Treat smarter with Sonata

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The ever-present COVID-19 pandemic has put a huge strain on hospital services in the UK and around the world. As the number of coronavirus cases rose, and hospitals became inundated, available space and resources were refocused. Elective procedures were deferred to allow the NHS to focus its efforts on coping with the needs of COVID patients.

As the initial wave recedes, infection control is uppermost in everyone’s mind. The hospital teams’ focus is now on dealing with the burgeoning waiting lists. That said, clinics are starting to be rescheduled and elective surgery is being resumed. Patients are clearly keen to have their treatments carried out but are understandably nervous about being treated in hospital with the worry of contracting COVID-19 from their hospital admission. Offering a procedure to patients that can be performed without a requirement for an overnight stay [1] is of real benefit to both the patent and the hospital at this difficult time.

 

Uterine fibroids

Uterine fibroids are the most common benign pelvic tumours in women, with the condition affecting one in three of the UK’s female population [2,3]. On average women wait 3.6 years before seeking treatment [4], despite presenting with symptoms such as heavy menstrual bleeding, dyspareunia (painful intercourse), pelvic pressure, and urinary frequency, constipation and reproductive issues [5].

Up until now, the treatments offered to women with uterine fibroids have included medical and hormone therapies; hysterectomy; myomectomy; and uterine artery embolisation – all with their own advantages and disadvantages. Now, there is a treatment available – transcervical fibroid ablation (TFA) with the Sonata® System – an incisionless procedure that uses radiofrequency (RF) energy for the treatment of symptomatic uterine fibroids. Sonata provides a safe and effective [1], minimally invasive treatment option, and its features are particularly relevant at this time when infection control is top of mind.

 

 

 

 

 

 

 

 

 

 

Outpatient procedure

The Sonata® Treatment is an incision-free alternative to more invasive options such as myomectomies and hysterectomies. The fibroids are treated from inside the uterus, and as such, it requires no incisions, no tissue is cut or surgically removed, and the uterus is preserved [6]. Equally, patients can be treated in the outpatients’ department [1] which, particularly at this time helps to alleviate the pressures on the hospital’s operating theatre.

The Royal College of Obstetricians (RCOG) states: “While all women should be offered a choice of anaesthesia and treatment settings for hysteroscopic procedures, they should be aware that an outpatient setting avoids hospital admission, thereby minimising the risk of exposure to SARS-CoV-2.” [11]

Furthermore, the Sonata procedure is not laparoscopic, and therefore has the advantage of avoiding the peritoneal cavity and the potential risk to healthcare personnel from aerosols and possible viral dissemination when deflating a pneumoperitoneum [6]. Because general anaesthesia is not required for all patients, this can avoid risks to healthcare providers from intubation and extubation.

 

Reduced hospital waiting lists

The CE-marked Sonata® System offers treatment as a day case procedure and is associated with procedural safety and durable clinical outcomes [1]. Transcervical fibroid ablation does not require general anaesthesia and as such, can be performed in the outpatient clinic, thus providing a faster recovery for patients.

The procedure takes typically 15-60 minutes, depending on the number and size of fibroids treated. A single fibroid ablation takes between 2-7 minutes. The average length of stay is 2.5 hours including procedure time, and patients report a rapid return to normal activity – two days on average, with at least half after just one day [1].

 

Long term outcomes, reducing reintervention

In a study, around ninety per cent of women who underwent treatment using the Sonata® System reported a reduction in menstrual bleeding within 3 months [7].   Much more importantly, reintervention rates have been low – in a US/Mexico study of 147 women with fibroids, only 8.2 per cent of patients underwent surgical reintervention through 3 years [10], and in a longer-term study no surgical reintervention occurred through the first 3.5 years for heavy menstrual bleeding [8]. Overall, there was an 11.8 per cent rate of surgical intervention through 5.4 years post treatment [8] and typically, patients can expect to return to work within four days. [1,9]

 

For further information please go to www.treatsmarterwithsonata.co.uk

 

References

1. 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.
2. Williams A. (2017). Uterine fibroids – what’s new? F1000Research, 6, 2109. https://doi.org/10.12688/f1000research.12172.1
3. https://www.nhs.uk/conditions/fibroids/
4. Miller CE, Osman KM. Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the SONATA Pivotal Trial. J Gynecol Surg. 2019;35:345-349.
5. Stovall DW. Clinical Symptomatology of Uterine Leiomyomas. Clin Obstet Gynecol. 2001;44:364-71.
6. Toub DB. A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System. Curr Obstet Gynecol Rep. 2017;6:67-73.
7. 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;13:27-35.
8. Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study. Journal of Gynecologic Surg. 2019; 35:19-23.5.
9. Bradley LD, Pasic RP, Miller LE. Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. J Laparoendosc Adv Surg Tech A. 2019;29:1507-1517.
10. Andrea Lukes,Minda A Green Three Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata
11. https://mk0britishsociep8d9m.kinstacdn.com/wp-content/uploads/2020/06/RCOG-BSGE-Statement-on-gynaecological-endoscopy-in-the-COVID-19-pandemic-170620.pdf