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Elective Fenestrated and Branched Endovascular Thoraco-abdominal Aortic Repair with Supracoeliac Sealing Zones and without Prophylactic Cerebrospinal Fluid Drainage: Early and Medium-term Outcomes.
No full textOBJECTIVE
To report the outcome of elective fenestrated and branch (FEVAR-BEVAR) endovascular aortic repair with supracoeliac (SC) sealing zones and the impact of staged repair without prophylactic cerebrospinal fluid (CSF) drainage on the incidence of spinal cord ischaemia (SCI).
METHODS
Two hundred and seventy consecutive patients (217 men; mean [SD] age, 72.8 ± 6.3 years; median (IQR) diameter 65 mm [62-75 mm]) with juxtarenal (JRAAA) (n = 69) or thoraco-abdominal aortic aneurysms (TAAAs) (n = 201) underwent elective FEVAR (n = 192) or BEVAR (n = 78) with renovisceral stent grafting, proximal SC (Zones 1-5; <40 mm [n = 83]; ≥40 mm [n = 187]) and distal infrarenal aorto-iliac sealing zone (Zones 9-11) between December 2008 and September 2017. A spinal cord protection protocol (SCPP) including staging without prophylactic CSF drainage was introduced in September 2012.
RESULTS
A total of 1026 renovisceral vessels (mean 3.8 ± 0.5 per patient) were targeted for preservation. One patient (0.4%) died in the institution within 30 days and 31 (11.4%) developed 36 major non-fatal complications including unplanned permanent dialysis (n = 1, 0.4%) and non-ambulatory SCI (n = 6, 2.2%). In patients with <40 mm SC coverage, none were staged or had prophylactic CSF drains and none developed SCI. In patients with ≥40 mm SC coverage, SCI occurred in 3.3% (pre-SCPP: 4/20 [20%; none staged, 13 prophylactic CSF drains] vs. post-SCPP: 2/167 [1.2%; 89 staged, no prophylactic CSF drains]; p = .001 [OR = 19.9]). Estimated survival (±SE) at one, two and three years was 92.6% ± 1.6%, 86.5% ± 2.4%, and 73.8% ± 3.5%, respectively, with no significant difference comparing extent of aneurysm or SC coverage. Forty-three (15.9%) patients required late re-intervention. Estimated freedom from re-intervention at one, two and three years was 91.9% ± 1.8%, 85.1% ± 2.5%, and 79.5% ± 3.2%, respectively.
CONCLUSION
Elective endovascular thoraco-abdominal aortic repair with SC sealing zones can be performed with low peri-operative risk and good medium-term outcomes. Selective staging without prophylactic CSF drainage contributed to a significant reduction in the incidence of SCI
Prophylactic anti-coagulation after severe burn injury in critical care settings.
No full textBackground
Severely burnt patients are at an increased risk of thromboembolic complications, hence sufficient prophylactic anticoagulation is of paramount importance. Local guidelines at the Burns Centre in the Queen Elizabeth Hospital, Birmingham therefore advise increasing the standard dose of low molecular weight heparin in these patients. An audit was carried out to assess the current practice in burns patients to ensure adequate anticoagulation and adherence to guidelines.
Materials and methods
Retrospective data was collected on all burns patients in the Burns Centre over a two-year period. The main objectives were to assess:anticoagulation regimes prescribed to severe burns patientsmonitoring of Anti-Factor Xa levelsadjustment of dosing based on the resultsThe locally produced trust guidelines were used as the comparator.
Results
All burns patients were prescribed anticoagulation, but often the dose was not increased as suggested in the guidelines. Although most of the severely burnt patients were prescribed adjusted higher doses of anti-coagulation, only 60% of these patients were monitored with Anti-Factor Xa assays. Of these assays, 66% showed sub-prophylactic levels. The majority of results led to the adjustment of the dose of anticoagulant. However, often dose changes were made late.
Discussion and conclusions
The audit confirmed the need for increased doses of prophylactic anticoagulation in severe burns. The better adherence to the guidelines can be achieved by additional training and implementation of decision support via electronic prescribing system
SQUID DKA - baseline audit of diabetic ketoacidosis management at a large NHS foundation trust in the West Midlands.
No full text
INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFRamplified glioblastoma.
No full textBACKGROUND
Depatux-M is a tumor-specific antibody-drug-conjugate consisting of an antibody (ABT-806) directed against the activated Epithelial Growth Factor Receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma.
PATIENTS AND METHODS
Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival.
RESULTS
260 patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 months) the hazard ratio (HR) for the combination arm compared to the control arm was 0.71, 95% CI [0.50, 1.02]; p = 0.062. The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI [0.73, 1.48]; p = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grade 3-4 in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28,7 months the HR for the comparison of the combination arm versus the control arm was 0.66 (95%CI [0.48, 0.93].
CONCLUSION
This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406)
Assessing the feasibility and impact of specially adapted exercise interventions, aimed at improving the multi-dimensional health and functional capacity of frail geriatric hospital inpatients: protocol for a feasibility study.
No full textBACKGROUND
Frailty is a common and clinically significant condition in older adults, predominantly due to its association with adverse health outcomes such as hospitalisation, disability and mortality. Exercise interventions have been shown to be a beneficial treatment for frailty. However, more high-quality studies are needed to assess the feasibility and impact of these interventions in frail geriatric populations within different settings, and their impact on broader aspects of health and well-being.
METHODS AND ANALYSIS
This study will use a 2-week, interventional, independent measures research design in order to assess the feasibility and impact of two specially adapted exercise training interventions (a specially adapted resistance training intervention, and Move It Or Lose It: an established community-based exercise intervention for older adults) aimed at improving the multidimensional health and functional capacity of frail geriatric hospital inpatients.
ETHICS AND DISSEMINATION
This study has received a favourable ethical opinion by the Coventry and Warwickshire NHS Research Ethics Committee and sponsorship by the University of Birmingham after review by the sponsors research governance office. The findings will be disseminated through publication in open access scientific journals, public engagement events, online via social media, conference presentations and directly to study participants on request.
TRIAL REGISTRATION NUMBER
NCT03141866
Tuberous Sclerosis Complex (TSC): Expert Recommendations for Provision of Coordinated Care.
No full textThe Acute Kidney Outreach to Prevent Deterioration and Death trial: a large pilot study for a cluster-randomized trial.
No full textBACKGROUND AND OBJECTIVES
The Acute Kidney Outreach to Reduce Deterioration and Death trial was a large pilot study for a cluster-randomized trial of acute kidney injury (AKI) outreach.
METHODS
An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas. In the intervention (after) phase, a working-hours AKI outreach service operated for the intervention hospital/area for 20 weeks, with the other site acting as a control. All AKI alerts in both hospital and community patients were screened for inclusion. Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team. The intervention arm included a model of escalation of renal care to AKI patients, depending on AKI stage. The 30-day primary outcome was a combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage. A total of 1762 adult patients were recruited; 744 at the intervention site during the after phase.
RESULTS
A median of 3.0 non-medication recommendations and 0.5 medication-related recommendations per patient were made by the outreach team a median of 15.7 h after the AKI alert. Relatively low rates of the primary outcomes of death within 30 days (11-15%) or requirement for dialysis (0.4-3.7%) were seen across all four groups. In an exploratory analysis, at the intervention hospital during the after phase, there was an odds ratio for the combined primary outcome of 0.73 (95% confidence interval 0.42-1.26; P = 0.26).
CONCLUSIONS
An AKI outreach service can provide standardized specialist care to those with AKI across a healthcare economy. Trials assessing AKI outreach may benefit from focusing on those patients with 'mid-range' prognosis, where nephrological intervention could have the most impact
Serum 25-hydroxyvitamin D fluctuations in military personnel during 6-month summer operational deployments in Afghanistan.
No full textSoldier operational performance is determined by their fitness, nutritional status, quality of rest/recovery, and remaining injury/illness free. Understanding large fluctuations in nutritional status during operations is critical to safeguarding health and well-being. There are limited data world-wide describing the effect of extreme climate change on nutrient profiles. This study investigated the effect of hot-dry deployments on vitamin D status (assessed from 25-hydroxyvitamin D (25(OH)D) concentration) of young, male, military volunteers. Two data sets are presented (pilot study, n 37; main study, n 98), examining serum 25(OH)D concentrations before and during 6-month summer operational deployments to Afghanistan (March to October/November). Body mass, percentage of body fat, dietary intake and serum 25(OH)D concentrations were measured. In addition, parathyroid hormone (PTH), adjusted Ca and albumin concentrations were measured in the main study to better understand 25(OH)D fluctuations. Body mass and fat mass (FM) losses were greater for early (pre- to mid-) deployment compared with late (mid- to post-) deployment (P<0·05). Dietary intake was well-maintained despite high rates of energy expenditure. A pronounced increase in 25(OH)D was observed between pre- (March) and mid-deployment (June) (pilot study: 51 (sd 20) v. 212 (sd 85) nmol/l, P<0·05; main study: 55 (sd 22) v. 167 (sd 71) nmol/l, P<0·05) and remained elevated post-deployment (October/November). In contrast, PTH was highest pre-deployment, decreasing thereafter (main study: 4·45 (sd 2·20) v. 3·79 (sd 1·50) pmol/l, P<0·05). The typical seasonal cycling of vitamin D appeared exaggerated in this active male population undertaking an arduous summer deployment. Further research is warranted, where such large seasonal vitamin D fluctuations may be detrimental to bone health in the longer-term