Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Three out of 5 experts were familiar with this technology and 2 had used the Sonata system before.
Most experts felt that the technology was a novel concept or design. The innovative aspects identified by experts were that it combines intrauterine ultrasound imaging with targeted radiofrequency ablation and offers a potential outpatient approach that could be applied in most hospitals. Alternative treatments for fibroids were identified by experts and included: medical therapy (gonadotropin-releasing hormone analogues), hysterectomy, myomectomy, fibroid embolisation, hysteroscopic resection of fibroids and MRI-guided focused ultrasound (MRgFUS). One of the experts regarded the Sonata system as a better alternative to open or laparoscopic myomectomy when suitable within a target patient group. One of the experts noted that because the Sonata system targets the fibroid only it may not be associated with the same risks as fibroid embolisation, such as premature menopause or emergency hysterectomy. MRgFUS was highlighted by 2 experts as an alternative incisionless technique to the Sonata system, with 1 noting that it also involves thermal-ablative destruction of fibroid tissue. It was noted that, compared with MRgFUS, the Sonata system has its own portable standalone ultrasound capability with no need for a pre-operative MRI scan. Some experts also identified that hysteroscopic tissue retrieval systems are competing technologies for treating small submucosal fibroids (usually less than 3 cm).
Experts stated that avoiding surgery, and its associated risks and prolonged recovery period, is a potential benefit for people having treatment with the Sonata system. One noted that people can return to work 48 hours after having treatment with the Sonata system compared with up to 6 weeks after abdominal myomectomy, which also leaves a large cosmetic scar on the abdomen, similar to a caesarean birth. One expert noted that, compared with uterine artery embolisation, the technology seems to have less negative effect on fertility and a lower risk of hysterectomy. People with fibroids who need a fertility sparing treatment or want to avoid surgery were identified by experts as those who would benefit most from the technology. Three experts noted that people benefitting from this treatment would have intramural fibroids, with 1 expert specifying FIGO type 2 to 5, another specifying FIGO type 3 and possibly type 4, and the remaining expert specifying a fibroid size of 3 cm to 5 cm. Another noted that they would be more inclined to use the Sonata system in people with fewer than 8 uterine fibroids. People at high risk of abdominal surgery because of obesity, previous surgery or anaesthetic problems were also identified. Most experts thought that the technology could change the current care pathway in some way. Experts noted that the technology could lead to less invasive treatment, shorter duration of hospital stays, lower risk of complications and a faster return to normal activities, but further evidence would be needed to support this.
Potential benefits to the healthcare system identified by the experts were reducing the number of surgical procedures for symptomatic fibroids, decreasing theatre occupancy (both operating and radiology) and bed stays, and freeing up time on MRI scanners. Most experts agreed that the Sonata system could replace existing treatment in selected people only. One of the experts thought that the technology would be an addition to standard care. Most experts thought that the Sonata system could be more cost effective than surgical treatments. One of them noted that costs for the device are substantial and that overall cost-savings may only be realised if reintervention rates are shown to be low. Another noted the expensive disposable cost per procedure but added that the procedure needs minimal extra equipment and takes no longer than 45 minutes of operating with no assistance. One expert thought that the technology would have similar costs to standard care but noted that comparative data is lacking. All experts noted that training would be needed on how to use the technology. One expert highlighted that a good level of ultrasound scanning ability would be needed to use the device. None of the experts were aware of any safety concerns surrounding the technology. One of them noted the limited long-term evidence for the technology, highlighting that long-term morbidity has not been yet studied.
According to some of the experts, the technology is currently being used at 2 UK NHS centres. Two of the experts said that the technology would be used initially in secondary care, with 1 adding that it is unlikely to be applied in primary care. The initial cost of the device and training needs were the main issues noted by experts that could prevent the Sonata system from being adopted. Apart from training needs, no other usability or practical aspects of the technology were identified. The 2 experts who have used the device before found it easy to use. Experts noted that evidence from comparative trials against standard care (laparoscopic or open myomectomy or hysterectomy), as well as other techniques used in the treatment of fibroids, such as intrauterine devices and hysteroscopic tissue retrieval systems, would be needed to address some of the uncertainties in the evidence base. Long-term follow-up data relating to subsequent pregnancy were also mentioned by some of the experts, as well as studies assessing postprocedural complications, the incidence of rare complications (such as perforation rate and thermal injuries) and the sizes of fibroids that are treatable using the Sonata system. One expert also noted a lack of evidence around methodological techniques for the procedure. One expert thought that about 25% of symptomatic fibroids could be considered for treatment with the Sonata system, adding that people wishing to maintain fertility or those with fibroids greater than 5 cm would not be eligible. Another said that the Sonata system would be suitable for 20% of their patients. However, the expert highlighted that many of their patients have large and numerous fibroids, and that in centres seeing people with smaller and fewer fibroids this percentage is likely to be higher. Two of the experts noted that, in their hospitals, around 40 or 50 people a year may be offered treatment with the Sonata system.