Darrien Rattray

Pre-hysterectomy Assessment of Immediate Tubal Occlusion With the Third-Generation ESSURE Insert (ESS505)

STUDY OBJECTIVE To assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion. DESIGN Prospective, single center, interventional cohort (Canadian Task Force classification II-1). SETTING Tertiary care hospital. PATIENTS Women scheduled to undergo hysterectomy. INTERVENTION Patients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement. MEASUREMENTS AND MAIN RESULTS Thirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects. CONCLUSION ESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.

Evaluation of the NovaSure Endometrial Ablation Procedure in Women With Uterine Cavity Length Over 10 cm

OBJECTIVE To evaluate procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-intervention in women with a sounded uterine length > 10 cm compared to women with a sounded uterine length ≤ 10 cm who underwent the NovaSure endometrial ablation procedure. METHODS We conducted a retrospective cohort study of 188 women from a Canadian community-based gynaecology practice. Eighty-seven women had a sounded uterine length > 10 cm, and 101 patients had a sounded length ≤ 10 cm. Procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-interventions were compared between groups. RESULTS Mean uterine sounding lengths were 11.0 ± 0.6 cm and 8.9 ± 0.8 cm in the > 10 cm and ≤ 10 cm groups, respectively. There were no differences between the groups in demographic characteristics or gynaecologic history, with the exception of higher BMI in the > 10 cm group and a greater prevalence of dysmenorrhea in the ≤ 10 cm group. Overall, 44.1% of all participants had been unsuccessfully treated with hormonal therapy, and 20.7% had failed non-hormonal treatment before the ablation procedure. The remaining 35.2% of participants had declined alternative therapy and proceeded directly to endometrial ablation. No serious procedure-related adverse events occurred in either group. Menstrual bleeding status at follow-up at 30.4 ± 15.3 months (> 10 cm group) and 30.5 ± 15.5 months (≤ 10 cm group) was not different between the groups (P = 0.85). In women who did not undergo surgical re-intervention after the initial ablation, amenorrhea was reported by 51.9% in the > 10 cm group and 65.9% in the ≤ 10 cm group. CONCLUSION The NovaSure endometrial ablation procedure was associated with successful menstrual bleeding outcomes in women with sounded uterine length > 10 cm. No serious procedure-related adverse events occurred, and the need for surgical re-intervention was low. There was no significant difference in bleeding rates between the > 10 cm and ≤ 10 cm uterine length cohorts.

Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada

Objective The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate. Patients and methods Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients’ responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work. Results Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL (p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes (p=0.018), and Lap-RFA required −34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (−44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days (p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD

Uterine artery pseudoaneurysm with an anastomotic feeding vessel requiring repeat embolisation

5,224.96) and myomectomy (CAD

Laparoscopic Cornuectomy as a Technique for Removal of Essure Microinserts

5,321.96). Conclusion Compared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

Confirmation Testing of Essure Microinserts in Unintended Pregnancies Using a 10-Year Retrospective Database

Uterine artery pseudoaneurysm (UAP) is a rare cause of delayed postpartum haemorrhage. Early diagnosis and endovascular management are effective in treating this condition. We present the case of a 36-year-old gravida 3, para 2 woman with delayed postpartum haemorrhage and endometritis following a spontaneous vaginal delivery. Ultrasound and catheter angiogram demonstrated a UAP arising from the distal aspect of the left uterine artery. Significant bleed persisted despite selective bilateral uterine artery embolisation. A repeat angiogram confirmed complete occlusion of bilateral uterine arteries, but abdominal aortogram demonstrated that the left ovarian artery was now feeding the pseudoaneurysm. A repeat embolisation procedure was performed to occlude the left ovarian artery. The patient was discharged the following day. Selective arterial embolisation is effective in the management of UAP. Persistent bleeding despite embolisation should raise the suspicion of anastomotic vascular supply and may require repeat embolisation.