Modular Femoral Sleeve and Stem Implant Provides Long-term Total Hip Survivorship

Background  

A femoral implant with a modular sleeve and stem has been designed to allow independent and complete metaphyseal-diaphyseal fit and fill as well as independent rotation to accommodate anteversion at the time of THA.     

Optic disc haemorrhages and vascular abnormalities in a glaucoma population

Purpose: To retrospectively examine the optic disc photographs of a glaucoma population for optic disc haemorrhages, vascular occlusions and vascular abnormalities. Methods: The optic disc photographs of 906 eyes of glaucoma and suspect glaucoma patients were examined. Optic disc photographs were taken annually, where possible, with the follow-up period varying between 1 and 14 years duration (mean, 2.89). Glaucoma patients are regularly reviewed every 4–6 months and glaucoma suspects every 1–2 years, depending on the ophthalmologist. Low-tension glaucoma patients were reviewed more frequently (mean, every 2.6 months). The results of the findings were compared to a control group of 39 subjects with a mean follow-up period of 7 years, using Fisher's exact test. Results: It was found that during the period under review, 7.4% (n= 67) of eyes had optic disc haemorrhages. The highest frequency of optic disc haemorrhages (37.5%) was found in the low tension glaucoma group (P= 0.0001) followed by 11.4% of primary open-angle glaucoma eyes (P= 0.03). In the normal group there were three eyes with optic disc haemorrhages and one with a disc collateral, which constitutes 5.1% vascular changes in this sub-group. Of the study eyes 2.8% had central retinal vein occlusions, 1.3% branch vein occlusion, 1.2% disc vessel abnormalities (loops) and 1.1% disc collaterals. Discrete nerve fibre layer haemorrhages and microaneurysms were found in 0.8% and 1.8% of eyes, respectively. Conclusions: A total of 16.8% of the eyes observed in this study had either disc haemorrhages or vascular changes. The underlying trend of vascular and haemorrhagic changes in glaucoma are demonstrated in this sample, which is in general agreement with previous studies. The high percentage of optic disc haemorrhages in low tension glaucoma is highlighted. The presence of microaneurysms and nerve fibre layer haemorrhages is interesting but of unknown significance.     

Seizures following cardiac surgery: the impact of tranexamic acid and other risk factors

Background

Seizures after cardiac surgery are a serious complication. The antifibrinolytic agent tranexamic acid (TA), which has known proconvulsant properties, may be associated with postoperative seizures. We sought to determine the association between TA and other risk factors for seizures after cardiac surgery.

Methods and results

We analyzed a database of consecutive cardiac surgery patients (April 2003 to December 2009) using multivariable logistic regression analysis to assess for seizure risk factors. Seizures occurred in 56 of 5,958 patients (0.94%). TA use was associated with an increased risk of seizures (odds ratio 7.4, 95% confidence interval 2.8?C19.3; P??20; preoperative cardiac arrest; preoperative neurological disease; open chamber surgery; cardiopulmonary bypass time?>?150?min; and previous cardiac surgery. Seizures occurred at a median of 5.3 hr (interquartile range 2.4?C15.1 hr) after the end of surgery. In all, 58.1% were grand mal, 14.5% were associated with a stroke, and 58.1% recurred in hospital. Altogether, 48.3% of the patients were able to discontinue anticonvulsant medications prior to discharge. Compared to the non-seizure group, seizure patients had an increased rate of postoperative neurological complications, defined as delirium and/or stroke (3.2% vs 19.6%, P?vs 4.7?days, P?<?0.001), and increased ICU mortality (1.4 % vs 9.7 %, P?=?0.001).

Conclusions

Our data suggest that multiple risk factors, including TA, are associated with seizures after cardiac surgery. Thus, the TA dose may be a readily modifiable risk factor for postoperative seizures.     

An application of a proposed framework for formulary listing in low-income countries

Background

The General Mutual Benefit Fund for Civil Servants and State Employees of Côte d’Ivoire (MUGEFCI; Mutuelle Générale des Fonctionnaires et Agents de l’État de Côte d’Ivoire) is a health mutual fund providing coverage (medical consultations, laboratory tests and treatment) for its enrolees (government officials and agents). This organization aims to improve its current drug reimbursement process because of budgetary constraints. One method of achieving this is to implement a formulary-listing framework specifically developed for low-income countries.

Objective

The aim of this study was to evaluate the feasibility of developing a new formulary for the MUGEFCI in Côte d’Ivoire, by implementing a formulary-listing framework specifically designed for under-researched settings.

Methods

The application of this formulary-listing framework (based on multi-criteria decision analysis [MCDA]) consisted of four steps. First, relevant formulary-listing criteria and their levels of variation were identified and weighted according to their importance in the decision making around drug reimbursement. Second, a set of priority treatments to be assessed was determined. Once the treatments eligible for reimbursement were determined, scores were assigned to these treatments according to their performance on the formulary-listing criteria levels. Finally, a composite league table (weighted matrix) was constructed to rank the set of treatments by priority order of reimbursement. A budget-impact analysis (BIA) was also conducted to appraise the economic implications of the new composite drugs league table. The extent to which the new priority list of reimbursable drugs was affordable for the MUGEFCI was then measured.

Results

Policy makers in Côte d’Ivoire considered severity of disease and cost effectiveness of treatment to be the most significant criteria for priority reimbursement of drugs. This translated into a general preference for antimalarials, treatments for asthma and antibacterials for urinary tract infection. Moreover, the results of the BIA suggest that the new priority list of reimbursable drugs would be affordable if the real economic impact of drugs per member is less than $US66. Over this threshold, the MUGEFCI would have to select reimbursable drugs according to their rank in the priority list and their respective budget impact per patient (cost per patient). This selection would start from the first treatment, going down the list until the $US66 per patient is exhausted.

Conclusion

It was possible to use MCDA to simultaneously consider different decision criteria for drug reimbursement in Côte d’Ivoire; therefore, it is feasible to use MCDA to establish a formulary for low-income countries. The application of this method is a step towards transparency in policy making.     

Relationship between opioid treatment and rate of healing in chronic wounds

Opioids are routinely used analgesics in patients with chronic wounds; however the impact of opioid exposure on wound healing is poorly understood. The purpose of this study was to investigate the association between opioid exposure and wound outcome in the Wound Etiology and Healing study. This longitudinal observational study was conducted on 450 subjects enrolled in the Wound Etiology and Healing biorepository. Data were collected prospectively including baseline characteristics, pain score, longitudinal opioid exposure, and total wound surface area (tWSA). Data were analyzed using static multivariate models, fixed‐effects mixed models, and time to event analysis. Using fixed‐effects models, opioid dose was significantly associated with tWSA after accounting for the effects of pain score and baseline co‐variates (p < 0.0001). For each 1‐unit increase in ln(opioid dose + 1) the ln(tWSA + 1) increased by 0.16 units (95% confidence interval 0.13–0.19, p < 0.0001). Visits where opioids were present had ln(tWSA + 1) 0.48 units larger (95% confidence interval 0.38–0.58, p < 0.0001) than visits with no opioid exposure. Using time‐to‐event analysis, patients who never received opioids healed faster than those who received opioids (log‐rank chi‐square 11.00, p  = 0.0009). Using Cox regression analysis, patients with mean opioid dose ≥10 mg were significantly less likely to heal than those with no opioid (HR 0.67 [0.49–0.91], p = 0.011) after adjusting for wound size. Patients with opioid dose >0 to <10 mg had a similar hazard of not healing as those with no opioid exposure (HR 0.88 [0.65–1.19], p = 0.40). In conclusion, opioid analgesics are commonly prescribed to patients with chronic wounds; however, the data presented suggest that opioid exposure is associated with reduced likelihood of healing in patients with chronic wounds. Whether this is a causal relationship will require further study.     

Prospective study of erythropoietin use on quality of life and cost effectiveness in acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation patients

BACKGROUND:

Despite frequent anemia and multiple transfusions in patients undergoing chemotherapy and allogeneic hematopoietic stem cell transplantation (allo‐HSCT) for acute myeloid leukemia , recommendations for use of erythropoiesis‐stimulating agents (ESAs) in these populations are still missing. The primary objective was the effect of ESA administration on patient's quality of life (QoL). Secondary objectives were hemoglobin (Hb) recovery, red blood cell (RBC) transfusions, overall survival, and event‐free survival.

METHODS:

Adult patients with Hb ≤ 11 g/dL after consolidation chemotherapy for acute myeloid leukemia (group 1), or after allo‐HSCT for any hematological diseases (group 2), were prospectively included. ESA was administered subcutaneously once per week during a maximum period of 6 months and was stopped when Hb level reached 12 g/dL. A paired‐matched analysis using a historical control group was performed for secondary endpoints. Fifty‐two patients were included in group 1, and 55 patients were in group 2.

RESULTS:

For the global population, a significant improvement of QoL was noticed with ESA use; 83% (group 1) and 71% (group 2) of patients achieved an Hb level ≥ 12 g/dL without transfusion requirement. The pair‐matched analysis showed a reduction of 4 RBC units per patient in group 1 (P = .0002) and 3 RBC units per patient in group 2 (P = .04). No significant difference in terms of thromboembolic events, overall survival, and event‐free survival was observed between ESA and control groups. A RBC transfusion median savings of €1712 per patient was estimated in each group.

CONCLUSIONS:

ESAs have a clinical and economic benefit on Hb recovery, could improve a patient's QoL, and lead to a significant reduction in number of RBC transfusions with no effect on survival. Cancer 2013. © 2012 American Cancer Society.