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

Chinn UrologyChinn Urology


Douglas Chinn MDDouglas Chinn MDChinn & Chinn UrologyChinn & Chinn Urology

Arcadia, CAArcadia, CA

HIFUHIFU


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:


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)


HIFU Kills TissueHIFU Kills Tissue

Thermal (80-100 oC)

Cavitation

Mechanical (Shearing forces)


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


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


Sonablate 500


Ablatherm


Sonablate 500


Ablatherm


Sonablate vs Ablatherm


1,2

3,4

5,6

1 2

5 6

43

Treatment Planning

Prostate Gland is divided into 6 treatment zones


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


HIFU Treatment

Prostate

Prostate

Transducer

Treatment Zone

End-On View Side View


Sonablate Therapy Mode

• HIFU computer control allows very precise tissue targeting, allowing us to fine tune therapy

Prostate Edge (NVB) External Sphincter


Subtotal Ablation

- Indiana University Medical Center Canine Studies on Prostate Sub-Total Ablation Protocol

- No Damage to Rectal Wall or Prostate Capsule


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


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


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


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


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%


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%


Complications of Treating CaP: Cryosurgery

• ED 98%

• Incontinence 3%

• Fistula 0%


Complications of Treating CaP:HIFU

• Incontinence 0%

• ED

Sonablate 500 <7%

Ablatherm-earliest series 30%

• Bowel dysfunction 0%


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



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



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%


•Next generation technology •High resolution treatment

planning•Real time treatment feedback•Integrated rectal protection

Sonablate 500


Morbidity Comparison

Impotence Incontinence Rectal fistula

Ablatherm 45-100% 1-23% <0.7-5%

Sonablate®

28-30% 0-2% <0.5-5%


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


HIFU Sites:

• Cabo San Lucas

• Puerto Vallarta

• Santiago, Dominican Republic


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


AmeriMed HospitalCabo San Lucas

www.amerimed-hospitals.com


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


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


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)


Current Applications of HiFu

• Prostate Cancer

• BPH

• Renal Tumors

• Liver Tumors


New Potential Applications of HiFu

• Pancreatic Cancer• Breast Cancer• Brain Cancer• Cardiac Node Ablation

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

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