1. Gerrit-Jan de Nooij CeloNova Biosciences
Presentation on PAE
Gerrit-Jan de Nooij
CeloNova Biosciences

2. Finland Kuopio Radiology congress
Personal background
10 years Intensive Care Nurse at Thoracic Surgery and Heart transplant Academic Centre Utrecht.
12.5 years as Head of Sales distribution partner in the Netherlands.
Since 2000 involved with micro-spheres.
Since 2008 CeloNova Biosciences.

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Achievements Finland;
In 2010 the first Embozene micro-spheres was successfully injected by Dr Wolf Roth in a liver patient.
Started up UFE in Hameenilla, trained in NL
In 2013 the first Tandem Embozene was successfully injected by Dr Jukka Perola.
Made 17 trips to support Interventional Radiologists.
All mayor hospitals use our Embozene and Tandem.

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How did it PAE start?
It started in Portugal with professor Pisco 4 years ago. He started with prostate bleedings and found out that patients had less problems with BPH. His urology department had to much BPH cases and started to refer to the professor. He performed now over 650 cases. Then Dr Carnevale started 3 years ago in Brazil.
Early followers where Dr Tinto, Lisbon, over 400 cases.
Dr Sandeep Bagla, Inova Alexandria, USA, over 75 cases.
Dr Nigel Hacking, Southampton, over 50 cases.
Dr Rares Nechifor, Bucharest, over 50 cases.

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HOW TO START PAE?
Understand that this is a field for pioneers.
Before you talk to your urologist make sure you know the following terms of BPH;
BPH EU guide-lines
I-PSS, ( International Prostate Symptom Score)
Quality of life score
LUTS ( Lower Urinary Tract Syndrome)
Peak flow rates

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Second step in starting up PAE.
Find yourself a true friend from the Urology department.
The international Urology Society had some presentations this year on PAE, it is not new to them.
Find a good patient to start on with the following;
Prostate to large to operate like over 100 gram.
A patient with cardiovascular/ pulmonary problems.
A patient on a urine catheter.

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Assess Anatomy with CTA or MRA
* Know the relevant vascular anatomy of your patient
* Usefulness of CTA to plan the procedure. You will:
- Know the anatomy of your patient
* Tortuosity; Calcium; Origin Stenosis; Aneurysms...
* Exclude some of them (<5%)
- Reduce radiation during the procedure (DSA, CBCT...)
- Reduce procedure time
- Reduce contrast injection
- Be confident and not lost
- Not need to catheterize all arteries
- Be surprised to find different anatomy not feasible with DSA
Reduce your complications by making a good overview

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What do anatomy books tell us...
The main prostatic artery is the inferior
vesical artery from the internal iliac
artery (...) that bifurcates in
vesicodeferential and vesicoprostatic.
(...). Accessory branches come from the
medium rectal and internal pudendal.
The posterior aspect of the gland is less
vascularized compared to the others

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Know the anatomy of your patient
Internal Iliac
Vesical Trunk
Superior Gluteal
Gluteal Pudendal Trunk
Prostato-Rectal Trunk
Inferior Gluteal
Internal Pudendal
Accessory Pudendal
Obturator

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Anatomical Challenges
* Too many actors on stage:
- IIA (Anterior and Posterior)
- Vesical Arteries
- Rectal Arteries
- Obturator Artery
- Accessory Pudendal Arteries
- Vesico-Deferential Artery
- Spermatic Artery
- Anastomosis
- Tortuosity
...
Do never forget: very different anatomy...

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Know the anatomy of your patient
PA almost always (+-85%) arises directly from:
Internal pudendal artery;
Anterior common gluteal-pudendal trunk;
Obturator artery;
Common trunk with the superior vesical or rectal arteries.

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Materials and technique
* Selective embolization
- Catheter: Roberts Uterine 5F
- Microcatheter
- 2.7F to 2.0F
- Shaped guidewire 0.018'
- Embolization Material
- Embozene® (250/400) (Yellow and Blue)
- Non target embolization
* Use micro-coils to avoid non-prostatic embolization
- End Point
* Near stasis in prostatic vessels, arterial flow interruption and
prostatic opacification

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Technical Obstacles
* Spasm
* Dissection
* Artery Dimension
* Extreme vascular tortuosity
* End-Point
* Non-target embolization
* Impossible to catheterize

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Technical Obstacles
* To reach the prostatic micro-vascularization we should
use small sized Embozene ( ).
- The use of such small particles may cause non target
embolization through anastomosis (>50%)

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Inclusion Criteria
* Age > 50 years.
* Prostate > 40 g
* Diagnosis of BPH with moderate to severe lower urinary
tract symptoms (LUTS) refractory to medical treatment for at
least 6 months;
with sexual dysfunction or accepting the risk of developing
sexual dysfunction after treatment;
* And one of the following:
IPSS > 18 and/or QoL > 3 and/or Qmax < 12 mL/s and/or Acute
urinary retention
Patients that cannot have general anesthesia or have prostate
dimension not suitable for TURP

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Exclusion Criteria
* Advanced atherosclerosis and tortuosity of iliac
arteries in Angio CT (exclusion rate < 5%)
* Non visualization at all of prostatic arteries on Angio CT
* Malignancy (PSA, TRUS, Biopsy)
* Detrusor Failure
* Neurogenic Bladder
* Bladder diverticulum or stones (surgery indicated)
* Urethral stenosis

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Results from Dr Hugo Tinto
* N = 255
* Technical Success 98%
* Good correlation between CTA and DSA
* > 50% Anastomosis with other pelvic organs
* 88% outpatient procedure, 3-5 hours.

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Conclusions
* Difficult anatomy due to several variations;
* Tortuosity and atherosclerosis limits feasibility;
* Small anastomosis may go undetected with
conventional angiography;
* No significant post-embolization symptoms, although
potential serious complications due to non-target embolization.

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Dr Hugo Tinto says as a conclusion; This can be a long and difficult procedure, so do not give up easily... If you want to go fast, go alone If you want to go far, go together.

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The first early results from Dr Sandeep Bagla, Inova Alexandria Hospital
Alexandria, Virginia USA
Embolization was technically successful in 18/20 (90%) of
patients and bilateral in 18/19 (95%)
* Unsuccessful embolization's were secondary to atherosclerotic
occlusion of prostatic arteries.
* 95% discharged same day and 1 patient overnight
observation
* No patients required urinary catheterization
* No reports of post procedural pain (VAS 0)

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* International Prostate Symptom Score (IPSS) 20
and/or reduction < 25%;
* Quality of Life (QoL) 4 and/or reduction < 1;
* Peak urinary flow (Qmax) improvement < 2.5 mL/s;

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* Mean fluoroscopy time was 30.2 mins (range , 10 frames/sec)
* Average dose μGycm2 (range ).
* Average procedure time was 72 minutes (range minutes).
* No minor or major complications (SIR classification system for reporting)
* No urologic complications including impotence,
incontinence, prostatitis or non target embolization.

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Early Trial Results: Conclusion
* Early results from this US trial demonstrate that PAE is a
safe procedure and has short term efficacy.
* Awaiting long terms results from the trial
* Results parallel European and SA clinical results
* Future trial at our institution will compare PAE

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What do I offer to start up your practice?
Be welcome to our PAE course in March and June 2015.
Ask for my USB stick full off the latest articles and presentations
Call Jaana from AdCare for a constructive meeting

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Please attend with your urologist one of our PAE master classes in There you meet Dr Hugo Tinto and see 3 PAE live cases.

27. Finland Kuopio Radiology congress 85% of the attending urologists and IR’s started working successfully within 3 months.

28. Finland Kuopio Radiology congress work and fun go together

29. Finland Kuopio Radiology congress work and fun go together

30. Finland Kuopio Radiology congress thank you very much