The Sonata system (previously called VizAblate; Gynesonics, Inc.) is a system for the diagnostic imaging and treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. The system consists of a reusable intrauterine ultrasound probe and a single-use disposable radiofrequency ablation handpiece with an introducer and needle electrode. These 2 components lock together to form a single treatment device. The intrauterine ultrasound probe is used to identify fibroids from within the uterus and guide the introducer and needle electrodes into one or more targeted fibroids. The radiofrequency ablation handpiece is used to deliver radiofrequency energy to the targeted areas to reduce the volume of the fibroids. The radiofrequency ablation handpiece also comes with proprietary graphical guidance software. This displays a real-time graphic overlay on the live ultrasound image to help guide treatment and target ablation zones.
By being placed transcervically, the Sonata system allows incisionless treatment of fibroids without the need for general anaesthesia. The technology has been shown to treat a wide range of fibroids, some of which cannot be treated with current transcervical methods (for example, FIGO types 3, 4, 5, 6 and types 2 to 5 [transmural]) and need more invasive open or laparoscopic surgery. By avoiding the peritoneal cavity, treatment with the Sonata system can reduce risk and morbidity associated with invasive fibroid treatment, such as hysterectomy and myomectomy. The technology may reduce the length of stay in hospital compared with invasive fibroid treatment and allow people to return to normal activity and work sooner. More than half of the people in the SONATA trial returned to normal activity within 1 day (with an overall mean of 2 days).
Asymptomatic fibroids do not need treatment. Symptomatic fibroids can be managed using a range of treatment options depending on fibroid size, number and location, as well as the person's desire to have children in the future. Treatment options for symptomatic fibroids include pharmacological treatment, hysterectomy (surgical removal of the uterus), myomectomy (surgical removal of the fibroids), uterine artery embolisation and endometrial ablation techniques. NICE's guideline on heavy menstrual bleeding provides further information about treatment.
The following publications have been identified as relevant to this care pathway:
NICE's interventional procedures guidance on transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids. It recommends that the procedure should only be used with special arrangements for clinical governance, consent and audit or research. This is because although evidence on the safety of the procedure raised no concerns, evidence on its efficacy was considered limited in quality.
The Sonata system is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Uterine fibroids (also called uterine myomas, fibromyomas or leiomyomas) are the most common benign tumours in women and are the leading reason for hysterectomy. Fibroids may be single or multiple and can vary in size from a few millimetres to 30 cm or more. They can be asymptomatic or cause symptoms including heavy menstrual bleeding, urinary incontinence, pelvic pressure or pain (NICE's clinical knowledge summary on fibroids).
The technology is intended as an alternative treatment to more invasive surgery such as hysterectomy or myomectomy, or to procedures such as uterine artery embolisation.
The Sonata system is used in secondary care as an outpatient procedure or day-case surgery. Treatment will be done by a consultant gynaecologist trained to use the technology. Training and support are provided free of charge by the company. Clinicians must attend a 2-hour theory and practical training session delivered by the company. The company also provides intraoperative support to theatre staff and gynaecologists during the early stages of use.
The single-use Sonata case kits (the consumable element used for treatment) cost £2,500 per unit (excluding VAT).
According to the company, the total cost per procedure with the Sonata system would be about £2,795 for an outpatient procedure or £3,403 for a day-case surgery (excluding VAT). This estimate includes the cost of healthcare professionals' time (sourced from Ang et al. 2016), hospital stay and consumables. The capital cost of purchasing the Sonata system is £84,800 (excluding VAT); the company will consider placement of the hardware based on a consumable usage agreement. If purchased, the system is expected to need annual servicing at a cost of 10% of the cost of the capital components. According to the company the Sonata system should last for a minimum of 5 years, but with regular servicing the company expects that the lifespan of the system will be much longer.
The average cost of standard care, assumed to be myomectomy (open or laparoscopic) or hysterectomy, is £3,664 (based on NHS reference costs 2018/19, using Healthcare Resource Group codes MA08A and MA08B). The company estimates that the costs for myomectomy (open or laparoscopic) and hysterectomy are about £5,374 (plus or minus £1,000), including healthcare professionals' time (sourced from Ang et al. 2016), hospital stay and consumables.
According to the company, the Sonata system is currently being used in 3 NHS centres.
Assuming that only 1 treatment is needed, adopting the technology in the NHS has the potential to be resource releasing. This is by reducing procedural time and length of stay compared with more invasive procedures (such as hysterectomy, myomectomy and uterine artery embolisation), and allowing the transfer of cases from an inpatient setting to day-case surgery and outpatient settings. If done in an outpatient department, the Sonata system could help cut staff costs by removing the need for an anaesthetist. According to the company, the technology can also help reduce general consumable costs per procedure compared with open surgical techniques and uterine artery embolisation. No changes to facilities or infrastructure would be needed to adopt the technology.
Two studies evaluating the cost consequence of adopting the technology were identified:
The INSPIRE study assessed the perioperative and 12-month health economic and clinical outcomes associated with hysterectomy, myomectomy, and sonography-guided transcervical fibroid ablation (TFA) using the Sonata system (Brooks et al. 2020a). The study reported that, compared with hysterectomy and myomectomy, treatment with the Sonata system was associated with significantly lower index procedure cost, complication cost, and length of stay. This contributed to a lower total payer cost over 12 months.
The CHOICES study compared short-term resource use, facility costs, and perioperative patient outcomes between TFA with the Sonata system and myomectomy (Brooks et al. 2020a). The study reported that, compared with myomectomy, treatment with the Sonata system was associated with significantly shorter operating room time and length of stay. The average total mean facility costs for TFA procedure ($7,563) were significantly lower than those associated with myomectomy ($11,425; p=0.002), including inpatient, abdominal, or laparoscopic myomectomy (p<0.001).