MR guided Focused Ultrasound surgery 

Note:  2007 AAGL meeting, Las Vegas, Nevada
November 7-8, 2006, four (4) live ExAblate procedures.

The Hope For Fibroids Organization attended the 2nd treatment on Tuesday, November 7^th at the ExAblate of Las Vegas Center.  The Center is the first to have the ExAblate equipment and MRI imaging equipment located at one outpatient location dedicated to this procedure.   Approximately 11 doctors (Interventional Radiologist and OB/GYN) were present for this session.

The ExAblate staff consisted of the following:  The patient's Gynecologist, MRI technician, two nurses, an ExAblate physician and a representative from InSightec who was training the site.  The first phase was acquiring the MRI images for the treatment, shaving any hair from the abdominal and pubic areas, preparing the patient for a Foley catheter to regulate fluid in the bladder, inserting an IV that the anesthesiologist uses to administer conscious sedation, preparing the ExAblate patient table, and positioning the woman face down on the table with her head facing the technician booth.  
 

ExAblate staff and attending physicians at a ExAblate 'live' procedure at the Las Vegas Center
 

A stop button was available for the patient so that in the event she experienced pain the treatment would be immediately stopped and her condition assessed.  (If the patient feels pain/discomfort, unusual warmth where the treatment beam is being directed, or sensations radiating from the treatment site it is VERY IMPORTANT that she tells the doctor immediately what she is experiencing so the doctor(s) can decide if the procedure should be stopped.)

During the entire session the patient must lie still because the Focused Ultrasound  beam has a precise location it is being directed to and any movement could cause the Focused Ultrasound energy to be misdirected. Due to the size and location of the fibroids in this patient a full bladder fill was required to move the organs out of the way so the fibroid could be treated.  Sometimes the rectum must be filled with air to move the intestines out of the MRI energy sonications path.  On the screen the area was marked around the fibroid to show if the patient was moving.  The Focused Ultrasound energy pulses were aimed directly into the marked middle area of the fibroid.

Immediately after the procedure the results can be monitored in real time with MRI images showing the heat change that occurred within the fibroid tissue and this gives the doctors the ability to see the coagulation necrosis (death) process of the fibroid.  The success as measured by “non perfused volume” was 80% for this specific case.  After the procedure the patient rested for approximately 30 minutes while the medication wore off and then went home.

We asked Richard Chudacoff, MD, Arthur Chan, Ph.D., and Bernard Cantor, MD to explain the ExAblate procedure in more detail.   
 

Dr. Richard Chudacoff, Medical Director Deployed Medical Solutions explains what the fibroid looks like after it is treated with this method, “Imagine an egg plant being put into a microwave.  After it is heated up the inside would be killed, but the outside would look like the normal shell until you picked it up.”

Training Requirements:  Arthur Chan, Ph.D., Clinical Applications and Training Manager with InSightec, explained, "ExAblate is a procedure that is quite easy to learn.  The graphic user interface guides the physician through every step of the procedure and ensures all safety features are utilized.  We train physicians how to use real-time MRI thermal feedback and patient feedback to optimize treatment efficacy and efficiency.  Our training program begins with a didactic training session followed by treatments coached by InSightec applications specialists.  We evaluate physicians based on a proficiency score.  Most physicians will be able to complete the training program and achieve the required proficiency in approximately 10 procedures (generally around 6-8 weeks).  Most physicians will start to feel comfortable with the procedure by the 3rd treatment.  Since each treatment is like a new puzzle that presents unique challenges, InSightec provides continued support and collaborative continued education programs after physicians have completed their training."

The medical information for the four (4) procedures that were performed on November 7-8, 2006:

All fibroids treated had non perfused volumes of 60%-100% (no blood flowed through 60-100% of each of the fibroids, which indicates that 60-100% of each fibroid was dead).   

Dr. Bernard Cantor, Medical Director – ExAblate of South Florida, explains the following ExAblate information:  

- Focused Ultrasound energy can go through liquids (water, K-Y Jelly). 

-  The bowel must be redirected away from the fibroid treatment area to eliminate possible injury to it. 

-   If a patient should feel any warmth or discomfort in the legs the treatment may need to be stopped and evaluated due to the risk of nerve damage.

- The Focused Ultrasound energy must be redirected around any scar tissue (ex. C-section incision scars) because the scar tissue will absorb the energy and may cause a burn.

-  Stretch marks will not impede the Focused Ultrasound beam.

-  Abdominal/pubic hair must be shaved because it absorbs energy, and there is a risk of burns.

-  The highest number of fibroids that can be treated in one ExAblate session is dependent on the size and location of the fibroids.  Actual treatment is limited to 3 hours.

- Fibroids that have been treated by uterine artery embolization (embolic material - microspheres) can not be treated by ExAblate because there may be a chance of the embolic material melting and blood supply is limited.  (Refer to "Information For Prescribers" manual.)

In general, a woman would be a candidate for MR Guided Focused Ultrasound (Exablate) if:

1) You have one or a few large fibroids rather than many small ones that are causing symptoms such as heavy bleeding, pain, or abdominal enlargement.

2) The fibroids are located in the body of the uterus-not on a stalk (pedunculated)

3) You have not had multiple abdominal surgeries that may result in bowel being adherent to the front of the uterus.

4) Your family is complete-this procedure is not FDA approved for women who contemplate becoming pregnant in the future.

5) You weigh less than 250 lbs and can lie comfortably on your abdomen for up to 3 hours.

6) You have no contraindications for MRI such as an implanted metal device (pacemaker, artificial joint, etc.).

ExAblate And Uterine Fibroids Seminar  

On Wednesday, November 8^th, Dr. Richard Gimpelson, AAGL President, was the Moderator for the ExAblate meeting.  The Speakers for this event were Dr. Richard Chudacoff, Dr. Elizabeth Stewart, and Mr. Chuck Cohen.  Dr. Chudacoff, Gynecologist from Houston, Texas, was one of the first gynecologists to perform the ExAblate procedure.  Dr. Stewart, Brigham and Women’s Hospital, performs the ExAblate procedure and handles some of the clinical research.  Mr. Cohen, President and CEO Sound Medical Solutions, partners with gynecologists to set up and operate ExAblate centers around the country.

The topics covered at the meeting: 

- How MR guided Focused Ultrasound Surgery works – Dr. Chudacoff

- MRgFUS clinical results and new developments – Dr. Stewart

- Incorporating MRgFUS into your office based Ob/Gyn practice -  Mr. Cohen

-Questions and Answers - Faculty 

Some research updates that were mentioned at the meeting: 

-Twenty-three (23 babies, 21 women) were born after having the ExAblate procedure. 

- Over 2,200 ExAblate procedures were performed worldwide since the technology was available in late 2004.

- The magnetic resonance-guided focused ultrasound research is in a number of areas such as breast, bone, prostate, liver, and brain tumors.

- November 7, 2006, the U.S. Food and Drug Administration (FDA) announced the ExAblate 2000 system as one of 14 medically significant products it approved during fiscal 2005.  Website URL: www.fda.gov/cdrh/annual/fy2005/ode/part1.html  

- In 2006, nine (9) Centers were opened for Gyns. The nine sites include the Deployed Medical Solutions sites plus the sites in Houston, Chicago, and Seattle.

- Twenty (20) ExAblate Centers are in the process of being scheduled for 2007. 

After the speakers presentation the audience was allowed to ask the panel of experts questions.  Several doctors from around the world discussed their experiences and concerns about the procedure.

AAGL - Continuing Physician Education: Seen Through The Eyes Of A Fibroid Support Group (article)

The AAGL meeting covered an enormous amount of gynecological subjects.  To find more of the 2007 AAGL Conference topics, photos, and seminar information please refer to www.obgyn.net.