Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: Long-term results

doi:10.1016/j.ejrad.2013.08.045

European Journal of Radiology

Volume 82, Issue 12, December 2013, Pages 2265-2269

https://doi.org/10.1016/j.ejrad.2013.08.045 Get rights and content

Abstract

Objectives

To compare the long-term outcome after uterine artery embolization (UAE) versus magnetic resonance-guided high-intensity focused ultrasound (MR-g HIFU) for symptomatic uterine fibroids.

Methods

Seventy-seven women (median age, 39.3 years; range, 29.2–52.2 years) with symptomatic uterine fibroids, equally eligible for UAE and MR-g HIFU based on our exclusion criteria underwent treatment (UAE, N = 41; MR-g HIFU, N = 36) from 2002 to 2009 at our institution. Symptom severity (SS) and total health-related quality of life (Total HRQoL) scores were assessed by the uterine fibroid symptom and quality of life (UFS-QoL) questionnaire before treatment and at long-term follow-up after UAE (median 61.9 months) and after MR-g HIFU (median: 60.7 months). Re-intervention rates were assessed for each therapy and compared.

Results

Re-intervention was significantly lower after UAE (12.2%) than after MR-g HIFU (66.7%) at long-term follow-up (p < 0.001). After UAE changes in SS (50 pre-treatment vs. 6.3 post-treatment) and Total HRQoL (57.8 pre-treatment vs. 100 post-treatment) were significantly better than changes in SS (42.2 pre-treatment vs. 26.6 post-treatment) and Total HRQoL score (66.4 pre-treatment vs. 87.9 post-treatment) after MR-g HIFU (p = 0.019 and 0.049 respectively).

Conclusions

Improvement of SS and Total HRQoL scores was significantly better after UAE resulting in a significant lower re-intervention rate compared to MR-g HIFU.

Introduction

Treatment options for symptomatic uterine fibroids have broadened over the last two decades. Moreover, many women are now seeking uterus-sparing alternatives that are less invasive than traditional surgical treatments [1]. Uterine artery embolization (UAE) has emerged as the leading minimally invasive treatment for fibroids after the seminal publication by Ravina et al. in 1995 [2]. Magnetic resonance-guided high-intensity focused ultrasound (MR-g HIFU), a non-invasive treatment involving focused ultrasound energy to ablate fibroid tissue, was approved by the U.S. Food and Drug Administration (FDA) and modified in 2004. Both UAE and MR-g HIFU have been recognized as safe and efficacious treatments in symptomatic fibroid disease, although so far no direct comparison has been published [3], [4], [5], [6], [7], [8], [9], [10], [11], [12].

The aim of the present study was to evaluate and compare the long-term re-intervention rate and changes in symptom severity (SS) and total health-related quality of life (Total HRQoL) scores among patients undergoing UAE or MR-g HIFU for symptomatic uterine fibroids, using for this comparison the validated uterine fibroid symptom severity and quality of life (UFS-QoL) questionnaire [13], [14].

Section snippets

Study participants and enrollment

This study was a retrospective analysis of a prospectively collected database. The institutional review board approved the entire study and each patient gave written informed consent. All women included in this study had symptomatic fibroids, were premenopausal, completed the UFS-QoL questionnaire at baseline and follow-up interview and underwent magnetic-resonance imaging (MRI) before therapy. All included women underwent UAE or MR-g HIFU between 2002 and 2009 at our institution and were

Results

In the period of 2002 and 2009 a total of 366 women with symptomatic fibroids and baseline UFS-QoL questionnaire either underwent UAE or MR-g HIFU therapy at our institution. Patients included in this study based on the exclusion criteria which are given in the flow-chart diagram (Fig. 1). Baseline demographic data of the study population are given in Table 4. Fibroid related SS and Total HRQoL were reevaluated by the UFS-QoL questionnaire after a median of 61.9 months after UAE and 60.7 months

Discussion

In this study, we compared the long-term outcome after UAE and MR-g HIFU in women with symptomatic fibroids.

With a re-intervention rate of 12.2% in the UAE group, our results are partly within the range of long-term outcomes reported for UAE in the literature like by Katsumori et al. with a cumulative rate of symptom control of 89.5% or Scheurig et al. with a failure rate of 17% and partly better than data given in the literature like Spies et al. with a failure rate of 20% until 5 years after

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Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial
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Émettre des recommandations pour la prise en charge des femmes ayant des ménorragies.
Un comité de 26 experts a été constitué. Une politique de déclaration et de suivi des liens d’intérêts a été appliquée et respectée durant tout le processus de réalisation du référentiel. De même, celui-ci n’a bénéficié d’aucun financement provenant d’une entreprise commercialisant un produit de santé (médicament ou dispositif médical). Le comité devait respecter et suivre la méthode GRADE® (Grading of Recommendations Assessment, Development and Evaluation) pour évaluer la qualité des données factuelles sur lesquelles étaient fondées les recommandations.
Les dernières recommandations du Collège national des gynécologues et obstétriciens français (CNGOF) sur la prise en charge des femmes ayant des ménorragies ont été publiées en 2008. Nous avons souhaité réactualiser ces recommandations selon la méthodologie GRADE® en identifiant 7 champs différents (diagnostic ; adolescente ; ménorragies idiopathiques ; hyperplasie et polype de l’endomètre ; myomes de type 0 à 2 ; myomes de type 3 et plus ; adénomyose). Chaque question a été formulée selon le format PICO (Patients, Intervention, Comparison, Outcome). L’analyse de la littérature et les recommandations ont été formulées selon la méthodologie GRADE®.
Le travail de synthèse des experts et l’application de la méthode GRADE ont abouti à 36 recommandations. Parmi les recommandations, 19 ont été établies avec un accord fort et 17 avec un accord faible. Il n’a pas été possible de statuer pour 14 questions pour lesquelles nous avons préféré nous abstenir plutôt que de fournir des avis d’experts.
Les 36 recommandations ont permis de préciser les stratégies diagnostiques et thérapeutiques des différentes situations cliniques des plus simples au plus complexes rencontrées par le praticien.
To provide French guidelines for the management of women with abnormal uterine bleeding (AUB).
A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized.
The last guidelines from the Collège national des gynécologues et obstétriciens français (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology.
The experts’ synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice.
The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.
Systematic review of reproductive outcomes after High Intensity Focused Ultrasound treatment of uterine fibroids
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Citation Excerpt :
Five case reports were included. Only one study reported on a control group of women treated by UAE [22]. Seven of the fourteen studies had reproductive outcomes as their primary outcome.
Myomectomy is currently the gold standard for the treatment of uterine fibroids in women who desire pregnancy. However, this surgical fibroid removal has a long convalescence. Promising alternatives may be non-invasive High Intensity Focused Ultrasound (HIFU) under either MRI (MR-HIFU) or ultrasound guidance (USgHIFU). In this systematic review, an overview is provided of reproductive outcomes after these two relatively new ablation techniques.
A systematic literature search was performed to identify studies reporting reproductive outcomes after HIFU treatment of fibroids. Only peer reviewed, full papers were included. Outcomes included pregnancy-, live-birth- miscarriage and caesarian section rate, time to conceive, reported complications, and possible prognostic factors.
In total 21 studies were included. Fourteen studies reported 124 pregnancies after MR-HIFU. Two placenta previas and no uterus ruptures were reported. Pregnancy rates were only retrospectively collected and ranged between 7% and 36%. Miscarriage rate in the oldest and largest prospective registry was 39%.
After USgHIFU 366 pregnancies were reported with one fetal intrauterine death, six placenta previas and no uterus ruptures. The only prospective study reported a pregnancy rate of 47% and a miscarriage rate of 11%.
Possible prognostic factors like age were not available in most studies.
Based on the heterogeneous data currently available, reproductive outcomes after HIFU appear non-inferior to outcomes after the current standard of care. However, a (randomized) controlled trial comparing reproductive outcomes after HIFU and standard care is necessary to provide sufficient evidence on the preferred fibroid treatment for women with a pregnancy wish.
Long-term Clinical Outcomes of US-Guided High-Intensity Focused Ultrasound Ablation for Symptomatic Submucosal Fibroids: A Retrospective Comparison with Uterus–Sparing Surgery
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Uterus-sparing surgery and ultrasound (US)-guided high-intensity focused ultrasound (HIFU) ablation are both treatment options for symptomatic submucosal fibroids. No study had compared the long-term clinical outcomes between the two techniques. Therefore, the aim of this study was to compare the long-term clinical outcomes between US-guided HIFU ablation and uterus-sparing surgery for the treatment of symptomatic submucosal fibroids.
A retrospective study was conducted on 245 women who were treated by US-guided HIFU ablation and 129 women who underwent uterus-sparing surgery for type I or type II symptomatic submucosal fibroids in a single institution from January 2007 to January 2015. The mean diameter of the fibroids was about 6 cm in both groups. They were followed up until December 2018. The symptom relief rate, symptom recurrence rate and incidence of major complications were compared between the two groups.
The symptom relief rate was 95.9% for US-guided HIFU ablation and 89.1% for uterus-sparing surgery. The cumulative symptom recurrence rate at 1-, 3-, 5-, and 8 years was 1.7%, 6.8%, 9.4%, and 11.9% for US-guided HIFU ablation and 6.1%, 12.2%, 22.6%, and 27.8% for uterus-sparing surgery. Compared to uterus-sparing surgery group, US-guided HIFU ablation had a statistically higher symptom relief rate and a lower symptom recurrence rate (p < 0.05). The major complication rate was 3.1% in the uterus-sparing surgery group. No major complications occurred in the US-guided HIFU ablation group.
This study showed that the long-term clinical outcomes of US-guided HIFU ablation may be better that of uterus-sparing surgery for the treatment of symptomatic submucosal fibroids. US-guided HIFU ablation may also be safer than uterus-sparing surgery. Further larger randomized trials are needed to confirm these findings.
Uterine Artery Embolization Compared with High-intensity Focused Ultrasound Ablation for the Treatment of Symptomatic Uterine Myomas: A Systematic Review and Meta-analysis
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Citation Excerpt :
Four studies [15–17,20] reported UFS-QoL scores at baseline and after treatment. The reintervention rate, incidence of adverse events, and pregnancy rate were reported in 5 studies [15–18,20], 2 studies [17,19], and 2 studies [15,16], respectively. The median age ranged between 41.2 years and 46.0 years in the UAE group and between 36.1 years and 44.0 years in the HIFU ablation group.
This study aimed to compare the clinical effects of uterine artery embolization (UAE) with those of high-intensity focused ultrasound (HIFU) ablation for the treatment of symptomatic uterine myomas.
We searched PubMed, EMBASE, Web of Science, Cochrane Library, Google Scholar, and ClinicalTrials.gov for studies from January 2000 to August 2020. Related articles and relevant references of the included studies were also searched.
Two researchers independently performed the data selection. We included comparative studies that compared the clinical outcomes of UAE with those of HIFU ablation in women with myomas.
We assessed the study quality using the Cochrane Handbook for Systematic Reviews of Interventions for evaluating the risk of bias. Two independent researchers performed the article selection according to the screening criteria and rated the quality of evidence for each article. We calculated pooled mean difference with 95% confidence interval (CI) for continuous data and relative risk (RR) with 95% CI for dichotomous data. The systematic review registration number is CRD42020199630 on the International Prospective Register of Systematic Reviews. A total of 7 articles (5 trials), involving 4592 women with symptomatic uterine myomas, were included in the meta-analysis. Compared with the HIFU ablation group, the decrease in “uterine fibroid symptom” scores as well as the increase in quality-of-life scores at the time of follow-up were higher in the UAE group, with overall mean difference 19.54 (95% CI, 15.21–23.87; p <.001) and 15.72 (95% CI, 8.30–23.13; p <.001), respectively. The women in the UAE group had a significantly lower reintervention rate (RR 0.25; 95% CI, 0.15–0.42; p <.001). The women undergoing UAE had a significantly lower pregnancy rate than those undergoing HIFU ablation (RR 0.06; 95% CI, 0.01–0.45; p = .006). The difference in the incidence of adverse events between the 2 groups was not statistically significant (p = .53).
Compared with HIFU ablation, UAE provided more significant alleviation of symptoms and improvement in quality of life, lower postoperative reintervention rate, and lower pregnancy rate for women with uterine myomas. However, we cannot conclude that HIFU ablation is more favorable for desired pregnancy than UAE because of the confounding factors.
Uterine Myomas: Extravascular Treatment
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Citation Excerpt :
Some series with limited follow-up length described a few cases who underwent further HIFU treatment, UAE or surgery for enlarging residual tumor, unsatisfactory results, or persistent symptoms.47,50,72,78 Some authors reported a high rate of re-interventions (47% at 15 months,74 58.64% at 5 years,79 66.7% at 60.7 months80). Gorny et al81 described the cumulative incidence of additional treatments after MR-guided HIFU ablation of 19% and 23% at 36- and 48-month follow-up, respectively; older patients and hypointense fibroids were associated with fewer additional treatments needed.
Uterine fibroids are common benign tumors that affect the female reproductive tract. They are responsible for considerable morbidity and deterioration of life quality. The main advantages offered by mini invasive techniques are low grade of invasiveness and short times of hospitalization. The most diffuse technique is uterine artery embolization (UAE). Common concerns with UAE include postprocedural pain, postembolization syndrome, and risk of infection. Image-guided thermal ablation techniques like radiofrequency ablation, percutaneous microwave ablation, and imaging-guided high-intensity focused ultrasound were introduced to overcome the side effects related to UAE and surgery. The aim of this review is to briefly analyze the ablative procedures and their role in the management of symptomatic fibroids, and to describe the safety profile and outcomes of these modalities.

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View full text

Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: Long-term results

Abstract

Objectives

Methods

Results

Conclusions

Introduction

Section snippets

Study participants and enrollment

Results

Discussion

Lancet

Acad Radiol

J Vasc Interv Radiol

Obstet Gynecol

Fertil Steril

Quality-of-life assessment of fibroid treatment options and outcomes

Radiology

Uterine artery embolization for fibroids: a review of current outcomes

Semin Reprod Med

Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up

Ultrasound Obstet Gynecol

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial

Am J Obstet Gynecol