Erwin Birnie

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial

BACKGROUND Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled trials reported outcomes in terms of health-related quality of life, clinical outcomes, efficacy, and cost-effectiveness after 1, 2, and 5 years of follow-up. OBJECTIVE The purpose of this study was to compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. STUDY DESIGN In all, 28 Dutch hospitals recruited patients with symptomatic uterine fibroids who were eligible for hysterectomy. Patients were 1:1 randomly assigned to uterine artery embolization or hysterectomy. The outcomes assessed at 10 years postintervention were reintervention rates, health-related quality of life, and patient satisfaction, which were obtained through validated questionnaires. Study outcomes were analyzed according to original treatment assignment (intention to treat). RESULTS A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. CONCLUSION In about two thirds of uterine artery embolization-treated patients with symptomatic uterine fibroids a hysterectomy can be avoided. Health-related quality of life 10 years after uterine artery embolization or hysterectomy remained comparably stable. Uterine artery embolization is a well-documented and less invasive alternative to hysterectomy for symptomatic uterine fibroids on which eligible patients should be counseled.

Symptomatic Uterine Fibroids: Treatment with Uterine Artery Embolization or Hysterectomy—Results from the Randomized Clinical Embolisation versus Hysterectomy (EMMY) Trial

PURPOSE To prospectively evaluate health-related quality of life (HRQOL) outcomes for uterine artery embolization (UAE) and hysterectomy up to 24 months after the intervention in terms of mental and physical health, urinary and defecatory function, and overall patient satisfaction. MATERIALS AND METHODS Ethics committee approval and informed consent were obtained for the Embolisation versus Hysterectomy Trial. Women (n = 177) with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy were randomly assigned to undergo UAE (n = 88) or hysterectomy (n = 89). HRQOL was measured six times during a 24-month follow-up period with the following validated questionnaires: Medical Outcome Study Short Form 36 (SF-36) mental component summary (MCS) and physical component summary (PCS), Health Utilities Index Mark 3, EuroQol 5D, urogenital distress inventory (UDI), incontinence impact questionnaire, and defecation distress inventory (DDI). Satisfaction was assessed with a seven-point Likert scale. Repeated measurement analysis was performed for between-group analysis. Paired t tests were performed for within-group analysis. Satisfaction was analyzed with the Fisher exact test. RESULTS The SF-36 MCS and PCS, Health Utilities Index Mark 3, EuroQol 5D, and UDI scores were improved significantly in both groups at 6 months and afterward (P < .05). The DDI score was improved significantly in only the UAE group at 6 months and afterward (P < .05). No differences between groups were observed, with the exception of PCS scores at 6-week follow-up: Patients in the UAE group had significantly better scores than did patients in the hysterectomy group (P < .001). Improvement in PCS score at 24-month follow-up was significantly higher for patients who were employed at baseline (P = .035). At 24-month follow-up, patients in the hysterectomy group were significantly more satisfied than those in the UAE group (P = .02). CONCLUSION Both UAE and hysterectomy improved HRQOL. No differences were observed between groups regarding HRQOL at 24-month follow-up. On the basis of HRQOL results, the authors determined that UAE is a good alternative to hysterectomy.

Comparing the Standard EQ-5D Three-Level System with a Five-Level Version

OBJECTIVES The aim of this study is a head-to-head comparison of the performance of the three-level EQ-5D (3L) and a newly developed five-level version (5L). METHODS Eighty-two respondents valued 15 standardized disease descriptions and their own health on three response scales (3L, 5L, and visual analog scale [VAS]) for all five EQ-5D dimensions. Performance was studied in terms of feasibility, face validity, redistribution properties, ordinality, convergent validity, discriminatory power, and test-retest and interobserver reliability. RESULTS The majority of participants judged 5L as the preferred system in terms of feasibility (76%) and face validity (75%). In total, 1.1% of responses were inconsistent. Ordinality of 5L was confirmed in all cases. Convergent validity of 3L-VAS (range: 0.88-0.99) and 5L-VAS (0.90-0.99) were high and about equal. Discriminatory power (informativity) improves considerably with 5L without loss of Evenness. Interobserver reliability (0.49 vs. 0.57) and test-retest reliability (0.52 vs. 0.69) were higher in 5L. CONCLUSION The EQ-5D five-level version appears a valid and reliable extension of the three-level system. The new 5L system is particularly useful for describing mild health problems and monitoring population health.

Systemic Inflammation and Lung Function Impairment in Morbidly Obese Subjects with the Metabolic Syndrome

Background. Obesity and asthma are associated. There is a relationship between lung function impairment and the metabolic syndrome. Whether this relationship also exists in the morbidly obese patients is still unknown. Hypothesis. Low-grade systemic inflammation associated with the metabolic syndrome causes inflammation in the lungs and, hence, lung function impairment. Methods. This is cross-sectional study of morbidly obese patients undergoing preoperative screening for bariatric surgery. Metabolic syndrome was assessed according to the revised NCEP-ATP III criteria. Results. A total of 452 patients were included. Patients with the metabolic syndrome (n = 293) had significantly higher blood monocyte (mean 5.3 versus 4.9, P = 0.044) and eosinophil percentages (median 1.0 versus 0.8, P = 0.002), while the total leukocyte count did not differ between the groups. The FEV1/FVC ratio was significantly lower in patients with the metabolic syndrome (76.7% versus 78.2%, P = 0.032). Blood eosinophils were associated with FEV1/FVC ratio (adj. B −0.113, P = 0.018). Conclusion. Although the difference in FEV1/FVC ratio between the groups is relatively small, in this cross-sectional study, and its clinical relevance may be limited, these data indicate that the presence of the metabolic syndrome may influence lung function impairment, through the induction of relative eosinophilia.

Familial disease with a risk of sudden death: A longitudinal study of the psychological consequences of predictive testing for long QT syndrome

BACKGROUND Since 1996, in the Netherlands, cardiac and molecular screening has been performed in families with the long QT syndrome, a potentially life-threatening but treatable cardiac arrhythmia syndrome. The psychological consequences of predictive cardiac and molecular screening in these families are relatively unknown. OBJECTIVE A psychological study was initiated to investigate the extent and course of distress caused by this new form of predictive genetic testing. METHODS We carried out a prospective study to assess the extent and course of disease-related anxiety and depression, caused by predictive genetic testing, in applicants and their partners from the time of first consultation until 18 months after the disclosure of the result of genetic testing. RESULTS Seventy-seven applicants and 57 partners were investigated for measures of distress in 3 assessments. Those individuals who received an uncertain electrocardiogram result seemed especially vulnerable for distress, at least in the short term. The distress levels in the whole group of applicants were largely restored within 18 months. However, the disease-related anxiety scores in carriers remained relatively increased at long term. As compared with partners of noncarriers, partners of mutation carriers had higher levels of disease-related anxiety at all 3 assessments. CONCLUSION Predictive testing for long QT syndrome consisting of cardiologic testing followed by molecular testing leads to distress, especially in carriers with an uncertain electrocardiogram and their partners at first visit. These distress levels return to normal at long term. However, for carriers with an uncertain electrocardiogram, the incidence of clinically relevant distress was high, most probably also caused by the consequences of having the disease.

Planned home compared with planned hospital births in the Netherlands: Intrapartum and early neonatal death in low-risk pregnancies

To the Editor: We congratulate van der Kooy et al on their report comparing delivery-related perinatal mortality between planned home and planned hospital births in the Netherlands.1 The study is an important and timely contribution to the literature on this topic. The results confirm the low absolute delivery-related perinatal mortality rate associated with planned home birth compared with planned hospital birth under the care of licensed midwives. However, the methods lead us to suspect that, in reality, the rate is likely to be higher than presented. Retrospectively excluding women prospectively planning home or hospital birth under the care of a midwife at labor onset reduced the obstetric risk of the entire cohort, thereby reducing the risk of delivery-related perinatal death. The subgroup excluded from the perfect guideline analysis included women with risk factors not necessarily predictable during the prenatal or intrapartum course but requiring transfer to hospital care. Dutch women planning home birth but requiring intrapartum transfer to the hospital experience the highest odds of delivery-related perinatal death.2 Moreover, a recent U.K. study demonstrated that perinatal mortality commonly is associated with women and their midwives proceeding with planned home birth despite recognizing one or more preexisting or late-developing contraindications, raising further questions about these exclusions.3 Although the authors’ approach generated the desired “low-risk” cohort, it likely did not yield a reality-based estimate of delivery-related perinatal mortality.4 Another concern arises from the lack of a comparison group of low-risk or high-risk pregnancies entering labor under in-hospital physician care. A recent report from Utrecht, Netherlands, shows significantly increased deliveryrelated perinatal mortality rates among low-risk women entering labor at home or in the hospital under the care of midwives compared with those of highrisk women entering labor in the hospital under the care of physicians.2 The authors note the absence of this comparison but not the important clinical and interpretive limitations conveyed by this exclusion.2 Finally, although the authors carefully summarize and reference criticisms of our prior publication, we would like to correct their oversight of neglecting to reference our responses and the journal editor’s note describing the postpublication review by three experts who independently affirmed our methods and confirmed our results (Wax JR, Pinette MG, Lucas FL. Reply to letter to the editor [letter-reply]. Am J Obstet Gynecol 2011;204:e18–20).

The yield of risk stratification for sudden cardiac death in hypertrophic cardiomyopathy myosin-binding protein C gene mutation carriers: focus on predictive screening

AIMS We investigated the presence of a clinical diagnosis of hypertrophic cardiomyopathy (HCM) and of risk factors for sudden cardiac death (SCD) at the first cardiological evaluation after predictive genetic testing in asymptomatic carriers of an MYBPC3 gene mutation. METHODS AND RESULTS Two hundred and thirty-five mutation carriers were cardiologically evaluated on the presence of HCM and risk factors. A clinical diagnosis of HCM was made in 53 carriers (22.6%). Disease penetrance at 65 years was incomplete for all types of MYBPC3 gene mutations. Women were affected less often than men (15 and 32% respectively, P = 0.003) and disease penetrance was lower in females than in males (13 and 30% at 50 years, respectively, P = 0.024). One risk factor was present in 87 carriers and 9 had two or more risk factors. Twenty-five carriers (11%) with one or more risk factors and manifest HCM could be at risk for SCD. CONCLUSION At first cardiological evaluation almost one-quarter of asymptomatic carriers was diagnosed with HCM. Risk factors for SCD were frequently present and 11% of carriers could be at risk for SCD. Predictive genetic testing in HCM families and frequent cardiological evaluation on the presence of HCM and risk factors for SCD are justified until advanced age.

Pain and Return to Daily Activities after Uterine Artery Embolization and Hysterectomy in the Treatment of Symptomatic Uterine Fibroids: Results from the Randomized EMMY Trial

PurposeTo evaluate the safety and efficacy of uterine artery embolization (UAE) and hysterectomy for symptomatic uterine fibroids by means of a randomized controlled trial. The present paper analyses short-term outcomes, i.e., pain and return to daily activities.MethodsPatients were randomized (1:1) to UAE or hysterectomy. Pain was assessed during admission and after discharge, both quantitatively and qualitatively, using a numerical rating scale and questionnaires. Time to return to daily activities was assessed by questionnaire.ResultsSeventy-five patients underwent hysterectomy and 81 patients underwent UAE. UAE patients experienced significantly less pain during the first 24 hr after treatment (p = 0.012). Non-white patients had significantly higher pain scores. UAE patients returned significantly sooner to daily activities than hysterectomy patients (for paid work: 28.1 versus 63.4 days; p < 0.001). In conclusion, pain appears to be less after UAE during hospital stay. Return to several daily activities was in favor of UAE in comparison with hysterectomy.

Genetic counseling and cardiac care in predictively tested hypertrophic cardiomyopathy mutation carriers: the patients' perspective

Hypertrophic cardiomyopathy (HCM) is a common hereditary heart disease associated with sudden cardiac death. Predictive genetic counseling and testing are performed using adapted Huntington guidelines, that is, psychosocial care and time for reflection are not obligatory and the test result can be disclosed by telephone or mail. Proven mutation carriers detected by predictive DNA testing are advised to undergo regular cardiac follow‐up according to international guidelines. We evaluated the opinion of 143 predictively tested HCM mutation carriers on received cardiogenetic care using questionnaires (response rate 86%). Predictive genetic counseling and DNA testing were evaluated on four domains: information provision, satisfaction with counseling, social pressure in DNA testing and regret of DNA testing. Opinions on cardiac follow‐up were assessed pertaining to communication, nervous anticipation, reassurance, and general disadvantages. Genetic counseling was valued positively and only four carriers would rather not have known that they were a mutation carrier. A majority received their DNA test result by mail or telephone, and almost all were satisfied. Only 76% of carriers received regular cardiac follow‐up. Those who did, had a positive attitude regarding the cardiac visits. General disadvantages of the visits were valued as low, especially by older carriers, men and carriers with manifest HCM. We conclude that our adapted Huntington guidelines are well accepted and that cardiogenetic care is generally appreciated by predictively tested HCM mutation carriers. To better understand the cause of the substantial portion of mutation carriers not receiving regular cardiac follow‐up, although recommended in international guidelines, further research is needed.

The phenotype of polycystic ovary syndrome ameliorates with aging

OBJECTIVE To assess the effects of aging on the features of polycystic ovary syndrome (PCOS). DESIGN Retrospective longitudinal follow-up study. SETTING Tertiary care center. PATIENT(S) Patients with PCOS, diagnosed according to the 2003 Rotterdam criteria, who visited the outpatient clinic on consecutive occasions with a minimum interval of 6 months. INTERVENTION(S) Comparisons were made between the first visit and the consecutive visit grouped by intervals. MAIN OUTCOME MEASURE(S) Changes in clinical and endocrine characteristics. RESULT(S) A total of 254 women visited the outpatient clinic on 2 occasions each. Consecutive visits were grouped into 0.5 to 3.9 years (n = 172; mean follow-up, 2.6 years) and 4.0 to 7.0 years (n = 82; mean follow-up, 5.5 years). At their second visit, significantly more women had regained a regular cycle. The total antral follicle count was similar. Serum levels of testosterone, androstenedione, and dehydroepiandrosterone sulfate had decreased significantly. Plasma glucose levels had increased, whereas serum insulin levels and homeostasis model assessment score had significantly decreased. CONCLUSION(S) The PCOS phenotype changed with aging, suggesting an amelioration of the phenotype and ovarian dysfunction as indicated by the increase in number of regular menstrual cycles, decrease in serum androgen levels, and decrease in insulin resistance.