EAP: donnes factuelles de la litrature ? M Sapoval,, O Pellerin, C - PowerPoint PPT Presentation

EAP: données factuelles de la litérature ? M Sapoval,, O Pellerin, C Del Giudice N Thiounn P Meria Vascular and Oncological Interventional Radiology Urology HEGP et St Louis Hôpital Européen Georges Pompidou Université Paris Renée Descartes

Conflit d’Intéret Consultant Merit Médical Europeen training center.

Ca marche ? • Rétentions aigues d’urines • Oui …… • SBAU en rapport avec une HBP • Oui ….

Level of Current Evidence Level 1 Plus de 100 peer reviewed papers Mid and long term follow up in 1000 cases x 4 RCTS from China, Brazil, Switzerland Spanish RCT presented CIRSE 2018 submitted for publication. Large Multi-centre Registry from UK x 3 Systematic Reviews Meta-analysis

RCT China results Gao et al Radiology 2014 270(3);920-928

Sao Paulo Group 12 month Results TURP oPAE PErFecTED IPSS 6.1 12.8 3.6 QoL 0.9 2.2 1.6 IIEF 16.1 12.6 18.7 Prostate Volume 32 50.9 50 PSA 1.6 2.2 1.7 PVR 8.3 62.3 48.6 Qmax 27.1 10.1 16.7 Carnevale et al. CVIR 2015

Swiss RCT published in BMJ June 2018 Dominik Abt, Lukas Hechelhammer et al Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial

UK-ROPE

Rétentions aigues d’urine Le premier traitement de la RAU Alpha-bloquants 48 h Retrait de la sonde En cas d’échec de désondage ...

Kenny A, Sapoval M Am J Med. 2019 May 16. AUR + TWOC failure n = 20 pts Failure to remove BIC Successfull BIC removal after PAE after PAE n = 15 (75%) n = 5 (25%) No Recatheterization Recatheterization event recatheterization event Free of IBC Failed to void independently thereafter thereafter event n = 1 n = 1 n = 13 pts Clinical success Clinical failure at 6m follow up at 6m follow-up after PAE after PAE n = 14 (70%) n = 6 (30%) *14 patients (70%) achieved spontaneous voiding during the first attempt to remove the IBC at 15 ± 3 days after PAE

Previous authors: different methodological approach and/or PAE technique - All single center studies - Definition of clinical success and follow-up after PAE differs between studies - All of them used Embospheres (size varied between 100-300 µm, 300-500 µm) - Only two of them attempted to perform the PErFecTED technique (no success % reported) - Policy regarding BPH medication discontinuation varies greatly between studies - Our group of patients has a mean PV bigger than the majority of the others studies and a significant shorter mean duration of catheter indwell before PAE

Ca marche longtemps ? Oui

Résultats à long terme (1) • 10%-30% of clinical failures • Non-responders (80%) Vs Relapsers (20%)

Kenny AG, Kenny AG, Kenny AG, Pellerin O, Moussa N, Del Giudice C, Amouyal G, Pellerin O, Moussa N, Del Giudice C, Amouyal G, Pellerin O, Moussa N, Del Giudice C, Amouyal G, Dé éan C, Thiounn N, Sapoval M an C, Thiounn N, Sapoval M D Déan C, Thiounn N, Sapoval M

Long-Term Patient’s Experience After Prostatic Artery Embolization How we did it? cohort of 44 consecutive Between December 2013 and July 2015: - 47 consecutive PAEs - All of them were refered to the interventional radiology departement after intolerance or failure of medical treatment for at least 6 month and refusal of surgery - The medical records were reviewed from our database - Complications* and further BPH invasive treatments after PAE were recorded - A phone interview was conducted to assess patient’s experience - 3 patients were lost to follow-up, they were excluded from the study - Our study group consisted of 44 patients * Complications were defined according to the SIR classification

Long-Term Patient’s Experience After Prostatic Artery Embolization How we did it? Les patients opérés étaient définis comme échec Clinique Les autres interview teléphonique standardisé: (1) avez vous des SBAU ? (2) prenez vous un tt ? (3) le referiez vous ? (4) le recommenderiez vous à vos proches

Long-Term Patient’s Experience After Prostatic Artery Embolization

Ca marche toujours ? • Non …… • Environ 20 % de non répondeurs: – Echec clinique – Malgré succès technique

Non-repondeurs ? 1. Patient characteristics: - Age? - Prostate vascularity? - Prostate volume? Median lobe? - Peak urinary flow-rate (Qmax) /post-void residual urine (PVR) – bladder function? - Symptom severity? - Acute urinary retention? 2. Technique - Uni/Bilateral? - Embolic agent/size

Que faire si echec • Si échec technique • Nouvelle tentative • Si échec clinique • Discuter ré embolisation • Discuter chirurgie • Discuter traitement médical renforcé ? • Utiliser les bons mots…. • amélioration insuffisante ? • aucune amélioration (non repondeur) • échec initial mais récidive ( « relapser »)

How can PAE fail ? M Sapoval, GEST 2019

Case of non responder • Before PAE • PV 75 ml • IPSS 28 • QOL 6 • 12m after PAE • PV: 75 ml • IPSS 23 • QOL 6

How can PAE fail ? M Sapoval, GEST 2019

MRI at 12 months 70 ml

Right first PAE Left first PAE Right Right re PAE Left re PAE Smaller PA Less blush Rectal anast. Smaller PA Less blush

How to manage ? Right side: go distal left side go distal embolize through a neo-anastomosis c d e (internal pudendal) i f g h

Follow up • 6 m POST PArE • IPSS 1 • QOL 1 • Take home: • Clinical failure can be explained by revascularisation by • Native PA • Collateral (internal pudendal) • In case of clinical failure a redo is an option

Insuficient improvment

a b c d e

Outcome of re embo

Points techniques … • Taille des billes ? • Matériel d’embolisation ? • Unilateral ou bilatéral ?

Role de la technique ? • Embolisation Unilatérale ? – moins bon résultats • Sur le désondage • Sur la réduction d’IPSS – Toujours bilatérale – Taille des particules ?

Particle size matters?

Particle size matters? More “aggressive” embolization? • PAE with smaller PVA particles (50µm + 100µm) had better outcomes 50µm + 100µm Before 1 week 12 months 100µm

Particle size matters? • PAE with smaller PVA particles (100µm) had worse outcomes than with larger (200µm)

Taille des particules • Embosphere – 300 -500 µm mieux que 100-300 µm – Plus de complications avec les 100-300 µm • PVA – 50 µm puis 100 µm fait mieux que 100 µm … – 200 µm fait mieux que 100 µm … – ?? • Notre choix: Embosphere 300 -500 µm

Do technical outcomes translate into clinical outcomes? • Clinical success: – Bilateral PAE – 75% – Unilateral PAE – 50% - older patients 2012

Benign Prostatic Hyperplasia Place of PAE among BPH treatments PAE ? Alpha blockers herbs 5 ARI Surgery/laser surveillance Radio frequency BPH symptoms

PARTEM Embolisation des artères prostatiques versus traitement médical dans l'hyperplasie bénigne de la prostate Investigateur coordonnateur : Pr Marc Sapoval – Service de radiologie interventionnelle Hôpital Européen Georges Pompidou (HEGP) Pr Nicolas Thiounn , Urologie (Pr Méjean, HEGP) Promoteur : Assistance Publique-Hôpitaux de Paris Département de la Recherche Clinique et de l’Innovation 44/67 12/09/2018 - MEP v1-3 15MSL-PARTEM - URC HEGP CIC EC

Objectif et critère de jugement principal • Objectif principal : Comparer les effets à 9 mois sur les SBAU • de l’Embolisation • versus Thérapie Combinée (alpha-bloquant + inhibiteur de la 5 alpha-réductase) • Critère de jugement principal : IPSS 9 mois après la randomisation 45/67 12/09/2018 - MEP v1-3 15MSL-PARTEM - URC HEGP CIC EC

Schéma du déroulement de la recherche pour le sujet 46/67 12/09/2018 - MEP v1-3 15MSL-PARTEM - URC HEGP CIC EC

Conclusion • Oui ca marche …. • Oui c’est difficile … • Non on ne connaît pas encore – Les bons répondeurs ? – Les résultats contre placebo (sham) ? – La place de l’EAP par rapport au traitement médical – La place de l’EAP par rapport au TK mini-invasives