1. HIFU: Technical Pearls
Stephen Scionti, MD
Medical Director
Vituro Health

2. HIFU: Technical Pearls Part I
Stephen Scionti, MD
Medical Director
Vituro Health

3. HIFU FDA Approval
October 9, 2015: SonaCare Medical: Sonablate device: de novo grant: regulatory approval for prostate tissue ablation
FDA special control: Training must be provided so that upon completion of the training program, the physician can:
Use all safety features of the device
Accurately target the high intensity ultrasound energy within the desired region of the prostate and
Perform the ablation procedure in a manner that minimizes damage to non-target tissues.
November 6, 2015 :EDAP Technomed: Ablatherm Integrated Imaging: 510k approval for prostate tissue ablation

4. No attenuation (water)
Focal point
Lesion formed by heat conduction at the focal point
Prostate tissue attenuation: ~0.33 4MHz)
No attenuation (water)

5. Pearl #1 Patient Selection
The most important “pearl” is to select the proper patients for HIFU treatment
Localized Low and Moderate risk disease
For Total Gland ablation: Small prostate glands < 40 cc volume and AP height < 3.4cm. Smaller is better for TG ablation
Calcifications > 1 cm can block energy

6. HIFU Outcomes and Disease Risk
Ganzer et al. 14 year outcomes in patients treated with HIFU: 538 patients treated with Ablatherm HIFU device
RISK
5y BDFS
10 y BDFS
10y MFS
P CA Survival
Low
88%
71%
99.6%
100%
Moderate
83%
63%
94.3%
96.2%
High
48%
32%
84.6%
89%
Best outcomes in Low and Moderate risk prostate cancer
et al. BJUI, 2013, 28 Jan epubGanzer

7. Prostate Size and Height
This prostate is too large: energy can not reach top of the prostate : due to attenuation of ultrasound waves as they traverse tissue
Thick rectal wall
Anterior tissue cannot be ablated
Remember to account for the rectal wall and Denon’s when selecting patients for treatment.

8. Importance of Overall Height
The Sonablate can deliver maximum ablative energy to a focal height of 4.0 cm , Ablatherm device 3.0 cm
Targeted Tissue beyond the ablation zone will not receive energy adequate for tissue ablation
Proper height measurement is essential to determine HIFU can ablate desired tissue
(Read Slide)
TRANSITION: Before we look at how to obtain the proper height measurement, let me take time to point out a couple of things:
(next slide)
SA-F _

9. Calcifications 1 cm maximum
Ultrasound can not pass through calcifications
Periurethral calcifications can be resected with TURP pre HIFU
Acoustic shadow
3 cm
2.5 cm

10. Pearl #2: TURP Pre Whole Gland HIFU
Pre HIFU TURP required for: larger glands, intravesicle median lobe, dense periurethral calcifications
Pre HIFU TURP lowered risk of Bladder Outlet Obstruction from 31% to 6% after Ablatherm HIFU*
Pre HIFU TURP decreased the catheterization time from 40 days to 7 days after Ablatherm HIFU**
My experience: advise TURP for virtually all whole gland ablation procedures
*Poissonnier et al. Eur Urol 51: 2007
**Chaussy et al. Curr Urol Rep 4: 2003

11. Pearl # 3 : Place Probe to achieve “flat rectal wall” with prostate centered on screen
Set gain to optimize image, centered in acoustic window
The RWD is constant:
T ∝Power X RWD/ attenuation
Flat rectal wall allows for consistent energy intensity in the focal zone.

12. Pearl # 4 Plan zones to achieve coverage of targeted tissue
If the AP measures less than 24 mm, treat the gland in 2 zones.
If prostate measures 24-26mm care must be taken to avoid over compression so that pubic bone is not included in treatment field.
AP height > 26mm usually is treated in 3 or more zones.
You must always design treatment to conform to actual prostate anatomy.
Zone 1
Zone 2
24 mm = AP height
Zone 1
28 mm = AP height
Zone 2
Zone 3

13. Pearl #5 :Confine HIFU to the Gland
The coronal view in VOLUME Stack (3D Stack) is most helpful in the following situations to define lateral borders and apex
Avoid placing energy on pubic bone
Identifying the true apex
2. Confirming the lateral edges of gland 3. Identifying the base and the bladder neck

14. Sparing the External Sphincter
Ultrasound imaging can identify external urethral sphincter, allowing sphincter sparing treatment to be delivered, resulting in low rates of incontinence
Because of the imaging capability of the probe, the external sphincter can be imaged and identified, allowing the sphincter to be spared resulting in low rates of incontinence.

15. Pearl #6: Doppler Imaging can assist in ID of NVB
Use Doppler imaging to assist in the identification of the neurovascular bundles

16. Pearl # 7: Notch to Reduce HIFU Stricture
Retrospective review of 90 patients with at least 6 months of follow up
2 techniques: lower energy across apex, or “notch”
Less risk of stricture
with notch
Central urethral apical notch
Scionti, S. International Experience with Visually Directed HIFU: Techniques to Reduce Urethral Strictures. Abstract presented at 2008 SIU meeting. Santiago, Chile

17. Pearl # 8: Adjust energy to achieve tissue response in treatment zone
Hyperechoic tissue changes suggest excellent treatment effect
Orange color in software is TCM software measuring tissue change in response to treatment

18. Pearl # 9: 4 things to monitor
Always monitor for :
Tissue Response: Popcorn+ Tissue Change Monitoring read
Near Field Changes (changes in echogenicity)
Rectal Wall Distance & RIM box
Compare reference and treatment images during HIFU for movement or swelling of prostate
During THERAPY eye should naturally move from top of sagittal window to bottom as you look at each of these things.

19. Pearl #10 : Don’t target the rectal wall !
The posterior capsule , fat layer and rectal wall is targeted. FISTULA RISK !!!!

20. Pearl #11: Tissue Preservation = Function Preservation
Hemi or Focal Tissue Preserving HIFU results in:
Up to 95% preservation of potency
95% pad free rate
>90% negative biopsy rate for clinically significant disease
1 year TRFECTA: 89%*
In my opinion, the best use of HIFU ablative treatment is for tissue sparing procedures
* Ahmed et al. J Urol

21. Pearl #12: Focal HIFU: Ideal Use of HIFU
Advanced Diagnostics: MRI, Fusion Biopsy
Focal, regional disease confirmed
MRI guided fusion HIFU
Adequate margin ( 1 cm where possible )
Seamless diagnostic and treatment platform
Excellent ablation and preservation of function

22. MRI image guidance?
Gleason grade 7 tumor in Right PZ
T2W
DWI

23. Pearl #13: Use MRI Fusion image guidance when the tumor is MRI visible.
MRI Fusion is incorporated into HIFU treatment platforms.
Allows HIFU surgeon to visualize the MRI visible tumor regions (even in total gland ablation)
Energy Density ( total dosage) can be increased over the most significant tumor regions

24. Pearl #14: Don’t start with salvage procedures
FDA Clinical Trial Outcomes Salvage HIFU A multicenter clinical study of the Sonablate® 450 (Sonablate) for the TreAtment of locally Recurrent prostate cancer with HIFU (STAR Trial)

25. STAR Trial: Device/Procedure Related Serious Adverse Events
SAE (N=116)
Number of Events
Hematuria 5
Rectal fistula 4
Bone infection (osteomyelitis) 3
Urinary Retention
Urinary tract infection
Urinary tract obstruction
Catheter-related infection (urosepsis) 1
Urinary fistula
Urinary incontinence
Small intestinal obstruction

26. To mitigate Fistula events, after 61 procedures, physician training was modified
After the first 61 procedures; enhancements to HIFU training program were
Developed Physician Instruction Manual in addition to User Manual
Confined treatment to prostatic tissue
Cases proctored by highly experienced physician proctor
Recommended that no instrumentation for up to 6 months post-HIFU without direct visualization (specific to post radiated salvage subjects)
100% review of cases to understand poor outcomes

27. STAR Trial : Rectal Fistula
Fistula Grade (N=116)
Pre-Training Program
Post-Training Program
Grade I – II Medical Management
3 (4.9%)
Grade III Surgical Management
1 (1.6%)
1 (1.8%)
Subjects treated 61 55
Fistula rate combined
4 (6.6%)

28. STAR Trial: pubic bone osteomyelitis
All 3 subjects:
The treatment field included part of the pubic bone
Had chronic uncontrolled UTIs
Were treated prior to investigator retraining
Subject # 22
Subject # 29
Subject # 41
Date of HIFU treatment
8-January-2010
19-May-2010
28-July-2010
Was energy placed outside of prostate?
Yes
Time to diagnosis
2.2 years
6 months
1.7 years
Signs & symptoms
recurrent UTIs, retention, stricture
recurrent UTIs, retention
Event outcome
resolved

29. Sonacare Medical: Training Proposed to FDA Advisory Panel ( PMA)
Level I: Online self-guided tutorial
Level II: Active learning & treatments with proctors
Minimum five (5) proctored cases
Case review and proctor sign off for independent status
Level III: Independent status
Five (5) solo cases blind reviewed two reviewers
Library case review with remote specialist and virtual simulator (up to 20 cases)
Level "+": Annual recertification
Final Pearl: Training is required for the delivery of safe HIFU treatment

30. Vituro Health Physician Training Program
Phase I – HIFU overview
Online Training
Phase II – Software Overview
Phase III – Simulator Experience
Phase IV- Live case observation
On Site Training
at Vituro University Sarasota
Phase V- Physician Proctored cases (2)
Remote Training at new Vituro affiliate site
Phase VI – Physician Proctored cases ( 2- 4)

31. Medical Director, Vituro Health Scionti Prostate Center
Stephen Scionti, MD
Medical Director, Vituro Health
Scionti Prostate Center
Sarasota, Florida