Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically ...recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty‐one overweight or obese individuals (body mass index BMI, 25–40 kg/m2) with biopsy‐proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (≥7%), compared with those who lost less than 7%, had significant improvements in steatosis (−1.36 versus −0.41, P < 0.001), lobular inflammation (−0.82 versus −0.24, P = 0.03), ballooning injury (−1.27 versus −0.53, P = 0.03) and NAS (−3.45 versus −1.18, P < 0.001). Conclusion: Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH. (HEPATOLOGY 2009.)
With significant improvements in success rates for free flap reconstruction of the head and neck, attention has turned to donor site morbidity associated with osteocutaneous free flaps. In this ...review, we address the morbidity associated with harvest of the four most commonly used osteocutaneous flaps; the free fibula flap, the scapula flap, the iliac crest flap and the radial forearm flap. A comprehensive literature search was performed to identify articles relevant to donor site morbidity for these flaps. We assessed morbidity in terms of incidence of delayed healing, chronic pain, aesthetic outcomes, site specific complications and patient satisfaction/quality of life. Weighted means were calculated when sufficient studies were available for review. The radial forearm and free fibula flaps are associated with high rates of delayed healing of approximately 20% compared to the scapular (<10%) and iliac flaps (5%). The radial forearm flap has higher rates of chronic pain (16.7%) and dissatisfaction with scar appearance (33%). For the majority of these patients harvest of one of these four osteocutaneous does not limit daily function at long-term follow-up. The scapular osteocutaneous flap is associated with the lowest relative morbidity and should be strongly considered when the recipient defect allows. The radial forearm is associated with higher morbidity in terms of scarring, fractures, chronic pain and wrist function and should not be considered as first choice when other flap options are available.
Weight loss is recommended to treat obstructive sleep apnea (OSA).
To determine whether the initial benefit of intensive lifestyle intervention (ILI) for weight loss on OSA severity is maintained at ...10 years.
Ten-year follow-up polysomnograms of 134 of 264 adults in Sleep AHEAD (Action for Health in Diabetes) with overweight/obesity, type 2 diabetes mellitus, and OSA were randomized to ILI for weight loss or diabetes support and education (DSE).
Change in apnea-hypopnea index (AHI) was measured. Mean ± SE weight losses of ILI participants of 10.7 ± 0.7, 7.4 ± 0.7, 5.1 ± 0.7, and 7.1 ± 0.8 kg at 1, 2, 4, and 10 years, respectively, were significantly greater than the 1-kg weight loss at 1, 2, and 4 years and 3.5 ± 0.8 kg weight loss at 10 years for the DSE group (
values ≤ 0.0001). AHI was lower with ILI than DSE by 9.7, 8.0, and 7.9 events/h at 1, 2, and 4 years, respectively (
values ≤ 0.0004), and 4.0 events/h at 10 years (
= 0.109). Change in AHI over time was related to amount of weight loss, baseline AHI, visit year (
values < 0.0001), and intervention independent of weight change (
= 0.01). OSA remission at 10 years was more common with ILI (34.4%) than DSE (22.2%).
Participants with OSA and type 2 diabetes mellitus receiving ILI for weight loss had reduced OSA severity at 10 years. No difference in OSA severity was present between ILI and DSE groups at 10 years. Improvement in OSA severity over the 10-year period with ILI was related to change in body weight, baseline AHI, and intervention independent of weight change.
•The main objective of the international microsurgery simulation society (IMSS) is to connect the main international specialists and educators of this sub-specialty to share and discuss the ethical ...and scientific basis of preclinical microsurgery teaching.•The development of this IMSS consensus sets the minimum recommended requirements for conducting basic microsurgery training courses, as well as suggestions for objective assessment of the learning curve and skills of trainees.
Microsurgery is a surgical technique that uses optical magnification as well as specific instruments to address necessary reconstructive procedures in different medical specialties. The apprenticeship of this technique requires overcoming a steep learning curve. There is a need for standardization of the training criteria in microsurgery. The International Microsurgery Simulation Society (IMSS) was born in 2011, since then its main objective has been to connect the main international specialists and educators of this sub-specialty to share and discuss the ethical and scientific basis of preclinical microsurgery teaching.
In order to achieve a consensus on the minimum standards for the organization of basic microsurgery training courses, the requirements for a microsurgical anastomosis global rating scale and minimum thresholds for training, a total of nineteen independent global experts participated in a formal consultative consensus development program. The agreement criteria for each statement was established when consensus of 65–100% was reached.
There have been established six recommendations concerning minimum standards for a basic microsurgery course, one recommendation in relation to minimum thresholds for training and four recommendations regarding the global rating scale as gold standard for a microsurgical anastomosis assessment. The eleven defined recommendations reached the agreement threshold of 65–100%.
The development of this consensus sets the minimum recommended requirements for conducting basic microsurgery training courses, as well as suggestions for objective assessment of the learning curve and skills of trainees.
Abdominoplasty and breast augmentation are two of the most commonly performed aesthetic procedures in the UK. When performed as a combined procedure, separate inframammary and abdominoplasty ...incisions are most frequently used. Transabdominoplasty breast augmentation, performed via a single abdominoplasty incision is also described.
A 69-year-old female, having undergone a transabdominoplasty breast augmentation 20 years previously, was diagnosed with ascending colon cancer and admitted for a laparoscopic-assisted, right hemi-colectomy. Despite all the port sites being abdominal and below the inframammary fold, on their removal, silicone from ruptured breast implants was leaking through the port sites.
The patient subsequently underwent an uneventful explantation of bilateral, ruptured, subglandular implants and recovered well.
We recommend that breast implant explantation should be considered when patients indicated for elective intra-abdominal surgery are noted to have ruptured breast implants on staging CT imaging, especially when inserted via an abdominoplasty approach.
Background
Despite significant improvements in survival rates, free flap failures still occur even in experienced hands and are most commonly due to arterial or venous thrombosis. In the absence of ...an evidence-based guideline on the prevention of thrombosis, we reviewed the literature to assess the evidence base for commonly used interventions aimed at its prevention.
Methods
A comprehensive literature search was performed using the following keywords “free flap” and microsurgery with “pre-operative screening,” “prevention of thrombosis,” “ketorolac,” “heparin,” “low molecular weight heparin,” “aspirin,” “dextran,” and “statins.”
Results
Thirteen clinical studies were included in this review. No high-level evidence is available to support any perioperative or postoperative interventions aimed at reducing the risk of flap thrombosis.
Conclusions
Higher level studies are needed to investigate the clinical use of antithrombotic medications in microsurgery; however, given the small failure rates in modern practice, these will need to be large multicenter trials in order to reach sufficient power.
Level of Evidence: Level III, risk/prognostic study.
Patellar tendon rupture is an uncommon clinical presentation, which generally affects the under 40s who are active in sport. Bilateral rupture of both tendons is much rarer. It occurs most frequently ...in patients with predisposing factors such as corticosteroid use or systemic diseases. The authors present the case of a 56-year-old male on long-term statin therapy who sustained this injury following a fall on ice. He had no known risk factors for tendon rupture. Surgical treatment involved tendon repair using Krakow suture via bony tunnels in the patella. Statins have previously been associated with tendon ruptures at other sites but there have been no published cases of bilateral patellar tendon rupture linked to statin use. We review the literature regarding the association between statins and tendon rupture.
To undertake the first detailed genomic analysis of methicillin-resistant
(MRSA) isolated in Sri Lanka.
A prospective observational study was performed on 94 MRSA isolates collected over a 4 months ...period from the Anuradhapura Teaching Hospital, Sri Lanka. Screening for
A,
C, and the Panton-Valentine leucocidin (PVL)-associated
genes and molecular characterization by
typing was undertaken. Whole genome sequencing (WGS) and phylogenetic analysis was performed on selected multilocus sequence type (MLST) clonal complex 5 (CC5) isolates from Sri Lanka, England, Australia, and Argentina.
All 94 MRSA harbored the
gene. Nineteen
types belonging to nine MLST clonal complexes were identified. Where origin of the sample was recorded, most isolates were from skin and soft tissue infections (70/91; 76.9%), with fewer causing bacteremia (16/91; 17.6%), empyema (3/91; 3.3%) and osteomyelitis (2/91; 2.2%). Sixty two (65.9%) isolates were PVL positive with the majority (56 isolates; 90.3%) belonging to a dominant CC5 lineage. This lineage, PVL-positive ST5-MRSA-IVc, was associated with both community and hospital-onset infections. Based on WGS, representative PVL-positive ST5-MRSA-IVc isolates from Sri Lanka, England and Australia formed a single phylogenetic clade, suggesting wide geographical circulation.
We present the most detailed genomic analysis of MRSA isolated in Sri Lanka to date. The analysis identified a PVL-positive ST5-MRSA-IVc that is prevalent among MRSA causing clinical infections in Sri Lanka. Furthermore, this clone was also found among isolates from the United Kingdom and Australia.
Abstract
Background
Clozapine is one of the most underused medications in psychiatry for many reasons including mandatory blood testing, fear of serious side-effects, lack of patient adherence. A ...critical barrier to adoption could be addressed with the ability to measure clozapine at point-of-care (POC) from a fingerstick. Current practice of clozapine measurements, however, was developed based on serum levels. Therefore, meaningful POC results must be reported as the serum equivalent. We evaluated a new immunoassay method to measure clozapine in whole blood to establish standardization to serum, and to assess the ability of the POCT to detect differences in patients’ clozapine levels compared to an existing laboratory method.
Methods
A whole blood POCT (MyCare® Insite Clozapine Test on the MyCare Insite)* immunoassay was compared to liquid chromatography tandem mass-spectrometry (LC-MS/MS) in serum with 95 matched patient samples. Passing-Bablok regression was used to compare results and establish calibrator values to standardize the POCT to report whole blood results as equivalent to serum. The standardization was validated by a method comparison to LC-MS/MS with 304 samples collected from patients with schizophrenia who were being treated with clozapine. Serial blood levels were taken for 13 patients to compare deviation from baseline for POCT and LC-MS/MS results. To detect a discordant difference in clozapine levels, the difference to the preceding value was calculated for 73 sequential samples of the 86 total results. Because of high intra-patient variability changes of > ±50% were considered significant.
Results
There was good correlation (R = 0.9) between the POCT and LC-MS/MS in the training set (N=95). Passing-Bablok statistics were: slope = 1.02, intercept = -2.3, R = 0.9, average bias -17.7 (-3.8%). The average values (± SD) were 479.7 (± 181.5) ng/mL for LC-MS/MS and 462.0 (± 199.1) ng/mL for POCT. The Passing-Bablok regression of the validation set (N=304), using the reassigned calibrator values as the training set, gave a slope = 0.971, intercept = -21.2, R = 0.9, mean values (± SD) of 445.6 (± 242.4) for LC-MS/MS and, 412.6 (± 245.7) for the POCT, average bias was -33.0 (-7.7%). Bias between POCT and LC-MS/MS for 12 individuals ranged from -22% to 22%. One patient with five sequential measurements had a total bias of -34% with 4 of 5 results, agreeing with assignment in or out of the presumptive target range of 350 – 600 ng/mL. The frequency of >±50% change in clozapine levels was <5%. Ninety percent (66 of 73) of results agreed, selectivity = 50%, specificity = 94%, positive predictive value (PPV) = 42.9%, negative predictive value (NPV) = 95.5%. Seven samples had a 50% change by one method and not the other. There was only one discrepant sample that was 66% lower with POCT.
Discussion
Differences in measurement methods are expected. The good correlation and similarity of results between the calibrator assignment training set and the validation set demonstrates the accuracy of the calibrator value assignment. The POCT was highly selective in detecting important changes in clozapine levels of more than 50% which would occur secondary to non-adherence, change in life-style habits or drug-drug interactions. The collection conditions gave consistent levels for most patients, with few large shifts in concentration, thus underestimating the PPV. These data suggest that clozapine levels can be accurately measured from a small volume of capillary blood collected via a fingerstick sample. This method makes blood sampling easier for both patients and clinical staff, and provides a result in a few minutes, at point of care. Its clinical implementation may facilitate the safe and effective use of clozapine in schizophrenia.
*CE mark/US RUO
With significant improvements in success rates for free flap reconstruction of the head and neck, attention has turned to donor site morbidity associated with osteocutaneous free flaps. In this ...review, we address the morbidity associated with harvest of the four most commonly used osteocutaneous flaps; the free fibula flap, the scapula flap, the iliac crest flap and the radial forearm flap. A comprehensive literature search was performed to identify articles relevant to donor site morbidity for these flaps. We assessed morbidity in terms of incidence of delayed healing, chronic pain, aesthetic outcomes, site specific complications and patient satisfaction/quality of life. Weighted means were calculated when sufficient studies were available for review. The radial forearm and free fibula flaps are associated with high rates of delayed healing of approximately 20% compared to the scapular (<10%) and iliac flaps (5%). The radial forearm flap has higher rates of chronic pain (16.7%) and dissatisfaction with scar appearance (33%). For the majority of these patients harvest of one of these four osteocutaneous does not limit daily function at long-term follow-up. The scapular osteocutaneous flap is associated with the lowest relative morbidity and should be strongly considered when the recipient defect allows. The radial forearm is associated with higher morbidity in terms of scarring, fractures, chronic pain and wrist function and should not be considered as first choice when other flap options are available.
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