Second-generation endometrial ablation treatment: Novasure

doi:10.1016/j.bpobgyn.2007.03.024

Best Practice & Research Clinical Obstetrics & Gynaecology

Volume 21, Issue 6, December 2007, Pages 989-994

https://doi.org/10.1016/j.bpobgyn.2007.03.024 Get rights and content

The Novasure endometrial ablation system consists of a single-use device and a radiofrequency controller. It is a three-dimensional, triangular-shaped bipolar ablation device. The generator functions at 500 kHz and has a power cut-off limit set at a tissue impedance of 50 Ohms. The self-terminating procedure is based on tissue impedance or time. A cavity assessment system works to detect perforations in the uterine cavity. No pretreatment is necessary. Randomized controlled trials have shown that the Novasure system has an amenorrhoea rate of 44–56% at 1-year follow-up, and the 5-year results of a randomized trial will be published shortly. Prospective observational studies show even higher amenorrhoea rates of up to 58–75% up to 5-year follow-up. Hysterectomy rates in the prospective trial were very low (4%). In summary, the Novasure endometrial ablation system is an effective second-generation ablation technique, resulting in a high percentage of amenorrhoea.

Section snippets

Technique

The Novasure endometrial ablation system consists of a single-use device and a radiofrequency controller (Figure 1).² It is a three-dimensional, triangular-shaped bipolar ablation device, with a conformable bipolar electrode mesh mounted on an expandable frame that can create a confluent lesion within the uterine cavity that involves the entire inner surface area (Figure 1). The electrode is triangular shaped in order to cover the entire uterine cavity. A variable electrode position over the

Research

The effectiveness of the Novasure system has been evaluated in several prospective non-randomized studies.3, *4, 5, *6 One trial of 107 patients has reported 1- and 3-year follow-up.3, *4 After 3 years of follow-up, Novasure demonstrated an amenorrhoea rate of 65% and a hysterectomy rate of 2.8%.⁴ No complications during treatment have been reported. A prospective trial of 200 cases reported an amenorrhoea rate of 43.1% and a hysterectomy rate of 5% after 1–4 years of follow-up.⁶ Another trial

Summary

Novasure endometrial ablation is an effective second-generation ablation technique. It is the only second-generation technique that is not based on time and temperature, but rather on tissue-specific physical characteristics. This is a key aspect of this system. The treatment procedure is finished when all of the endometrial tissue is vaporized. This means that endometrial pretreatment is not necessary. A thicker endometrial layer will simply increase the treatment time. The Novasure procedure

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NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients
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Cited by (21)

Women's preferences for the levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding
2018, European Journal of Obstetrics and Gynecology and Reproductive Biology
Citation Excerpt :
Endometrial ablation is another frequently used, minimally invasive treatment option for HMB. Both treatments are effective in decreasing blood loss, but there is insufficient evidence to suggest a significant difference in blood loss reduction between the two treatment options [1,7–10]. Consequently, current treatment choice is based on patient preferences.
Women’s preferences for treatment of heavy menstrual bleeding (HMB) are important in clinical decision-making. Our aim was to investigate whether women with HMB have a preference for treatment characteristics of the levonorgestrel intrauterine system (LNG-IUS) or endometrial ablation and to assess the relative importance of these characteristics.
A discrete choice experiment was performed in general practices and gynaecology outpatient clinics in the Netherlands. Women with HMB were asked to choose between hypothetical profiles containing characteristics of LNG-IUS or endometrial ablation. Characteristics included procedure performed by gynaecologist or general practitioner; reversibility of the procedure; probability of dysmenorrhea; probability of irregular bleeding; additional use of contraception; need to repeat the procedure after five years; and treatment containing hormones. Data were analysed using panel mixed logit models. The main outcome measures were the relative importance of the characteristics and willingness to make trade-offs.
165 women completed the questionnaire; 36 (22%) patients were recruited from general practices and 129 (78%) patients were recruited from gynaecology outpatient clinics. The characteristic found most important was whether a treatment contains hormones. Women preferred a treatment without hormones, a treatment with the least side effects, and no need for a repeat procedure or additional contraception. Women completing the questionnaire at the gynaecology outpatient clinic differed from women in primary care in their preference for a definitive treatment to be performed by a gynaecologist.
Whether or not a treatment contains hormones was the most important characteristic influencing patient treatment choice for HMB. Participants preferred characteristics that were mostly related to endometrial ablation, but were willing to trade-off between characteristics.
Effect of Undiagnosed Deep Adenomyosis After Failed NovaSure Endometrial Ablation
2015, Journal of Minimally Invasive Gynecology
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.
Superficial hysteroscopic resection for polypoid endometrium: Preliminary results of an innovative approach for women of childbearing age
2012, Journal de Gynecologie Obstetrique et Biologie de la Reproduction
Évaluer l’efficacité de la résection superficielle hystéroscopique d’un endomètre polypoïde symptomatique (ménorragies, dysménorrhées et infertilité inexpliquée).
Étude rétrospective monocentrique incluant 44 patientes opérées par hystéroscopie entre le 1^er janvier 2004 et le 31 décembre 2009 d’un endomètre polypoïde. Une enquête téléphonique évaluant l’évolution des symptômes et de la fertilité a été réalisée en postopératoire.
Respectivement, 59 % et 52 % des patientes présentant exclusivement des ménorragies ou des dysménorrhées ont indiqué une amélioration à long terme de leurs symptômes. Parmi les 26 patientes qui présentaient une infertilité (primaire ou secondaire) et un désir de grossesse immédiat, 58 % (n = 15) ont présenté une grossesse après la chirurgie avec un taux de naissance vivante de 38 %. Le taux de grossesse en cas d’infertilité primaire et secondaire était respectivement de 53 % (n = 8/15) et 64 % (n = 7/11).
La résection superficielle de l’endomètre est une approche chirurgicale destinée à traiter un épaississement endométrial polypoïde symptomatique tout en préservant la fertilité potentielle des patientes.
To evaluate the reproductive safety and long-term efficacy of hysteroscopic superficial endometrial resection for polypoid endometrium in symptomatic patients (menorrhagia, dysmenorrhea and unexplained infertility).
The present retrospective descriptive case series study included 44 patients of reproductive age who underwent superficial hysteroscopic endometrial resection between January 1st, 2004 and December 31, 2009. Reproductive outcome, and the patients’ perceptions of menstrual symptoms after the surgical intervention were collected from the clinical notes and a semi-structured telephone interview.
Of the patients presenting abnormal uterine bleeding, 59% reported long-term improvement of this symptom; of those with dysmenorrhea, 52% reported long-term relief. Among 26 infertile women who wanted to become pregnant immediately after the procedure, 58% succeeded (n = 15), with a live-born rate of 38%. The pregnancy rate in primary and secondary infertility cases was respectively 53% (n = 8/15) and 64% (n = 7/11).
Superficial endometrial resection is an alternative for treating polypoid endometrium when it is associated with menorrhagia, dysmenorrhea and infertility. It treats menstrual symptoms successfully, with no adverse impact on fertility.
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.
Endometrial ablation with the NovaSure system in Iran
2011, International Journal of Gynecology and Obstetrics
Citation Excerpt :
An ideal technique for endometrial ablation would be completely safe and effective, in addition to being easy and quick to perform—requiring only local anesthesia with or without the administration of oral pain medication. Current data show that the NovaSure system (Hologic, Bedford, MA, USA) is effective for the treatment of menorrhagia and has few complications compared with first-generation endometrial ablation techniques [11–13]. The efficacy of the system has been evaluated in several studies, which have shown that—during a period of 1–5 years of follow-up after treatment—the rate of amenorrhea was 43%–69% [14–16].
To evaluate the rate of response to treatment with the NovaSure endometrial ablation device among Iranian women with menorrhagia.
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.
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.
The NovaSure system is effective and should be considered by gynecologists for the treatment of menorrhagia.
Predictors of Long-Term NovaSure Endometrial Ablation Failure
2018, Journal of Minimally Invasive Gynecology
Endometrial ablation using the NovaSure system (Hologic Inc., Marlborough, MA) is 1 of the treatment options for heavy menstrual bleeding (HMB), which has a reported success rate of 81% to 90%. We aimed to identify predictors for NovaSure endometrial ablation failure. This will contribute to a more effective and individualized preoperative counseling.
A retrospective multicenter cohort study (Canadian Task Force classification II-2).
One university hospital and 1 large teaching hospital.
Four hundred eighty-six patients with HMB who had undergone NovaSure endometrial ablation between 2008 and 2014.
The NovaSure endometrial ablation system for patients with HMB.
In total, the required characteristics of 486 patients were collected and analyzed. With a median follow-up of 45 months, 19.3% (n = 94) required a secondary treatment and thus were considered NovaSure failures. Multivariate logistic regression analysis showed that younger age (p = .019), a history of sterilization (p = .002), the presence of dysmenorrhea (p < .001) and the presence of an intramural leiomyoma on transvaginal sonography (p = .005) were independent predictors of NovaSure ablation failure. Preoperative hysteroscopy appeared to be a protective factor (p = .001).
Within a median follow-up of 45 months, 19.3% of patients required a secondary treatment. Identification of specific predictive factors for endometrial ablation failure is important in preoperative counseling and patient selection. In the current era of personalized medicine, doctors and patients will ideally choose the therapy that results in the highest chance of success in the individual case.

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9Second-generation endometrial ablation treatment: Novasure

Section snippets

Technique

Research

Summary

J Am Assoc Gynecol Laparosc

Am J Obstet Gynecol

J Obstet Gynaecol Can

J Minim Invasive Gynecol

J Am Assoc Gynecol Laparosc

Fertil Steril

J Am Assoc Gynecol Laparosc

Fertil Steril

J Am Assoc Gynecol Laparosc

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Second-generation endometrial ablation treatment: Novasure