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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 May 2008 (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 May 2008 in addition to the Clinical Evidence systematic search to support the comments and clinical guide sections. RESULTS: We found 47 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, systemic methotrexate, systemic methotrexate following salpingotomy, and expectant management.

Hysteroscopic myomectomy for menorrhagia using Versascope bipolar system: efficacy and prognostic factors at a minimum of one year follow up.

OBJECTIVE: To evaluate the effectiveness of hysteroscopic submucous myomectomy for women with heavy menstrual bleeding (HMB) over a minimum 1-year period and assess prognostic factors associated with treatment success. STUDY DESIGN: Prospective observational study set in a university teaching hospital in UK involving 92 women symptomatic of HMB with submucous myomas consecutively recruited between June 2003 and November 2006. Hysteroscopic myomectomy was performed under outpatient local anaesthetic (n=35, 38%) or daycase general anaesthesia (n=57, 62%) using Gynecare Versascope bipolar system. The main outcome measures were: the need for secondary surgical or medical re-intervention, menstrual improvement and patient satisfaction. Other outcome measures include: successful completion of primary resection, type of secondary treatment. RESULT: Mean follow up was 2.6 years (95% CI 2.3-2.9). Complete fibroid excision was achieved in 66%. Secondary surgical re-intervention was required in 27 (29%) of which 11 (12%) were repeat hysteroscopic myomectomy and 10 (11%) were hysterectomy procedures. Multiple uterine fibroids and adenomyosis were identified in 80% of hysterectomies. At follow up, improved menstrual symptoms and patient satisfaction were reported by 91% and 86%, respectively. Irregular cycle HMB and incomplete fibroid excision were associated with secondary retreatment. Size of the submucous fibroid resected, presence of intramural and subserosal fibroids, or LA vs. GA setting were unrelated to treatment success. CONCLUSION: HMB with submucous myomas may be successfully treated by completely removing the intracavity myoma component, irrespective of co-existent intramural or subserosal fibroids or size of fibroid resected. This effect remains sustained over at least a 1-2 year period.

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.

Predicting negligence in female sterilization failure using time interval to sterilization failure: analysis of 131 cases.

BACKGROUND: Sterilization failure due to 'tubal non-occlusion' or 'wrong structure sterilization' is considered negligent, whereas 'spontaneous tubal recanalization' or 'fistula formation' is considered non-negligent. We examined whether interval to pregnancy failure was predictive of a negligent rather non-negligent failure mechanism. We aim to test this hypothesis in a selected population series of known mechanisms of sterilization failure and their time interval to failure. METHODS: Analyses of 131 failed sterilizations pooled from UK (NHS Litigation Authority, Medical Protection Society and our hospital), Australia and a qualitative systematic review. RESULTS: We identified 88 negligent and 43 non-negligent sterilization failures. Filshie and ring methods failed earlier than diathermy and Pomeroy methods. Sterilization failure occurred significantly earlier in negligent than non-negligent failure mechanisms [median failure intervals 7.0 versus 12.0 months; Hazard ratio (2.35 95% CI 1.31-4.21)]. Knowing that sterilization failure occurred early, increased the probability that the failure mechanism was likely to be negligent rather than non-negligent. CONCLUSIONS: A short interval to failure is suggestive of a negligent failure mechanism. There is less certainty in the predictive value of longer time intervals on the mechanism of failure due to a paucity of cases. A national register of failed sterilizations that have been systematically investigated is needed to improve our understanding of negligent and non-negligent failure mechanisms.