Fractionated doses of gemtuzumab ozogamicin with escalated doses of daunorubicin and cytarabine as first acute myeloid leukemia salvage in patients aged 50-70-year old: a phase 1/2 study of the acute leukemia French association

This Phase 1/2 study aimed to determine optimal doses of daunorubicin (DNR; mg/m²) and cytarabine (mg/m²) to be combined with fractionated doses of gemtuzumab ozogamicin (GO, Mylotarg®; 3 mg/m² on day 1, 4, and 7) satisfying safety requirements. Three dose levels of DNR/AraC were investigated namely (45, 100), (60, 100), and (60, 200). Patients included were acute myeloid leukemia in first relapse, aged 50–70 years. Hematological recovery was 31 days for neutrophil and 32 days for platelet counts. A documented infectious episode > Grade 2 occurred in 11/20 patients (55%). None of the 20 patients had signs of veno‐occlusive disease. Overall, eleven patients reached complete remission (CR), two CR with incomplete platelets recovery. The results showed that combination of fractionated GO doses with DNR at 60 mg/m²/d for 3 days and cytarabine at 200 mg/m²/d for 7 days is tolerable and could be further investigated in the front‐line therapy. Am. J. Hematol., 2012. © 2011 Wiley Periodicals, Inc.     

Does the force level modulate the cortical activity during isometric contractions after a cervical spinal cord injury?

ObjectiveThis study investigated the effects of a cervical spinal cord injury (SCI) on the modulation of cortical desynchronization (ERD) during isometric contractions at different force levels.MethodsFor 8 able-bodied (AB) and 6 cervical SCI participants, the net joint moment and electroencephalographic activities were recorded during isometric contractions of the right elbow in flexion and in extension at 3 force levels, that is, during intact and altered muscle contractions for SCI participants. The mean net moment and ～20 Hz ERD from C3 electroencephalographic electrode were compared between AB and SCI participants.ResultsIn flexion, that is, during intact contractions for all participants, the mean net moment and the ERD increased with the required force level. In extension, that is, during altered contractions, the mean net moment increased for 3 SCI participants while it was almost zero for 3 other SCI participants. The associated ERD increased with the required force level for all participants.ConclusionThe cortical desynchronization was modulated by the intent to modulate the force level rather than the actual modulation of the force production.SignificanceThese results provide a better understanding of the modulation of the cortical desynchronization following SCI. Potential applications could include the control of neuroprostheses.     

Morphometry of corpus callosum in Williams syndrome: shape as an index of neural development

Brain abnormalities in Williams syndrome (WS) have been consistently reported, despite few studies have devoted attention to connectivity between different brain regions in WS. In this study, we evaluated corpus callosum (CC) morphometry: bending angle, length, thickness and curvature of CC using a new shape analysis method in a group of 17 individuals with WS matched with a typically developing group. We used this multimethod approach because we hypothesized that neurodevelopmental abnormalities might result in both volume changes and structure deformation. Overall, we found reduced absolute CC cross-sectional area and volume in WS (mean CC and subsections). In parallel, we observed group differences regarding CC shape and thickness. Specifically, CC of WS is morphologically different, characterized by a larger bending angle and being more curved in the posterior part. Moreover, although CC in WS is shorter, a larger relative thickness of CC was found in all callosal sections. Finally, groups differed regarding the association between CC measures, age, white matter volume and cognitive performance. In conclusions, abnormal patterns of CC morphology and shape may be implicated in WS cognitive and behavioural phenotype.     

Pediatric Single‐Lumen Cannula Venovenous Extracorporeal Membrane Oxygenation: A French Center Experience

Single‐lumen cannula venovenous (VV) extracorporeal membrane oxygenation (ECMO) is a special extracorporeal life support (ECLS) technique used for neonatal and pediatric refractory hypoxemia. This is an alternative flow rate ECLS that consists of successive clamping on the drainage and the injection lines. Currently, the Armand‐Trousseau's pediatric intensive care unit remains the only pediatric ECMO center proposing this partial assistance. This article details a technical note and a retrospective analysis of our experience in refractory hypoxemia. The retrospective study, from 2007 to 2011, included all pediatric and neonatal patients treated by single‐lumen cannula VV ECMO. The study was focused on pre‐ECMO patient characteristics and complications during ECMO course. During the last 5 years, 67 pediatric patients were assisted by this single‐lumen cannula VV ECMO. Sixty‐one patients (91%) were newborns. Thirty‐nine patients presented with meconium aspiration syndrome (58%), which was the most frequent etiology. Before cannulation, mean oxygenation index (OI) was 32 ± 11, alveolar‐arterial oxygen difference was 604 ± 47 mm Hg, and partial pressure arterial oxygen/fraction inspired oxygen ratio was 59.2 ± 35.8. Forty‐eight patients (72%) presented pulmonary hypertension, and 66 patients were treated by nitric oxide (98%). Fifty patients (75%) were treated by vasopressors or inotropic drugs. Average duration of ECMO was 13.2 ± 7.8 days. There were forty‐six survivors (69%). The worst prognosis was for respiratory syncytial virus pneumonia. Complications like acute renal injury and hematologic and transfusion acts were not so different than those observed in classical ECMO techniques. Nevertheless, 19 patients presented a stroke (28% of the overall population), but this high rate did not seem to be due to the ECLS technique used. Single‐lumen cannula VV ECMO is a partial and efficient ECMO support. Our experience shows that this technique is as efficient and less invasive than two cannulas ECMO. The single‐lumen cannula VV ECMO is a simple and safe ECLS support used for neonatal or pediatric refractory hypoxemia. Because this is a partial assistance, it is a promising ECLS support.     

Impact of Excess Skin from Massive Weight Loss on the Practice of Physical Activity in Women

Background

Over 70 % of people who undergo bariatric surgery (BS) develop excess skin (ES). The physical and psychosocial consequences of ES may become a barrier to the practice of physical activity (PA), which is highly recommended to optimize the results of BS. The purpose of this study was to evaluate the impact of ES on the practice of PA in women who have undergone BS.

Methods

Questionnaires administered to 26 women having undergone BS 2?±?0.2 years before (BMI?=?29.1?±?0.8 kg/m²) evaluated the impacts of ES, the practice of PA, physical self-perception, and physical exercise beliefs. We also used the 6-min walking test and muscular endurance tests to evaluate physical fitness and photographs with anatomical markers to quantify ES.

Results

Of the women, 76.9 % declared mobility limitations due to ES during the practice of PA and 45.2 % stated avoiding PA because of ES which caused flapping and unwelcome stares from others. The women who stated that they avoided PA because of ES had significantly lower physical self-perception and physical fitness and reported experiencing more embarrassment during PA despite no significant difference in the magnitude of ES (p?=?0.06), BMI, daily life inconveniences, and energy expenditure compared to those women who did not avoid PA.

Conclusion

Although ES after BS is a barrier to the practice of PA for some women, it does not in itself prevent the regular practice of PA. The main reason women with ES avoid PA seems to have less to do with the magnitude of ES itself and more with psychosocial inconveniences.     

“GIOSAT”: a tool to assess CanMEDS competencies during simulated crises

Purpose

Our objective was to develop and evaluate a Generic Integrated Objective Structured Assessment Tool (GIOSAT) to integrate Medical Expert and intrinsic (non-medical expert) CanMEDS competencies with non-technical skills for crisis simulation.

Methods

An assessment tool was designed and piloted using two pediatric anesthesia scenarios (laryngospasm and hyperkalemia). Following revision of the tool, we used previously recorded videos of anesthesia residents (n = 50) who managed one of two intraoperative advanced cardiac life support (ACLS) scenarios (ventricular tachycardia or ventricular fibrillation). Four independent trained raters, blinded to the residents’ level of training, analyzed the video recordings using the GIOSAT scale. Inter-rater reliability was calculated using intraclass correlations (ICCs) for single raters (single measure) and the average of the four raters (average measure), and construct validity was investigated by correlating GIOSAT scores with postgraduate year of residency (PGY).

Results

Total GIOSAT scores for the ACLS scenarios had single measure ICCs of 0.62 and average measure ICCs of 0.85. Inter-rater reliability was substantial for both Medical Expert and intrinsic competencies (single measure ICCs 0.69 and 0.62, respectively; average measure ICCs 0.90 and 0.82, respectively). We found significant correlations between PGY level and total GIOSAT score (r = 0.36; P = 0.011) and between PGY level and Medical Expert competencies (r = 0.42; P = 0.003); however, correlations were not found between PGY level and intrinsic CanMEDS competencies (r = 0.24; P = 0.09).

Conclusion

Inter-rater reliability of the total GIOSAT scores using four trained raters was substantial. Significant correlation between PGY and (i) total GIOSAT score and (ii) Medical Expert competencies supports construct validity. Evidence of validity was not obtained for intrinsic CanMEDS competencies.     

Comparison between single-incision and conventional laparoscopic cholecystectomy: a prospective trial of the Club Coelio

Background

The aim of this study was to compare the outcomes of single-incision laparoscopic cholecystectomy (SILC) and conventional laparoscopic cholecystectomy (CLC).

Method

Patients’ inclusion criteria were uncomplicated gallstones, BMI ≤30, ASA score ≤2, and no past surgery in the upper abdomen. Five surgeons performed only SILC and seven only CLC. Data analyzed included operative time, morbidity, quality of life (QOL), cosmetic result, and global patient satisfaction. The last three parameters were evaluated 3 months after surgery. QOL was assessed with the Gastrointestinal Quality of Life Index (GIQLI) questionnaire. Cosmetic result and patient satisfaction were rated using a 5-grade Likert scale.

Results

This study included 104 patients operated on between April and June 2010. A SILC was performed in 35 patients and a CLC in 69. The preoperative characteristics of the two groups were similar. Median operative time for SILC was higher than that for CLC: 55 versus 40 min (p < 0.001). Postoperative complications (0 vs. 2) and postoperative GIQLI scores (123 ± 13 vs. 121 ± 18) were not significantly different between groups. Cosmetic result and patient satisfaction were better for SILC than for CLC. The percentages of results rated as excellent were 68 versus 37 % (p < 0.006) and 80 versus 57 % (p < 0.039), respectively. For the whole group, multivariate statistical analysis revealed that postoperative GIQLI score and cosmetic result were independent predictive factors of patient satisfaction. The percentages of satisfaction rated as excellent were greater in patients who had a postoperative GIQLI score ≥130 (92 vs. 49 %, odds ratio [OR] = 4, p < 0.001) and in patients who had an excellent cosmetic result (82 vs. 47 %, OR = 7, p < 0.001).

Conclusions

Compared to CLC, SILC is associated with a longer operative time, an equivalent morbidity and QOL, and a better cosmetic result. The improved aesthetic result also leads to a better global patient satisfaction.