Hysterectomy for Complications after Uterine Artery Embolization for Leiomyoma: Results of a Canadian Multicenter Clinical Trial

doi:10.1016/S1074-3804(05)60242-3

The Journal of the American Association of Gynecologic Laparoscopists

Volume 10, Issue 1, February 2003, Pages 99-106

The Journal of the A...

https://doi.org/10.1016/S1074-3804(05)60242-3 Get rights and content

Abstract

Study Objective

To determine the complication-related hysterectomy rate after uterine artery embolization (UAE) for symptomatic uterine leiomyomas.

Design

Prospective, multicenter, nonrandomized, single-arm clinical trial (Canadian Task Force classification II-2).

Setting

Eight Ontario University-affiliated teaching and community hospitals.

Patients

Five hundred fifty-five women.

Intervention

Polyvinyl alcohol particles were delivered through a catheter into uterine arteries under fluoroscopic guidance.

Measurements and Main Results

Prospective follow-up investigations consisted of telephone interviews, ultrasound examinations, and reviews of pathology and surgery reports. Median follow-up was 8.1 months, and all but five patients had complete 3-month follow-up. At 3 months, eight women (1.5%, 95% CI 0.6–2.8) underwent complication-related hysterectomy. Half of the surgeries were performed at institutions other than where UAE had been performed. Indications for hysterectomies were infections (2), postembolization pain (4), vaginal bleeding (1), and prolapsed leiomyoma (1).

Conclusion

The 3-month complication rate resulting in hysterectomy after UAE in a large cohort of women was low. Hysterectomy after UAE is an important measure of safety and a key outcome measure of this new therapy.

Section snippets

Materials And Methods

The Ontario, Canada, UAE trial is a registry-based, multicenter clinical trial involving seven university-affiliated teaching hospitals and one community hospital. It includes the practices of 11 interventional radiologists, all experienced in angiographic and interventional techniques. Institutional review board approval was obtained at all sites for a single-arm prospective trial, and informed consent was obtained from all patients before treatment.

Women with symptomatic leiomyomata were

Results

Among 555 women undergoing UAE, no intraprocedural surgical conversions were necessary. Median follow-up was 8.1 months; all but 2 women had follow-up at 2 weeks and all but 3 others at 3 months. All five exceptions moved or left the country. Eight hysterectomies were performed for complications (Table 1), three within 1 month and five within 3 months of UAE. The overall complication-related cumulative hysterectomy rates after UAE at 1 and 3 months were 0.5% (95% CI 0.1–1.6) and 1.5% (95% CI

Discussion

We found complications after UAE resulting in hysterectomy to be rare, although in some patients hysterectomy was performed as an emergency. It is also worth while to note that these surgeries were commonly performed at institutions other than where embolization was done. Interventional radiologists were not sent, or had not requested, copies of surgery or pathology reports for their patients. This raises several issues. First, UAE for uterine leiomyomas is in the early stages of development,

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Cited by (46)

Nonsurgical Alternatives for Uterine Fibroids
2016, Best Practice and Research: Clinical Obstetrics and Gynaecology
Citation Excerpt :
Spontaneous abortion rate was 32%, the postpartum hemorrhage rate 9%, the premature delivery rate 22%, the malpresentation rate 22%, and the rate of cesarean delivery 65% [40]. Moreover, the Ontario UFE multicenter trial reported 19 pregnancies in 167 patients who wished to conceive, with two cases of placenta accreta and one membranous placenta [41]. Women should be aware of the lack of data on potential risk for pregnancy outcomes and placental complications [26].
Uterine leiomyomata are the direct cause of a significant health-care burden for women, their families, and society as a whole.
Because of the long experience with the mode of treatment, surgical myomectomy remains the gold standard for treating reproductive-age women; however, in the recent years, the wide evolution of less invasive approaches led to a change in the options used by the clinician to treat symptomatic fibroids.
Minimally invasive procedures such as uterine artery embolization (UAE) are increasingly used to treat symptomatic fibroids. Other alternative treatments are becoming more diffuse, such as magnetic resonance–guided high-frequency focused ultrasound surgery (MRgFUS), cryomyolysis, vaginal occlusion, and laparoscopic closure of the uterine arteries. Both advantages and limitations of these techniques under development must be taken into account, but this wider range of choices is being increasingly considered for a tailored treatment.
This article aims to enable health-care providers with the tools to provide the latest evidence-based care in the minimally invasive or noninvasive management of this common problem.
Antibiotics in interventional radiology
2015, Clinical Radiology
Citation Excerpt :
In the Ontario Uterine Fibroid Embolization Trial, which included 555 women, prophylactic antibiotics were only routinely given at four centres, whereas the remaining four reserved prophylaxis for high-risk patients. They reported two hysterectomies related to infection following 570 procedures, one in each group.115,117 There have been four reported deaths in the literature, two related to sepsis118,119 and two following pulmonary embolism.120,121
The range and number of interventional procedures is rapidly increasing each year. A major complication associated with many procedures is infection, which can result in serious adverse outcomes for the patient. Consequently, antibiotics are amongst the most common pharmaceuticals used by the interventionist, particularly for non-vascular procedures, yet almost no randomized controlled trial data exist to inform our decision when formulating appropriate antibiotic prophylaxis regimens. The purpose of this review is to provide an update on the utilization of antibiotics for common interventional radiology procedures, focusing on timing and duration of antibiotic prophylaxis.
Role of embolization in the management of uterine fibroids
2011, Journal de Gynecologie Obstetrique et Biologie de la Reproduction
L’embolisation des artères utérines aux particules non sphériques de PVA ou aux microsphères de tris-acryl de plus de 500 μm traite efficacement les ménorragies, les symptômes de compression et les douleurs pelviennes dans 90 % des cas à court terme. À long terme, l’efficacité sur les ménorragies et les symptômes de compression est de 75 % à cinq à sept ans. La réduction du volume utérin à six mois varie entre 30 et 60 % et la réduction de volume du fibrome dominant varie entre 50 et 80 % à six mois. Le taux de complications est évalué à 3 % en cours d’hospitalisation. Le taux d’hystérectomie pour complication est inférieur à 2 % à trois mois. Le taux d’aménorrhée définitive est inférieur à 5 % chez les femmes âgées de moins de 45 ans. Il n’existe pas d’impact significatif de l’embolisation sur la fonction hormonale chez les femmes de moins de 45 ans présentant un bilan hormonal préalable normal. Le taux d’hystérectomie secondaire pour inefficacité ou récidive clinique est de 14 à 28 % à cinq ans. Les particules non sphériques de PVA sont associées à un taux plus important d’occlusion des microcathéters que les microsphères de tris-acryl. Il n’existe aucune différence entre les différentes particules en termes d’intensité de douleurs post-embolisation ou de doses d’antalgiques. Les microsphères de PVA (Contour SE et Bead Block) ont une efficacité clinique et un taux de dévascularisation des fibromes en IRM moindres que les microsphères de tris-acryl (embosphère). Il n’existe pas de différence entre les particules non sphériques de PVA et les microsphères de tris-acryl (> 500 μm) en termes d’efficacité clinique, de réduction du volume utérin et de taux de complications. Les études comparant l’embolisation à l’hystérectomie permettent de conclure que les réinterventions sont plus fréquentes après une embolisation qu’après une hystérectomie. L’hystérectomie secondaire est nécessaire après embolisation dans 13 à 24 % des cas à deux ans, et dans 28 % des cas à cinq ans. Les durées d’hospitalisation, de convalescence et d’arrêt de travail sont plus courtes après embolisation qu’après hystérectomie. Le coût de l’embolisation est inférieur à celui de l’hystérectomie à 12 mois et à 24 mois, y compris en prenant en compte le coût de l’imagerie et des réinterventions. Les études comparant l’embolisation à la myomectomie montrent qu’à court et moyen termes il n’existe pas de différence en termes d’efficacité sur les ménorragies ou les symptômes de compression. Il n’existe pas de différence de réduction du volume utérin après embolisation et après myomectomie, ni de différence de qualité de vie à six mois entre les deux traitements. Les taux de complications péri-opératoires et à 30 jours sont équivalents entre les deux traitements. Le taux de complications à six mois est plus élevé après myomectomie qu’après embolisation. Le taux de réinterventions est plus élevé après embolisation qu’après myomectomie. Les durées d’hospitalisation, de convalescence, et d’arrêt de travail sont plus courtes après embolisation qu’après myomectomie. L’embolisation chez les femmes désireuses de grossesse doit être discutée au cas par cas car il existe peu d’études randomisées permettant de recommander l’embolisation alternative à la myomectomie. L’élévation du taux de FSH est plus fréquente après embolisation qu’après myomectomie. Le taux de conception et le nombre de grossesses à terme après myomectomie est plus élevé qu’après embolisation. Le taux de fausse couche est plus élevé après embolisation qu’après myomectomie. Il n’existe pas différence significative entre embolisation et myomectomie en ce qui concerne le taux d’accouchement prématuré, de césarienne, d’hémorragie du post-partum, de prééclampsie ou de retard de croissance in utero. L’embolisation avant myomectomie (préopératoire ou technique combinée) peut se discuter au cas par cas mais il n’existe pas de preuve suffisante de son intérêt.
Uterine artery embolization using non spherical PVA particles or calibrated tris-acryl microspheres above 500 μm is effective to treat menorrhagia, bulk-related symptoms and pelvic pain in more than 90% of cases in the short-term. In the long-term, embolization is effective in 75% of cases at 5–7 years. At 6 months, uterine volume reduction and dominant fibroid volume reduction varies between 30–60% and 50–80% respectively. During hospital stay, the complication rate is 3%. Secondary hysterectomy for complication is less than 2% at 3 months. Definitive amenorrhea is reported in less than 5% of cases in women of less than 45 years of age. No significant impact of embolization on hormonal function has been reported in women less than 45 years with normal baseline function. Secondary hysterectomy for clinical failure or recurrence is reported in 14–28% of cases at 5 years. Non-spherical PVA particles are associated with more microcatheter occlusion than tris-acryl microspheres. No difference between PVA particles and tris-acryl microspheres was found in terms of post-embolization pain or analgesic doses. PVA microspheres (Contour SE et Bead Block) are associated with lower clinical success and lower fibroid devascularization using MRI than tris-acryl microspheres. No difference between PVA particles and tris-acryl microspheres was found in terms of clinical efficacy, uterine volume reduction and complication rate. Randomized studies comparing embolization to hysterectomy demonstrate that reinterventions are more frequently performed after embolization. Secondary hysterectomy is performed in 13 to 24% of cases at 2 years and in up to 28% of cases at 5 years. Hospital stay, duration of recovery and time off work are shorter after embolization compared to hysterectomy. Embolization is cheaper than hysterectomy at 12 and 24 months even taking into consideration the additional costs of imaging and reinterventions. Randomized studies comparing embolization to myomectomy demonstrate that in the short- and mid-term there is no difference in terms of control of menorrhagia and bulk-related symptoms. Uterine volume reduction and quality of life were not different at 6 months. Periprocedural and 30-day complication rates are not different. At 6 months, the rate of complications is higher after myomectomy. Reinterventions are more frequent after embolization compared to myomectomy. Hospital stay, duration of recovery and time off work are shorter after embolization compared to myomectomy. Embolization should be considered with caution in pregnancy-seeking women since there is still a lack of good quality data available in the specific group of patients. FSH level is more frequently elevated after embolization compared to myomectomy. Pregnancy rate and term pregnancy rate are higher after myomectomy compared to embolization. Spontaneous abortion is more frequent after embolization than after myomectomy. There is no difference between embolization and myomectomy for the rates of pre-term delivery, cesarean section, post-partum hemorrhage, pre-eclampsia or intra-uterine growth retardation. Embolization performed before myomectomy (preoperative or combined procedures) can be discussed for an individual patient but there is not enough data to support its routine use.
Practice guideline for adult antibiotic prophylaxis during vascular and interventional radiology procedures
2010, Journal of Vascular and Interventional Radiology
Citation Excerpt :
Cefazolin is inexpensive and has activity against the likely source of pathogens during solid organ embolization, ie, skin pathogens (Staphylococcus or Streptococcus species), as well as activity against E coli (9). Other options that have been described include gentamicin plus clindamycin, ampicillin, ampicillin/sulbactam, or vancomycin in the penicillin-allergic patient (9,72,80). Patients with a history of hydrosalpinx may warrant special consideration before UAE, although there is no published consensus regarding which agents should be used.
Uterine artery embolization in the treatment of symptomatic uterine myoma: 2-year outcomes in 90 patients
2009, Progresos de Obstetricia y Ginecologia
Evaluar los resultados a medio plazo y la satisfacción de las pacientes después de la embolización de las arterias uterinas en mujeres con miomas uterinos sintomáticos, así como la seguridad del tratamiento.
Estudio prospectivo que incluye 90 casos tratados en el Hospital de Sabadell, entre diciembre del 2002 y octubre del 2006.
La recogida de datos se realizó mediante un cuestionario introducido posteriormente en una base de datos específica; el análisis estadístico se realizó con el programa SPSS 15.0.
Todas las pacientes tuvieron un seguimiento de 2 años después del procedimiento a nivel clínico, analítico y mediante técnicas de imagen.
Los síntomas fueron valorados como desaparición o mejoría, sin cambios o empeoramiento. Los efectos adversos se anotaron según la clasificación de la Sociedad de Radiología Intervencionista. También se recogió la satisfacción de las mujeres embolizadas.
Se consideró un fracaso de la técnica la necesidad de histerectomía o la persistencia de clínica.
La mejoría de los síntomas a los 2 años fue del 90,7%. En 4 casos se practicó una segunda embolización y en 6 casos se realizó una histerectomía.
A los 6 meses, el 92,8 % de los miomas mostraban una vascularización nula o escasa. A los 2 años, la disminución media en el volumen del mioma dominante fue del 76,3%.
El porcentaje de complicaciones mayores fue del 12,7%.
La satisfacción por el procedimiento fue del 90,2%.
La embolización de las arterias uterinas en mujeres con miomas uterinos sintomáticos es un tratamiento efectivo con una buena aceptación de las pacientes después de un seguimiento a medio plazo.
To evaluate the mid-term outcomes and patient satisfaction following UAE in women with symptomatic leiomyomata, as well as to assess safety treatment.
Prospective study of 90 patients from Sabadell Hospital between December 2002 and October 2006.
Data were collected using a questionnaire and was later introduced in a specific database. Statistical analysis of data was carried out using SPSS 15.0.
All patients went on a 2-year follow-up after UAE, including clinical, laboratory and diagnostic imaging examinations.
Symptoms were scored as successful, improvement, unchanged or worsened. Adverse events were noted following the Society of Interventional Radiology's classification. Patients were also asked about their satisfaction.
The need of an eventual hysterectomy or the persistence of symptoms was considered to be a treatment failure.
The improvement of symptoms occurred in 90,7% of all the embolized women. We had to perform a second embolization in 4 cases, and a hysterectomy in 6 cases.
6 months later, null vascularisation or hypovascularisation of the myoma was observed in 92.8% of women. Over two years, the average volume reduction of the dominant myoma was 76.3%.
The rate of major complications was 12.7%. Patient satisfaction for the procedure was 90.2%.
Uterine artery embolization is an effective treatment for women with symptomatic uterine leiomyomata, being well accepted by the patients in the mid-term follow-up.
Image-Guided Thermal Therapy of Uterine Fibroids
2009, Seminars in Ultrasound, CT and MRI
Thermal ablation is an established treatment for tumors. The merging of newly developed imaging techniques has allowed precise targeting and real-time thermal mapping. This article provides an overview of the image-guided thermal ablation techniques in the treatment of uterine fibroids. Background on uterine fibroids, including epidemiology, histology, symptoms, imaging findings, and current treatment options, is first outlined. After describing the principle of magnetic resonance thermal imaging, we introduce the applications of image-guided thermal therapies, including laser ablation, radiofrequency ablation, cryotherapy, and in particular, magnetic resonance-guided focused ultrasound surgery, and how they apply to uterine fibroid treatment.

View all citing articles on Scopus

: Presented at the 56th annual meeting of the Society of Obstetricians and Gynecologists, Montreal, Quebec, June 17–21, 2000; and the 29th annual meeting of the American Association of Gynecologic Laparoscopists, Orlando, Florida, November 15–19, 2000.

: Funded in part by Boston Scientific Corporation, Boston, Massachusetts.

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Original ArticlesHysterectomy for Complications after Uterine Artery Embolization for Leiomyoma: Results of a Canadian Multicenter Clinical Trial

Abstract

Study Objective

Design

Setting

Patients

Intervention

Measurements and Main Results

Conclusion

Section snippets

Materials And Methods

Results

Discussion

Lancet

J Vasc Interv Radiol

J Vasc Interv Radiol

J Am Assoc Gynecol Laparosc

J Vasc Interv Radiol

J Vasc Interv Radiol

Lancet

Obstet Gynecol

J Vasc Interv Radiol

J Vasc Interv Radiol

Fertil Steril

Obstet Gynecol

Value of preoperative embolization of uterine fibromas: Report of a multi-center series of 31 cases

Contracept Fertil Sex

Uterine artery embolization for fibroid disease: Results of a 6 year study

Minim Invas Ther Allied Technol

Original Articles
Hysterectomy for Complications after Uterine Artery Embolization for Leiomyoma: Results of a Canadian Multicenter Clinical Trial