Chinn Urology Chinn Urology
Dec 23, 2015
Chinn UrologyChinn Urology
Douglas Chinn MDDouglas Chinn MDChinn & Chinn UrologyChinn & Chinn Urology
Arcadia, CAArcadia, CA
HIFUHIFU
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WHAT IS HIFU?
• Sound waves are generated by an ultrasound transducer
• These low power waves are focused into a small area, generating very high power
High Intensity Focused Ultrasound:
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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)
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HIFU Kills TissueHIFU Kills Tissue
Thermal (80-100 oC)
Cavitation
Mechanical (Shearing forces)
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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
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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
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1,2
3,4
5,6
1 2
5 6
43
Treatment Planning
Prostate Gland is divided into 6 treatment zones
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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
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HIFU Treatment
Prostate
Prostate
Transducer
Treatment Zone
End-On View Side View
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Sonablate Therapy Mode
• HIFU computer control allows very precise tissue targeting, allowing us to fine tune therapy
Prostate Edge (NVB) External Sphincter
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Subtotal Ablation
- Indiana University Medical Center Canine Studies on Prostate Sub-Total Ablation Protocol
- No Damage to Rectal Wall or Prostate Capsule
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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
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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
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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
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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
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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%
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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%
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Complications of Treating CaP: Cryosurgery
• ED 98%
• Incontinence 3%
• Fistula 0%
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Complications of Treating CaP:HIFU
• Incontinence 0%
• ED
Sonablate 500 <7%
Ablatherm-earliest series 30%
• Bowel dysfunction 0%
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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%70-71%Moderate 60-76% 61-89% 66-82% 51-58% 26-60%
BDFS definitions do vary but are comparable
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Five year outcome comparisons
Negative Biopsy Rates
74
8285
52
35
73
29
38
32
8287 85
81
75
93
100
87
95
0
20
40
60
80
100
Brachy XRT CRYO 3D-CRT HIFU
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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% 1.3-5.4% <0.5%
HIFUHIFU 28-100%28-100% 0-23%0-23% < 0.5–7.5%< 0.5–7.5%
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•Next generation technology •High resolution treatment
planning•Real time treatment feedback•Integrated rectal protection
Sonablate 500
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Morbidity Comparison
Impotence Incontinence Rectal fistula
Ablatherm 45-100% 1-23% <0.7-5%
Sonablate®
28-30% 0-2% <0.5-5%
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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
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HIFU Sites:
• Cabo San Lucas
• Puerto Vallarta
• Santiago, Dominican Republic
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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
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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
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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
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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)
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Current Applications of HiFu
• Prostate Cancer
• BPH
• Renal Tumors
• Liver Tumors