An analysis of long-term clinical outcome following the use of excimer laser coronary atherectomy in a large UK PCI center.

BACKGROUND: Excimer laser atherectomy (ELCA) is an established adjunctive technique to facilitate acute success in percutaneous coronary intervention (PCI). Despite this there are a lack of contemporary outcome data, particulary longer-term, forpatients treated with ELCA PCI. AIMS: To evaluate the contemporary use ofELCA in PCI, the frequency of periprocedural complications and the longer-term outcomes associated with ELCA PCI. METHODS: This was a retrospective study that included all patients undergoing PCI (with or without ELCA) between April 2005 and May 2021. Relevant features from all cases were downloaded from the patient record and matched to hospital data on mortality on November 22, 2022. Kaplan Meier curves were used to compare mortality between the ELCA PCI and non-ELCA PCI cohorts with a landmark at 1 year. Multivariable Cox regression was performed to assess whether ELCA PCI was independently associated with long-term mortality. RESULT: There were 21,256 patients in this analysis, of which 448 (2.1%) were treated with ELCA PCI. ELCA PCI was associated with a higher frequency of any periprocedural complication. Median follow-up was 2812 days (IQR, 1577-4245 days) with higher mortality in ELCA PCI (38.2% vs. 29.0%, p < 0.001). However, on multivariable analysis, ELCA PCI was not independently associated with long-term mortality. The TVR frequency in ELCA PCI was 16.7% but TVR was significantly higher for cases of in-stent restenosis (ISR) (29.5%). CONCLUSION: Despite ELCA PCI being used in higher risk populations with complex coronary artery disease there was no long-term increased mortality associated with the use of this device. ELCA PCI for ISR is highly effective and safe although TVR in this cohort remains high in long-term follow-up.

Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis.

BACKGROUND: Overweight and obesity pose a big challenge to pregnancy as they are associated with adverse maternal and perinatal outcome. Evidence of lifestyle intervention resulting in improved pregnancy outcome is conflicting. Hence the objective of this study is to determine the efficacy of antenatal dietary, activity, behaviour or lifestyle interventions in overweight and obese pregnant women to improve maternal and perinatal outcomes. METHODS: A systematic review and meta-analyses of randomised and non-randomised clinical trials following prior registration (CRD420111122 http://www.crd.york.ac.uk/PROSPERO) and PRISMA guidelines was employed. A search of the Cochrane Library, EMBASE, MEDLINE, CINAHL, Maternity and Infant care and eight other databases for studies published prior to January 2012 was undertaken. Electronic literature searches, study selection, methodology and quality appraisal were performed independently by two authors. Methodological quality of the studies was assessed according to Cochrane risk of bias tool. All appropriate randomised and non-randomised clinical trials were included while exclusions consisted of interventions in pregnant women who were not overweight or obese, had pre-existing diabetes or polycystic ovarian syndrome, and systematic reviews. Maternal outcome measures, including maternal gestational weight gain, gestational diabetes and Caesarean section, were documented. Fetal outcomes, including large for gestational age and macrosomia (birth weight > 4 kg), were also documented. RESULTS: Thirteen randomised and six non-randomised clinical trials were identified and included in the meta-analysis. The evidence suggests antenatal dietary and lifestyle intervention in obese pregnant women reduces maternal pregnancy weight gain (10 randomised clinical trials; n = 1228; -2.21 kg (95% confidence interval -2.86 kg to -1.59 kg)) and a trend towards a reduction in the prevalence of gestational diabetes (six randomised clinical trials; n = 1,011; odds ratio 0.80 (95% confidence interval 0.58 to 1.10)). There were no clear differences reported for other outcomes such as Caesarean delivery, large for gestational age, birth weight or macrosomia. All available studies were assessed to be of low to medium quality. CONCLUSION: Antenatal lifestyle intervention is associated with restricted gestational weight gain and a trend towards a reduced prevalence of gestational diabetes in the overweight and obese population. These findings need to be interpreted with caution as the available studies were of poor to medium quality.

A comparison of the modified Pomeroy tubal ligation and Filshie clips for immediate postpartum sterilisation: a systematic review.

OBJECTIVES: The modified Pomeroy procedure is currently the most widely used method for postpartum sterilisation. Alternative options are Filshie clips, Hulka-Clemens clips and Falope rings. In this systematic review we pooled the available evidence in order to compare the failure rates, complications, technical difficulties, and reversibility of the Pomeroy method and Filshie clips when resorted to for postpartum sterilisation. METHODS: We gathered data from MEDLINE, EMBASE (1970-2010), the Cochrane database, and reference lists of randomised controlled trials (RCTs) and observational studies. We extracted information on study design, sample characteristics, interventions, and outcomes. RESULTS: Our search yielded 294 citations of which 43 were retrieved for detailed evaluation. Fourteen studies were included in the systematic review. One RCT and three observational studies compared failure rates of the Pomeroy method vs. Filshie clips. A random-effects analysis of the pooled studies showed no difference in the failures rates between these two methods (odds ratio 0.76 [95% confidence interval 0.30-1.95]). Complication rates were similar although the Filshie clip technique was reported to be easier. CONCLUSIONS: Filshie clip application is easier to perform. The failure and complication rates are comparable to those of the modified Pomeroy method, when performed in the postpartum period.

Prognostic significance of estrogen and progesterone receptor expression in LNG-IUS (Mirena) treatment of endometrial hyperplasia: an immunohistochemical study.

We performed immunohistochemical analysis of estrogen (ERalpha) and progesterone receptors (PRA and PRB), phosphatase and tensin homolog (PTEN) and aromatase in endometrial hyperplasia treated with Mirena (levonorgestrel-releasing intrauterine system; LNG-IUS) and explored their prognostic significance. The baseline pre-treatment endometrial hyperplasia of a selected prospective cohort was analyzed [complex (n = 29) and atypical (n = 5)]. Study participants were categorized into those that showed endometrial regression (responders, n = 28) and those that showed non-regression or histological progression to atypia or malignancy (non-responders, n = 6). Immunohistochemical expression was expressed as a histological score (HS). Responders compared to non-responders showed significantly higher HSs for estrogen and progesterone receptors. Absence of estrogen and progesterone receptors predicted non-responder status with likelihood ratios of 9.33 (95% CI 2.19-39.81) and 2.92 (95% CI 1.47-5.79), respectively. Neither PTEN nor aromatase expression were associated with LNG-IUS therapy responsiveness. Responsiveness of endometrial hyperplasia to LNG-IUS therapy may be determined through analysis of baseline estrogen and progesterone receptors, but these exploratory findings require confirmation in a larger dataset.

Outpatient Thermachoice endometrial balloon ablation: long-term, prognostic and quality-of-life measures.

STUDY OBJECTIVE: To evaluate short- and long-term treatment outcomes of outpatient local anaesthetic thermal balloon endometrial ablation (LA-TBEA) and identify any prognostic factors. STUDY DESIGN: Prospective observational study in a UK teaching hospital involving 102 menorrhagic women undergoing LA-TBEA between 2001 and 2005. Women underwent either Gynecare® Thermachoice I (n = 51) or Thermachoice III (n = 51) TBEA performed in the outpatient setting under local anaesthesia without conscious sedation. The main outcome measures were: treatment completion, pain and analgesia, duration of stay (from admission to discharge), duration of follow-up, primary treatment success and nature of any secondary treatment, menstrual symptoms and amenorrhoea, patient satisfaction, and quality of life. RESULTS: TBEA was completed in 97% of women. Mean duration of stay was 8.0 h (95% CI 6.6-9.3). Mean follow-up was 30 months (95% CI 26-32). Secondary treatment with the levonorgestrel intrauterine system, repeat TBEA or hysterectomy occurred in 19/102 (19%). Overall, 50% of surgical re-interventions occurred by 19 months. There were high rates of amenorrhoea (29%) and treatment satisfaction (76%). Higher mean intrauterine ablation pressure was associated with increased treatment satisfaction. CONCLUSION: TBEA can be successfully performed in the outpatient setting. Higher endometrial ablation pressure may improve long-term treatment outcome.

Laparoscopic entry techniques: clinical guideline, national survey, and medicolegal ramifications.

BACKGROUND: This study aimed to establish criteria for safe laparoscopic entry through a systematic literature search and evidence-based medicine appraisal, to determine surgeon preferences for laparoscopic entry in the United Kingdom, and to appraise the medicolegal ramifications of complications arising from laparoscopic entry. METHODS: A systematic literature search of MEDLINE and EMBASE (1996-2007) was performed as well as a national surgeon survey by questionnaire (May-December 2006). RESULTS: Laparoscopic entry criteria involving 10 steps were established based on the systematic literature search and evidence-based critical appraisal. The national survey had 226 respondents, with the majority aware of the Middlesbrough consensus or Royal College of Obstetricians and Gynaecologists [RCOG]-sourced guidance. There was considerable variation in preferred laparoscopic entry techniques. Currently, there is clear judicial guidance on the medicolegal stance toward laparoscopic entry-related complications. CONCLUSIONS: Despite widespread awareness of laparoscopic entry guidelines, there remains considerable variation in the techniques adopted in clinical practice. Unless practice concurs with recommended guidance, women undergoing laparoscopy will be exposed to increased unnecessary operative risk. Laparoscopic entry-related injury in an uncomplicated woman is considered negligent practice according to UK legal case law.

Hospital recovery following Thermachoice ablation is not dependent on setting (outpatient or daycase) or rescue analgesia: unexpected result.

BACKGROUND: Thermal balloon endometrial ablation (TBEA) is increasingly being performed in the outpatient setting under local anaesthesia (LA) rather than in a daycase setting under general anaesthesia (GA). Our aim was to compare the post operative rescue analgesia requirements and duration of hospital stay in women undergoing outpatient (LA) and daycase (GA) TBEA. METHODS: Prospective observational study of consecutively recruited women who underwent outpatient (LA) TBEA (n=51) and daycase (GA) TBEA (n=50) over the same time period. Analgesia that was provided additional to the standard administered analgesic regimen was considered rescue analgesia. The main outcome measures were requirement for rescue analgesia and duration of hospital stay in both cohorts. RESULT(S): LA compared to GA cohorts had shorter hospital stays (11 h [95% CI 9-13] vs. 17 h [95% CI 14-20]) and lower analgesia requirements. However, multivariate regression, correcting for all known confounders, showed that duration of stay was independent of setting for ablation or amount of rescue analgesia. CONCLUSION(S): Duration of hospital stay is not entirely dependent on whether outpatient or daycase endometrial ablation is considered. This unexpected preliminary finding deserves to be validated in future confirmatory trials that compare outpatient and daycase treatments. We also discuss the confounding factors that should be considered when designing such trials.

The effectiveness of a levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of endometrial hyperplasia--a long-term follow-up study.

OBJECTIVES: Medical treatment of non-atypical endometrial hyperplasia with oral progestogens has limited efficacy and poor compliance. A levonorgestrel-releasing intrauterine system (LNG-IUS) has been shown to successfully treat hyperplasia in small-sized studies. Our aim was to examine the effectiveness of LNG-IUS in a larger study with long-term follow up. STUDY DESIGN: Prospective observational study of 105 women diagnosed with endometrial hyperplasia and treated with LNG-IUS between 1999 and 2004 at a University Teaching hospital. Baseline characteristics and outpatient endometrial Pipelle sampling were undertaken at 3 and 6 months post LNG-IUS insertion and 6-monthly intervals thereafter in all cases. Outcome included histological data derived from both Pipelle and uterine histologies at 1 and 2 years LNG-IUS therapy. RESULTS: LNG-IUS achieved endometrial regression in 90% (94/105) of cases by 2 years, with a significant proportion (96%, 90/94) achieving this within 1 year. Regression occurred in 88/96 (92%) of non-atypical and 6/9 (67%) of atypical hyperplasias, and in all 22 cases of endometrial hyperplasia associated with HRT. Regression rates did not differ between histological types of hyperplasia. Twenty-three women (22%) underwent hysterectomy of which 13 were indicated and 10 were performed at patient request despite regressed endometrium. Two cases of cancer (one uterine and one ovarian) were identified. CONCLUSION: LNG-IUS is highly effective in treating endometrial hyperplasia. Beneficial effects are observed by the majority within 1 year. Treatment can be reliably monitored through regular 6-montly outpatient endometrial Pipelle surveillance. LNG-IUS treatment of non-atypical hyperplasias is likely to reduce the number of hysterectomies performed in this subgroup.

Evaluation of knowledge and utility of the 2014 Australian sexually transmissible infection and HIV testing guidelines for asymptomatic men who have sex with men among general practitioners in Sydney.

The Australian sexually transmissible infection and HIV testing guidelines for asymptomatic men who have sex with men were updated in 2014. An evaluation study targeting Sydney-based general practitioners was conducted among 85 clinicians. Respondents with knowledge of guideline recommendations were significantly more likely to feel comfortable asking men who have sex with men about their sexual history (98.1% vs 81.3%, P=0.039), and to recommend at least annual testing (94.0% vs 68.8%, P=0.015), 3-month retesting after chlamydia or gonorrhoea treatment (96.2% vs 73.3%, P=0.017) and syphilis testing with routine HIV monitoring bloods (90.2% vs 57.1%, P=0.037). Familiarity with the guidelines was associated with a range of positive outcomes on general practitioners' clinical practice. Novel approaches are required to ensure more widespread distribution of future guidelines.

Antibiotic treatment of bacterial vaginosis in pregnancy: multiple meta-analyses and dilemmas in interpretation.

There is considerable evidence to show an association between genital tract infections, such as bacterial vaginosis (BV), and preterm delivery (PTD). Meta-analyses to date have shown screening and treating BV in pregnancy does not prevent PTD. This casts doubt on a cause and effect relationship between BV and PTD. However, the meta-analyses reported significant clinical, methodological and statistical heterogeneity of the included studies. We therefore undertook a repeat meta-analysis, included recently published trials, and applied strict criteria on data extraction. We meta-analysed low and high-risk pregnancies separately. We found that screening and treating BV in low-risk pregnancies produced a statistically significant reduction in spontaneous PTD (RR 0.73; 95% CI 0.55-0.98). This beneficial effect was not observed in high-risk or combined risk groups. The differences in antibiotic sensitivity between high and low risk groups may suggest differing causal contributions of the infectious process to PTD. The evidence, along with prior knowledge of differing predisposing factors and prognosis between these risk groups, supports the hypothesis that PTD in high and low risk pregnant women are different entities and not linear extremes of the same syndrome.

Non-contraceptive uses of levonorgestrel-releasing hormone system (LNG-IUS)--a systematic enquiry and overview.

Levonorgestrel releasing-intrauterine systems (LNG-IUS) were originally developed as a method of contraception in the mid 1970s. The only LNG-IUS approved for general public use is the Mirena LNG-IUS, which releases 20 mcg of levonorgestrel per day directly in to the uterine cavity. However, new lower dose (10 and 14 mcg per day) and smaller sized LNG-IUS (MLS, FibroPlant-LNG) are currently under clinical development and investigation. Research into the non-contraceptive uses of LNG-IUS is rapidly expanding. In the UK, LNG-IUS is licensed for use in menorrhagia and to provide endometrial protection to perimenopausal and postmenopausal women on estrogen replacement therapy. There is limited evidence to suggest that LNG-IUS may also be beneficial in women with endometriosis, adenomyosis, fibroids, endometrial hyperplasia and early stage endometrial cancer (where the patient is deemed unfit for primary surgical therapy). This systematic enquiry and overview evaluates the quality of evidence relating to the non-contraceptive therapeutic uses of LNG-IUS in gynaecology.

Do screening-preventative interventions in asymptomatic pregnancies reduce the risk of preterm delivery--a critical appraisal of the literature.

Recent research has suggested that women who experience preterm delivery (PTD) may be identified earlier in pregnancy and before onset of symptoms. Interventions commenced at this earlier asymptomatic stage may offer an opportunity to prevent PTD or lengthen gestation sufficiently to reduce adverse perinatal outcome. Our objective was to examine the evidence that supports or refutes this approach to preventing PTD. We therefore conducted a systematic search and critical appraisal of the identified literature. We found evidence that introducing screening-preventative strategies for asymptomatic pregnancies may reduce the rate of PTD. Evidence for screening and selective treatment exists for: asymptomatic bacteriuria; bacterial vaginosis in low-risk population groups; elective cervical cerclage in high-risk pregnancies; indicated cervical cerclage in women with short cervical length on ultrasound; prophylactic progesterone supplementation in high-risk pregnancies, and smoking cessation. However, for most other strategies, such as increased antenatal attendance, or routine administration of prophylactic micronutrients, the evidence is inconsistent and conflicting. Information on neonatal outcomes apart from PTD (such as serious neonatal morbidity and mortality) was found to be lacking in most studies. It was therefore not possible to establish whether preventing PTD or prolonging gestation would correlate to improved perinatal outcome, and this lessened the potential clinical usefulness of any proposed preventative strategy. No studies were found that evaluated the effectiveness of combining screening-preventative strategies. The review concludes with a suggested an antenatal management plan designed to prevent PTD based on current practice and the evidence presented in this article.

Determining the quality of educational climate across multiple undergraduate teaching sites using the DREEM inventory.

BACKGROUND: Our obstetrics and gynaecology undergraduate teaching module allocates 40-50 final year medical students to eight teaching hospital sites in the West Midlands region. Based on student feedback and concerns relating to the impact of new curriculum changes, we wished to objectively assess whether the educational environment perceived by students varied at different teaching hospital centres, and whether the environment was at an acceptable standard. METHODS: A Dundee Ready Education Environment (DREEM) Questionnaire, a measure of educational environment, was administered to 206 students immediately following completion of the teaching module. RESULTS: The overall mean DREEM score was 139/200 (70%). There were no differences in the education climate between the teaching centres. CONCLUSION: Further research on the use of DREEM inventory, with follow up surveys, may be useful for educators to ensure and maintain high quality educational environments despite students being placed at different teaching centres.

Australian sexually transmissible infection and HIV testing guidelines for asymptomatic men who have sex with men 2014: a review of the evidence.

Men who have sex with men (MSM) in Australia and overseas are disproportionately affected by sexually transmissible infections (STIs), including HIV. Many STIs are asymptomatic, so regular testing and management of asymptomatic MSM remains an important component of effective control. We reviewed articles from January 2009-May 2013 to inform the 2014 update of the 2010 Australian testing guidelines for asymptomatic MSM. Key changes include: a recommendation for pharyngeal chlamydia (Chlamydia trachomatis) testing, use of nucleic acid amplification tests alone for gonorrhoea (Neisseria gonorrhoeae) testing (without gonococcal culture), more frequent (up to four times a year) gonorrhoea and chlamydia testing in sexually active HIV-positive MSM, time required since last void for chlamydia first-void urine collection specified at 20min, urethral meatal swab as an alternative to first-void urine for urethral chlamydia testing, and the use of electronic reminders to increase STI and HIV retesting rates among MSM.

Heavy menstrual flow: current and future trends in management.

Menorrhagia accounts for a large number of secondary care referrals in the West. Women of different ages have different expectations from the treatment offered to them. Young women of reproductive age often demand treatment that simultaneously reduces bleeding, preserves fertility, and has very few side effects, whereas older women who ultimately wish to keep their reproductive organs may have reason to avoid hormonal manipulation. This article discusses possible management options and introduces a hierarchical approach to the management of menorrhagia based on the medical therapies and surgical procedures currently available. We explore the medical therapies for menorrhagia, which include hormone-modifying drug therapies and the new combined oral contraceptive pill. We also review novel fibroid surgical therapies and the latest surgical procedures, such as laparoscopic bilateral uterine artery occlusion, transvaginal Doppler-guided vascular clamp, and laparoscopic and intrauterine ultrasound-guided radiofrequency ablation.

Tubal ectopic pregnancy.

INTRODUCTION: Approximately 1/100 pregnancies are ectopic, with the conceptus usually implanting in the fallopian tube. Some ectopic pregnancies resolve spontaneously, but others continue to grow and lead to rupture of the tube. Risks are higher in women with damage to the fallopian tubes due to pelvic infections, surgery, or previous ectopic pregnancy. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What treatments improve outcomes in women with unruptured tubal ectopic pregnancy? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2011 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations, such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The authors also separately searched Medline and Pubmed up to July 2011 in addition to the Clinical Evidence systematic search to support the comments and clinical guide sections. RESULTS: We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: salpingotomy, salpingectomy, methotrexate, methotrexate following salpingotomy, methotrexate plus mifepristone, and expectant management.

Evaluation of strategies for confirming Neisseria gonorrhoeae nucleic acid amplification tests.

The implementation of widespread unselected screening for Neisseria gonorrhoeae in England, using nucleic acid amplification tests (NAATs), has raised concerns regarding the potential increase in misdiagnoses. To increase the positive predictive value, confirmatory testing of positive specimens has been recommended; however, in practice this can be difficult to perform. This study examined the role of two different testing strategies for confirming the N. gonorrhoeae status of specimens that had been examined by the ProbeTec Strand Displacement Amplification (SDA) assay (Becton Dickinson). A total of 227 residual clinical specimens in SDA assay collection tubes were sent for confirmatory testing using two different testing approaches: (i) examination using two in-house real-time PCR assays (opa and porA pseudogene) and (ii) examination using the APTIMA Combo 2 (AC2) assay and the APTIMA Monospecific N. gonorrhoeae (AGC) tests (Gen-Probe). Of the 113 SDA-positive specimens (including low positives) examined, 93 % were confirmed as N. gonorrhoeae-positive using either one or both real-time PCR assays. In contrast, only 34 % were confirmed using the AC2 and/or the AGC assays. All 114 SDA-negative specimens were confirmed as negative using all four confirmatory tests. Clearly the AC2 and AGC assays cannot reliably be used to confirm residual specimens in SDA assay transportation buffers, due to the incompatibility of different platform chemistries. Although high rates of confirmation (93 %) can be achieved when examining residual SDA assay specimens using independent real-time PCR assays, establishing well-validated in-house real-time PCR assays for diagnostic use is a large undertaking for many primary laboratories and so such tests may be better confined to specialist laboratory services.

Initial clinical and radiological findings in patients with SSPE: are they predictive of neurological outcome after 6 months of follow-up?

Subacute sclerosing panencephalitis (SSPE) is a progressive, devastating neurologic disorder caused by mutant measles virus. In this study we evaluated the prognostic value of neuroimaging abnormalities in SSPE. Thirty consecutive patients with SSPE were included. Diagnosis of SSPE was based on the criteria described by Dyken. Patients were followed for 6 months. Neuroimaging studies were performed at inclusion and after 6 months. Regression or progression of the disease was defined as a change of one, or more than one, stage in Jabbour's staging system. Degree of disability was assessed using the modified Rankin scale (mRS) score. Neuroimaging abnormalities were seen in 27 patients. Dominant imaging abnormalities were cerebral atrophy, white matter signal changes, cortical grey matter abnormalities and signal change in the basal ganglia. After 6 months of follow-up, 18 (60%) patients had a poor outcome (mRS score: 3-6); one patient died. The remaining 12 patients (40%) had a stabilized clinical condition (mRS score: 0-2). On univariate analysis, predictors of death or disability were: poor mRS score at baseline (p = 0.003) and Jabbour's clinical stage III (p = 0.019). None of the neuroimaging abnormalities were associated with a poor prognosis or clinical deterioration (p > 0.05). We conclude that we did not observe any association between cerebral neuroimaging at baseline and neurological outcome after 6 months in patients with SSPE.