (and not men) presented severe psoriasis when they suffered from alexithymia (p: 0.049). The relationship between alexithymia and age was significant from the age of 40 (p: 0.024). The association between psoriasis and another psychosomatic diseases was significantly more important than for the controls (p: 0.03; RR: 4.6). Psoriasis was not correlated to psychoactive substance (tobacco and alcohol, in our study). However, in the group of patients with alexithymia, alcohol consumption was associated with psoriasis severity (p: 0.05). DISCUSSION: In alexithymia, there is a risk that physical and emotional feelings will be used without distinction as signs of psychological distress, which can explain the somatic complaint due to the lack of the expression of psychological suffering. This can lead to the apparition of psoriasis. The relationship between psoriasis and alexithymia is increasingly studied in epidemiological surveys that use different instruments to measure alexithymia. However, the results of these surveys do not concord with ours. Our results demonstrated a close link between the two conditions. Moreover, the risk of further psychosomatic diseases increases in the presence of alexithymia. The consumption of alcohol was also high in cases of severe forms of psoriasis. CONCLUSION: Alexithymia does not appear to be a simple condition, related to psoriasis, but a worsening of the condition, exposing the patient to the association of other psychosomatic diseases and alcoholism, and thus worsening the global prognosis of these patients. The psychological approach, which favours the expression of emotions and permits a symbolic dimension, is as important as the biological approach, and necessary for the improvement of these patients.

Proof of patient information: Analysis of 201 judicial decisions.

INTRODUCTION: The ruling by the French Court of Cassation dated February 25, 1997 obliged doctors to provide proof of the information given to patients, reversing more than half a century of case law. In October 1997, it was specified that such evidence could be provided by "all means", including presumption. No hierarchy in respect of means of proof has been defined by case law or legislation. The present study analyzed judicial decisions with a view to determining the means of proof liable to carry the most weight in a suit for failure to provide due patient information. MATERIAL AND METHOD: A retrospective qualitative study was conducted for the period from January 2010 to December 2015, by a search on the LexisNexis® JurisClasseur website. Two hundred and one judicial decisions relating to failure to provide due patient information were selected and analyzed to study the characteristics of the practitioners involved, the content of the information at issue and the means of proof provided. The resulting cohort of practitioners was compared with the medical demographic atlas of the French Order of Medicine, considered as exhaustive. RESULTS: Two hundred and one practitioners were investigated for failure to provide information: 45 medical practitioners (22±3%), and 156 surgeons (78±3%) including 45 orthopedic surgeons (29±3.6% of surgeons). Hundred and ninety-three were private sector (96±1.3%) and 8 public sector (4±1.3%). Hundred and one surgeons (65±3.8% of surgeons), and 26 medical practitioners (58±7.4%) were convicted. Twenty-five of the 45 orthopedic surgeons were convicted (55±7.5%). There was no significant difference in conviction rates between surgeons and medical practitioners: odds ratio, 1.339916; 95% CI [0.6393982; 2.7753764] (Chi2 test: p=0.49). Ninety-two practitioners based their defense on a single means of proof, and 74 of these were convicted (80±4.2%). Forty practitioners based their defense on several means of proof, and 16 of these were convicted (40±7.8%). There was a significant difference in conviction rate according to reliance on single or multiple evidence of delivery of information: odds ratio, 0.165; 95% CI [0.07; 0.4] (Chi2 test: p=1.1×10-5). DISCUSSION: This study shows that surgeons, and orthopedic surgeons in particular, are more at risk of being investigated for failure to provide due patient information (D=-0.65 [-0.7; -0.6]). They are not, however, more at risk of conviction (p=0.49). Being in private practice also appeared to be a risk factor for conviction of failure to provide due information. Offering several rather than a single means of proof of delivery of information significantly reduces the risk of conviction (p=1.1×10-5). LEVEL OF EVIDENCE: Level IV: Retrospective study.

[Treatment of prostheto-digestive fistulas using in situ prosthetic bypass]. / Traitement des fistules prothéto-digestives par pontage prothétique in situ.

Secondary aorto-enteric fistula is one of the most serious complications of abdominal aortic reconstruction. Conventional management includes removal of all infected prosthetic graft, oversewing of aortic stump and restoration of lower limbs blood flow by extraanatomic bypass grafting, reporting high rates of mortality, limb loss, and even infection of the extraanatomic grafts. Dissatisfied by these results, frequently, due to aortic stump blowout or extraanatomic by-pass reinfection, some authors attempted a more conservative approach with au in situ replacement by a new synthetic graft. The aim of this paper was to verify the role of in situ graft replacement. From December 1989, 8 patients with secondary aorto-enteric fistula underwent in situ PTFE graft replacement. One patient (12.5%) died perioperatively for acute myocardial infarction. No limb loss occurred. One patient died after 44 months from pulmonary neoplasia without signs of graft infection. The others are doing well at 34 months follow-up. The authors suggest that, in selected patients, in situ prosthetic graft replacement provides better early and late results than extranatomic bypass.

[Renal artery stenosis and aorto-iliac restoration: is it necessary to do extensive evaluation?]. / Sténoses des artères rénales et restauration aorto-iliaque: faut-il faire un bilan extensif?

In patients with aortoiliac disease and a stenosis of one or two renal artery, renal hypertension is rarely the sole mechanism of the elevated blood pressure. The preservation of nephron mass being the aim of the renal revascularization, we firmly believe that only three tests are required for the operative decision: renal ultrasonography, nephroscintigraphy and global and selective aortography.

[The role of vena cava filters in the prevention of pulmonary embolism and hemodynamic changes in the venous system of the lower limbs]. / Il ruolo dei filtri cavali nella prevenzione dell'embolia polmonare e sue applicazioni emodinamiche nel distretto venoso degli arti inferiori.

BACKGROUND: On the basis of recent investigations, pulmonary embolism represents the third cause of death. If only hospitalized population over 65 years of age is considered, this pathology is quite the first cause of mortality. As deep venous thrombosis of the lower limbs represents the main cause of pulmonary embolism (90%), it should be right to suggest interruption of venous flow at caval level. The aim of this prospective report is to evaluate the efficacy of vena cava filter in pulmonary embolism prevention and the hemodynamic variations it can cause in the venous district of lower limbs. METHODS: 137 definitive caval filters were positionated from 1989 to 1996. Average follow-up was 12.6 months. Patients were controlled at 2-7 days, 1 month and than every 6 months. RESULTS: Filter perviousness was observed with Kaplan and Meyer's curve and it was 94.7%. There was pulmonary embolism in just 2 cases (1.4%). Filter perviousness was not depending on anticoagulant treatment. CONCLUSIONS: In conclusion, this prospective experience underlines that: caval filter is effective in pulmonary embolism prophylaxis; there are not important hemodynamic alterations of inferior vena cava, below filter; anticoagulating treatment does not influence filter perviousness; there are not hemodynamic alterations after slight dislocations of caval filter; finally there is a direct relation between level of deep venous thrombosis and post-phlebitic manifestations.

[Peripartum cardiomyopathy. A critical analysis of immunosuppression]. / Cardiomiopatia periparto. Análise critica da immunossupressão.

The authors review the literature about peripartum cardiomyopathy and describe a case of a white woman, 31 years old, primipara, who developed myocardial failure six hours after caesarian operation, with good results after immunosuppressive therapy.

[Intra and postoperative control in carotid surgery]. / Il controllo intra e post-operatorio in chirurgia carotidea.

After fourty years of practice in carotid surgery the rate of neurologic complications related to technical defects seems not to be reduced and still is responsible of 30-40% of all perioperative strokes. Intraoperative quality control seem at present, of outmost importance to further reduce the impact of technical defects on perioperative neurological complications. Angiography, Duplex Scanning and more recently angioscopy have been utilized as intraoperative assessments. All of them demonstrated imperfections of arterial reconstruction potentially at risk for early and late patency failure and indicated immediate intraoperative correction. In some report this behaviour determined a relevant reduction both on perioperative results and lesser incidence of early restenosis. Concerning postoperative control of carotid endarterectomy early restenosis represent the most important and more common failure after carotid endarterectomy. In spite of the efforts to clear the causes of this phenomenon, none of the numerous papers published in literature has defined a specific cause determining restenosis. Nevertheless, at present, this hyperplastic response of the arterial wall to trauma after operation is generally considered benign because rarely is responsible for new neurological symptoms or early internal carotid artery occlusion. This unanimous conviction has been achieved after years of instrumental and clinical postoperative follow-up performed all over the world. At the same time and probably for the above mentioned reasons, recently, has begun a new discussion about the usefulness and cost-effectiveness of prolonged Duplex scanning postoperative surveillance of the endarterectomized carotid arteries. After a meticolous review of our experience as the review of many reports of literature we, in agreement with others, are convinced that the patients operated of carotid endarterectomy, need, in most cases, a short even aggressive period of careful follow up (generally the first six months). If during this period no irregularities or new stenosis is detected at the site of the endarterectomy, we believe that it is justified the patients to be withdrawn from a prolonged instrumental follow-up, permitting laboratory working time to be redirected towards the diagnosis of new vascular diseases.