Non Invasive Thyroid Nodule Therapy in Europe with HIFU
Treatment of Benign Thyroid Nodules with Echotherapy
using High Intensity Focused Ultrasound (HIFU)
Information for Patients
You have been diagnosed a benign thyroid nodule. A thyroid nodule is an abnormal growth of thyroid cells that forms a lump within the thyroid gland. Thyroid nodules are extremely common. Ninety-five percent of all thyroid nodules are benign, and one-third of them show continuous growth. By age 60, about one-half of all people have a thyroid nodule that can be found either through physical examination or on ultrasound imaging.
Your doctor suggests treating your nodule with echotherapy. Echotherapy is delivered by a medical device, which delivers high-intensity focused ultrasound (HIFU) to destroy the cells of the thyroid nodule.
What are the expected benefits?
The expected benefit is the decrease in volume of your thyroid nodule without any surgery.
Principles of operation and result of clinical studies
Echotherapy is based on the delivery of High Intensity Focused Ultrasound (HIFU): High-energy ultrasound waves propagate through the skin and are focused on the thyroid nodule, generating intense heat and causing the death of the targeted tissue.
The medical device that delivers the treatment has received CE mark in 2007 (which authorizes its clinical routine use in the European Community) for the treatment of benign thyroid nodules. During a study registry performed between December 2012 and March 2014, 20 patients with benign thyroid nodules were effectively treated using this device. The HIFU treatment was well tolerated. In the meantime, many more thyroid patients have undergone a HIFU treatment.
What are the risks or possible side effects?
Like any medical treatment, there may be risks associated with the use of HIFU for the destruction of thyroid nodules.
The potential risks are the following:
Bruising at the site of treatment (temporary)
Redness at the site of treatment (temporary)
Edema of the skin tissue that may cause a slight difficulty of swallowing (temporary)
Pain/discomfort in the treatment area or skin related to the stabilizing device and/or the HIFU procedure (temporary)
Skin burns can occur. The occurrence of skin burns will be reduced by proper treatment technique.
Impairment of the vocal cord mobility (temporary).
Alteration of the vocal cord function on the side of the treated nodule leading to a voice modification or in rare cases, to dysphonia (generally recovered between several days to several months).
Events that may last up to a month or longer include pain in the area of treatment, nerve damage or loss of sensation in the treated or neighboring areas, and scar formation from skin burn (expected to be rare).
Unintentional damage in the tissue at the focal point of treatment.
Patient motion during treatment is monitored by a laser. An undetected motion might be a residual risk (expected to be rare), and could possibly result in inaccurate tissue ablation (potentially outside the planned treatment area).
Additional pre-cautions for women:
If you are pregnant, please let your doctor know.
Other unexpected risks:
You may experience side effects that are unexpected. Please inform your doctor if you have any symptoms or problems.
What are alternative treatments?
When the nodule is benign, small and does not cause any symptoms, no immediate treatment is needed. It should, however, be followed up regularly.
Drug intake is an option for both hot and cold nodules.
Hot nodules are “overactive”. Hot nodules are generally treated with drugs, called “thyroid blockers”. These reduce the formation of thyroid hormone or block it completely. Unfortunately, this might also cause reduced function of the thyroid. Other drugs called thyrostatics can ease the symptoms. However, the autonomous regions are not removed by this treatment, which is why drugs are generally used only as a temporary treatment until a definitive procedure is undertaken. If the nodules are small and cold, and are therefore benign, thyroid hormone is given. This should prevent the growth of the gland tissues.
Radioiodine therapy is an option for the treatment of hot nodules. Iodine is given in the form of capsules or fluid. The thyroid cells in the nodule take up the iodine and die. Pregnant women should not receive this treatment because of the exposure to radiation.
When malignancy is suspected, or when the nodules cause symptoms because of their size or excessive function, they should be removed. To date, this usually means surgery under full anesthetic. During the operation, depending on the situation, the doctor either removes the entire thyroid, a lobe of the thyroid or the nodule itself. The operation can be performed as open or minimally invasive (with small cuts) surgery.
The option of thermoablation has been available for a few years. With thermal ablation, the nodule is “melted down”. This is the case during radiofrequency ablation, laser and microwave ablation, e.g. where a probe is inserted into the thyroid through a small cut.
What are the consequences if you don’t want to treat your nodule with echotherapy?
You can perfectly decide not to treat your benign nodule with echotherapy. Your physician will discuss with you the alternative treatments, described above.
What are the costs of the treatment and the conditions of reimbursement?
The total cost of the treatment is related to travel to HIFU centers in Europe and Asia. HIFU is still not FDA approved in the US. Santa Monica Thyroid Center has a special relationship with ablation centers in Europe and Asia. A complete evaluation in my clinic including consultation,Lab, neck ultrasound and recent re-biopsy and molecular markers may find you a candidate for HIFU. I will send all your records to the HIFU center you chose and you will be treated with minimal time in the country. Usually overnight then treatment,next day post op ultrasound, and then fly home that day.Your HIFU records would be sent to me.Several follow up visits post HIFU at 3,6 and 12 months for ultrasound.
Call Matt at 1-310-393-8860 for Pre-HIFU Benign thyroid nodule candidate evaluation.
You don’t have to have surgery after all.
Richard Guter MD,FACE,ECNU