Introduction
Women, mostly in their reproductive age, suffer from uterine leiomyomas, also called uterine fibroids or uterine myomas. These are benign tumors of uterine muscle and are clinically detectable with prolonged heavy bleeding during the menstrual period, sacral pain, secondary dysmenorrhea, constipation, increased frequency of UTIs, and pregnancy-associated problems1. About 25% of women are clinically symptomatic2. Fibroids may affect fertility, thereby negatively influencing a woman who desires pregnancy. These uterine fibroids also impact the usual activities, leads to diminished quality of life and increasing healthcare costs3. Although surgeries like hysterectomy are the gold standard for most women4, this approach is not the prime choice for women who want to conceive. Enucleation via laparoscopy is a uterine-conserving treatment. Medical treatment options are also available and applied, but their aftermath is sizeable as it results in the recurrence of leiomyomas. Non-invasive procedures are making ground in recent years because of fewer complications, patient compliance, short hospital stay, and cost-effectiveness. They include uterine artery embolization (UAE) and Magnetic Resonance-High Intensity Focused Ultrasound (MR-HIFU)5-6.
In place of uterine conserving treatment and fertility, however, UAE leads to a potential reduction of the ovarian reserve. Even though it is an attractive efficacious treatment choice, its implication is confined only to pre-or post-menopausal women.
MR-HIFU is a non-invasive ablative novel therapy. The process of MR-HIFU involves coagulative necrosis of the fibroid by thermal effect and no disruption to the adjacent structures. There are no bleeding or drug side effects after this treatment modality7. Usually, tissue necrosis occurs when subjected to 43°C or more for at least an hour; however, the necrosis can occur within a second if subjected to 56°C or more 8,9. Two real times guided HIFU treatments are available; ultrasound-guided and MRI-guided. The ultrasonography-guided HIFU has a low resolution and limited precision for targeting and visualizing the adjacent structure’s details. Simultaneously, MRI-guided HIFU has a high resolution allowing detection of even a tiny thermal increase outside the target points before any tissue damage10-11. Various studies have also shown that MR-HIFU effectively eradicates multiple uterine fibroids and leads to a reduction in the non-perfused volume (NPV) of fibroids with no side effects12.
Even after the effective therapy of MRI guided HIFU, all patients are not eligible for this treatment modality. Funaki type 3 fibroids are challenging to treat because of high T2 signal intensity and high BMI of women are the significant reasons for excluding this treatment option for uterine fibroid 13.
Rationale: Several studies on the efficacy of MRHIFU therapy for uterine fibroids have been released to date. Overall, they found that MRHIFU successfully reduces symptoms, but there was a high rate of re-intervention14–17. However, trials that used restrictive treatment methods that are no longer in use in clinical practice influenced the findings of these analyses.
Objectives: The aim was to re-evaluate the efficacy of MR-HIFU in reducing fibroid-related symptoms using treatment protocols that focused solely on total ablation. We also looked at care failures and technical performance as assessed by the post-treatment NPV percent. We also looked at the disease-specific quality of life, re-intervention rates, stability, fertility, costs, and fibroid shrinkage.