NovaSure impedance controlled endometrial ablation: Long-term follow-up results

doi:10.1016/j.jmig.2006.09.002

Journal of Minimally Invasive Gynecology

Volume 14, Issue 1, January–February 2007, Pages 85-90

Clinical results of this research were presented at the 34th annual meeting of the AAGL, Chicago, Illinois, November 9–12, 2005.

https://doi.org/10.1016/j.jmig.2006.09.002 Get rights and content

Abstract

Study objective

A 7-year follow-up evaluation of the safety, efficacy, and long-term outcome of endometrial ablation when using the NovaSure system in patients with menorrhagia secondary to abnormal uterine bleeding (AUB).

Design

Prospective, single-arm study (Canadian Task Force classification II-1).

Setting

St. Imre Teaching Hospital, Budapest, Hungary.

Patients

Seventy-five premenopausal women with menorrhagia secondary to AUB.

Interventions

Endometrial ablation using the NovaSure System without the use of endometrial pretreatment.

Measurements and main results

Loss of menstrual blood was measured using pictorial blood loss assessment chart diaries. Treatment times, complications, and rate of surgical re-interventions were recorded. No intra or postoperative complications were noted. Median follow-up period at the time was 7.8 years (range 6–8.6 years). The proportion of patients with fewer than 7 and 7 or more years of follow-up was 28.8% and 71.2%, respectively. The median treatment time was 92 seconds (range 40–120 seconds). At 7-year follow-up, 97.1% of evaluable patients reported amenorrhea. However, all patients (100%, actuarial rate: 97% with 95% CI [83%–100%]) experienced a successful reduction in bleeding to normal levels or less. Six of 75 patients underwent hysterectomy, and one of 75 had a repeat ablation representing a total of 92% (95% CI: 83%–96%) avoidance of additional surgery during the follow-up period.

Conclusions

Clinical results demonstrate that the use of NovaSure System is safe and effective, with a low rate of surgical re-intervention at 7-year follow-up.

Section snippets

Materials and methods

After formal approval of the protocol by the hospital ethics committee, and after signing a patient informed consent, 75 premenopausal women with menorrhagia secondary to AUB were included in the study between 1997 and 2000. The follicle-stimulating hormone (FSH) level was determined to confirm the patients’ premenopausal status (FSH < 40 u/L).

The study used a validated pictorial blood loss assessment chart (PBAC) scoring system¹⁴ to quantify patients’ pre and postablation menstrual blood loss

Results

Based on data available to date, patients treated in the study had a median baseline PBAC score of 866 (range 195–2458). The median age of patients in this study was 45 years (range 31–54 years). At the time the procedure was performed, all patients had completed childbearing. In this study cohort 2 (2.7%) patients had no pregnancies, 4 patients (5.3%) had 1 previous pregnancy, 19 (25.3%) had 2, 23 (30.7%) had 3, and 27 (36.0%) had 4 or more pregnancies. Distribution between 0, 1, 2, and 3

Discussion

Endometrial ablation as a minimally invasive approach in the treatment of AUB has always been of interest for the OB/GYN community worldwide. A large number of publications are available on this topic; and with the introduction of new global technologies, researchers continue to assess the true performance and applicability of these technologies in an attempt to clearly define the optimal operation so that patient expectations can be managed accordingly.

This clinical research project was

Conclusions

For patients suffering from menorrhagia secondary to AUB, the NovaSure Impedance Controlled Endometrial Ablation System continues to be proven as a safe and effective treatment method. The high amenorrhea and success rates and very low retreatment rates at 7 years after treatment support this treatment for menorrhagia as the system of choice. A safe and effective minimally invasive alternative for treating AUB, the NovaSure System offers gynecologists and patients a treatment option with

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Cited by (30)

Endometrial ablation
2018, Best Practice and Research: Clinical Obstetrics and Gynaecology
Citation Excerpt :
However, at this point, it seems that most clinicians perform the procedure in procedure rooms or operating theaters. The NovaSure system has been the subject of a number of prospective observational studies [81,82,85,86] and randomized clinical trials, comparing the device with REA [80] and other NREA techniques [83,87]. In the US pivotal RCT, 265 subjects were enrolled at 9 clinical centers in a 2:1 randomization scheme.
Endometrial ablation (EA) includes a spectrum of procedures performed with or without hysteroscopic direction, designed to destroy the endometrium for the treatment of the symptom of heavy menstrual bleeding (HMB) secondary to a spectrum of causes, but most commonly those that are endometrial in origin (AUB-E) or ovulatory disorders (AUB-O). Resectoscopic endometrial ablation (REA) is often mistakenly referred to as the “first generation” technique, while proprietary devices that do not use the resectoscope (nonresectoscopic EA or NREA) are often misperceived as “second generation” devices. Indeed, the origins of NREA date back to the late 19th century with the use of steam, and the early and mid 20th century, when radiofrequency and cryotherapy based NREA techniques were published – long before the resectoscope was used and reported. The NREA devices have also been mislabeled as “global”, a misleading term borrowed from the marketing departments of device manufacturers - there is no device that predictably treats the entire endometrium. Consequently, none can be construed as being “global”. Instead, EA is a procedure designed for women as an alternative to hysterectomy, or, perhaps, medical therapy, when future fertility is no longer desired. Women who select EA should anticipate a relatively low risk procedure that will likely reduce their HMB to normal levels or less. This paper will review the spectrum of EA techniques and devices, their clinical outcomes and adverse events, and explore their value compared to hysterectomy and selected medical therapies.
Effectiveness of bipolar impedance controlled radiofrequency (NovaSure) endometrial ablation for the treatment of menorrhagia in Hong Kong Chinese women
2017, Gynecology and Minimally Invasive Therapy
Citation Excerpt :
Success of the procedure remains similar if submucosal fibroid is less than 3 cm while successful cases has been reported in those with underlying adenomyosis which some suggested as a contraindication for the procedure. One of the longest available data with 7 years follow up reported reduced uterine bleeding in 98% and amenorrhoea in up to 75–97% patients.6 A more recent report of pooled data included 3 single armed study and 7 RCTs regarding outcomes of bipolar impedance controlled radiofrequency ablation at 12 months after the procedure.
Bipolar impedance controlled radiofrequency endometrial ablation is a valuable treatment options for menorrhagia. We examined the short term outcomes of Hong Kong Chinese women undergone this procedure.
All patients who underwent this procedure at Queen Elizabeth Hospital, Hong Kong during January 2013 to August 2016. Method this is a prospective cohort study where the menstruation status among the selected patients was questioned at each 6 monthly follow-up after the procedure. A validated MIQ (menorrhagia impact questionnaire) was sent to assess quality of life before and after the procedure.
44 patients underwent the procedure. 77.4% had reduced or minimal bleeding with 19.4% achieving amenorrhoea. 96.77% were found to have reduced bleeding or amenorrhoeic at 3 months; 96.3% at 6 months, 95.83% at 12 months; 95.45% at 18 months; 100% at 24 and 36 months of follow up. Endometritis occurred in 9.7%. No case required blood transfusion or other surgical management post-operatively. Improvement in all aspects of MIQ was seen when compared post-operative scores to pre-operative scores (p < 0.01). 100% claimed improvement in menstruation and 87.1% suggested they would recommend the procedure to family and friends.
Bipolar impedance controlled radiofrequency endometrial ablation appears to be an effective method for managing menorrhagia amongst Chinese women in Hong Kong.
Radiofrequency endometrial ablation for the treatment of heavy menstrual bleeding among women at high surgical risk
2015, International Journal of Gynecology and Obstetrics
To evaluate quality of life (QoL) after radiofrequency endometrial ablation (RFEA) for heavy menstrual bleeding among women at high surgical risk.
An observational study was undertaken among women aged at least 18 years who underwent RFEA at Hanover Medical School, Germany, between June 2010 and November 2012. A validated menorrhagia outcomes questionnaire (MOQ) was used to evaluate QoL and global outcomes among patients at high risk and low risk of complications after major surgery. The high-risk group included women with anemia, coagulopathy, anticoagulation, thromboembolism, transplantation, malignancy, severe cardiovascular or pulmonary disease, and obesity.
Overall, 235 women underwent RFEA during the study period. Median follow-up was 13 months (range 3–30). Questionnaire responses were received from 202 (86.0%) women, including 132 (65.3%) high-risk patients. The MOQ total outcome (mean difference 2.0; P = 0.166) and QoL/satisfaction (mean difference 0.8; P = 0.601) scores were similar in the two groups. Success (i.e. symptom relief and no further surgery) was recorded for 119 (90.2%) patients in the high-risk group and 67 (95.7%) patients in the low-risk group (P = 0.155).
RFEA improved QoL and achieved a high rate of satisfaction for both high- and low-risk patients. RFEA offers a less invasive alternative to hysterectomy and its associated perioperative risks, particularly among high-risk patients.
Effect of Undiagnosed Deep Adenomyosis After Failed NovaSure Endometrial Ablation
2015, Journal of Minimally Invasive Gynecology
Citation Excerpt :
Of these, however, only 1 assessed the prevalence of adenomyosis after failed NovaSure endometrial ablation. In that study, 6 of 75 patients (8%) were found to have adenomyosis after a failed NovaSure procedure [6]. By contrast, in another study in which most of the cohort (75%) had undergone NovaSure ablation, 44% of these patients were found to have adenomyosis after endometrial ablation [18].
To determine the prevalence of adenomyosis and deep adenomyosis after NovaSure (Hologic Inc., Newark, DE) endometrial ablation in hysterectomy specimens after NovaSure endometrial ablation failure.
Prospective observational study (Canadian Task Force classification II-2).
The TweeSteden Hospital, a teaching hospital in the south of the Netherlands.
All women who underwent hysterectomy for menorrhagia and/or dysmenorrhea after failure of NovaSure endometrial ablation between November 2007 and January 2011.
All patients who underwent hysterectomy between January 2005 and April 2009 for the same indication but did not undergo prior endometrial ablation from choice or the lack of availability of the endometrial ablation procedure.
Of 213 patients who underwent NovaSure therapy, 22 (10.3%) underwent a hysterectomy because NovaSure failed. Of these, 10 (45.5%) exhibited adenomyosis in their hysterectomy specimens. The control group patients had a similar adenomyosis prevalence (74/173, 42.8%). However, the NovaSure failure group had a significantly higher prevalence of deep adenomyosis (>2.5 mm endometrial penetration) (9/22, 40.9%) than the control group (37/173, 21.4%, p < .05).
Deep adenomyosis after failed NovaSure endometrial ablation was present in a significant number of patients. It is not clear whether adenomyosis is induced by endometrial ablation or whether it causes endometrial ablation failure.
La répétition d'un geste de destruction endométriale permet-elle d'améliorer les symptômes de ménomé trorragie, et diminue-t-elle le taux de réintervention par hystérectomie?
2014, Journal de Gynecologie Obstetrique et Biologie de la Reproduction
Les gestes de résection ou de destruction endométriale par hystéroscopie pour ménorragies ou métrorragies post-ménopausiques représentent une alternative à l’hystérectomie du fait d’une morbidité moindre. En cas d’échec, une hystérectomie est généralement proposée. La place de la répétition d’un geste de destruction de l’endomètre en cas de récidive des saignements n’a pas été évaluée. L’objectif de notre étude est d’évaluer la faisabilité, l’efficacité et la satisfaction après deux techniques de destruction en cas de ménométrorragies.
Dix-neuf patientes ont bénéficié entre 2004 et 2011 dans notre service et dans cette indication d’un 2^e geste conservateur par hystéroscopie.
Sur les 19 patientes initialement incluses, 16 (84,2 %) patientes ont répondu à un questionnaire. Le recul global depuis la deuxième intervention chirurgicale est de 27 mois [25,3 ; 28,8] en moyenne. Parmi elles, 8 (soit 50 %) ont eu recours à une hystérectomie ultérieure, dont 5 sont attribuables à un échec de traitement, soit 31,2 %. Les patientes se sont dites globalement satisfaites (68,8 %) avec un fort taux de recommandation de la prise en charge à une amie (93,8 %).
Nos résultats suggèrent une certaine efficacité d’un second temps deuxième geste conservateur en cas de récidive des ménométrorragies. Une hystérectomie pourrait être évitée dans 50 % des cas. Un deuxième temps pourrait être particulièrement intéressant chez les patientes avec des contre-indications à une chirurgie lourde ou désireuses de conserver leur utérus.
Hysteroscopic endometrial resection or destruction in the indication of abnormal uterine bleeding or post-menopausal bleeding represents an alternative to hysterectomy, as it carries a lower morbidity rate. In case of failure of such procedure though, hysterectomy will most often be proposed as a second line of treatment. The place of the repetition of an endometrial destruction procedure has not yet been evaluated. The aim of our study is to evaluate the efficiency and the satisfaction after two consecutive techniques of endometrial destruction in case of abnormal uterine bleeding or post-menopausal bleeding.
Nineteen patients presenting with recurring abnormal uterine bleeding after one procedure of endometrial destruction, underwent in our department, between 2004 and 2011, a second conservative endometrial procedure.
No complication occurred during the repeated procedure. Sixteen of the nineteen patients (84.2 %) included answered a questionnaire. The mean delay since the second procedure was 27 months [25; 29]. Eight patients (i.e. 50 %) later underwent a hysterectomy, with 5 of them (31.25 % of all 16 patients) being directly attributed to treatment failure. Patients said to be satisfied with the management of their condition in 68.75 % of cases, and 93.75 % of them would recommend it to a friend.
Our results suggest that a second conservative management in case of recurrence of AUB is effective. Hysterectomy could be avoided in 50 % of cases. A second conservative treatment could be an interesting option for patients with medical contra-indication for heavier surgery, as well as for patients willing to keep their uterus.
Improved Premenstrual Syndrome Symptoms after NovaSure Endometrial Ablation
2011, Journal of Minimally Invasive Gynecology
To evaluate the change in premenstrual syndrome (PMS) symptoms in women with heavy periods who underwent endometrial ablation.
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).
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.
Women with heavy menses and associated PMS symptoms who undergo NovaSure endometrial ablation showed improvement in PMS symptoms, as well as reduced menstrual bleeding.

View all citing articles on Scopus

: The authors have no financial interest in the instrument manufacturer (Cytyc Corporation) and do not serve as consultants for the company. No research grants for this research were provided.

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Original articleNovaSure impedance controlled endometrial ablation: Long-term follow-up results

Abstract

Study objective

Design

Setting

Patients

Interventions

Measurements and main results

Conclusions

Section snippets

Materials and methods

Results

Discussion

Conclusions

Am J Obstet Gynecol

Obstet Gynecol

J Am Assoc Gynecol Laparosc

Am J Obstet Gynecol

J Am Assoc Gynecol Laparosc

J Am Assoc Gynecol Laparosc

Fertil Steril

An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia

Br J Obstet Gynaecol

Gynecological surgery

MedPro Month

Management of Anovulatory Bleeding

ACOG Practice Bulletin 14

Effect of hysterectomy vs. medical treatment on health-related quality of life and sexual functioning

JAMA

Original article
NovaSure impedance controlled endometrial ablation: Long-term follow-up results