Outpatient Myosure Audit Marianne Baithun Natasha Barbanegra Viswapriya Sivashnamugarajan Wasim Lodhi

Background Myosure is a hysteroscopic morcellation procedure that can be done under general anaesthetic or as an outpatient under LA to remove polyps or fibroids

Normal saline used Preserves histology Simultaneously cuts and suctions maintaining clear view Single insertion of hysteroscope into uterus unlike traditional hysteroscopic resection More rapid and therefore reduced risk of fluid overload and less traumatic injury to uterus Myosure lite recommended for polyps up to 3cm and myosure classic for fibroids up to 3cm and all polyps

Payment by Results Guidance 2013/14 has concluded that performing OP procedures offers advantages to both the patient and the provider, due to a quicker recovery allowing patients to get back to work and their daily life sooner.

Complications NICE review of MAUDE FDA database of hysteroscopic morcellation of fibroids: Approx 180000 procedures Overall reported adverse event rate < 0.1% Bowel damage- 12 patients (2 needed temporay colostomy and ITU admission) Serious fluid overload requiring intubation and ITU- 11 patients Uncomplicated fluid overload resolving spontaneously or with conservative treatment- 19 patients Uterine perforation not needing additional surgery- 28 patients Others- bleeding, infection, device failure, poor visualistion, failure of outflow and defective device In 1 case- blade fell off in cavity and couldn’t be retrieved and patient required hysterectomy

RCOG recommendations for OP hysteroscopy Local anaesthetic is associated with a reduction in pain experienced during outpatient hysteroscopy but its unclear how clinically significant the reduction is. Routine administration of LA is not indicated.

NICE audit criteria (guideline is for fibroids) published June 2015

Audit group 28 patients having outpatient myosure procedure between November 2014 to July 2015 Age 26-82 Mixture of retrospective and prospective audit data Outpatient myosure satisfaction survey carried out in retrospect

Results

Patient Experience Questionnaire

All 16 participated patients responded YES to the following: Useful verbal information Happy with the clinic set up/toilet and changing facilities Chance to ask questions Friendly and helpful staff Felt listened by the staff Felt respected by the staff All 16 patients responded YES to the following: Useful verbal information Happy with the clinic set up/toilet and changing facilities They had chance to ask questions Friendly and helpful staff Felt listened by the staff Felt respected by the staff

Summary of results Of the 15 with times recorded, 14 had procedure completed in <5 mins 89% success rate Unable to comment on fluid deficit as not recorded in 18 cases NICE audit criteria results that we looked at: Percentage adverse events- 10.7% (3 patients and all were due to device issues or fibroid being too big) Written consent- 100% 25 patients able to be treated as outpatient avoiding GA and the extra cost of GA procedure

Costings £3520 spent on myosure equipment Government pays £1000 per patient therefore £11200-£14000 extra if done as outpatient Saving of £25200-£28000 doing under LA rather than GA Outpatient Myosure for polyps Myosure as daycase under GA Cost per procedure £500-600 £1500 Cost for 28 patients £14000-£16800 £42000

Recommendations Ensure everyone is given trust leaflet prior to procedure when consented in clinic Pointers for operators: Need to record operation timing Need to record fluid deficit NICE requires ongoing audit of all hysteroscopic morcellation procedures, therefore audit proforma to be filled out for all patients having procedure Try and follow up patients with phone call after procedure to assess if symptoms have improved and satisfaction with procedure to allow improvements to be made. NICE recommends follow up of outcomes including symptom relief, quality of life, recurrence rates and information about fertility and subsequent pregnancies.(Beyond scope of audit but potential for research study)