Elsevier

Journal of Minimally Invasive Gynecology

Volume 16, Issue 6, November–December 2009, Pages 692-699
Journal of Minimally Invasive Gynecology

Original Article
Efficacy of Bipolar Radiofrequency Endometrial Ablation vs Thermal Balloon Ablation for Management of Menorrhagia: A Population-Based Cohort

https://doi.org/10.1016/j.jmig.2009.06.022Get rights and content

Abstract

Study Objective

To compare the efficacy of bipolar radiofrequency ablation (RFA) and thermal balloon ablation (TBA) using treatment failure and postprocedure amenorrhea as outcome measures.

Design

Population-based cohort study (Canadian Task Force classification II-2).

Setting

Two medical centers in the upper Midwest.

Patients

Using the medical records linkage system of the Rochester Epidemiology Project, we identified 455 residents of Olmsted County, Minnesota, who underwent global endometrial ablation because of menorrhagia from January 1, 1998, through December 31, 2005. Amenorrhea was defined as complete cessation of menstruation that started immediately after ablation and lasted at least 12 months. Treatment failure was defined as necessity of repeat ablation or hysterectomy because of persistent bleeding or pain. Time to treatment failure for each procedure was compared using Kaplan-Meier plots. Relevant clinical data and complications were abstracted from medical records. Risk adjustments were performed using Cox and logistic regression models.

Interventions

Radiofrequency ablation (n=255) and thermal balloon ablation (n=200).

Measurements and Main Results

Mean (SD) patient age was 43.3 (5.5) years, and median follow-up was 2.2 years. The 3-year cumulative failure rate was 9% (95% confidence interval [CI], 5%–16%) for RFA and 12% (95% CI, 7%–16%) for TBA (p=.26). The difference remained nonsignificant after adjusting for known predictors of treatment failure such as age, parity, pretreatment dysmenorrhea, and tubal ligation (adjusted HR, 0.7; 95% CI, 0.4–1.4; p=.31). However, women had significantly higher rates of amenorrhea after RFA compared with TBA (32% vs 14%; p <.001). This difference remained significant after adjusting for known predictors of amenorrhea such as age, uterine length, and endometrial thickness (adjusted odds ratio, 2.9; 95% CI, 1.7–4.8; p <.001). Complications were infrequent and similar in the 2 groups.

Conclusion

Both RFA and TBA were equally effective treatments for menorrhagia in a population-based cohort. However, women who underwent RFA were 3 times more likely to have postprocedure amenorrhea.

Section snippets

Material and Methods

This study was approved by the Mayo Clinic and Olmsted Medical Center institutional review boards. The cohorts of patients included in this study were identified previously in a study from our research group. The methods used for identification and construction of the cohorts have been published [21].

Study Subjects

Of the 458 women identified, 3 were excluded because of menopause at the time of the procedure. Thus, 455 women were included in the analyses: 255 underwent RFA and 200 underwent TBA (Fig. 1). Their mean (SD) age was 43.3 (5.6) years, and median parity was 2 (IQR, 2–3). Median follow-up was 2.2 years (IQR, 1.3–3.5 years), and only 3 patients (<1%) were lost to follow-up. Baseline patient characteristics and clinical data were similar in the RFA and TBA groups (Table 1). Comparison of baseline

Discussion

In the present study, we directly compared the effectiveness of bipolar RFA and TBA in a population-derived cohort. Outcome measures included treatment failure and postablation amenorrhea. We reported procedural characteristics and other secondary outcomes, including duration of menstruation and change in hemoglobin and ferritin concentrations after ablation. Procedure-related complications were also documented and reported.

We observed no significant differences in treatment failure rates

References (27)

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The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.

Presented at the 37th Global Congress of Minimally Invasive Gynecology, Las Vegas, Nevada, October 28–November 1, 2008.

Dr. Famuyide has received honoraria from Hologic Inc, Bedford, Massachusetts, for consultation services not related to this article.

This study was indirectly supported by NIH grant Rochester Epidemiology Grant (AR30582-Dr. W.A. Rocca, Pl).

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