Increased MR-guided high intensity focused ultrasound (MR-HIFU) sonication efficiency of uterine fibroids after carbetocin administration

Purpose: We investigated whether administration of the long-acting uterus stimulant carbetocin increased intra-subject sonication efficiency during Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids. Method: In this prospective cohort study, thirty women with symptomatic uterine fibroids undergoing MR-HIFU treatment were included between January 2018 and January 2019. Treatment started with three sonications on one side of the uterine fibroid. Subsequently, one ampoule of 1 mL carbetocin (100 µg/mL) was administered intravenously and treatment continued with three sonications on the other side of the uterine fibroid. We compared the intra-subject sonication efficiency, in terms of Energy Efficiency Factor (EEF), thermal dose volume and sonication time to ablate one cm 3 of fibroid tissue, before and after carbetocin administration. Adverse events that occurred within 30 min after carbetocin administration were recorded. Results: Sonication efficiency improved after carbetocin administration as indicated by a significant decrease in EEF and sonication time (p = 0.006 and p = 0.001 respectively), and a significant increase in thermal dose volume reached (p = <0.001). Five women (16.7%) experienced temporary tachycardia, one women in combination with headache, within 30 min after carbetocin administration. Conclusion: Administration of the long-acting uterus stimulant carbetocin improved the MR-HIFU treatment intra-subject sonication efficiency in women with symptomatic uterine fibroids

Decision making in prenatal screening; money matters

Research into fetal development and medicin

Decision making in prenatal screening: money matters

Research into fetal development and medicin

Long-term follow-up after successful Essure sterilization: evaluation of patient satisfaction, symptoms, and the influence of negative publicity

OBJECTIVE: To evaluate long-term patient satisfaction and symptoms after successful Essure sterilization and the influence of negative publicity on patients' opinion. DESIGN: Survey study. SETTING: Two nonacademic hospitals. PATIENT(S): All 924 women who underwent successful Essure sterilization between 2003 and 2009. INTERVENTION(S): A questionnaire was sent between 2008 and 2010 and in 2018. MAIN OUTCOME MEASURE(S): Patient satisfaction, symptoms, and the influence of negative publicity on patients' opinion of Essure sterilization. RESULT(S): After a median follow-up of 29 months, 689 of 924 women (74.6%) responded to the first questionnaire. Of these women, 673 of 689 (97.7%) was satisfied with their Essure sterilization and 607 of 689 (88.1%) recommended Essure sterilization to other women. Of the 689 women, 71 (10.3%) reported having symptoms after Essure sterilization for which they had to consult a physician. Most reported symptoms were menstrual and abdominal pain. After a median follow-up of 144 months, 317 of 577 women (54.9%) responded to the second questionnaire. A total of 157 of 317 (49.5%) women reported having symptoms and in 51 (16.1%) women the Essure devices were surgically removed. Among these women, 29 (57%) reported that their symptoms disappeared afterward and 33 of 51 (65%) women reported that negative publicity had somehow affected their decision to undergo surgery. CONCLUSION(S): After a follow-up of 144 months, approximately 50% of the women reported having symptoms and 16% underwent Essure removal surgery. Publicity had a negative influence on patients' opinion of Essure sterilization, as well as an effect on the decision-making process regarding Essure removal. These data are important when facing women with possible Essure-related complaints

The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids: Gynecological Surgery

The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate (TM) System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofrequency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from baseline by an average of 68.1 +/- 28.6 and 67.4 +/- 31.9 %, respectively, while total fibroid volumes were reduced from baseline by an average of 54.7 +/- 37.4 and 66.6 +/- 32.1 %, respectively (all P <.001 compared with baseline; Wilcoxon signed-rank test). At 12 months, mean MP score and SSS decreased by 53.8 +/- 50.5 and 55.1 +/- 41.0 %, respectively; the mean HRQOL score increased by 277 +/- 483 %. There were four surgical reinterventions (8 %) within 12 months. This is the first report of the 12-month follow-up for patients in the FAST-EU Trial. In concert with previously reported 3- and 6-month endpoint data, the 12-month results of the FAST-EU Trial suggest that in addition to substantially reducing the perfused and total volume of targeted uterine fibroids, the VizAblate System is safe and effective through 12 months in providing relief of abnormal uterine bleeding associated with submucous, intramural, and transmural fibroids

Intracavitary deposits on Essure® hysteroscopic sterilization devices : A case report

Objective To study the composition of intracavitary deposits on Essure® hysteroscopic sterilization devices. Design Case report. Setting Reproductive Medicine and Gynecology department of a University Hospital. Patient(s) A 39 years old patient presenting with a request for surgical removal of Essure® sterilization devices. Diagnostic hysteroscopy showed a crystal like white deposit attached to one of the devices. Intervention Diagnostic hysteroscopy and surgical removal of Essure® devices was performed. The deposits were collected and infrared spectroscopy analysis was performed. Main Outcome Measure Chemical composition of the deposits attached to the device. Result(s) Infrared spectroscopy of the material showed patterns conclusive with calcite (calcium carbonate, CaCO3). Conclusion Until now, it is not clear if there is a relationship between reported complaints and formation of calcite deposits on Essure®. Capsule Infrared spectroscopy of deposits on Essure® devices showed a pattern conclusive with calcite. The relationship between reported complaints and the formation of calcite deposits on Essure® remains unclear