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前列腺局灶治療 HIFU
- 2. WHAT IS HIFU? The focusing of "sound" energy onto a specific focal point that destroys targeted tissue. …Like a Magnifying Glass
- 3. Physiology of HIFU Ablation • Ultrasound energy is absorbed and converted to heat in the focal zone • Temperature elevation depends on tissue absorption coefficient and thermal response of tissue • Biologic response depends on maximum temperature and duration of exposure (thermal dose) • Temperature elevation, if sufficient, melts lipid membranes, denatures proteins, produces vascular endothelial cell damage, and ultimately leads to coagulative necrosis
- 4. HIFU - A NEW TREATMENT PARADIGM Target/Focal HIFU ablation offers a clinical option between surveillance and surgery SurgerySurveillance SonaSurgery HIFU Ablation
- 5. PREFERRED HIFU PRODUCTS Sonasource™ Console Sonablate® Trans-rectal HIFU probe for prostate ablation Sonablate® has 510(K) clearance in the U.S. under a De Novo regulatory classification; Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
- 7. HIFU ABLATION HIFU can deliver targeted, non-invasive ablation to specific prostate tissue regions
- 8. Sonablate® software allows for a customizable and targeted ablation plan tailored to each patient’s prostate. SONABLATE® PROSTATE ABLATION This tailored ablation plan allows the user to perform a whole or partial gland ablation. WHOLE GLAND HEMI GLAND FOCAL GLAND
- 9. SONABLATE® WHOLE GLAND Two months post HIFU • Shrinkage of necrotic volume through mixture of sloughing, resorbtion and fibrosis • T1W axial MRI • 1 min post gadolinium contrast Image courtesy of Professor Mark Emberton, University College London
- 10. Prostate HIFU Hemi Ablation of the patient’s left lobe performed at University College of London T1-weighted gadolinium enhancement at 1 week post Left Hemi-HIFU SONABLATE® HEMI ABLATION Image courtesy of Professor Mark Emberton, University College London
- 11. Prostate HIFU Focal Ablation of focal site on the patient’s left side MRI study following-up using DCE /gadolinium shows positive ablation results Image courtesy of Professor Mark Emberton, University College London SONABLATE® FOCAL ABLATION
- 12. TCM is a unique quantitative software module that displays real-time changes in prostate tissue destruction resulting from the HIFU ablation. Tissue Change Monitoring (TCM) Tissue Change Monitoring (TCM) Tissue Change Monitoring
- 13. Patient Selection • Gland height / gland size • Calcifications • Other considerations / contraindications
- 14. • Height requirements oWhole gland: Restricted by AP height oSubtotal gland: Restricted by region of interest (ROI) height • Gland size oWhole gland ablation: 40cc or less oSubtotal gland ablation: 40cc or more (*sometimes) Gland Height / Gland Size
- 15. This distance must be ≤ 3.7 cm Whole Gland Height Limitation
- 16. • Calcifications: hyperechoic and cause acoustical shadowing • Large and dense calcifications = HIFU beam attenuation • Calcifications must be less than 1cm • Numerous small calcifications • Calcifications within 1.0 cm of the rectal wall may deflect the HIFU energy and may cause rectal wall heating • Intervention Calcifications
- 17. Shadows Caused by Calcifications
- 18. Special Considerations in Radiation Salvage Patients • Considerations oThick rectal wall oCompromised vascular perfusion • Utilize oExtra cooling 3/6 duty cycle Pauses oPower titration
- 19. • Rectal surgery • Inflammatory bowel disease with rectal involvement such as Chron’s disease or ulcerative colitis • Metal implants or stents in the urethra, within the area to be ablated • Brachytherapy seeds adjacent to the posterior prostate capsule, Denonvilliers’ fascia, or the rectal wall • Rectal Stenosis Contraindications
- 20. The Latest HIFU Publications • Largest cohort of focal HIFU patients in publication (N=1032)1 • Longest follow up period (median of 56 months)2 • Intermediate – High risk disease population (80%-85%)1, 2 1 Stabile et al. BJU 12 Feb 2019 2 Guillaumier et al. Eur Urol. 2018; 74(4): 422-429
- 21. Sonablate Clinical Data MedianMonths Follow-up 45 Number ofPatients Intermediate/HighRisk 82% Patientswith GleasonScore≥7 76% Sonablate® Study1 Sonablate® Study2 Sonablate® Study3 Sonablate® Study Average1,2,3 1,809 54 152 88% 69% 625 85% 72% 36 1,032 80% 80% 56 †Salvage defined as requiring whole gland and/or systemic therapy for recurrent disease. Clinically Significant Disease Failure Free Survival Salvage Procedures† Repeat Focal Procedures 13% 96% 6.8% 18.5% 4% 90% 10.3% 11% 9% 92.5% 7% 19% 16% 98% 6.6% 26% Sonablate® Study1 Sonablate® Study2 Sonablate® Study3 Sonablate® Study Average1,2,3 Sonablate® Study1,2 Urethral Stricture Urinary Tract Infection Post HIFU TURP Pad-Free Retain Sexual Function 2% 9% 0% 98% 85% 1.3% 2.6% 99% 86% 2% 9% 0% 98% 85% Sonablate® Study1 Sonablate® Study2 Sonablate® Study3 Not Reported 1 Hindley et al. In Press 2 Guillaumier et al. Eur Urol. 2018; 74(4):422-429 3 Stabile et al. BJU 12 Feb 2019 Bibliography
Editor's Notes
- Narration Notes: Depicted here are the stepper, the probe arm, and the probe. The 3-axis stepper is attached to the bedrail and supports the probe arm. The stepper allows imaging adjustments in 3 planes: transverse, anterior/posteriorly, and sagittally. The multi-pivot probe arm has a collar to support the probe during the case. The probe arm can be moved in various directions for initial positioning and then locked into place. The sonablate probe houses electronic motors to precisely control the transducer movement during HIFU delivery. The concave transducers in the probe tip allow for imaging and precise targeting of ablation. Water from the sonachill is circulated through the probe tip bolus for rectal wall cooling (the water flow tubing and sheath bolus are not pictured here).
- Narration Notes: Patient selection is a vital component for successful HIFU ablation. Considerations include gland height, gland size, calcifications, as well as other contraindications which are addressed in the following slides.
- Narration Notes: Gland height and gland size restrictions are dependent on the ablation approach With whole gland ablations, the anterior/posterior gland height is particularly important. If the goal of a whole gland ablation is to ablate the entire prostate, the physician must include the anterior gland tissue in the anterior HIFU ablation zone. If the gland is too tall and cannot be included in the anterior focal zone, some anterior tissue will be spared and a whole gland ablation will likely not be acheived. The maximum gland height for whole gland ablation will be demonstrated in the next slide. Glands greater than 40 cc in size generally are not great HIFU candidates for whole gland ablation based on the inability to provide adequate ablation coverage to the entire gland. On the other hand, subtotal glands, such as focal and hemi ablations, are often not restricted by gland height. For instance, if the gland is tall but the targeted lesion(s) are in the mid and posterior gland, then it is highly likely the targets can be reached. If a subtotal gland ablation is planned, glands larger than 40 cc may be considered depending on the location of target. Also be aware that a large gland may extend beyond the Sonablate imaging field of view, so the ultrasound volume images may not include the entire gland thus fusion, if being utilized, could be inaccurate (i.e. not fusing apples to apples).
- Narration Notes: These illustrations depict the inclusion of rectal wall and posterior tissue in the AP height when screening for whole gland ablation. Again, if this measurement is greater than 3.7 cm, any anterior tissue above the 3.7 cm mark, will be spared during ablation. This 3.7 cm height restriction may not apply to hemi and focal ablations if the target lesions are in the mid and posterior gland.
- Narration Notes: If a patient is a HIFU candidate, please screen for the presence of large shadowing calcifications or multiple small calcifications. Calcifications on ultrasound are hyperechoic and attenuate the beam which causes acoustic shadowing beyond/above the calcification. If the calcification is large and dense enough to affect the imaging beam, then the calcification will also attenuate and disrupt the therapeutic HIFU beam; ….energy sufficient for ablation will not be delivered beyond the calcification. A good rule of thumb is: “If you can’t see beyond the calcification, you cannot ablate beyond the calcification”. Calcifications greater than 1 cm are contraindications for HIFU ablations. Subtotal ablations such as focal and hemi ablations could be performed on glands with calcifications as long as the calcifications do not *disrupt the HIFU beam*. Numerous small calcifications tightly grouped may also cause significant attenuation and hinder the delivery of ablative energy. Calcifications within 1 cm of the rectal wall may reflect and absorb energy which in turn may cause rectal wall heating. Potential HIFU candidates with numerous midline, peri-urethral calcifications may benefit from a TURP before HIFU ablation to alleviate potential disruption of energy to desired tissue. The following slides demonstrate calcifications that would be contraindicated for adequate delivery of HIFU energy beyond the calcification. (QUESTION: ask Karen if we want to address pre-HIFU intervention for calcs, such as TUPR, greenlight laser (we did suggest this in another presentation). I NEED TO FIND PRESESENTATION WHERE pre-HIFU intervention WAS ADDRESSED (1/29/2018 BLEE). Please find the presentation where we address so that we can use the same language. (1 Feb 2019 KC)
- Narration Notes: These images demonstrate dense, hyperechoic calcifications greater than 1 cm that produce acoustic shadowing. Note the inability to visualize tissue beyond the calcifications. If the imaging beam is hindered by the calcification, then the therapeutic HIFU beam will also be obstructed. Remember, “If you can’t see through it, you can’t ablate through it! There is a “near field heat” training presentation illustrates the above with a video. *add arrows to correlate with the timing of “calcifications” and “shadowing” when narrated. KC Will do, BLee
- If HIFU is a consideration for radiation salvage, please note the patient may have a thick rectal wall. The thick rectal wall should be included in the screening measurement to ensure that the anterior prostatic margin can be included in the 3.7 cm maximum target height, if you are trying to ablate the whole gland. Also consider that rectal wall vascular perfusion may be compromised in a post radiation patient. Compromised perfusion may result in the rectal wall’s inability to dissipate HIFU energy thus increasing the chance of a rectal wall injury. In these cases, monitor the rectal wall closely for the absorption of HIFU energy. Allowance for extra cooling during HIFU and titration of HIFU power are considerations for controlling rectal wall energy absorption during salvage cases. These will be discussed in subsequent training presentations. (transition) ... Next, another consideration in patient selection, … calcifications.
- Narration Notes: The following are contraindications to safe and efficient HIFU delivery: - Previous rectal surgery may elevate the risk for rectal wall injury if subjected to HIFU energy Inflammatory bowel disease with rectal involvement such as Chron’s disease or ulcerative colitis carry elevated risk with HIFU Urethral implants, within the area to be ablated, should be considered a contraindication Brachytherapy seeds adjacent to the posterior prostate capsule, Denonvilliers’ fascia, or the rectal wall may absorb or reflect the HIFU beam and are contraindicated Rectal stenosis may prohibit the safe insertion of the Sonablate probe. The next slide offers more insight: