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
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
Quantifyingsymptoms• 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 efficacyPisco 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 dataPisco, 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 dataCarnevale, 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 dataCarnevale, 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
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
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 inferiorObturator 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 hoursSheath = 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
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
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
BEST StudyBPH 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