NovaSure Endometrial Ablation Research Articles

Post-ablation tubal sterilization syndrome following NovaSure endometrial ablation: two case reports

Endometrial ablation procedures are extensively used for the treatment of menorrhagia on premenopausal patients who failed medical therapy. The increasing popularity of safe, effective, less invasive, nonresectoscopic global endometrial ablation procedures could potentially increase the incidence of unusual adverse outcomes. Post-ablation tubal sterilization (PATSS) is one of these delayed complications, which could be challenging to diagnose. PATSS is a complication that potentially occurs following a global endometrial ablation in women with previous tubal sterilization. PATSS presents as cyclic pelvic pain caused by tubal distention from occult bleeding into the obstructed tubes. Review of the literature shows that majority of PATSS occurred after rollerball resection and ablation. We report two cases of PATSS after NovaSure® radiofrequency endometrial ablation.

NovaSure® Endometrial Ablation: Effectiveness and Patient Satisfaction

Objective: The purpose of this study was to describe effectiveness of and patient satisfaction with NovaSure® endometrial ablation in patients with dysfunctional uterine bleeding. NovaSure procedures performed in the outpatient clinic (OPC) and the operating theater (OT) were compared. Design: This was a retrospective cohort study. Materials and Methods: The study was conducted on all NovaSure endometrial ablation procedures (n=112) performed between April 2007 and October 2008 on patients diagnosed with dysfunctional uterine bleeding in the Meander Medical Centre, Amersfoort, The Netherlands. Data were collected from medical records and a retrospective questionnaire. Main outcome measures were effectiveness: the presence of amenorrhea, dysmenorrhea and blood clots, and menstruation duration. Pain experience and patient satisfaction scores ranged from 0 to 10. Results: After NovaSure treatment an amenorrhea rate of 51.4% was found. The mean menstruation duration significantly decreased, as well as the presence of blood clots and dysmenorrhea (p<0.001). Mean patient satisfaction score was 8.5 and patient satisfaction was significantly higher in the OT group (p=0.027). A hysterectomy rate of 1.9% was noted after a follow-up period of 6 months up to 2 years. Conclusions: NovaSure endometrial ablation is an effective treatment option for patients with dysfunctional uterine bleeding, when performed in both the OPC and OT. NovaSure treatment in the OPC is good option for a selected patient population. Significantly lower patient satisfaction was found in the OPC, probably resulting from the pain experienced by these patients. High pain experience during menstruation prior to the NovaSure predicts for high pain experience of the NovaSure treatment. Therefore, treatment in the OPC is recommended only for patients without dysmenorrhea. (J GYNECOL SURG 28:1)

Essure Contraception Followed by NovaSure Endometrial Ablation: Preservation of Viable Tissue In-Growth after Ablation

Essure Contraception Followed by NovaSure Endometrial Ablation: Preservation of Viable Tissue In-Growth after Ablation

Endometrial Cancer Diagnosed at the Time of Novasure Endometrial Ablation: A Case Series Report

Endometrial Cancer Diagnosed at the Time of Novasure Endometrial Ablation: A Case Series Report

Improved Premenstrual Syndrome Symptoms after NovaSure Endometrial Ablation

Study Objective To evaluate the change in premenstrual syndrome (PMS) symptoms in women with heavy periods who underwent endometrial ablation. Design The study used a prospective, single-arm cohort of adult women who were to undergo NovaSure endometrial ablation for heavy menses who also reported symptoms of PMS. A brief baseline survey was done to evaluate menstrual bleeding and baseline PMS symptoms, and two 30-day prospective validated measures of PMS were used. Follow-up surveys were sent at 4 to 6 months and included both the brief survey questions and the validated measures of PMS (Canadian Task Force classification II-3). Measurements and Main Results Thirty-six women with heavy periods who were to undergo endometrial ablation had PMS symptoms and completed all surveys at baseline and follow-up. The mean age was 41.4 years, with a mean body mass index of 26.7. Most (27/36, 75%) had failed hormonal management. All measures of PMS showed significant improvement after endometrial ablation. Self-rating of PMS symptoms on a scale of 0 (none) to 10 (severe) improved from a baseline of 7.4 to a follow-up rating of 3.2 (p <.05). The vast majority of women (35/36, 97%) reported improvement in PMS after undergoing endometrial ablation. Both validated measures of PMS, Daily Symptoms Report and Daily Record of Severity of Symptoms, showed statistically significant improvement in PMS symptoms. Conclusion Women with heavy menses and associated PMS symptoms who undergo NovaSure endometrial ablation showed improvement in PMS symptoms, as well as reduced menstrual bleeding.

NovaSure endometrial ablation: a review of 400 cases

The objective of this study is to review outcomes and factors predictive of patient satisfaction following NovaSure endometrial ablation in the treatment of menorrhagia. NovaSure endometrial ablation has been established as a safe and effective treatment for menorrhagia. The setting of a hospital that is the biggest user of NovaSure in Ireland, coupled with a stable population, provided a unique opportunity to obtain accurate long-term follow-up data on the largest sample size reported to date. This is a retrospective observational study of 400 women who attended for NovaSure endometrial ablation between December 2006 and December 2009. Information was collected from patient charts and followed up with postal and telephone questionnaires. Statistical analysis was performed using SPSS version 18. The mean age and parity of patients were 44 years and 2.84, respectively. Three hundred and sixty-eight patients underwent the procedure, with an average treatment time of 88 seconds’. Eighty-seven percent of patients were satisfied with the procedure, with 59% achieving amenorrhoea. Subsequent hysterectomy was performed in 7.6%. The complication rate was 14% (32 abandoned procedures and 23 in-patient admissions following the procedure). There were no uterine perforations. Women with longer uterine cavities were less likely to be satisfied with the procedure (p = 0.045). Satisfaction rate at 1-year follow-up was 95%. NovaSure endometrial ablation is a highly effective treatment for menorrhagia. We recommend outpatient follow-up of women with longer cavities as further treatment may be necessary.

Endometrial ablation with the NovaSure system in Iran

Objective To evaluate the rate of response to treatment with the NovaSure endometrial ablation device among Iranian women with menorrhagia. Methods Twenty 35–50-year-old women with menorrhagia who were referred to Arash Hospital, Tehran, Iran, in 2008 were enrolled. They underwent endometrial ablation via the NovaSure system and were followed-up for 2 years. Results The incidence of amenorrhea was 30.0% at the end of the 2-year follow-up period. Hypomenorrhea was reported by 40.0% of women. The mean number of days of bleeding per month decreased significantly, from 30.0 ± 6.4 days before treatment to 3.1 ± 2.6 days after 2 years ( P < 0.001). The severity of bleeding decreased significantly within 2 years after treatment ( P < 0.001). In total, 85.0% of women were satisfied and 90.0% had responded to treatment—as defined by amenorrhea, hypomenorrhea, or return to normal menstruation. Conclusion The NovaSure system is effective and should be considered by gynecologists for the treatment of menorrhagia.

Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases

ObjectiveTo assess the success rate, complications, and technical difficulties of concomitant NovaSure radiofrequency global endometrial ablation (NS-GEA) and Essure hysteroscopic sterilization (EHS). MethodsWe conducted a retrospective descriptive study of 100 women undergoing concomitant NS-GEA and EHS for abnormal uterine bleeding. The combined procedure was completed using conscious sedation, in an outpatient setting. Patients were asked to return three months post procedure to have proper microinsert positioning confirmed by hysterosalpingogram, ultrasound, and/or pelvic radiograph. ResultsAn average of five micro-inserts were left trailing into the endometrial cavity. The mean duration of the procedure was on average 17.1 minutes. Eighty-seven patients returned for follow-up. The combined procedure was successful in 80 of these 87 patients (92%) and not successful in seven patients (8%). To improve visualization of the tubal ostia, 25 patients had suction curettage after NS-GEA, with no significant increase in the procedure time (P=0.927). Technical difficulties included impaired visualization of the tubal ostia (7.4%), difficulty in visualizing or counting micro-inserts after placement (3.2%), and resistance to micro-insert placement (3.2%). The procedure complications were intrauterine synechiae (5.7%), endometritis (2.3%), pain that required an emergency room visit (2.3%), and migration of micro-inserts with or without perforation (4.6%). ConclusionConcomitant NS-GEA and EHS is a safe and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization. The combined procedure can be safely moved from the operating theatre to an outpatient setting, completely independent of anaesthesia and day surgery services. Suction curettage should be considered before EHS. A small proportion of patients may develop post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingogram.

Success rate, quality of life, and descriptive analysis after generalized endometrial ablation in an obese population

Objective To describe the success rate of and the quality of life after global endometrial ablation in an obese population. Methods A follow-up survey was mailed to 72 women who had undergone global endometrial ablation. The survey included a menorrhagia-specific NovaSure endometrial ablation questionnaire. The mean follow-up time was 2.5 years. Results Forty-four women (61%) responded, with a mean body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) of 30.5. Overall, patients reported a decrease in missed social activities, in inability to perform activities of daily living, in missed work days, in bleeding tendencies, and in pain. The amenorrhea rate was 37%, and the success rate (those not requiring any further therapeutic treatment) was 86%. Patient satisfaction was 93%. Conclusion Global endometrial ablation improved quality of life for obese women with menorrhagia and had a high rate of satisfaction, even for patients not achieving amenorrhea. Patients with a BMI of more than 34 showed a trend toward failure and a higher rate of hysterectomy.

NovaSure endometrial ablation under local anaesthesia in an outpatient setting: An observational study

The use of NovaSure under local anaesthesia (LA) has been described as part of efficacy trials, but its use in an outpatient setting has not previously been explored. This prospective study was conducted to determine feasibility and efficacy of NovaSure in the outpatient setting under LA. The study included all women with menorrhagia unresponsive to medical management and were agreeable for treatment under LA (n = 50). The mean duration of procedure was 100 s. A total of 47 (94%) patients were discharged home the same day. Simple analgesics controlled postoperative pain in 44 (88%) patients. Seven (14%) patients gave preference for general anaesthesia for future treatment. The mean pain scores at 30, 60 and 90 min were 4.18, 4.38 and 3.85, respectively on the visual analogue scale. At follow-up, the improvement in menstrual symptoms was seen in 47 (94%) and the satisfaction rate was 43 (86%) and 47 (94%) at 4 and 6 months, respectively.

Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization – Review of 100 Cases

Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization – Review of 100 Cases

Change in Premenstrual Syndrome Symptoms in Females with Heavy Menstrual Bleeeding Following NovaSure Endometrial Ablation

Study Objective: To evaluate premenstrual syndrome (PMS) symptom scores in females with heavy menstrual bleeding who are to undergo NovaSure endometrial ablation, and then to compare baseline or pre-procedure symptom scores with follow-up symptom scores after ablation.

Feasibility of Hysterosalpingography To Evaluate Tubal Occlusion Following Concomitant Adiana® Transcervical Sterilization and NovaSure® Endometrial Ablation

Study Objective: To evaluate whether concomitant Adiana hysteroscopic sterilization with NovaSure endometrial ablation can limit the ability to perform a three month post-operative hysterosalpingogram (HSG) with pathology tissue correlation.

Vaginal Myoma Expulsion after NovaSure Endometrial Ablation

A 46-year old multiparous woman visited a 1-stop clinic for abnormal uterine bleeding. There was a small submucosal type 2 myoma of 2 cm in her normal sized uterus. We treated her using Novasure endometrial ablation. One year later the patient suffered from sudden excessive vaginal bleeding and collapse. A myoma of 4 cm was being expelled from the uterus.

Prospective Analysis of Pain Tolerance during Radiofrequency Endometrial Ablation Using Local Anesthesia and Mild Sedation in the Premenopausal Patient

Study Objective: To evaluate the safety and feasibility of endometrial ablation (EA) using NovaSure Endometrial Ablation System performed immediately after placement of Essure micro-inserts. Design: A retrospective chart analysis of 10 cases of hysteroscopic placement of Essure followed by the NovaSure EA. Demographic information, type of anesthesia, bilateral placement rate, ablation treatment time, intra-operative and post-procedure complications, and follow up information were collected and reviewed. Setting: A private gynecologic practice in the Southern United States. Patients: 10 women between the ages of 28e52 were identified for this study. Each had undergone Essure tubal sterilization followed by NovaSure EA in the same surgical session under IV sedation. All participants had benign uterine bleeding and desired permanent contraception. Intervention: Patients underwent bilateral Essure placement followed by NovaSure EA and were monitored with at least one post operative visit. Measurements and Main Results: Bilateral micro-insert placement was achieved in all of the patients. There were no complications at the time of or immediately following the combined procedures. Trailing coil lengths ranged between 3 and 5 coils. Ablation treatment time ranged from 47 seconds to 120 seconds. 100% of the patients have been relying on the Essure micro-inserts for contraception for 18e22 months with no reported pregnancies. Patients were instructed to use an alternative form of contraception for 6 months after the combined procedures. Micro-insert placement was confirmed by ultrasound at 3 months. All patients have been followed from 15 to 22 months post-procedure. Review of followeup visits include one patient that underwent TAH/ BSO one year post-ablation secondary to persistent bleeding and a large fibroid. Conclusion: This retrospective analysis demonstrates that performing NovaSure EA immediately following Essure micro-insert placement appears to be feasible, safe and effective. The optimal point in time for Essure micro-insert placement is prior to EA to ensure adequate visualization of the tubal ostia and successful bilateral micro-insert placement.

Essure® Transcervical Sterilization Combined with NovaSure ® Endometrial Ablation: A Perihysterectomy Safety Study

Study Objective: To evaluate the safety of Essure micro-insert placement followed by NovaSure endometrial ablation (NEA). This perihysterectomy study evaluated: 1) uterine and fallopian tube serosal temperatures during NEA with the micro-inserts and 2) degree, if any, of thermal fallopian tube injury associated with the micro-inserts.

Perforation of a Previously Undiagnosed Unicornuate Uterus during a Novasure Endometrial Ablation, after Successfully Passing the Cavity Assessment Test

Perforation of a Previously Undiagnosed Unicornuate Uterus during a Novasure Endometrial Ablation, after Successfully Passing the Cavity Assessment Test

New-onset pelvic organ prolapse after Novasure endometrial ablation

Endometrial ablation with bipolar radiofrequency energy (NovaSure) for dysfunctional uterine bleeding has gained wide acceptance due to its ease and efficacy. A 45-year-old, gravida three, para two, female developed symptomatic Stage 3 pelvic organ prolapse (POP) 1 month after endometrial ablation using NovaSure. To our knowledge, this is the first published case of new-onset POP briefly after an endometrial ablation. It is not clear whether there is a causal association between the ablation procedure and de novo POP. Should there be any additional cases of de novo POP post endometrial ablation, further investigation would be warranted.

Does the radiofrequency impedance-controlled endometrial ablation have any morphologic effects on uterine leiomyomata?: Report of 3 cases

A variety of novel endometrial ablation technologies are now in routine use. A subset of uteri that had previously undergone these treatments will ultimately be evaluated by the pathologist. However, the full spectrum of histologic changes that may result from these treatments has received only sporadic attention. The NovaSure™ [Hologic Corporation, Marlborough, MA, USA] endometrial ablation system is one of several available second-generation technologies and its particular endometrial ablative power is based on the delivery of radiofrequency energy. The present analysis was designed to decipher any histologic changes (if any) associated with the NovaSure™ endometrial ablation system relative to benign smooth muscle tumors of the uterine corpus. Over a one-year period, 3 uteri that had previously undergone the NovaSure™ endometrial ablation and which also had leiomyomatous mass lesions were evaluated. The leiomyomatous mass lesions were extensively sampled and were evaluated for cellular shapes (epithelioid change, cellular rounding, extraordinary cytoplasmic eosinophilia, clear cell change, cytoplasmic vacuolation), nuclear changes (nucleomegaly, nucleolomegaly, multinucleation, hyperchromasia, symplastic changes), necrosis (coagulative and/or infarct), mitotic activity, apoptotic bodies or pyknotic cells, myxoid change, hyalinization. The three uteri were resected 61, 47 and 74 (mean 60.7) days post-ablation. After a detailed evaluation of multiple submucosal, intramural and subserosal leiomyomata from these 3 uteri, no noteworthy histologic changes were identified in the tumors. Since the presence or absence of tumor necrosis is one histologic criterion by which malignant potential is assigned to uterine smooth muscle neoplasms, defining any extrinsic processes that may establish, or contribute to this finding is clinically relevant. The findings reported herein suggests that if a leiomyoma that was obtained from a patient that had recently undergone the NovaSure™ endometrial ablation displays any degenerative changes such as necrosis, the changes are probably not attributable to the ablation.

11: Comparison of Theatre Time, Complication Rates and Short-term Outcomes for Hydrothermal Ablation, Microwave Endometrial Ablation and NovaSure Endometrial Ablation

11: Comparison of Theatre Time, Complication Rates and Short-term Outcomes for Hydrothermal Ablation, Microwave Endometrial Ablation and NovaSure Endometrial Ablation