2. HIFU
Douglas Chinn MD
Chinn & Chinn Urology
Arcadia, CA

3. WHAT IS HIFU? High Intensity Focused Ultrasound:
Sound waves are generated by an ultrasound transducer
These low power waves are focused into a small area, generating very high power

4. HIFU Energy Delivery High Intensity Focused Ultrasound:
Low Intensity at Transducer Face (20-40 Watts/cm2)
Translates to Very High Site Intensity at the Focal Point ( Watts/cm2)

5. HIFU Kills Tissue Thermal (80-100 oC) Cavitation
Mechanical (Shearing forces)

6. HIFU As opposed to radiation, this ultrasound energy is non-ionizing
This means that any tissue in the unfocused path of HIFU is NOT injured or damaged in any way

7. Procedure Overview: This is a very minimally invasive procedure
It utilizes a transrectal approach for imaging and treating
There are no incisions or stab wounds
Procedure takes 2-4 hrs
Spinal/Epidural Anesthesia

8. Sonablate 500

9. Ablatherm

10. Sonablate 500

11. Ablatherm

12. Sonablate vs Ablatherm

13. Prostate Gland is divided into 6 treatment zones
Treatment Planning
1,2
3,4
5,6 1 2 5 6 4 3
As a second important factor,
There are 2 types of tissue ablation pattern are available on the Sonablate-200 system.
In Upper treatment pattern, treatment zone is placed in the inside of the prostate capsule.
But, you can see from the slide, some part of the peripheral site is not treated.
This means that viable cancer tissue is untreated.
On the other hand, Lower part of the ablation pattern, total prostate including the capsule was ablated.
However, we had concerned a capsular perforation as a severe complication.
Prostate Gland is divided into 6 treatment zones

14. HIFU Treatment Serial images are acquired
Treatment zones are mapped out and logged into the computer
Treatment is then begun
Treatment can be interrupted and changed at any time
Live imaging occurs before each HIFU spike

15. HIFU Treatment

17. Sonablate Therapy Mode
HIFU computer control allows very precise tissue targeting, allowing us to fine tune therapy
Prostate Edge (NVB)
External Sphincter

18. Subtotal Ablation
Indiana University Medical Center Canine Studies on Prostate Sub-Total Ablation Protocol
No Damage to Rectal Wall or Prostate Capsule

19. Complications Transient Incontinence 15% at 90 days – 0% at 180 days
Dysuria % at 30 days – 0% at 180 days
UTI % at 90 days – 0% at 180 days
Perineal Discomfort 5% after 30 days – 0% at 180 days
Impotence % at 90 days (1 of 16)
Complication rates from Indiana University Medical Center Phase I Localized Prostate Cancer Studies

20. Indications for HIFU Clinically localized prostate cancer Stage T1c-T3
Any Gleason Score
Radiation Failure
Radical Failure if a mass can be localized
T3-T4 palliative or debulking

21. Contraindications Extensive prostatic calculi Large prostatic calculus
Gland size > 40cc (will need downsizing)
Rectal stenosis
Metallic foreign bodies in rectal wall
History of rectal fistula

22. HIFU Post-Operative Recovery
Catheterization for days
Moderate to Severe Sloughing
Mild pain in abdomen possible
Up to 3-6 months before excellent urinary stream & force

23. Complications of Treating CaP: Radical prostatectomy
Incontinence %
ED %
Bowel dysfunction %
Urethral stricture and BNC %
Blood transfusion <5%

24. Complications of Treating CaP: Radiation: (ERT or Brachytherapy)
Incontinence % Previous TURP >50%
ED %
Bowel dysfunction %
Seed migration %
Irritative symptoms %

25. Complications of Treating CaP: Cryosurgery
ED 98%
Incontinence 3%
Fistula 0%

26. Complications of Treating CaP: HIFU
Incontinence 0% ED
Sonablate <7%
Ablatherm-earliest series 30%
Bowel dysfunction 0%

27. Five year outcome comparisons
Biochemical Disease Free Survival RP
CRYO
Brachy
3DCRT
XRT
HIFU
Low
76-98%
60-92%
78-89%
76-87%
81-86%
70-71%
Moderate
60-76%
61-89%
66-82%
51-58%
26-60%
BDFS definitions do vary but are comparable

28. Five year outcome comparisons
Negative Biopsy Rates

29. Five year outcome comparisons
Morbidity
Imp.
Incont.
(any pad)
Rectal injury
Urge
Bleeding
Diarrhea
Fistula RP
51-96%
7-52%
6-16%
1-3%
6-19% RT
50-61%
0-15%
19-17%
13-17%
12-42%
Cryo
82-100% %
<0.5%
HIFU
28-100%
0-23%
< 0.5–7.5%

30. Sonablate 500 Next generation technology
High resolution treatment planning
Real time treatment feedback
Integrated rectal protection

31. Morbidity Comparison Impotence Incontinence Rectal fistula Ablatherm
45-100%
1-23%
<0.7-5%
Sonablate®
28-30%
0-2%
<0.5-5%

32. HIFU Not FDA approved in the U.S.
Approved in Europe, Asia, Latin America
Not covered by insurance
Phase I & II FDA safety and efficacy trials have already been done
Phase III trials hope to begin this year
Not all patients will fit into the study criteria

33. HIFU Sites: Cabo San Lucas Puerto Vallarta
Santiago, Dominican Republic

34. HIFU: Cabo San Lucas HIFU cost: currently $20,000
Airline cost (Alaska): $350/person
Hotel Cost (RIU Cabo Palace): $300/person/nite
Food and drink included at hotel
Transportation between hospital and hotel included
Airport taxi: $60-70 each way/taxi

35. AmeriMed Hospital Cabo San Lucas

36. AmeriMed Hospital Opened March 2001
Modern, comfortable, air conditioned in-patient rooms with satellite TV
Fully equipped modern ICU
Fully equipped modern operating room
Large birthing area
CT Scanner, X-Ray & Ultrasound
Well equipped laboratory with immediate results
Hemodialysis Arthroscopy and laparoscopy
Well trained bilingual neurosurgeon
Ambulance services
Medical office complex next to the hospital with all major specialists and subspecialists

37. Why HIFU? Very minimally invasive procedure
Outpatient procedure, can travel the following day
Aside from wearing a catheter, can resume all activities immediately
Can be repeated
Very low incidence of incontinence
Excellent chance to preserve potency in properly selected patients

38. Downsides to HIFU? Must wear a catheter (radical & cryosurgery)
Will have variable urethral sloughing (cryosurgery & radiation)
No 10 year data (5 year data is available)
Not FDA approved
Not covered by insurance
Difficult/unable to treat seminal vesicle disease (seeds, surgery, cryo)

39. Current Applications of HiFu
Prostate Cancer
BPH
Renal Tumors
Liver Tumors

40. New Potential Applications of HiFu
Pancreatic Cancer
Breast Cancer
Brain Cancer
Cardiac Node Ablation