[Switch of methoxy-polyethylene-glycol-epoetin beta to darbepoetin alfa in 263 dialysis patients]. / Étude de la conversion du méthoxypolyéthylèneglycol-époétine bêta vers la darbépoétine alfa chez 263 patients hémodialysés.

In early 2012, due to national supply disruption, the methoxy-polyethylene glycol-epoetin beta (CERA) was no longer available and has been replaced by darbepoetin alfa (DA) in all dialysis patients. Official recommendations for the replacement of one by the other is missing or unclear. On this occasion, we wanted to examine how the shift from CERA to DA was done in terms of dose conversion factor and the other factors that could have influenced the dose of DA prescribed (hemoglobin, patient weight, dose of CERA). This retrospective multicenter open conducted in six dialysis centers in Alsace is the first large study (n=263) that evaluated the switch from CERA to DA in all chronic hemodialysis patients. We found that the instantaneous ratio of dose adjustment is close to 1 and that nephrologists are mainly based on the dose of CERA for determining the DA dose, before hemoglobin and weight. However, establishing a true dose-response ratio between the two molecules requires a long term prospective study.

[Physical activity level and home blood pressure measurement: Pilot study "Acti-HTA"]. / Niveau d'activité physique et contrôle ambulatoire de l'hypertension artérielle. Résultats de l'étude pilote « Acti-HTA ¼.

While physical activity (PA) is recommended for high blood pressure management, the level of PA practice of hypertensive patients remains unclear. We aimed to assess the association between the level of both PA and blood pressure of individuals consulting in 9 hypertension specialist centres. Eighty-five hypertensive patients were included (59 ± 14 years, 61% men, 12% smokers, 29% with diabetes). Following their consultation, they performed home blood pressure measurement (HBPM) over 7 days (2 in the morning+2 in the evening), they wrote in a dedicated form their daily activities to estimate the additional caloric expenditure using Acti-MET device (built from International physical Activity Questionnaire [IPAQ]). Thus, patients completed a self-administered questionnaire "score of Dijon" (distinguishing active subjects with a score>20/30, from sedentary<10/30). Subjects with normal HBPM value (<135/85 mm Hg) (55% of them) compared to those with high HBPM were older, had a non-significant trend towards higher weekly caloric expenditure (4959 ± 5045 kcal/week vs. 4048 ± 4199 kcal/week, P=0.3755) and score of Dijon (19.44 ± 5.81 vs. 18.00 ± 4.32, P=0.2094) with a higher proportion of "active" subjects (48.9% vs. 34.2%, P=0.1773). In conclusion, our results demonstrate a "tendency" to a higher level of reported PA for subjects whose hypertension was controlled. This encourages us to continue with a study that would include more subjects, which would assess PA level using an objective method such as wearing an accelerometer sensor.

Influence of dialysis on the glucose profile in patients with diabetes: usefulness of continuous glucose monitoring.

We sought to investigate the impact of dialysis on glucose profiles of diabetic patients using continuous glucose monitoring (CGM). The study included 33 hemodialyzed patients with diabetes (14 females and 19 males; mean age: 66±8 years; patients with type 2 diabetes: 30; mean duration of dialysis: 3.8±2.6 years) who were under insulin treatment. After a run-in period, CGM was performed for 48 h, including a dialysis session. Three CGM sessions were proposed for each patient over a 3-month period. CGM results were analyzed during and after dialysis at 6 different time points. Moreover, data were analyzed in 7 different day periods according to meals. Of the 99 CGM available, 21 were excluded because of technical issues or patient refusal. The CGM results indicated that mean glucose values (7.5±2.5 mmol/l vs. 9.4±1.9 mmol/l; p<0.001) and variability indices (p<0.001) were lower, whereas the frequency of hypoglycemia (4.4±9.6% vs. 2.1±7.9%; p<0.001) was higher during hemodialysis sessions. Significant differences were observed in glucose values only before and 2 h after breakfast (p<0.001). Compared with other day periods, glucose values were lower during the second half of the night and higher before and after dinner (p<0.001). In summary, CGM allows the identification of a particular glucose profile in hemodialyzed diabetic patients. CGM seems feasible and clinically useful for the analysis of glucose profiles in this group of patients.

[Salt, hypertension, and public health]. / Sel, HTA et santé publique.

A modest albeit significant relationship has been demonstrated in the past years among dietary sodium intake, individual as well as population blood pressure levels, and even possibly increase in blood pressure with ageing. Intervention data are still limited but globally suggest the validity of the concept i.e. that limiting sodium intake could reduce by several mm Hg the blood pressure levels in the population at large and significantly decrease the hypertension prevalence. Insofar the feasibility of such measures is uncertain and most of the data suggest that they are better driven by public health policies than individual efforts.

Diabetic nephropathy in the elderly.

Renal impairment is frequent in aged diabetic patients, notably with type 2 diabetes. It results from a multifactorial pathogeny, particularly the combined actions of hyperglycaemia, arterial hypertension and ageing. Diabetic nephropathy (DN) is associated with an increased cardiovascular mortality. DN often leads to end stage renal failure (ESRF) which causes specific problems of decision and practical organization of extra-renal epuration in diabetic and aged patients. In the absence of renal biopsy, clinical signs are often insufficient to assess the diabetic origin of a nephropathy in an elderly diabetic patient. Prevention of DN is principally based on tight glycaemic and blood pressure control. The progression of renal lesions can be retarded by strict blood pressure control, notably by blocking of the renin-angiotensin system, if well tolerated in aged patients. It is absolutely necessary to avoid the worsening of renal lesions by potentially nephrotoxic products, notably non steroidal anti-inflammatory drugs (NSAIDs) and iodinated contrast media. At the stage of renal failure, it is important to adapt the antidiabetic treatment, and in the majority of the cases, to switch to insulin when glomerular filtration rate (GFR) is below 30 ml/mn/1.73 m2.

Laparoscopic resection of type 1 choledochal cysts in pediatric patients.

BACKGROUND: Choledochal cyst resection and hepaticojejunostomy have historically been performed using an open technique. We describe here the largest single experience with this procedure using laparoscopic techniques in eight consecutive pediatric patients. METHODS: There were six girls and two boys, of ages ranging from 3 months to 13 years. All had type I choledochal cysts. Three were asymptomatic, having been noted on prenatal ultrasonography. Five ports were utilized: one 5-mm telescope port at the umbilicus, two 3-mm operating ports on both sides of the umbilicus, one 5-mm left subcostal port for liver retraction, and one LLQ 5-mm assistant port. RESULTS: The median operating time was 155 min (range 110-250 min), with one conversion to an open procedure due to a high transection of the cyst leading to partial retraction of the left hepatic duct into the liver substance. Mean hospital stay was 3 days. At a mean follow-up of 18.8 months, all patients were anicteric and asymptomatic. CONCLUSIONS: Laparoscopic resection of choledochal cysts can be performed safely in pediatric patients with minimal morbidity and good long-term results.

The ontogeny of scarless healing II: EGF and PDGF-B gene expression in fetal rat skin and fibroblasts as a function of gestational age.

Twenty years ago, surgeons noted the ability of early-gestation fetal skin to heal in a scarless manner. Since that time, numerous investigators have attempted to elucidate the mechanisms behind this phenomenon. As a result of this effort, it is now well established that many animals undergo a transition late in development from scarless cutaneous healing to a scar-forming, adultlike phenotype. The authors have been interested in the role played by cytokines known to be involved in the adult wound-healing process and how they relate to scarless repair. They therefore asked the following question: Are genes for epidermal growth factor (EGF) and platelet-derived growth factor-B (PDGF-B) expressed differentially as a function of gestational age in fetal rat skin and dermal fibroblasts? To answer this question, skin from fetal Sprague-Dawley rats (N = 56) at time points that represented both the scarless and scar-forming periods of rat gestation was harvested. In addition, fibroblasts derived from fetal rat skin were cultured in vitro at similar times. These cells were expanded in culture and, when confluent, total ribonucleic acid from both fibroblasts and whole skin was extracted and subjected to Northern blot analysis with probes for EGF and PDGF-B. Results demonstrated that neither EGF nor PDGF-B gene expression changed markedly as a function of gestational age in fetal fibroblasts alone. In whole skin, however, both EGF and PDGF-B demonstrated a marked decrease in gene expression with increasing gestational age. Furthermore, the most striking decrease in gene expression for both cytokines came between 16 and 18 days of gestation-the transition point between scarless and scar-forming repair in the fetal rat. These data suggest that EGF and PDGF may play a role in the mechanism of scarless cutaneous repair. Moreover, it appears that fetal fibroblasts are not the cell type responsible for this differential gene expression. These results raise questions about the unique cytokine milieu likely to be present during the time of scarless healing and the cells that ultimately guide the mechanisms leading to skin regeneration.

Strategic management simulations is a novel way to measure resident competencies.

BACKGROUND: The Strategic Management Simulation (SMS) has been used extensively to test and train higher cognitive functions in persons who occupy professional and leadership positions (i.e., skills like those needed by a surgeon). METHODS: The SMS was used to predict surgical residents' competency in decision making. Skills required for integrative surgical decision making including critical thinking, crisis management, flexibility, factual knowledge, and team building were assessed. Surgical residents with at least 2 years of experience participated. In additional, attending faculty familiar with the residents' work evaluated each resident with a standard comprehensive rating scale. Simulation performance on multiple measures was compared with faculty ratings. RESULTS: A number of measures obtained on simulation performance (eg, activity level, response speed, initiative, adequate usage of and appropriate search for relevant information) generated high correlations with comprehensive faculty assessment (eg, measures of crisis management, team interactions, flexibility of approach). CONCLUSION: The simulation technique is able to accurately assess performance of surgical residents (on a number of parameters) in a relatively brief time period. Simulation data were highly similar to faculty ratings that were based on at least 2 years of experience with the resident.

Use of a human patient simulator in the development of resident trauma management skills.

BACKGROUND: Computerized human patient simulators (HPSs) have been used to improve diagnostic and therapeutic decision making. The goal of this study was to investigate the impact of HPSs and Advanced Trauma Life Support (ATLS) on the development of trauma management skills and self-confidence in surgical interns. METHODS: Three teams of interns completed two ATLS-like trauma scenarios on the HPS (pre-ATLS). They then took the ATLS provider course. After ATLS, the interns were evaluated on two different HPS trauma scenarios (post-ATLS). Two teams of senior residents, experienced in trauma care, completed the same HPS scenarios and were used as controls. Trauma management skills were scored in three areas--critical treatment decisions, potential for adverse outcomes, and team behavior--by staff trauma surgeons. After participating in the HPS trauma scenarios, the interns completed self-confidence questionnaires and a course evaluation survey. RESULTS: Trauma management skill scores increased 23% in critical treatment decisions, 25% in potential for adverse outcomes, and 47% in team behavior after ATLS/HPS (p < 0.002). Senior residents' performance on HPS trauma scenarios was better than the interns (p < 0.05) in all three areas evaluated. The interns' self-confidence scores rose significantly after the course. (p < 0.01) The HPS course evaluation survey averaged 8.3 out of a maximum 10. CONCLUSION: Use of HPSs in conjunction with ATLS appears to enhance the development of trauma management skills. The surgical interns participating in the study deemed the HPS to be a worthwhile experience and a confidence-building tool. In particular, trauma team behavior improved significantly after ATLS/HPS.

Trocar injuries in laparoscopic surgery.

BACKGROUND: Disposable trocars with safety shields are widely used for laparoscopic access. The aim of this study was to analyze risk factors associated with injuries resulting from their use as reported to the Food and Drug Administration. STUDY DESIGN: Manufacturers are required to report medical device-related incidents to the Food and Drug Administration. We analyzed the 629 trocar injuries reported from 1993 through 1996. RESULTS: There were three types of injury: 408 injuries of major blood vessels, 182 other visceral injuries (mainly bowel injuries), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from vascular injuries and 6 (19%) resulted from bowel injuries. Eighty-seven percent of deaths from vascular injuries involved the use of disposable trocars with safety shields and 9% involved disposable trocars with a direct-viewing feature. The aorta (23%) and inferior vena cava (15%) were the vessels most commonly traumatized in the fatal vascular injuries. Ninety-one percent of bowel injuries involved trocars with safety shields and 7% involved direct-view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality rate in this group was 21%. In 41 cases (10%) the surgeon initially thought the trocar had malfunctioned, but in only 1 instance was malfunction subsequently found when the device was examined. The likelihood of injury was not related to any specific procedure or manufacturer. CONCLUSIONS: These data show that safety shields and direct-view trocars cannot prevent serious injuries. Retroperitoneal vascular injuries should be largely avoidable by following safe techniques. Bowel injuries often went unrecognized, in which case they were highly lethal. Device malfunction was rarely a cause of trocar injuries.

Chemo-, regio-, and stereoselective cyclizations of 1,3-bis(trimethylsilyloxy)-1,3-butadienes with alpha-chloroacetic acid chlorides and alpha-chloroacetic acetals.

Treatment of 1,3-bis(trimethylsilyloxy)-1,3-butadienes with alpha-chlorocarboxylic acid chlorides resulted in chemo- and regioselective formation of 6-chloro3,5-dioxo esters, which were regioselectively converted into functionalised 3(2H)furanones. Chemo- and regioselective condensation of 1,3-bis(trimethylsilyloxy)-1,3-butadienes with alpha-chloroacetic dimethyl acetal afforded 6-chloro-5-methoxy-3-oxo esters, which could be regio- and stereoselectively transformed into 2-alkylidene-4-methoxytetrahydrofurans.

Are surgery training programs ready for virtual reality? A survey of program directors in general surgery.

BACKGROUND: The use of advanced technology, such as virtual environments and computer-based simulators (VR/CBS), in training has been well established by both industry and the military. In contrast the medical profession, including surgery, has been slow to incorporate such technology in its training. In an attempt to identify factors limiting the regular incorporation of this technology into surgical training programs, a survey was developed and distributed to all general surgery program directors in the United States. STUDY DESIGN: A 22-question survey was sent to 254 general surgery program directors. The survey was designed to reflect attitudes of the program directors regarding the use of computer-based simulation in surgical training. Questions were scaled from 1 to 5 with 1 = strongly disagree and 5 = strongly agree. RESULTS: A total of 139 responses (55%) were returned. The majority of respondents (58%) had seen VR/CBS, but only 19% had "hands-on" experience with these systems. Respondents strongly agreed that there is a need for learning opportunities outside of the operating room and a role for VR/CBS in surgical training. Respondents believed both staff and residents would support this type of training. Concerns included VR/CBS' lack of validation and potential requirements for frequent system upgrades. CONCLUSIONS: Virtual environments and computer-based simulators, although well established training tools in other fields, have not been widely incorporated into surgical education. Our results suggest that program directors believe this type of technology would be beneficial in surgical education, but they lack adequate information regarding VR/CBS. Developers of this technology may need to focus on educating potential users and addressing their concerns.

G2H--graphics-to-haptic virtual environment development tool for PC's.

For surgical training and preparations, the existing surgical virtual environments have shown great improvement. However, these improvements are more in the visual aspect. The incorporation of haptics into virtual reality base surgical simulations would enhance the sense of realism greatly. To aid in the development of the haptic surgical virtual environment we have created a graphics to haptic, G2H, virtual environment developer tool. G2H transforms graphical virtual environments (created or imported) to haptic virtual environments without programming. The G2H capability has been demonstrated using the complex 3D pelvic model of Lucy 2.0, the Stanford Visible Female. The pelvis was made haptic using G2H without any further programming effort.