MINT Hospital

MR-HIFU: Clear and precise images of the MRI enable detailed and safe procedure.

Uniqueness of MR-HIFU

MINT Hospital uses the new Sonalleve MR-HIFU from Philips,
approved by the US FDA(IDE).

Process observation and measurement with high-resolution MRI, and confirmation of treatment outcome
Completely non-invasive treatment (No scar, no bleeding, no anesthesia,no radiation)
Real-time temperature monitory resulting in enhanced safetey
IDE approval for mechanical saftey by the US FDA
Discharged on the day of procedure Return to daily life the next day

Limitation of MR-HIFU

Relatively long procedure time(average 2~3 hours), depending on characteristic,location, and number of fibroids and patient codition
Limited range of treatment (40% of fibroids are suitable for HIFU)

MRI scan + HIFU procedure + Outcome confirmation

ONE STOP

Uterine fibroid MR-HIFU for patient’s safety and convenience

Totally non-invasive treatment
Ultrasound generated from outside of the body is passes through body tissue and exclusively burns fibroids and adenomyosis.Not even a needle is required since the procedure is observed and monitored with MRI No scar, no bleeding, no anesthesia, no radiation.
Safe, accurate treatment
MRI provides better image quality and much more information than sonography(ultrasound), enabling safe and accurate procedure.Hence the possibility of complications and side effects is remarkably low.
One-stop care system
MR-HIFU procedure & outcome confirmation by MRI can be done simultaneously. MRI is essential for treatment planning and outcome evaluation
Daily activity possible from the day after procedure
: As it does not use any knife or needle, there is less physicalㆍpsychological burden and recovery is faster. You can leave hospital on the very day after resting 1~2 hours at the hospital and you can return to your daily life the day after surgery.

Safety of MR-HIFU

Approval of IDE for mechanical safety by the US FDA

According the study by Dr. Kim Young Sun, MD-Ph.D, of MINT Hospital, immediately after MR-HIFU in a total of 117 submucosal fibroids, 95.7% of the endometrium were normal(56.4%) or minimally damaged(less than 1cm). In cased of damage of 1 cm or more (4.3%), they showed recovery during follow-up. This study has proven that MR-HIFU can be a safe treatment option with minimal endometrial damage for fibroid patients who are planning pregnancy.

This study is limited to MR-HIFU, and is not applicable to some ultrasound-guided HIFU(US-HIFU) devices using high energy ultrasound

+ Cases of side effects after US-HIFU using high energy ultrasound.
Publication by Dr. Kim, Young Sun, Ph.D, MINT hospital uterine myoma total care center, European Society of Radiology(ESR), September edition., 2017

+ Read Abstract

Complications of MR-HIFU

We strive to minimize the complications of MR-HIFU by real-time temperature monitoring with MRI and the rich clinical experiences of out medical staff

During the procedure

- Hot skin flash
- Numbness or stiffness of leg
- Pelvic pain similar to dysmenorrhea
- Pressure to coccyx

These symptoms quickly subside once the procedure is finished.

After the procedure

- Lower abdomen discomfort
- Body ache(5~10%)
- Painful/uncomfortable urination
- Heat damage to subcutaneous fat/colon/lower limb nerve(sciatic nerve)/ small intestine
- Skin burn (2~3%)
- Vaginal bleeding(amount similar to menstruation)

Most symptoms are temporary and less than 0.5 % require hospitalization.
As for heat damage, an experienced doctor can predict and prevent it from occurring based on the symptom the patient is experiencing during the procedure.

Treatment process

Before the treatment

Outpatient consultation/ Sonography

Initial assessment of appropriacy for HIFU
Full MRI test / Decision of procedure

Final assessment of treatability / treatment outcome prediction
Blood test etc./ Procedure reservation

Hormone therapy if necessary

The day of procedure

Admission and procedure preparation

Admission at the morning, preparation for safe treatment(Fasting/hair removal/enema/Foley catheter insertion)
MR-HIFU

Immediate contrast-enhanced MRI after treatment / Outcome confirmation
1~2 hour stabilization

Return to home after stabilization or discharge on the day after surgery (Either)

After treatment

+

2-year guarantee

Uterus check-up at 1 week/ 3 months / 6 months / 1 year / 2 year (sonography or MRI)
+

Consistent follow-up by doctor

Your doctor will be in charge of you consultation, tests, and treatment, and be responsible for your lifetime uterine health.
+

Special uterus management program

We run a management program in collaboration with the Gynecology Center to prevent and treat various uterine diseased other than fibroids

Treatment outome

Necrosis rate

98%

Treated case: Contrast-enhanced MRI

The necrotized fibroid shrinks to 30~40% of its original volume at 1 year after treatment
and continues to get smaller afterward.
It is harmless to let it stay in the body as it is dead tissue Discomfort from the fibroid improves.

Before the procedure

Uterine fibroid in white due to blood flow
After the procedure

Uterine fibroid turning black as it becomes necrotized due to blockage of blood flow

Treatment candidates

MINT Hospital performs MR-HIFU only
if treatment is necessary and is expected to yield excellent results.

Indication
performed
if excellent outcome is anticipated
- Those with symptoms from uterine fibroid(bleeding, anemia, pain, etc.)
- Patient over 18 and before menopause
- Uterine fibroid less than 13cm in diameter and multiple myoma
- Patient with immunologic deficiency due to cancer therapy
- Those who want to avoid surgery due to religious or emotional reason
Consideration
Procedure is decided after sufficient
consultation with the patient
- Planning future pregnancy
- Overweight
- Over-vascular, cellular
- Uterus blocked by intestine
Contraindication
- Currently pregnant
- Those with difficulty of taking MRI
  (Clau strophobia, pacemaker)
- Other pelvic disease
  (cancer, pelvic inflammation)

!MINT’NOTE

MR-HIFU is performed only if excellent results are expected.

For the 10~20% of patients not suitable for HIFU, MINT Hospital Uterine Fibroid center selects the optimal treatment including embolization and fibroid resection.

Criteria of uterine fibroid suitable for HIFU

To minimize the side effects of HIFU,
fibroids that are suitable for HIFU must be selected based on accurate MRI diagnosis

Criterion 1

High proportion of collagen fibers in the fibroid.

The blacker the image is, the more collagen fiber there is in the fibroid.

TYPE. 1 (Applicable)

The fibroid has high content of collagen,can be treated with ultrasound of relatively low temperature (60~65℃) and has low risk of side effect.
TYPE. 2 (Applicable)

The fibroid has an even content of muscle cells and collagen fibers, and can be treated with ultrasound of intermediate temperature(65~80℃)
TYPE. 3 (Inapplicable)

The fibroid has a high content of muscles cells(70%) is water and requires ultrasound of high temperature(more than 80 C) with high risk of side effects.

!MINT’NOTE

Fibroids initially originate from abnormal muscle cells, but may grow to have many other components including collagen fibers. Fibroids can be classified by the proportion of components, and type 1 and type 2 fibroids which have a high collagen content yield good results after HIFU treatment.
Type 3 fibroids, mainly composed of muscle cells, do not even show good response to high temperatures due to their high water content. This increased the risk of side effects and are thus not suitable for HIFU treatment. In these cases, embolization or laparoscopic resection may be a better alternative.

Reference

Dr. Funaki Kaoru, Japanese gynecologist, Journal of Minimally Invasive Gynecology (JMIG), 2007

+ Read Abstract

Criterion 2

Low blood flow to the fibroid

Uterine fibroids can have a diverse range of vascular distributions. High blood flow in a fibroid has a coolling effect during HIFU treatment, necessitating higher temperature from ultrasound. This is very dangerous since the higher the temperature of ultrasound , the higher the risk of damage to adjacent organs, bones, and nerves. A risky procedure can be a 'gamble' rather than a treatment for both the patient and doctor.We only perform HIFU on fibroids with low blood flow to minimize side effects. This can only confirmed by MRI.

Reference
Prof. Kim Young Sun Department of Radiology, Samsung Seoul Medical Center (Currently Director of MINT hospital), Radiological Society of North America (RSNA), 2014

+ Read Abstract

MR-HIFU and pregnancy

Influence of MR-HIFU on pregnancy and MINT Hospital's treatment principle

Pregnancy analysis
on patients who had
MR-HIFU
(54 patients)

Pregnant at the time of study: 20%

Normal delivery: 41%
Average newborn weight 3.3kg

Induced abortion: 11%,

Spontaneous abortion: 28%

Research by Dr. Rabinovici, Jaron, Israeli gynecologist (Published in Fertil Steril, a US gynecology journal, in 2010)

+ See Original Article

In the medical field

It is general understanding that HIFU seems to have partial influence on pregnancy, but does not have significant influence. There are many reports of pregnancy after HIFU. The table on the left is its evidence
In medical society guidelines
- Foreign : Treatment was initially banned, but is now being gradually permitted based on accumulated research data. but changed it's policy to 'can be considered' in 2015
  US FDA banned MR-HIFU for woman who are planning pregnancy in 2004, but changed its policy to ‘considerable’.
  ※ only for MR-HIFU, not Ultrasound-HIFU)
- Domestic : iIn 2016, the Korean Society of Obstetrics and Gynecology(KSOG) has set planning for future pregnancy as a relative contraindication in its 'HIFU clinical guideline'.the merits and demerits of treatment through sufficient consultation with a doctor.
At MINT Hospital

Based on scientific evidence and principles, we perform MR-HIFU according to the KSOG guidelines

+ Read HIFU guideline (KSOG)

(Korean Society of Obstetrics and Gynecology guideline)

MR HIFU vs Ultrasound-HIFU

Imaging guidance method

determines the accuracy and safety of the treatment.

Since HIFU burns the inner part of the body that is not visible externally, it can be very dangerous if observation through imaging is inadequate.Therefore, safety of the procedure can be guaranteed by obtaining as much information as possible through MRI. In addition, unlike ultrasound-HIFU, the entire treatment process is saved in a 3-dimensional space, allowing more delicate treatment especially in cases of large or multiple fibroids.

MR-HIFU HIFU performed under MRI observation Clearly differentiated lesion (fibroid in black)	Treatment	Ultrasound-HIFU HIFU performed under ultrasound observation Indistinct and unclear lesion hard to differentiate
High-intensity focused ultrasound (Identical)	Treatment principle	High-intensity focused ultrasound (Identical)
MRI	Imaging observation	Ultrasound
High-resolution 3-dimensional image	RImage quality	Low-resolution single-plane image
Whole pelvic area	Image coverage	Limited to treatment area
Image acquired every 0.5~1 second(difficult to image moving organ)	Real time imaging	Smooth image (Convenient to image moving organs like heart)
★★★★	Tissue differentiation	★
Possible	Real time temperature measurement	Not possible
Possible	Foreign body detection (burn prevention)	Not possible
MRI right after the procedure	Treatment outcome confirmation	Separate MRI imaging, waiting required
Covered	Diagnosis related group(DRG) coverage by National Health Insurance	Not covered

philips

Phillips Sonalleve MR-HIFU

There are two MR-HIFU products; Sonalleve from Phillips and Exablate from Insitech.
MINT hospital uses the newest Sonalleve MR-HIFU from Phillips

Volumetric heating

Ultrasound beam quickly scans the area of the fibroid, and adjusts its size from 16mm to 40mm in an oval trajectory and induces necrosis by delicately burning the tissue. This allows treatment of relatively large fibroids and effectively shortens the treatment period.
Precise temperature monitoring

Uterine fibroid is filmed in 6 different planes and its color temperature map is provided every 0.5 second.
Thus, the treating area can be fully monitored while temperature of surrounding organs is recognized, preventing any complications.
Skin foreign body

Focusing ultrasound onto a foreign body of the skin such as a simple scar or a surgery scar can induce a skin burn. MR-HIFU avoids these areas and selectively burns the fibroid, preventing the risk of skin burn

Video

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