Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were identified from the Hospital Episode Statistics database. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. 92,246 first-time surgical mesh procedures (56,648 TVT, 34,704 TOT, 834 SS and 60 combinations) were identified, including 68,002 unconfounded procedures. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 [2.3–2.5]% and 1.7 [1.6–1.8]% respectively; 5.9 [5.7–6.1]% were readmitted at least once within 5 years for further mesh intervention or symptoms of complications, the highest risk being within the first 2 years. Complication rates were higher in the potentially confounded cohort. The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% This evidence can inform future decision-making on this procedure.
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The Microlife® ‘WatchBP Home A’ oscillometric blood pressure monitor detects irregular pulse, suggestive of atrial fibrillation (AF). Early detection of AF can prevent thromboembolic stroke via anticoagulation therapy. The device was considered by the Medical Technologies Evaluation Programme of the UK National Institute for Health and Care Excellence (NICE). The sponsor (Microlife) identified 10 studies. These were reviewed by an External Assessment Centre (EAC) which considered three relevant to the decision problem, including one which found the device detected AF more accurately (sensitivity 96.8 %, specificity 88.8 %) than pulse palpation (87.2, 81.3 %). The EAC concluded the technology had potential to improve detection of AF, but the three studies had uncertain external validity. From a cost-consequence model with a 1-year timeframe, the sponsor calculated the device would reduce electrocardiogram (ECG) referrals and prevent strokes, but incur anticoagulation therapy costs, with net NHS savings of £11.6 million and prevention of 221 strokes, annually. The EAC criticised the model for its limited time horizon, and its consideration of symptomatic AF patients who were outside the scope issued by NICE. The EAC applied a de novo Markov model, with a 10-year timeframe. The per use saving was calculated as £2.98 for asymptomatic patients aged 65–74 years and £4.26 for those aged 75–84 years, with the prevention of 53–117 nonfatal and 28–65 fatal strokes per 100,000 people screened. Following consideration by the NICE Medical Technologies Advisory Committee, NICE judged that the case for adoption was supported by the evidence (Medical Technologies Guidance 13; MTG13).
A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.
The possible effects of ocean acidification on growth, organic tissue and protein profile in the bryozoan Myriapora truncata (Pallas, 1766) were studied in samples transplanted along a gradient of different pH conditions in an area of natural volcanic CO 2 vents at Ischia Island (Tyrrhenian Sea, Italy). Living colonies from normal (mean pH 8.10), intermediate (pH 7.83) and low (pH 7.32) pH sites were investigated after intervals of 34, 57 and 87 d of exposure. M. truncata formed new and complete zooids at the normal site, whereas at the intermediate and low pH sites, neither partial nor complete zooids were produced. After 34 d at intermediate and low pH conditions, the organic cuticle which envelops the skeleton increased in thickness when compared to normal colonies, suggesting a protective role against dissolution of the high-Mg calcite skeleton. Significant changes in the protein profile and expression displayed by samples from intermediate and low pH conditions suggest that M. truncata makes an initial attempt to overcome the decrease in pH by up-regulating protein production but eventually, especially in the lowest pH condition, exhausts biochemical energy to maintain this rate of protein production, leading to eventual death. KEY WORDS: Ocean acidification · Bryozoa · Organic tissues · Protein · Growth · Mediterranean Sea · Myriapora truncataResale or republication not permitted without written consent of the publisher Aquat Biol 13: 251-262, 2011 252 effects for global ecosystems (Pörtner et al. 2005, Kleypas et al. 2006.Biominerals are composed of inorganic minerals and organic macromolecules such as proteins, pro teoglycans, lipids and polysaccharides. These macromole cules are fundamental in controlling the intricate detail of shell formation, determining nucleation, stabilisation and mineral polymorph formation (Ma rin et al. 1996, Cölfen & Antonietti 2005, Fu et al. 2005, Nudelman et al. 2007, Cusack & Freer 2008. Organic macromolecules also play an active role in the formation of organic tissues that, in most calcifying organisms, separate shell or skeletons from ambient seawater (Ries et al. 2009). Crustaceans, for ex ample, enclose their carapace within a thick epi cuticle (Roer & Dillaman 1984); molluscs and brachio pods cover their shells with a periostracum (Marin et al. 1996, Nudelman et al. 2007, Cusack & Freer 2008, Evans 2008; corals nucleate aragonite beneath several layers of epithelial tissue (Gattuso et al. 1999, Perrin 2003; and the bryozoan skeleton is enveloped by an organic cuticle (Lutaud 1961, Hunt 1972, TavenerSmith & Williams 1972.Among biomineralisers, bryozoans are a key component of marine ecosystems, secreting calcareous skeletons that provide habitat for other organisms while playing an important role in the carbon cycle (Cocito 2004, Smith 2009). These colonial organisms are composed of modular units (i.e. zooids) which include inorganic (i.e. skeleton) and organic components (i.e. cuticle and polypide; McKinney & Jackson 1989) strictly connected to each ...
Pediatric tracheostomy is often performed to facilitate longterm ventilation. 1 It is frequently associated with ongoing problems requiring medical attention. 1,2 Little is known about current health care resource use (HRU) after pediatric tracheostomy. We used a comprehensive database to report hospital HRU and costs associated with caring for children after a tracheostomy at a national level.
Objectives To identify paediatric intracapsular Coblation tonsillectomy procedures from routine administrative data in England, and determine their safety. Design Retrospective observational cohort study of four ENT centres using routine data from Hospital Episode Statistics (HES). Setting Acute NHS trusts in England conducting exclusively intracapsular Coblation tonsillectomy. Participants Children (≤16 years old) undergoing bilateral intracapsular Coblation tonsillectomy. Main outcome measures Number of procedures, readmissions for pain, readmissions for bleeding and requirement for additional surgery for regrowth. Results A total of 5525 procedures were identified. The median patient age was 4 (IQR 2–5). In‐hospital complications occurred in 1%, with 0.1% returning to theatre for arrest of primary tonsil bleeding. Almost half of the procedures were conducted as a day‐case (44%), with only a small proportion staying in hospital more than one night (7%). Within 28 days, 1.2% of patients were readmitted with bleeding, 0.7% with infection and 0.3% with pain; 0.2% of patients required return to theatre for control of secondary haemorrhage. Longitudinal follow‐up has found that revision tonsil surgery is 0.3% at 1 year (n = 4498), 1.1% at 2 years (n = 2938), 1.7% at 3 years (n = 1781), 1.9% at 4 years (n = 905) and 2.2% at 5 years (n = 305). Conclusions Intracapsular coblation tonsillectomy safety outcomes in this study show primary and secondary bleeding rates and emergency return to theatre rates are lower than all tonsillectomy techniques reported in the National Prospective Tonsillectomy Audit and also lower than previously published Hospital Episode Statistics analysis of tonsillectomy procedures.
Background To determine real-world outcomes of prostatic urethral lift (UroLift) procedures conducted in hospitals across England. Methods A retrospective observational cohort was identified from Hospital Episode Statistics data including men undergoing UroLift in hospitals in England between 2017 and 2020. Procedure uptake, patient demographics, inpatient complications, 30-day accident and emergency re-attendance rate, requirement for further treatment and catheterization were captured. Kaplan–Meier and hazard analysis were used to analyse time to re-treatment. Results 2942 index UroLift procedures from 80 hospital trusts were analysed; 85.3% conducted as day-case surgery (admitted to hospital for a planned surgical procedure and returning home on the same day). In-hospital complication rate was 3.4%. 93% of men were catheter-free at 30 days. The acute accident and emergency attendance rate within 30 days was 12.0%. Results of Kaplan Meier analysis for subsequent re-treatment (including additional UroLift and endoscopic intervention) at 1 and 2 years were 5.2% [95% CI 4.2 to 6.1] and 11.9% [10.1 to 13.6] respectively. Conclusions This real-world analysis of UroLift shows that it can be delivered safely in a day-case setting with minimal morbidity. However, hospital resource usage for catheterization and emergency hospital attendance in the first 30 days was substantial, and 12% required re-treatment at 2 years.
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