ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… ·...
Transcript of ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… ·...
![Page 1: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/1.jpg)
PD61-01 WATER VS WATER II: TWO YEAR COMPARISON OF AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIADavid-Dan Nguyen*, Kevin C. Zorn, Dean S. Elterman, Naeem Bhojani
![Page 2: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/2.jpg)
Aquablation Therapy
(Ultrasound and Articulating Arms not pictured)
Clarity Consistency Control
BPH Surgery Reimagined
![Page 3: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/3.jpg)
The Aquablation Robotic Solution
Optimal tissue removal plan for each patient
Personalized, Patient-specificSurgical Standardization
• Autonomous execution • Precision and accuracy• Tissue Removal
AUTONOMOUS TISSUE REMOVAL
Tissue-selectiveCavitation
• Tissue-selective• Eliminates thermal
complications
CAVITATING WATERJET
Enhanced Information & Data Integration
• Improved decision making• Personalized treatment
planning
MULTI-DIMENSIONAL IMAGING
CystoscopicVisualization
UltrasoundVisualization
![Page 4: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/4.jpg)
Aquablation FDA Clinical Trials
• Prostates 30 – 80 mL• N = 181 (Aquablation therapy = 116, TURP = 65)• 17 sites in the United States, UK, Australia &
New Zealand (14 sites: no prior experience with Aquablation therapy)
RESULTS: Superior safety & non-inferior efficacy compared to TURP
THE ONLY FDA PIVOTAL STUDY RANDOMIZED TO TURP
(GOLD STANDARD)
• Prostates 80 – 150 mL• N = 101• 16 sites in the United States and Canada
(9 sites: no prior experience with Aquablation therapy)
RESULTS: Safe & effective in larger prostates, without significant increase in procedure or resection time
THE ONLY PROSPECTIVE MULTICENTER STUDY SUCCESSFULLY COMPLETED
FOR LARGE PROSTATES
![Page 5: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/5.jpg)
Baseline Characteristics WATER
(n=116)WATER II
(n=101)
Mean SD Mean SD P value
Age 65.9 7.3 67.5 6.6 0.0854
BMI 28.4 4.1 28.3 4.1 0.8232
IPSS 22.9 6.0 23.2 6.3 0.6930
Prostate volume, mL 54.1 range (25-80) 16.3 107.4 range (80-150) 20.2 <0.0001
PSA, ng/mL 3.7 3.0 7.1 5.9 <0.0001
Qmax, mL/sec 9.4 3.0 8.7 3.4 0.111
MSHQ-EjD 8.1 3.7 8.1 3.9 0.9160
IIEF-5 (SHIM) 17.2 6.5 15.1 7.4 0.0500
![Page 6: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/6.jpg)
Procedure Outcomes WATER
(n=116)WATER II
(n=101)
Mean SD Mean SD P value
TRUS in to Cath in (min) 39.7 15.2 54.5 19.2 <0.0001
Resection Time (min) 3.9 1.4 8 3.2 <0.0001
Number of passes 1.1 0.3 1.8 0.6 <0.0001
Catheter days 2 2.3 3.9 3.6 <0.0001
Hospital length of stay (days) 1.4 0.7 1.6 1.0 0.0868
Hemoglobin at discharge 13.0 1.7 11.9 2.2 <0.0001
![Page 7: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/7.jpg)
Safety Endpoint
OTHER NOTABLE SAFETY RATES
WATER(n=116)
WATER II(n=101)
Incontinence 0% 2% de novo
Erectile dysfunction 0% 0%
Ejaculatory dysfunction 10% 19%
Perioperative Transfusion 0.9% 5.9%
D/C to Day 30 Transfusion 0% 4.0%
3-MONTH RATE
CD1P CD2 CD3 CD4
50%
40%
30%
20%
10%
0%
CLAVIEN-DINDO BREAKDOWN
WATERWATER II
1. CD grade definitions: CD1P (ejaculatory dysfunction, incontinence), CD2 (requiring pharmacological treatment, blood transfusions), CD3 (endoscopic or surgical interventions), CD4 (complications requiring ICU management)
![Page 8: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/8.jpg)
New Hemostasis Method: Focal Bladder Neck Cautery
NEW 3/188 (1.6%)0/16 (0.0%) 3/172 (1.7%)
EXP 0/439 (0.0%)0/266 (0.0%) 0/173 (0.0%)
ALL 3/627 (0.5%)0/282 (0.0%) 3/345 (0.9%)
TOTAL(prostate size 20 – 230mL)2019 2020
New sites defined as 20 or less Aquablation casesExperienced sites defined as more than 20 Aquablation cases
Data as of 01Apr2020
![Page 9: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/9.jpg)
BPH Symptom Improvement
DAYS FROM PROCEDURE
IPSS
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##0
35
30
25
20
15
10
5
0
WATER
WATER II
DAYS FROM PROCEDURE
QUALITY OF LIFE
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##00
2
4
6
Data reported as mean (95% CI)
![Page 10: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/10.jpg)
Uroflow: Qmax & PVR
Data reported as mean (95% CI)MONTHS FROM PROCEDURE
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##00
5
10
15
20
25
WATER
WATER II
Qmax (mL/sec) PVR (mL)
MONTHS FROM PROCEDURE #,##0
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
#,##0 #,##0
0
25
50
75
100
125
150WATERWATER II
![Page 11: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/11.jpg)
Durability at 2-Years
WATER 2.2% 3.7 3.0
WATER II 1.0% 7.1 4.9
ANNUALIZED RETREATMENT
RATE
PSA
Baseline 2-Year
![Page 12: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/12.jpg)
Limitations
We did not directly compare Aquablation to volume independent surgical alternatives, such as HoLEP and PVP.
With only a 36-month follow-up for WATER and 24-month follow-up for WATER II, longer-term follow-up data from these cohorts are
needed to demonstrate the durability of the treatment outcomes.
![Page 13: ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $' éÖÙ Z( ̨I2¿° S4 P(mo ·ßmÚrDp ....… · 2020. 5. 3. · Title ôÁÙeS XäG½¥ eæ ÈÏ´«ÊhêÓ£³Æ $" éÖÙ Z( ̨I2¿°](https://reader031.fdocuments.net/reader031/viewer/2022011920/602304b0a8ac11119e59de17/html5/thumbnails/13.jpg)
Conclusion
First comparison of 2-year data from two
prospective Aquablation clinical studies, comparing
prostates < 80 mL vs. > 80 mL
• Aquablation therapy clinically normalizes outcomes among patients regardless of prostate size or shape
• Symptom improvement and flow rates were consistent in both studies with durable results out to two years
• Retreatment rates were low and similar across studies