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Pae 5
Prostate Artery Embolization for
  Benign Prostatic Hyperplasia
                  Case study, anatomy, and technique




                       Justin McWilliams, MD

Western Angio and Interventional Society 2012



                                                       2
No financial disclosures.




                            3
Chapter 1: The Introduction




                              4
5
Patient MB
• 62 year old male


• Severe lower urinary tract symptoms
  • Intermittency,urgency, nocturia, weak
   stream, straining, frequency


• Prostate volume 140 cc
  • Too   big for TURP
  • Patient   did not want open surgery
  • Had   researched PAE, and wanted it done



                                               6
Chapter 2: Becoming An “Expert”




                                  7
Urology residency in one slide
• BPH affects 40% of men over age 60
• “LUTS”: Hesitancy, decreased urinary stream, incomplete
  emptying, nocturia, frequency, urgency
• Medical therapy
    •   Selective alpha-blockers (relax smooth muscle tone of the prostate)
    •   5-alpha-reductase inhibitors (reduce size of the prostate)

• Surgical therapy
    •   TURP for prostates up to ~80 grams
           •   Hospitalization 2-3 days, indwelling Foley
           •   Capsule perforation (2%), voiding dystunction, blood transfusion (1%)
    •   Open prostatectomy for prostates > ~80 grams
           •   Hospitalization 3-5 days, indwelling Foley
           •   Urinary incontinence, erectile dysfunction (4%), retrograde ejaculation
               (90%), bladder neck contracture (4%), blood transfusion (5-10%)

                                                                                         Image courtesy of harvardprostateknowledge.org




                                                                                                                                          8
Quantifying
symptoms
• IPSS: International Prostate Symptom Score

    •   7-item questionnaire, score 0-35

    •   0-7: mild, 8-19: moderate, 20-35: severe

    •   Patient MB: 29


• Peak flow: Maximum urinary flow rate during

  voiding

    •   Normal >12-25 cc/sec

    •   Patient MB: <5 cc/sec


• Urinary QOL:

    •   How would you feel about living the rest of your life with

        your urinary condition the way it is?

    •   Patient MB: “Terrible”




                                                                     9
Pubmed search for “prostate
       artery embolization”



                              10
The world literature on PAE safety and
                     efficacy
Pisco et al, JVIR 2011                               Carnevale et al, CVIR 2010
• 15 patients with symptomatic BPH who failed        • 2 patients with acute urinary retention and
  medical therapy                                      indwelling Foley

• PAE with 200 micron PVA                            • PAE with 300-500 micron Embospheres

• 93% technical success                              • Foley removed in both patients, 3-15 d later

• Mean f/u 8 months                                  • 6 mo follow-up

     •   IPSS decreased 6.5 points (p = .005)             •   Both patients voiding normally

     •   Peak flow increased 4 mL/sec (p= .015)           •   Prostate volume decreased 25-40%

     •   Prostate volume decreased 26 cc (p=.0001)   • No complications
• 4 clinical failures

• 1 major complication (ischemic bladder wall)




                                                                                                      11
Additional data
Pisco, SIR 2012                      • 52 clinical successes (91%)

• 57 patients with symptomatic BPH      •   Mean prostate volume decreased 28%

                                        •   IPSS decreased 9.8 points
• PAE performed using 100-200
                                        •   QoL increased 1.9 points
 micron PVA
                                        •   IIEF increased 1.8 points
• Mean follow-up 9 months               •   Peak urinary flow increased 6.1 cc/sec

• 96% technical success rate (3/57      •   PSA decreased 26%

 unilateral)                            •   Results better with 100 micron than 200 micron PVA


• 52/57 treated as outpatients       • Complications
                                        •   1 major (bladder wall ischemia), 11 minor

                                        •   6 patients had pain during the procedure




                                                                                                 12
Additional data
Carnevale, CIRSE 2012
• 52 patients with symptomatic BPH

• PAE performed using Embospheres
    •   Mostly 300-500 micron, 7 cases used 100-300
        micron

    •   Bilateral PAE in 90%

    •   Unilateral PAE in 10%

• Clinical success in 98%




                                                      Slide courtesy of Francisco Carnevale, MD




                                                                                                  13
Additional data
Carnevale, CIRSE 2012
• 52 patients with symptomatic BPH

• PAE performed using Embospheres
    •   Mostly 300-500 micron, 7 cases used 100-300
        micron

    •   Bilateral PAE in 90%

    •   Unilateral PAE in 10%

• Clinical success in 98%




                                                      Slide courtesy of Francisco Carnevale, MD




                                                                                                  14
Chapter 3: The Battle




                        15
Timeline
•   2/9/12: Patient contacts me for possible PAE, discussed by phone


•   2/13/12: Clinic visit, history and physical


•   2/14/12: Receive return emails from 2 urologists caring for patient (3rd urologist did not respond)

        •   #1: “I have no clinical objection to your proceeding, as long as you follow proper protocol for a non-FDA-approved interventional procedure.”


        •   #2: “I have read about this procedure in some very sketchy papers out of Israel.”


•   3/1/2012: Authorization initiated by clinic staff


•   3/12/2012: First peer-to-peer with Blue Cross (denied)


•   3/24/2012: Met with Dr. Pisco and Dr. Carnevale at SIR meeting in San Francisco


•   3/26/2012: Second peer-to-peer with appeal reviewer


•   3/28/2012: Insurance authorization approved


•   4/3/2012: Prostate artery embo performed




                                                                                                                                                            16
Chapter 4: The Procedure




                           17
Patient MB – pre-procedure
• Baseline PSA performed

• Baseline MRI prostate

    •   Pelvic coil not prostate coil

• Baseline uroflowmetry

    •   Peak flow and post-void residual

• Baseline symptom scores

    •   IPSS, IIEF, SF-12

• Prostate medications stopped 1 week prior

• Naproxen and Cipro initiated 2 days prior

• CTA pelvis performed




                                              18
Pelvic aortogram 12/24. No prostate blush seen.
Internal iliac angiograms, AP projection. Too much overlap.
Internal iliac angiograms, ipsilateral oblique with slight tilt of II toward the head.
Green arrow = Superior vesical. Blue arrow = Superior gluteal. Purple arrow = Inferior gluteal. Orange arrow = Obturator. White arrow =
                     internal pudendal. Long red arrow = Origin of prostatic. Short red arrow = Distal prostatic.
Anterior division




                                                                                                  Common inferior
Obturator                                                                                        gluteal – pudendal
            Middle rectal      Superior vesical                     Umbilical                           trunk
  12%
                                                                                                        28%




                                                                                Internal pudendal                    Inferior Gluteal
                                                                                       56%                                  4%




                    Prostatic-inferior vesical artery origin

                                    Bilhim et al. Prostatic arterial supply: demonstration by multirow detector angio CT and catheter angiography
L internal pudendal, from just beyond the origin of the      L prostatic artery. Obvious prostate blush without
 prostatic. Tiny branches feed the prostate from this     nontarget branches. I embolized from here to stasis with
 artery, but they were too small to microcatheterize.                 300-500 micron Embospheres.
AP spot film showing stasis in the prostatic   AP view of anterior division post-embolization. Slowed
                  artery.                       flow in L internal pudendal with no filling of prostatic
                                                        artery and no obvious prostate blush.
R internal pudendal artery, just above prostatic artery   R prostatic artery superselected.
                      take-off.
Total time spent in room = 3.5 hours

Sheath = Standard 10 cm 6 French sheath in R common femoral artery.

              Base catheter = RUC catheter (vs Cobra)

     2.8F microcatheter (smaller may be better in difficult cases)

  Embolic material = Total of ½ vial of 300-500 micron Embospheres

                       Contrast used = 210 cc

                      Fluoro time = 41 minutes




                      Procedure details
Chapter 6: Brazil




                    27
Sao Paulo




            28
PAE Lessons Learned
• Screen patients carefully pre-procedure
    •   Not surgical candidate or refuses surgery
    •   Exclude prostate CA (PSA +/- prostate biopsy)
    •   Patent IIA without excessive atherosclerosis

• Place Foley catheter with contrast
    •   Marks position of bladder and prostate

• Use oblique projection to open up IIA branches
    •   35 degree ipsilateral oblique, 10-15 degree caudal-cranial
    •   Identify branches to prostate, bladder and rectum

• Superselective angiography and embo
    •   Small size microcatheter
    •   Consider Dyna-CT to confirm safe position
    •   Embolize to stasis
Chapter 7: Follow-Up




                       30
PAE Case – 1 month f/u
• Occasional mild pain x 1 week (no medication required)

• Improvement noted in urinary symptoms within several days

• By 1 week post-procedure, symptoms almost completely
  alleviated

    •   No hematuria, painful urination, frequency, urgency.

    •   Able to empty bladder fully without straining

• Erectile function normal

• Prostate volume 110 cc (from 140 cc)

• IPSS 2 (from 28!)

• Peak flow 13 cc/sec (from <5 cc/sec)

• Urinary QOL: “Delighted”



                                                               31
PAE Case – 3 month f/u
• Flow slightly less and some
  urgency recurred

• Self-limited episode of
  hematuria occurred ~2 months
  after the procedure

• Prostate volume 97 cc

• IPSS 9

• Urinary QOL: “Pleased”


                                 32
PAE Case – 6 month f/u
• Getting up once during the night
• Pressure of urine stream much better than pre-
  procedure, but has reduced somewhat from 1st week
  after procedure
• Occasional episodes of mild painless hematuria
• IPSS 11
• Urinary QOL: “Pleased”
• Patient remains very happy with procedure results



                                                      33
Chapter 8: What’s next




                         34
BEST Study
BPH with EmboSphere Treatment
 Phase    III, FDA IDE approved, international study

 Sites   have been selected (number limited by FDA)

 Randomized     to TURP 2:1 with 186 patients

 Primary   endpoint = IPSS at 12 months, plus 4 years follow up

 Co-investigators   IR and Urology


                                                   Slide courtesy of Francisco Carnevale, MD
jumcwilliams@mednet.ucla.edu

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Pae 5

  • 2. Prostate Artery Embolization for Benign Prostatic Hyperplasia Case study, anatomy, and technique Justin McWilliams, MD Western Angio and Interventional Society 2012 2
  • 4. Chapter 1: The Introduction 4
  • 5. 5
  • 6. Patient MB • 62 year old male • Severe lower urinary tract symptoms • Intermittency,urgency, nocturia, weak stream, straining, frequency • Prostate volume 140 cc • Too big for TURP • Patient did not want open surgery • Had researched PAE, and wanted it done 6
  • 7. Chapter 2: Becoming An “Expert” 7
  • 8. Urology residency in one slide • BPH affects 40% of men over age 60 • “LUTS”: Hesitancy, decreased urinary stream, incomplete emptying, nocturia, frequency, urgency • Medical therapy • Selective alpha-blockers (relax smooth muscle tone of the prostate) • 5-alpha-reductase inhibitors (reduce size of the prostate) • Surgical therapy • TURP for prostates up to ~80 grams • Hospitalization 2-3 days, indwelling Foley • Capsule perforation (2%), voiding dystunction, blood transfusion (1%) • Open prostatectomy for prostates > ~80 grams • Hospitalization 3-5 days, indwelling Foley • Urinary incontinence, erectile dysfunction (4%), retrograde ejaculation (90%), bladder neck contracture (4%), blood transfusion (5-10%) Image courtesy of harvardprostateknowledge.org 8
  • 9. Quantifying symptoms • IPSS: International Prostate Symptom Score • 7-item questionnaire, score 0-35 • 0-7: mild, 8-19: moderate, 20-35: severe • Patient MB: 29 • Peak flow: Maximum urinary flow rate during voiding • Normal >12-25 cc/sec • Patient MB: <5 cc/sec • Urinary QOL: • How would you feel about living the rest of your life with your urinary condition the way it is? • Patient MB: “Terrible” 9
  • 10. Pubmed search for “prostate artery embolization” 10
  • 11. The world literature on PAE safety and efficacy Pisco et al, JVIR 2011 Carnevale et al, CVIR 2010 • 15 patients with symptomatic BPH who failed • 2 patients with acute urinary retention and medical therapy indwelling Foley • PAE with 200 micron PVA • PAE with 300-500 micron Embospheres • 93% technical success • Foley removed in both patients, 3-15 d later • Mean f/u 8 months • 6 mo follow-up • IPSS decreased 6.5 points (p = .005) • Both patients voiding normally • Peak flow increased 4 mL/sec (p= .015) • Prostate volume decreased 25-40% • Prostate volume decreased 26 cc (p=.0001) • No complications • 4 clinical failures • 1 major complication (ischemic bladder wall) 11
  • 12. Additional data Pisco, SIR 2012 • 52 clinical successes (91%) • 57 patients with symptomatic BPH • Mean prostate volume decreased 28% • IPSS decreased 9.8 points • PAE performed using 100-200 • QoL increased 1.9 points micron PVA • IIEF increased 1.8 points • Mean follow-up 9 months • Peak urinary flow increased 6.1 cc/sec • 96% technical success rate (3/57 • PSA decreased 26% unilateral) • Results better with 100 micron than 200 micron PVA • 52/57 treated as outpatients • Complications • 1 major (bladder wall ischemia), 11 minor • 6 patients had pain during the procedure 12
  • 13. Additional data Carnevale, CIRSE 2012 • 52 patients with symptomatic BPH • PAE performed using Embospheres • Mostly 300-500 micron, 7 cases used 100-300 micron • Bilateral PAE in 90% • Unilateral PAE in 10% • Clinical success in 98% Slide courtesy of Francisco Carnevale, MD 13
  • 14. Additional data Carnevale, CIRSE 2012 • 52 patients with symptomatic BPH • PAE performed using Embospheres • Mostly 300-500 micron, 7 cases used 100-300 micron • Bilateral PAE in 90% • Unilateral PAE in 10% • Clinical success in 98% Slide courtesy of Francisco Carnevale, MD 14
  • 15. Chapter 3: The Battle 15
  • 16. Timeline • 2/9/12: Patient contacts me for possible PAE, discussed by phone • 2/13/12: Clinic visit, history and physical • 2/14/12: Receive return emails from 2 urologists caring for patient (3rd urologist did not respond) • #1: “I have no clinical objection to your proceeding, as long as you follow proper protocol for a non-FDA-approved interventional procedure.” • #2: “I have read about this procedure in some very sketchy papers out of Israel.” • 3/1/2012: Authorization initiated by clinic staff • 3/12/2012: First peer-to-peer with Blue Cross (denied) • 3/24/2012: Met with Dr. Pisco and Dr. Carnevale at SIR meeting in San Francisco • 3/26/2012: Second peer-to-peer with appeal reviewer • 3/28/2012: Insurance authorization approved • 4/3/2012: Prostate artery embo performed 16
  • 17. Chapter 4: The Procedure 17
  • 18. Patient MB – pre-procedure • Baseline PSA performed • Baseline MRI prostate • Pelvic coil not prostate coil • Baseline uroflowmetry • Peak flow and post-void residual • Baseline symptom scores • IPSS, IIEF, SF-12 • Prostate medications stopped 1 week prior • Naproxen and Cipro initiated 2 days prior • CTA pelvis performed 18
  • 19. Pelvic aortogram 12/24. No prostate blush seen.
  • 20. Internal iliac angiograms, AP projection. Too much overlap.
  • 21. Internal iliac angiograms, ipsilateral oblique with slight tilt of II toward the head. Green arrow = Superior vesical. Blue arrow = Superior gluteal. Purple arrow = Inferior gluteal. Orange arrow = Obturator. White arrow = internal pudendal. Long red arrow = Origin of prostatic. Short red arrow = Distal prostatic.
  • 22. Anterior division Common inferior Obturator gluteal – pudendal Middle rectal Superior vesical Umbilical trunk 12% 28% Internal pudendal Inferior Gluteal 56% 4% Prostatic-inferior vesical artery origin Bilhim et al. Prostatic arterial supply: demonstration by multirow detector angio CT and catheter angiography
  • 23. L internal pudendal, from just beyond the origin of the L prostatic artery. Obvious prostate blush without prostatic. Tiny branches feed the prostate from this nontarget branches. I embolized from here to stasis with artery, but they were too small to microcatheterize. 300-500 micron Embospheres.
  • 24. AP spot film showing stasis in the prostatic AP view of anterior division post-embolization. Slowed artery. flow in L internal pudendal with no filling of prostatic artery and no obvious prostate blush.
  • 25. R internal pudendal artery, just above prostatic artery R prostatic artery superselected. take-off.
  • 26. Total time spent in room = 3.5 hours Sheath = Standard 10 cm 6 French sheath in R common femoral artery. Base catheter = RUC catheter (vs Cobra) 2.8F microcatheter (smaller may be better in difficult cases) Embolic material = Total of ½ vial of 300-500 micron Embospheres Contrast used = 210 cc Fluoro time = 41 minutes Procedure details
  • 28. Sao Paulo 28
  • 29. PAE Lessons Learned • Screen patients carefully pre-procedure • Not surgical candidate or refuses surgery • Exclude prostate CA (PSA +/- prostate biopsy) • Patent IIA without excessive atherosclerosis • Place Foley catheter with contrast • Marks position of bladder and prostate • Use oblique projection to open up IIA branches • 35 degree ipsilateral oblique, 10-15 degree caudal-cranial • Identify branches to prostate, bladder and rectum • Superselective angiography and embo • Small size microcatheter • Consider Dyna-CT to confirm safe position • Embolize to stasis
  • 31. PAE Case – 1 month f/u • Occasional mild pain x 1 week (no medication required) • Improvement noted in urinary symptoms within several days • By 1 week post-procedure, symptoms almost completely alleviated • No hematuria, painful urination, frequency, urgency. • Able to empty bladder fully without straining • Erectile function normal • Prostate volume 110 cc (from 140 cc) • IPSS 2 (from 28!) • Peak flow 13 cc/sec (from <5 cc/sec) • Urinary QOL: “Delighted” 31
  • 32. PAE Case – 3 month f/u • Flow slightly less and some urgency recurred • Self-limited episode of hematuria occurred ~2 months after the procedure • Prostate volume 97 cc • IPSS 9 • Urinary QOL: “Pleased” 32
  • 33. PAE Case – 6 month f/u • Getting up once during the night • Pressure of urine stream much better than pre- procedure, but has reduced somewhat from 1st week after procedure • Occasional episodes of mild painless hematuria • IPSS 11 • Urinary QOL: “Pleased” • Patient remains very happy with procedure results 33
  • 35. BEST Study BPH with EmboSphere Treatment  Phase III, FDA IDE approved, international study  Sites have been selected (number limited by FDA)  Randomized to TURP 2:1 with 186 patients  Primary endpoint = IPSS at 12 months, plus 4 years follow up  Co-investigators IR and Urology Slide courtesy of Francisco Carnevale, MD