Radiofrequency ablation (Sonata): The fibroid treatment option for women desiring a uterine-sparing option and future fertility
Written in association with:
Obstetrician - gynaecologist
Published: 16/01/2024
Edited by: Sophie Kennedy
In this informative article, highly respected women’s health expert and consultant gynaecologist Mr Mahantesh Karoshi shares expert insight on Sonata, a treatment option for uterine fibroids that uses radiofrequency ablation, enabling women to preserve their fertility for the future.
How are uterine fibroids managed and treated?
Uterine fibroids are a common condition that affects up to 80 per cent of reproductive age group women.
Many women with fibroids are asymptomatic, but some experience problems that can profoundly disrupt their lives, such as abnormal uterine bleeding, pelvic pain, and bulk symptoms including bladder and bowel dysfunction.
Many women seek conservative management of uterine fibroids. Hormonal treatment, such as contraceptive pills, levonorgestrel intrauterine devices, and gonadotrophin-releasing hormone analogues, can improve heavy menstrual bleeding and anaemia. Additionally, uterine artery embolisation is a non-surgical and uterine sparing option. However, these treatments are not ideal options for women who want to conceive in future.
For reproductive age group women who desire future fertility, myomectomy has been the standard of care. Unfortunately, by the time patients become symptomatic from their fibroids and seek care, they may have numerous and sizable fibroids that result in high blood loss, surgical scarring, and the probable increased need for caesarean delivery in future.
For patients who desire future pregnancy, treatment of uterine fibroids poses a challenge in which optimising symptomatic improvement must be balanced with protecting fertility and improving reproductive outcomes. In recent years, radiofrequency ablation (RFA) has been presented as less invasive, uterine-sparing alternative option for fibroid treatment that could potentially provide that balance.
Overview of uterine-sparing treatments
Two approaches can be considered for fibroid treatment: fibroid removal (myectomy surgery) and fibroid necrosis (Sonata).
For reproductive age women who wish to conceive, surgical removal of fibroids has been the standard of care for symptomatic patients. Myomectomy can be performed via laparotomy (traditional open approach), laparoscopy (keyhole surgery), robot assisted surgery, and hysteroscopy (hysteroscopic resection of fibroid through the vaginal route). The most appropriate mode of surgery depends on the fibroid characteristics (size, number, and location) and the surgeon’s skill set.
Although some variation in the data exists, overall surgical outcomes, including blood loss, postoperative pain, and length of stay, are generally more favourable for minimally invasive approaches compared with open surgery. Nonetheless, from a technical point of view, a posteriorly located fibroid removal through keyhole can be extremely challenging for the surgeon.
There are no significant differences in fibroid recurrence or reproductive outcomes, i.e., live birth rate, miscarriage rate, and caesarean delivery rate, when comparing open and keyhole operations. Keyhole surgery comes at the expense of longer operating time compared with open surgery.
While myomectomy often effectively reduces abnormal uterine bleeding and pelvic pain, it's important to consider its potential reproductive consequences. Although the procedure is intended to enhance fertility, it can sometimes lead to complications that adversely affect this goal.
For instance, if the surgical removal of a fibroid results in an opening in the womb's cavity, this can significantly increase the risk of developing intrauterine adhesions, known as Asherman's syndrome. Additionally, such surgery might elevate the risk of uterine rupture during pregnancy and labour. There is also a heightened chance of the placenta becoming abnormally attached to the areas of the uterus that have been scarred by the fibroid surgery.
While the above complications are rare, much like any operation, outcomes can be difficult to predict. Some of the post-myomectomy complications can potentially be catastrophic and should not be forgotten.
Uterine artery embolisation
As a nonsurgical alternative to myomectomy, uterine artery embolisation (UAE) has gained popularity as a conservative fibroid treatment. It is less invasive than myomectomy, a benefit for patients who decline surgery or are not ideal candidates for surgery where it carries significant risk to patient’s life.
Evidence suggests that UAE produces overall comparable symptomatic improvement compared with myomectomy. One study showed no significant differences between UAE and myomectomy in terms of decreased uterine volume and menstrual bleeding at 6 month follow-up.
In terms of long-term outcomes, a large multicentre study showed no significant difference in reintervention rates at 7 years post treatment between UAE and myomectomy (8.9 per cent vs 11.2 per cent respectively), and a significantly higher rate of improved menstrual bleeding with UAE (79.4 per cent vs 49.5 per cent), with no significant difference in bulk symptoms.
Evidence suggests that UAE produces overall comparable symptomatic improvement. compared with myomectomy. Overall UAE can be considered as reasonable alternative to myomectomy in terms of symptomatic improvement. Pregnancy outcome data, however, is mixed and UAE is not often recommended for patients with future fertility plans.
In a large review article that compared minimally invasive fibroid treatments, UAE was associated with a lower live birth rate compared with myomectomy and ablation techniques (60.6 per cent for UAE , 75.6 per cent for myomectomy, and 70.5 per cent for ablation). It also had the highest rate of miscarriage (27.4 per cent for UAE vs 19.0 per cent for myomectomy and 11.9 per cent for ablation) and abnormal placentation.
While UAE remains an effective option for conservative treatment of symptomatic fibroids, it appears to have a worse impact on reproductive outcomes compared with myomectomy or ablative treatments.
Magnetic resonance guided focussed ultrasound (MRgFUS) is not available for treatment in the UK.
Radiofrequency ablation (RFA- Sonata): A promising option
Radiofrequency ablation (RFA) is another non-invasive fibroid ablation technique that has become more widely adopted in recent years.
The RFA technique uses hyperthermic energy from a handpiece and real-time ultrasound for targeted coagulative necrosis via transcervical (TC-RFA) approach. Ultrasound guidance allows placement of the radiofrequency needles directly into the fibroid to target local treatment to the fibroid tissue only. Once the fibroid undergoes coagulative necrosis, the process of fibroid resorption and volume reduction occurs over weeks to months, depending on the size of the fibroid.
Transcervical RFA (Sonata) has shown significant decreases in pelvic pain and heavy menstrual bleeding associated with fibroids and a low re-intervention rate that emphasises the durability of their impact. Sonata has shown a low re-intervention rate of around 5 per cent in the first 24 months post-procedure with significant improvement in health-related quality of life and high patient satisfaction.
Reproductive outcomes
A large case series that included clinical trials reported a miscarriage rate (13.3 per cent) similar to that of the general obstetric population and no cases of uterine rupture, invasive placentation, preterm delivery, or placental abruption noted.
Uterine impact
One study of TC-RFA (Sonata) patients showed a greater than 65 per cent reduction in fibroid volume (with a 90 per cent reduction in fibroid volume for fibroids larger than 6cm prior to RFA), and 54 per cent of patients reported complete resolution of symptoms, with another 36 per cent reporting decreased symptoms.
Additionally, a large secondary analysis of a TC-RFA clinical trial showed that patients did not have any significant decrease in uterine wall thickness or integrity on follow-up with magnetic resonance imaging compared with baseline measurements, and they did not have any new myometrial scars (assessed as non-perfused linear areas).
Existing studies have demonstrated promising aspects of RFA that argue its usefulness in women with fertility plans.
A prospective trial that evaluated intrauterine adhesion formation with use of a TC-RFA device found no new adhesions on 6-week follow-up hysteroscopy compared with baseline pre-RFA hysteroscopy.
Because intrauterine adhesion formation and uterine rupture are both significant concerns with other uterine-sparing fibroid treatment approaches such as myomectomy, these findings suggest that RFA may be a better alternative for women who are planning future pregnancies, as they may have increased fertility success and decreased catastrophic complications.
Consensus is growing that radiofrequency ablation is a safe and effective option for women seeking minimally invasive fibroid treatment and preserved fertility.
Unique benefits of RFA
In this article, I highlighted RFA (Sonata) as an emerging treatment option for fibroid management, particularly for women who desire a uterine-sparing approach to preserve their reproductive options. Although myomectomy has been the standard of care for many years, with UAE as the alternative nonsurgical treatment, neither approach provides the best balance between symptomatic improvement and reproductive outcomes, and neither is without risks to pregnancy.
In addition, many women with symptomatic fibroids do not desire future conception but decline fibroid removal for religious or personal reasons. RFA offers these women an alternative minimally invasive option for uterine sparing fibroid treatment. RFA presents a unique “incision-free” fibroid treatment that is truly minimally invasive. This technique minimises the risks associated with myomectomy, such as intra-abdominal adhesions, intrauterine adhesions (Asherman’s syndrome), need for caesarean delivery, and pregnancy complications such as uterine rupture or invasive placentation.
Furthermore, the evolution of an RFA transcervical approach has enabled treatment with no abdominal or uterine incisions, thus offering all the above reproductive benefits as well as the operative benefits of a faster recovery, less pain, and less risk of intra-peritoneal surgical complications.
While many women desire uterine-sparing fibroid treatment even without future fertility plans, the larger question is whether we should treat fibroids more strategically for women who desire future fertility. Myomectomy and UAE are effective and reliable in terms of fibroid symptomatic improvement, but RFA promises more beneficial reproductive outcomes. The ability to avoid uterine myometrial incisions and still attain significant symptomatic improvement should be prioritised in these patients.
RFA technology could also address the gap in uterine-sparing treatment for reproductive-age women with adenomyosis. According to recent studies, RFA produces similar improvement in both uterine volume and symptom severity in women with adenomyosis.
If you are seeking treatment for uterine fibroids and wish to schedule a consultation with Mr Karoshi, visit his Top Doctors profile today.