Patient-Controlled Analgesia and Length of Hospital Stay in Orthognathic Surgery: A Randomized Controlled Trial.

PURPOSE: The objective of this prospective, randomized controlled pilot study of patients undergoing orthognathic surgery was to compare the hospital length of stay (LOS) in patients using intravenous patient-controlled analgesia (PCA) versus patients receiving scheduled and as-needed oral analgesia. PATIENTS AND METHODS: A total of 40 patients (19 male and 21 female patients) aged 16 to 56 years (mean, 20.73 years; standard deviation, 6.87 years) were recruited prospectively and randomized to PCA and non-PCA groups of equal size. Recording of the patient-reported pain score using a visual analog scale was commenced at 8:00 am on day 1 after surgery until discharge. The pain score from routine nursing observations during the postoperative period was recorded until the patient was discharged from the hospital. RESULTS: Randomization resulted in approximately equal proportions of male patients (45% vs 50%) and median ages (18.5 years vs 20 years) for the PCA group versus the non-PCA group; however, the PCA group was noted to have a higher proportion of double-jaw surgery (65% vs 40%). The median LOS was 2 days for both the PCA and non-PCA groups (P = .06). No statistically significant difference in pain scores was found between the 2 groups either at rest (P = .27) or on movement (P = .13). CONCLUSIONS: No evidence was found to indicate the superiority of either the PCA or non-PCA regimen with respect to LOS and pain scores; however, this is not evidence of equivalence of the 2 pain management approaches.

First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease.

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Improved outcomes and reduced costs associated with a health-system-wide patient blood management program: a retrospective observational study in four major adult tertiary-care hospitals.

BACKGROUND: Patient blood management (PBM) programs are associated with improved patient outcomes, reduced transfusions and costs. In 2008, the Western Australia Department of Health initiated a comprehensive health-system-wide PBM program. This study assesses program outcomes. STUDY DESIGN AND METHODS: This was a retrospective study of 605,046 patients admitted to four major adult tertiary-care hospitals between July 2008 and June 2014. Outcome measures were red blood cell (RBC), fresh-frozen plasma (FFP), and platelet units transfused; single-unit RBC transfusions; pretransfusion hemoglobin levels; elective surgery patients anemic at admission; product and activity-based costs of transfusion; in-hospital mortality; length of stay; 28-day all-cause emergency readmissions; and hospital-acquired complications. RESULTS: Comparing final year with baseline, units of RBCs, FFP, and platelets transfused per admission decreased 41% (p < 0.001), representing a saving of AU$18,507,092 (US$18,078,258) and between AU$80 million and AU$100 million (US$78 million and US$97 million) estimated activity-based savings. Mean pretransfusion hemoglobin levels decreased 7.9 g/dL to 7.3 g/dL (p < 0.001), and anemic elective surgery admissions decreased 20.8% to 14.4% (p = 0.001). Single-unit RBC transfusions increased from 33.3% to 63.7% (p < 0.001). There were risk-adjusted reductions in hospital mortality (odds ratio [OR], 0.72; 95% confidence interval [CI], 0.67-0.77; p < 0.001), length of stay (incidence rate ratio, 0.85; 95% CI, 0.84-0.87; p < 0.001), hospital-acquired infections (OR, 0.79; 95% CI, 0.73-0.86; p < 0.001), and acute myocardial infarction-stroke (OR, 0.69; 95% CI, 0.58-0.82; p < 0.001). All-cause emergency readmissions increased (OR, 1.06; 95% CI, 1.02-1.10; p = 0.001). CONCLUSION: Implementation of a unique, jurisdiction-wide PBM program was associated with improved patient outcomes, reduced blood product utilization, and product-related cost savings.

Increased hospital costs associated with red blood cell transfusion.

BACKGROUND: Red blood cell (RBC) transfusion is independently associated in a dose-dependent manner with increased intensive care unit stay, total hospital length of stay, and hospital-acquired complications. Since little is known of the cost of these transfusion-associated adverse outcomes our aim was to determine the total hospital cost associated with RBC transfusion and to assess any dose-dependent relationship. STUDY DESIGN AND METHODS: A retrospective cohort study of all multiday acute care inpatients discharged from a five hospital health service in Western Australia between July 2011 and June 2012 was conducted. Main outcome measures were incidence of RBC transfusion and mean inpatient hospital costs. RESULTS: Of 89,996 multiday, acute care inpatient discharges, 4805 (5.3%) were transfused at least 1 unit of RBCs. After potential confounders were adjusted for, the mean inpatient cost was 1.83 times higher in the transfused group compared with the nontransfused group (95% confidence interval, 1.78-1.89; p < 0.001). The estimated total hospital-associated cost of RBC transfusion in this study was AUD $77 million (US $72 million), representing 7.8% of total hospital expenditure on acute care inpatients. There was a significant dose-dependent association between the number of RBC units transfused and increased costs after adjusting for confounders. CONCLUSION: RBC transfusions were independently associated with significantly higher hospital costs. The financial implication to hospital budgets will assist in prioritizing areas to reduce the rate of RBC transfusions and in implementing patient blood management programs.

Vitamin D status and predictors of serum 25-hydroxyvitamin D concentrations in Western Australian adolescents.

Despite the importance of skeletal growth during adolescence, there is limited research reporting vitamin D status and its predictors in adolescents. Using prospective data from the Western Australian Pregnancy Cohort (Raine) Study, we investigated vitamin D status and predictors of serum 25-hydroxyvitamin D (25(OH)D) concentrations in adolescents. Serum 25(OH)D concentrations were measured in the same participants at 14 and 17 years (n 1045 at both time points). The percentage of adolescents with serum 25(OH)D concentrations < 50, 50-74·9 and ≥ 75 nmol/l was reported year-round and by month of blood collection. We examined the predictors of serum 25(OH)D concentrations, including sex, race, month of blood collection, physical activity, BMI, family income, and Ca and vitamin D intakes (n 919 at 14 years; n 570 at 17 years), using a general linear mixed model. At 14 years, 31 % of adolescents had serum 25(OH)D concentrations between 50 and 74·9 nmol/l and a further 4 % had concentrations < 50 nmol/l. At 17 years, 40 % of adolescents had serum 25(OH)D concentrations between 50 and 74·9 nmol/l and 12 % had concentrations < 50 nmol/l. Caucasian ethnicity, being sampled at the end of summer, exercising more, having a lower BMI, a higher Ca intake and a higher family income were significantly associated with higher serum 25(OH)D concentrations. The proportion of adolescents with serum 25(OH)D concentrations < 50 nmol/l was low in this Western Australian cohort. There is a need for international consensus on defining adequate vitamin D status in order to determine whether strategies to increase vitamin D status in adolescents are warranted.

Anaphylaxis: clinical patterns, mediator release, and severity.

BACKGROUND: Prospective human studies of anaphylaxis and its mechanisms have been limited, with few severe cases or examining only 1 or 2 mediators. OBJECTIVES: We wanted to define the clinical patterns of anaphylaxis and relationships between mediators and severity. METHODS: Data were collected during treatment and before discharge. Serial blood samples were taken for assays of mast cell tryptase, histamine, anaphylatoxins (C3a, C4a, C5a), cytokines (IL-2, IL-6, IL-10), soluble tumor necrosis factor receptor I, and platelet activating factor acetyl hydrolase. Principal component analysis defined mediator patterns, and logistic regression identified risk factors and mediator patterns associated with reaction severity and delayed reactions. RESULTS: Of 412 reactions in 402 people, 315 met the definition for anaphylaxis by the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network. Of 97 severe reactions 45 (46%) were hypotensive, 23 (24%) were hypoxemic, and 29 (30%) were mixed. One patient died. Severe reactions were associated with older age, pre-existing lung disease, and drug causation. Delayed deteriorations treated with epinephrine occurred in 29 of 315 anaphylaxis cases (9.2%) and were more common after hypotensive reactions and with pre-existing lung disease. Twenty-two of the 29 delayed deteriorations (76%) occurred within 4 hours of initial epinephrine treatment. Of the remaining 7 cases, 2 were severe and occurred after initially severe reactions, within 10 hours. All mediators were associated with severity, and 1 group (mast cell tryptase, histamine, IL-6, IL-10, and tumor necrosis factor receptor I) was also associated with delayed deteriorations. Low platelet activating factor acetyl hydrolase activity was associated with severe reactions. CONCLUSION: The results suggest that multiple inflammatory pathways drive reaction severity and support recommendations for safe observation periods after initial treatment.

Measuring the incidence of hospital-acquired complications and their effect on length of stay using CHADx.

OBJECTIVES: To use an automated Classification of Hospital Acquired Diagnoses (CHADx) reporting system to report the incidence of hospital-acquired complications in inpatients and investigate the association between hospital-acquired complications and hospital length of stay (LOS) in multiday-stay patients. DESIGN: Retrospective cross-sectional study for calendar years 2010 and 2011. SETTING: South Metropolitan Health Service in Western Australia, which consists of two teaching and three non-teaching hospitals. MAIN OUTCOME MEASURES: Incidence of hospital-acquired complications and mean LOS for multiday-stay patients. RESULTS: Of 436 841 inpatient separations, 29 172 (6.68%) had at least one hospital-acquired complication code assigned in the administrative data, and there were a total of 56 326 complication codes. The three most common complications were postprocedural complications; cardiovascular complications; and labour, delivery and postpartum complications. In the subset of data on multiday-stay patients, crude mean LOS was longer in separations for patients with hospital-acquired complications than in separations for those without such complications (17.4 days v 5.4 days). After adjusting for potential confounders, separations for patients with hospital-acquired complications had almost four times the mean LOS of separations for those without such complications (incident rate ratio, 3.84; 95% CI, 3.73-3.96; P < 0.001). CONCLUSIONS: An automated CHADx reporting system can be used to collect data on patients with hospital-acquired complications. Such data can be used to increase emphasis on patient safety and quality of care and identify potential opportunities to reduce LOS.

Correlation of paired toxic plasma and saliva paracetamol concentrations following deliberate self-poisoning with paracetamol.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: • Paracetamol is commonly used in deliberate self poisoning (DSP) and this requires blood sampling to refine risk assessment. If saliva concentrations agreed with plasma concentrations, then this could support the development of non-invasive testing. Our pilot work supports this hypothesis, but was largely confined to nontoxic concentrations. WHAT THIS STUDY ADDS: • We found agreement between the indications for treatment of paracetamol DSP based on plasma and saliva paracetamol concentrations. Saliva may hold promise as a non-invasive method to risk stratify paracetamol poisoning. AIMS: Paracetamol is commonly used in deliberate self poisoning (DSP) and requires blood sampling to refine risk assessment. We aimed to test the agreement between plasma and saliva paracetamol concentrations in the toxic range in DSP. METHODS: Contemporaneous paired plasma and saliva paracetamol concentrations were measured. Saliva was collected using a Sarstedt Salivette® device and the concentration was measured using a colorimetric method. RESULTS: Fifty-six patients (44, 78% female) median age 26 years (IQR 20-41) were enrolled. The median reported paracetamol ingestion was 10 g (IQR 6-14). Specimens were collected at a median of 4 h (IQR 4-5.3) post ingestion. The median plasma and saliva paracetamol concentrations were 29 mg l(-1) (IQR 8-110) and 38 mg l(-1) (IQR 10-105) respectively [mean difference 8 mg l(-1) , 95% confidence interval (CI) 2, 14]. Lin's concordance correlation was 0.97 (95% CI 0.96, 0.98). There were 15 patients who were treated with N-acetylcysteine. Their median reported paracetamol ingestion was 14 g (IQR 10-23) and samples were collected at a median of 4 h post ingestion. The median plasma and saliva paracetamol concentrations were 167 mg l(-1) (IQR 110-200) and 170 mg l(-1) (IQR 103-210) respectively (mean difference 15 mg l(-1) , 95% CI -4, 35). Lin's concordance correlation was 0.94 (95% CI 0.88, 0.99). No patient needing treatment would have been missed using saliva concentrations only. CONCLUSIONS: The agreement between the indications for treatment of paracetamol DSP based on plasma and saliva paracetamol concentrations extends into the toxic range, but with slightly lower agreement. Saliva may hold promise as a non-invasive method to risk stratify paracetamol poisoning.

A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease.

OBJECTIVE: This trial was conducted to determine if covered stents offer a patency advantage over bare-metal stents in the treatment of aortoiliac arterial occlusive disease. METHODS: The Covered Versus Balloon Expandable Stent Trial (COBEST), a prospective, multicenter, randomized controlled trial, was performed involving 168 iliac arteries in 125 patients with severe aortoiliac occlusive disease who were randomly assigned to receive a covered balloon-expandable stent or bare-metal stent. Patient demographic data, clinical signs and symptoms, TransAtlantic Inter-Society Consensus (TASC) classification, and preprocedure and postprocedure ankle-brachial index measurements were recorded. The primary end points included freedom from binary restenosis and stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography, or both. Postprocedural follow-up was at 1, 6, 12, and 18 months. RESULTS: Aortoiliac lesions treated with a covered stent were significantly more likely to remain free from binary restenosis than those that were treated with a bare-metal stent (hazard ratio [HR], 0.35; 95% confidence interval (CI), 0.15-0.82; P = .02). Freedom from occlusion was also higher in lesions treated with covered stents than in those treated with a bare-metal stent (HR, 0.28; 95% CI, 0.07-1.09); however, this did not reach statistical significance (P = .07). Subgroup analyses demonstrated a significant difference in freedom from binary restenosis for covered stents in TASC C and D lesions compared with a bare stent (HR, 0.136; 95% CI, 0.042-0.442). This difference was not demonstrated for TASC B lesions (HR, 0.748; 95% CI, 0.235-2.386). CONCLUSIONS: COBEST demonstrates covered and bare-metal stents produce similar and acceptable results for TASC B lesions. However, covered stents perform better for TASC C and D lesions than bare stents in longer-term patency and clinical outcome.

Multicentre Covariate Adjustment Analysis of Short-Term and 5-Year Outcomes after Endovascular Repair according to Sex.

BACKGROUND: Several studies have reported worse outcomes in women compared to men after endovascular aneurysm repair (EVAR). This study aimed to evaluate sex-specific short-term and 5-year outcomes after EVAR. METHODS: A total of 409 consecutive patients underwent elective EVAR from 2004 to 2017 at two tertiary hospitals in Western Australia. Baseline, intraoperative, and postoperative variables were examined retrospectively according to sex. The primary outcome was 30-day mortality (death within 30 days after EVAR). Secondary outcomes were 30-day composite endpoint, length of stay after EVAR, 5-year survival, freedom from reintervention, residual aneurysm size after EVAR, and major adverse event rate at 5-year follow-up. RESULTS: A cohort of 409 patients, comprising 57 women (14%) and 352 men (86%), was analysed. Female patients were older (median age, 76.8 versus 73.5 years, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%. CONCLUSION: This study found no significant differences in 30-day and 5-year outcomes between female and male patients treated with EVAR, implying that EVAR remains a safe treatment choice for female patients.

Production of IgG antibodies to pneumococcal polysaccharides is associated with expansion of ICOS+ circulating memory T follicular-helper cells which is impaired by HIV infection.

Dysfunction of T follicular-helper (TFH) cells is a possible cause of impaired germinal centre (GC) and IgG antibody responses in individuals with human immunodeficiency virus-1 (HIV-1) infection and might contribute to decreased magnitude and isotype diversification of IgG antibodies to pneumococcal polysaccharides (PcPs). We examined the production of IgG1 and IgG2 antibodies to PcPs 4, 6B, 9V and 14 by enumerating antibody secreting cells (ASCs) at day (D) 7 and determining fold-increase in serum antibody levels at D28 after vaccination with unconjugated PcPs in HIV seronegative subjects (n = 20) and in HIV patients who were receiving antiretroviral therapy (ART) (n = 28) or who were ART-naive (n = 11) and determined their association with ICOS+ and ICOS- circulating memory TFH (cmTFH) cells (CD4+CD45RA-CD27+CXCR5+PD-1+) and short lived plasmablasts (SPBs) at D7, and with PcP-specific and total IgM+ and IgG+ memory B cells at D0. In HIV seronegative subjects, production of IgG1+ and IgG2+ ASCs was consistently associated with the frequency of ICOS+ cmTFH cells but not ICOS- cmTFH cells or memory B cells. In contrast, post-vaccination ASCs in HIV patients, regardless of ART status, were lower than in HIV seronegative subjects and not associated with ICOS+ cmTFH cells, the expansion of which was absent (ART-naive patients) or much lower than in HIV seronegative subjects (ART-treated patients). Production of SPBs was also lower in ART-naive patients. Fold-increase in IgG2 antibodies at D28 also correlated with ICOS+ cmTFH cells at D7 in HIV seronegative subjects but not in HIV patients. These novel findings provide evidence that ICOS+ cmTFH cells contribute to the regulation of PcP-specific IgG antibody responses, including isotype diversification, and that TFH cell dysfunction may be a cause of impaired PcP-specific IgG antibody responses and increased susceptibility to pneumococcal disease in HIV patients.

Patient perceptions of the potential lethality associated with deliberate self-poisoning.

INTRODUCTION: Little is known about patient perceptions of the lethality of their overdose. Our aim was to compare patient perceptions with the risk assessment of clinical toxicologists. METHODS: A prospective observational study of overdose patients presenting to a tertiary hospital. Eligible patients were surveyed once they were medically fit for psychiatric evaluation. Descriptive data were collected, including the Pierce Suicide Intent Scale (SIS). In response to 'how dangerous did you think this overdose was when you took the tablets?' patients marked a 10 cm VAS, with 0 = would be harmless, 10 = certain to cause death. A panel of clinical toxicologists independently made a risk assessment on a 10 cm VAS, with 0 = non-toxic ingestion and 10 = uniform lethality even with full medical intervention. RESULTS: Of 202 patients enrolled, 118 (58.4%, 95% CI 51-65) were female; median age 33 years (interquartile range [IQR] 24-42). One hundred and three (51%, 95% CI 44-58) stated it was their intention to kill themselves and 44 (21.8%, 95% CI 16-28) wrote a suicide note. They most commonly used their own prescription medications (141, 69.8%, 95% CI 63-76). The median patient visual analog scale (VAS) was 5.8 (IQR 2.3-8.3) and median toxicology VAS was 1.4 (IQR 0.6-2.8); this difference was statistically significant (P < 0.0001). The correlation between the patient visual analog scale (VAS) and Pierce SIS (median 8.5/25 [IQR 4-12]) was strong (r= 0.73, P < 0.0001). CONCLUSIONS: Patient perceptions of the lethality of their overdose are correlated with their suicidal intent as measured on the Pierce SIS, with a significant mismatch between patient perceptions and the toxicological risk assessment.