Uterine Fibroid Embolisation-Standard Treatment Guidelines

Whenever a woman of child bearing age presents with menorrhagia (excessive bleeding during menstruation), dysmenorrhea (painful menses), or recurrent abortion.

Introduction

Uterine fibroid is a common benign tumour smooth muscle cells and fibrous connective tissue that develop within the walls of the uterus. It generally affects the middle-aged women and present with menorrhagia and pressure effects on the urinary bladder and or the rectum. Women with fibroids may also have dysmenorrhea. When occurring in the child bearing age, these fibroids may interfere with pregnancy and the lady is either unable to conceive or unable to carry the pregnancy till completion. Uterine fibroid embolisation (UFE) is a minimally invasive, percutaneous, endovascular (interventional radiological) therapy to treat the fibroids, by blocking the arteries supplying the fibroid.

Ministry of Health and Family Welfare, Government of India has issued the Standard Treatment Guidelines for Uterine Fibroid Embolisation.

Following are the major recommendations :

Indications
It is indicated for treatment of symptomatic uterine fibroids, causing menorrhagia /dysmenorrhea / pressure effects on rectum or urinary bladder.

INCIDENCE OF THE CONDITION IN OUR COUNTRY
Fibroids is a common ailment of the middle aged women, occurring in up to 20%.

DIFFERENTIAL DIAGNOSIS

Other causes of uterine masses could be cancer cervix, endometrial cancer. Occasionally ovarian cancer may mimic a uterine fibroid. Imaging with Ultrasound / MRI and histopathological studies can give the correct diagnosis.

PREVENTION AND COUNSELING

Menorrhagia / lower abdominal masses should be evaluated by imaging and histopathology, to arrive at the correct diagnosis, and early appropriate treatment should be implemented. The middle aged women should be always evaluated with a PAP smear to rule out any malignancy of uterine cervix.

OPTIMAL DIAGNOSTIC CRITERIA, INVESTIGATIONS, TREATMENT & REFERRAL CRITERIA / FOLLOW UP

Diagnostic Criteria

• Ultrasound: Reveals a spherical mass with heterogeneous middle level echoes. Most fibroids are intramural. Occasionally they may be pedunculated and apparently detached from the uterus or they could be subendometrial There is always an accompanied displacement of the endometrial echo, which also serves an indirect indicator for the isoehoic fibroids.


• MRI: Reveals a uterine mass that is heterogeneously hyperintense on T2 and isointense on T1 images. There is hypertrophy of the uterine arteries.

Investigations

• Ultrasound Pelvis


• MRI Pelvis


• PAP smear from Cervix


• Endometrial biopsy, if there is suspicion of endometrial Ca


• Blood - Hb, TLC, DLC, ESR


• Blood – Platelets count


• Blood – PT(INR) and APTT


• Blood Creatinine

Treatment

Uterine fibroid embolisation – The uterine artery is accessed endovascularly and the tip of the catheter / microcatheter is placed distal to the ovarian / cystic / cervical branch, and embolised with Poly Vinyl alcohol particles, till the flow becomes very sluggish.

Referral criteria

Patients meeting the criteria for UFE should be referred to centers equipped with capability to perform UFE.

Follow up

Patient would be admitted a day prior to the embolisation and managed as inpatient till 2-3 days till the pain and nausea gets tolerable. There after Clinical follow up is done at 2 week, 6 weeks, 3 months and 6 months. During these follow up ultrasound could be done to assess the size of the fibroid.

Situation 1: At Secondary Hospital/ Non-Metro situation: Optimal Standards of Treatment in Situations where technology and resources are limited

Clinical Diagnosis: As above

Investigations: As above

Treatment

Standard Operating procedure

Patient would be assessed and evaluated by the primary gynecologist to rule out any other gynecological problems. Thereafter patient will be assessed by the interventional radiologist for the feasibility of embolisation. Most of the times the procedure would be done under local anesthesia and if required the anesthesiologist's consultation can be taken. The patient's uterine artery would then be accessed by endovascular approach; the catheter tip will be placed beyond the branches to the ovary, urinary bladder and uterine cervix. Then polyvinyl alcohol particle would be injected for embolisation of the artery till the flow becomes sluggish.

a. In Patient: UFE is to be done as inpatient.
b. Out Patient: no.
c. Day Care: no
e) Referral criteria: As above

Situation 2: At Super Specialty Facility in Metro location where higher-end technology is available

Clinical Diagnosis: As above
Investigations: As above
Treatment: As above

Standard Operating procedure: As above.
a. In Patient-The procedure will be done as an inpatient therapy
b. Out Patient - No
c. Day Care - No
Referral criteria: As above.

Designation	Clinical Role		Timeline
Gynecologist	Clinical Evaluation and assessment of the gynecologic status of the patient. To rule out any other malignancy by PAP smear. Pharmacological control of bleeding and symptomatic management of pain till the embolisation is done. Patient to be informed about option of UFE and referred to interventional radiologist. Following this the patient should decide between hysterectomy / myomectomy / UFE		Screening on presentation to OP till the embolisation is performed. Post embolisation, to be followed up by gynecologist and interventional radiologist
Pathologist	To assess the PAP smear or any other histopathology examination		As soon as possible
Diagnostic Radiologist	Imaging of the uterine pathology by USG or MRI		As soon as possible.
Interventional Radiologist	Assessment for feasibility for uterine fibroid embolisation		As soon as possible.
Biochemist	Biochemical evaluation		As soon as possible
Cardiologist	Cardiac evaluation		After consultation by and on the request of interventional radiologist for patients who are high risk for cardiac status
Interventional Radiologist	Performs the uterine fibroid embolisation		After the patient is declared fit for the procedure by the above timelines
Nursing Staff	Assist in managing the patient as Inpatient in ward and in Interventional Radiology Suite	NA
Technician	Assist in Imaging the patient, assist the IR specialist in the IR suite, and manage the DSA images also.	NA

RESOURCES REQUIRED FOR ONE PATIENT / PROCEDURE (PATIENT WEIGHT 60 KGS)

(Units to be specified for human resources, investigations, drugs and consumables and equipment. Quantity to also be specified)

SITUATION	HUMAN RESOURCES	INVESTIGATIONS	DRUGS & CONSUMABLES	EQUIPMENT
1.	Doctors – (Gynaecologist– 1, Interventional Radiologist – 1, Diagnostic Radiologist -1, Technician(s) – 1, Nursing - 1	Hemoglobin, Random Blood Sugar, PT, APTT or INR, Platelet Count, Se. Creatinine, HBsAg, HIV	1. Drugs: MRI contrast media, Lignocaine, Nitroglycerine, , Heparin, Non Ionic radiographic contrast media 2. Consumables: Angiographic catheters – pigtail - 1, Cobra / sim2/uterine -1, Guidewire 0.035"– 1 Vascular sheath – 1 PVA particles – 2 vials	Ultrasound (1) MRI Digital Subtraction Angiography
2.	Doctors – (Gynaecologist– 1, Interventional Radiologist – 1, Diagnostic Radiologist -1, Technician(s) – 1, Nursing - 1	Hemoglobin, Random Blood Sugar, PT, APTT or INR, Platelet Count, Se. Creatinine, HBsAg, HIV	1. Drugs: Lignocaine, Nitroglycerine, , Heparin, Non Ionic radiographic contrast media 2. Consumables: Angiographic catheters – pigtail - 1, Cobra / sim2/uterine -1, Guidewire 0.035"– 1 Vascular sheath – 1 Microcatheter and guidewire – 1 each, PVA particles – 2 vials	Ultrasound (1) MRI Digital Subtraction Angiography System (1) Sterile Suite Multichannel invasive monitor (1) Resuscitation equipment (1) Crash Trolley (1)

Guidelines by The Ministry of Health and Family Welfare :

Dr. Chander Mohan
Dr. B.L. Kapur Hospital
New Delhi