Douglas Chinn MD Chinn & Chinn Urology Arcadia, CA

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 (1600 - 2000 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. 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 Procedure Overview:

8. Sonablate 500

9. Ablatherm

10. Sonablate 500

11. Ablatherm

12. Sonablate vs Ablatherm

13. 1 2 1,2 3 4 3,4 5 6 5,6 Treatment Planning 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. HIFU computer control allows very precise tissue targeting, allowing us to fine tune therapy Sonablate Therapy Mode 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 10% at 30 days – 0% at 180 days • UTI 6% at 90 days – 0% at 180 days • Perineal Discomfort 5% after 30 days – 0% at 180 days • Impotence 6% 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 14-30 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 8-25% • ED 60-75% • Bowel dysfunction 1-3% • Urethral stricture and BNC 5-10% • Blood transfusion <5%

24. Complications of Treating CaP: Radiation: (ERT or Brachytherapy) • Incontinence 11-15% Previous TURP >50% • ED 50-70% • Bowel dysfunction 15-30% • Seed migration 30% • Irritative symptoms 30%

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

26. Complications of Treating CaP:HIFU • Incontinence 0% • ED Sonablate 500 <7% Ablatherm-earliest series 30% • Bowel dysfunction 0%

27. Five year outcome comparisons Biochemical Disease Free Survival BDFS definitions do vary but are comparable

28. Five year outcome comparisons Negative Biopsy Rates

29. Five year outcome comparisons Morbidity

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

31. Morbidity Comparison

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 HospitalCabo San Lucas www.amerimed-hospitals.com

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