VP44 Rapid Health Technology Assessment – High-Intensity Focused Ultrasound For Breast Fibroadenomas And Benign Thyroid Nodules

Abstract

INTRODUCTION:

High-intensity focused ultrasound (HIFU) is a non-invasive ablative technique to treat breast fibroadenomas and benign thyroid nodules. A rapid Health Technology Assessment (HTA) was commissioned to inform the Changi General Hospital's decision on procuring a HIFU system.

METHODS:

A systematic literature search was conducted for systematic reviews, HTA reports and clinical practice guidelines on the clinical effectiveness of HIFU systems with the following PICO elements:

Patients = patients with benign breast fibroadenomas or thyroid nodules

Intervention = HIFU

Comparator = conventional treatment

Outcomes = clinical outcomes

Retrieved studies were summarized in a narrative synthesis.

RESULTS:

A few small case series showed reduction in volume of fibroadenomas/nodules in the short term and side effects were minor. Additionally, in HIFU for benign thyroid nodules, conference abstracts described a small open-label, randomized controlled trial where patients receiving HIFU had nodule volume reduction of over 30 percent compared to no reduction in the observation group, at 6 months; and a small non-randomized controlled study where volume reduction was about 70 percent in patients receiving HIFU compared to active observation.

Recent clinical guidelines do not mention HIFU as a therapeutic option for fibroadenomas/nodules.

Major United States health insurers do not cover HIFU and consider it experimental, investigational or unproven. In Germany, HIFU for breast fibroadenomas and benign thyroid nodules are covered by some insurers under special integrated care contracts.

CONCLUSIONS:

HIFU for fibroadenomas/nodules is a technology still developing its evidence base. The peer-reviewed literature comprises a few small case series and two controlled trials showing fibroadenoma/nodule reduction in the short term (up to 12 months) but no long term outcomes. Professional opinion from current guidelines does not mention HIFU as an option.

It may be prudent to await stronger evidence on long-term patient-important outcomes before offering the treatment as a hospital service. HIFU may be suitable for further clinical research.