The Sonata® Advantage: a part to play in the Covid backlog recovery plan?

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Patient numbers awaiting elective surgeries have never been so high following a period of suspension as a result of the Covid-19 pandemic [1,2]. There are burgeoning waiting lists for procedures to be carried out in theatre, and processes are often slower than they were beforehand [1,2].

The government’s recently published patient backlog blueprint [3] will no doubt be welcomed by the number of women waiting for gynaecological services that rose from 15,647 in May 2019 to 87,628 in 2021 [1]. While acute surgery has continued, surgery for non-urgent conditions such as fibroids has plateaued. Added to the slowdown on elective and non-urgent procedures, a proportion of patients have been reluctant about spending time in a hospital environment. This is why the introduction of revolutionary technology for the treatment of symptomatic uterine fibroids – the Sonata® System – is so timely, giving clinicians the opportunity to relieve some of the pressure hospitals currently face by treating fibroids in an outpatient setting [4,5].

The CE-marked Sonata® System is the only treatment option for intrauterine fibroids that integrates imaging guidance (ultrasound) and therapy (radiofrequency) into a single, uniquely portable, handheld delivery system used to locate and target individual fibroids. It can provide an innovative and safe alternative to the more invasive treatment options such as myomectomies and hysterectomies [3].

Thanks to its uniquely minimally invasive system, patients can be treated and released from hospital in less than a day [6]. The Sonata System’s fibroid ablation technique does not require general anaesthesia and as such, can be performed in an outpatient setting, with an average length of stay of 2.5 hours, thus providing a faster recovery for patients and freeing up bed space for those in need [4].

A further advantage of using Sonata to treat fibroids is the rapid recovery time. In comparison to those of a hysterectomy (6-8 weeks) [7] and myomectomy (4-6 weeks) [8], a clinical study of 147 women found that 50 per cent of those treated with Sonata returned to normal activities the day after the procedure, with patients returning to work on average between 3-4 days afterwards [4].

As well as the reduced recovery time, the long-term outcomes for patients are also established, with less than 1 per cent of those treated needing any kind of surgical intervention within 12 months of treatment with the Sonata System [9]. Nearly 9 out of 10 women reported a reduction in menstrual bleeding within three months of having a Sonata treatment, and 95 per cent within 12 months [4].

With infection prevention top of mind because of the pandemic, the Sonata System has clear advantages. Firstly, the procedure is not laparoscopic, and therefore avoids the peritoneal cavity and the potential risk to healthcare personnel from aerosols and possible viral dissemination when deflating a pneumoperitoneum [8]. Secondly, general anaesthesia is not required for all patients undergoing the Sonata treatment, which then avoids the associated infection risks to healthcare providers from intubation and extubation.

The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Common side effects include bleeding, spotting, cramping, and/or discharge. As with any procedure, there are potential risks with this treatment such as skin burn and uterine perforation. Women who are pregnant, have a pelvic infection, are known to have gynaecologic cancer, or have intratubal implants for sterilisation should not have this procedure.

Find out more about the Sonata system at www.treatsmarterwithsonata.co.uk

References:

1. https://www.theguardian.com/society/2021/aug/11/people-waiting-vital-nhs-services-england-covid-delays-treatment

2. https://www.kingsfund.org.uk/blog/2021/09/elective-backlog-deprivation-waiting-times

3. https://www.england.nhs.uk/coronavirus/publication/delivery-plan-for-tackling-the-covid-19-backlog-of-elective-care/

4. Garza-Leal, J.G., León, I.H. & Toub, D. Pregnancy after transcervical radiofrequency ablation guided by intrauterine sonography: case report. Gynecol Surg 11, 145–149 (2014). https://doi.org/10.1007/s10397-013- 0830-4 s

5. https://www.nice.org.uk/advice/mib255/chapter/Expert-comments

6. Chudnoff, S., Guido, R., Roy, K., Levine, D., Mihalov, L. and Garza-Leal, J.G., 2019. Ultrasound-guided transcervical ablation of uterine leiomyomas. Obstetrics & Gynecology, 133(1), pp.13-22.

7. https://www.nhs.uk/conditions/hysterectomy/recovery/

8. https://myhealth.alberta.ca/Health/aftercareinformation/pages/conditions

9. Brölmann H, Bongers M, Garza-Leal JG et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016;27-35

Staff Writer