Prostate Artery Embolization

Prostate Artery Embolization
Proud partner of the PAE pioneers

PAE pioneers

By improving treatment, enabling new methods and streamlining processes, Siemens Healthineers innovations help to advance medical progress. To enhance benign prostatic hyperplasia (BPH) therapy, we teamed up with the pioneers in Interventional Radiology and paved the way for groundbreaking alternative treatment:

Prostate artery embolization (PAE). Minimally invasive and highly effective, this procedure could change the way prostate hyperplasia is treated in the future. For even better patient outcomes, our cutting-edge imaging helps make PAE as safe and accurate as it can possibly be.²

Clinical Evidence

Prof. Marc Sapoval performs PAE in a multidisciplinary setting at Hôpital Européen Georges-Pompidou in Paris, France

Watch video: PAE - Minimally-invasive treatment for Benign Prostatic Hyperplasia (BPH)

Benign prostatic hyperplasia is one of the most common diseases in men over 50 years of age. As an age-related noncancerous neoplasm, it can cause severe lower urinary tract symptoms (LUTS) which can limit the patient’s quality of life. Increased life expectancy has contributed to a rise in incidence of BPH. More than 50% of men aged 60–69 years and as many as 90% aged 70–89 have symptoms of BPH. In 2000, there were 4.5 million visits to physicians for BPH in the United States, with a direct cost of $1.1 billion.³��

Prostate artery embolization is a new, minimally invasive procedure to treat BPH that can, under certain conditions, be performed on an outpatient basis. PAE can shrink the prostate by blocking the blood supply with microspheres delivered through a catheter, using X-ray images for guidance. A recent study of 1000 patients in a single cohort center showed that PAE is an effective and safe procedure to treat symptomatic BPH (moderate to severe LUTS) with good results in the short, medium and long term.⁴

In June 2017, Merit Medical Systems, Inc. received 513(f)(2) (de novo) classification from the FDA to expand the indication for its Embosphere® Microspheres to include PAE for symptomatic BPH. The number of PAE procedures performed in the United States is expected to grow rapidly, at a rate of 88% per year.⁵

Since the very early clinical trials in 2011, Siemens Healthineers has been working with PAE pioneers around the globe to improve the efficiency, effectiveness and safety of the procedure – and to make PAE a success story. We now offer the most extensive system portfolio designed to support the specific needs of IR teams performing PAE. Excellent image quality and low dose imaging options in 2D and 3D, plus a broad range of dedicated, innovative applications provide optimal support at every step of the procedure - from planning and guidance, to minimizing the risk of non-targeted embolization, to in-room assessment of complete treatment.

Solutions

Image-guided solutions for PAE

Prostate artery embolization (PAE) is a complex and challenging procedure that requires a cautious approach. Intra-procedural image guidance technology can help IR professionals strike the ideal balance – by providing safe and effective treatment at the lowest possible dose.

Dealing with complex and varied vessel anatomy

The vessel anatomy in the pelvic area varies extremely and includes highly branched, small arteries. This makes catheter navigation a lengthy, laborious process, with a high risk of unintentional non-targeted treatment. Careful assessment of the vasculature as well as thorough planning and monitoring of the procedure is therefore key to performing the intervention effectively and efficiently.

syngo DynaCT

Access 3D soft-tissue information directly in the angio suite – for planning, guidance and monitoring, reduction of risk of complications, plus confirmation of treatment results
200° rotation from HEAD, LEFT and RIGHT side with Artis ceiling systems and ARTIS pheno – for uncompromised 3D soft-tissue image quality in the pelvis and any other body region

Prof. Carnevale: “syngo DynaCT is the most important software for the embolization procedure. It identifies the arteries feeding the prostate, gives me an idea of the percentage of the prostate I am treating, and – even more importantly – helps me avoid non-targeted embolization.”¹

Learn more about the spectrum of syngo DynaCT protocols

syngo Fusion Package

Choose syngo 3D/3D Fusion or syngo 2D/3D Fusion for easy multimodality integration of pre-procedural CTA, MRA or MRI
syngo 2D/3D Fusion allows for 3D image guidance during intervention without the need of an intra-procedural 3D scan
Reduce radiation dose and contrast injections

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Discover more about syngo Fusion Package

Balancing procedure safety and low dose in a sensitive body region

The use of 3D image information helps to increase procedure safety, limit the risk of complications in PAE, and achieve better clinical outcomes. On the other hand, it is important to explore all the possible options to actively reduce radiation dose, given that PAE targets an extremely dose-sensitive area of the body.

In line with the CARE strategy, 3D imaging does present opportunities to reduce dose. Dedicated acquisition programs can reduce the number of frames or the dose per frame, thus helping to lower overall radiation dose while maintaining procedure safety.

syngo DynaCT with lower dose

Perform syngo 3D/3D Fusion based on intra-procedural 3D datasets acquired with up to 72% less dose using the syngo DynaCT Low Dose protocol
Confirm treatment completion and exclude non-target embolization in dose-sensitive regions with syngo DynaCT Body CARE - a dedicated soft-tissue imaging protocol with less dose and shorter acquisition time
Slab mode - a cranial/caudal collimation during syngo DynaCT acquisitions - reduces dose by limiting the area examined and improves image quality due to less scattered radiation

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Reducing overall radiation dose and contrast material with faster microcatheter navigation

Given the complex vessel anatomy of the pelvic region, it is a challenge to find the arteries that feed the prostate gland, define the optimal catheter position and navigate quickly to the planned treatment position. Long navigation times result in long fluoro times and hence increased radiation exposure. Every Artis system includes a CARE package that actively reduces dose and helps IR specialists to work effectively with low dose settings.

syngo Embolization Guidance

Simple planning and guidance for catheter-based interventions
Automatic path computation from a marked proximal position (e.g. the tip of a diagnostic catheter) to the marked distal vessels feeding a lesion
Compatible with syngo DynaCT as well as CT, PET-CT or MR volumes
Overlay of planning data onto live fluoroscopy with syngo 3D Roadmap

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Discover the functionalities of syngo Embolization Guidance

syngo 3D Roadmap

Simplify guidewire navigation by overlaying anatomic structures such as 3D vessel trees or planning data with live 2D fluoroscopy or acquisitions
Improve orientation in all three dimensions when navigating the catheter through complex vessel anatomy
Reduce catheter navigation times, radiation dose and the amount of contrast material required by using 3D overlay techniques
Automatic real-time updates for C-arm angulation, SID, zoom and table movement

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Find out more about overlay of 3D information

PAE workflow support

Image guidance software supports the entire PAE workflow – from procedure planning through embolization guidance to confirmation that the treatment is complete.

Interventional Radiology - PAE - lesion segmentation syngo embolization guidance

Overlay targets on live 2D images facilitating feeder reconsideration
Define the target region using lesion segmentation in syngo Embolization Guidance

Clinical protocols and case studies

Learn from the PAE pioneers who streamlined their clinical workflow in a way that effective and safe treatment as well as reduction of radiation dose are always highest priority. Get tips and tricks on the use of image guidance, on optimal injection and acquisition protocols, or the integration of pre-interventional imaging during the intervention.

Prostate Artery Embolization – A study protocol

This in-depth study protocol features syngo DynaCT Body Care with low dose, as a guide to acquisition and reconstruction.

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Find out more in the protocol

Voice of Experts

Interview with Dr. Shivank Bhatia:

Prostate Artery Embolization at University of Miami

Interventional Radiology - PAE - Interview with Dr. Shiwank Bhatia

“We receive excellent imaging which supports guidance into the vessel.”¹

��The PAE program at UHealth shows what can be achieved with research, teamwork, cutting-edge technology and great passion for improving patients’ lives.

Interview with Prof. Francisco Cesar Carnevale:

Angiography offers hope for patients suffering from prostate-related urinary disorders

“syngo DynaCT is the most important software for the embolization procedure. It identifies the arteries feeding the prostate, gives me an idea of the percentage of the prostate I am treating, and – even more importantly – helps me avoid non-targeted embolization.”¹

A minimally invasive catheterization technique known as prostatic artery embolization shows promise as an outpatient treatment for patients suffering from increasingly prevalent prostate hyperplasia. Pioneered by Prof. Francisco Cesar Carnevale, the procedure began U.S. Food and Drug Administration approved trials in twelve centers in the USA and Europe in fall 2014.

Interview with Prof. Marc Sapoval, and Dr. Olivier Pellerin:

The benefits of PAE over TURP: “Fewer minor and major complications.”

Interventional Radiology - PAE - Interview with Dr. Marc Sapoval, and Dr. Olivier Pellerin

“In the context of the very complex pelvic vessel anatomy, access path planning and guidance during catheter navigation is a very much desired support functionality. This is where syngo Embolization Guidance comes into play as a navigation tool to the prostate. It helps speed up the procedure and thereby facilitates reduction of fluoroscopy time and contrast material.”¹

Marc Sapoval, MD, PhD, and Olivier Pellerin, MD, talk about the practical aspects of prostate artery embolization to treat benign prostatic hyperplasia.

Watch video: Aspects to consider when starting a PAE service

Dr. Nigel Hacking (at CIRSE 2016) shares his experience on aspects that are essential when starting a PAE service: how to enhance personal skills, what procedural challenges are to be expected, what is the standard clinical workflow, and which role does image guidance play for effective and safe PAE treatment.

“I’ve got a lot of experience using DynaCT in liver embolization but now with prostate it gives me the confidence to embolize just the prostate and not the surrounding organs.”¹

Watch video: Using DynaCT to avoid non-target embolizations

Prof. Francisco Cesar Carnevale (at CIRSE 2014) explains how DynaCT helped him to avoid complications during the PAE procedure:

“…at that time, when we were not using DynaCT, we have observed some complications, and some serious complications related to non-target embolisations. … Since we have used DynaCT, we have seen no complications.”¹

Watch video: Using low dose DynaCT and slab-mode during prostate artery embolization

Prof. Marc Sapoval shared his experience of using DynaCT during the PAE procedure:

“…(DynaCT on) the Artis system is very useful, because it allows you to control the position of the catheter and is helpful to accessing the appropriate artery, checking where the embolization site is and to make sure that only the lobe of the prostate is embolised and no other important organs could be damaged during the intervention.”¹

Publications

Interventional News Educational Supplement

Interventional News, Educational Supplement, , 2017.

Scientific Publications

Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. bju.14249. Epub 2018 May 6.

Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, et al. Urology. 2018;

Abt D, Hechelhammer L, Müllhaupt G, et al. BMJ. 2018;361:k2338.

Teichgräber U, Aschenbach R, Diamantis I, von Rundstedt FC, Grimm MO, Franiel T. Fortschr Röntgenstr 2018; 190(09): 847-855

Bhatia S, Harward SH, Sinha VK, et al. J Vasc Interv Radiol. 2017;28:898–905.

Carnevale FC, Soares GR, de Assis AM, Moreira AM, Harward SH, Cerri GG. Cardiovasc Interv Radiol. 2017;40:1321–37.

Bagla S, Smirniotopoulos J, Orlando J, Piechowiak R. Cardiovasc Interv Radiol. 2017;40:1694–7.

Pisco JM, et al. J Vasc Intvent Radiol. 2016;27:1115–22.

Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. J Vasc Interv Radiol. 2016;27(11):1686–97.

Amouyal G, Thiounn N, Pellerin O, Yen-Ting L, Del Giudice C, Dean C, Pereira H, Chatellier G, Sapoval M. Cardiovasc Intervent Radiol. 2016;39(3):367–75.

Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Cardiovasc Interv Radiol. 2016;39(1):44–52.

Bagla S, Smirniotopoulos JB, Orlando JC, van Breda A, Vadlamudi V. J Vasc Interv Radiol. 2015;26(12):1832–8.

McWilliams JP, Kuo MD, Rose SC, Bagla S, Caplin DM, Cohen EI, et al. J Vasc Interv Radiol. 2014;25:1349–51.

Somani BK, Hacking N, Bryant T, Coyne J, Flowers D, Harris M, et al. BJU Int. 2014;114(5):639–40.

Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, et al. J Vasc Interv Radiol. 2014;25(1):47–52.

Carnevale FC, Moreira AM, Antunes AA. Cardiovasc Interv Radiol. 2014;37(6):1602–5.

Bagla S, Rholl KS, Sterling KM, et al. J Vasc Interv Radiol. 2013;24:1603–1607.

Carnevale FC, Antunes AA. Cardiovasc Interv Radiol. 2013;36(6):1452–63.

Carnevale FC, da Motta Leal Filho JM, Antunes AA, Baroni RH, Marcelino ASZ, Cerri LMO, et al. J Vasc Interv Radiol. 2013;24:535–42.

Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, et al. Eur Radiol. 2013;23(9):2561–72.

Antunes AA, Carnevale FC, da Motta Leal Filho JM, Yoshinaga EM, Cerri LM, et al. Cardiovasc Interv Radiol. 2013;36(4):978–86.

Pisco JM, Pinheiro LC, Bilhim T, Duarte M, Mendes JR, Oliveira AG. J Vasc Interv Radiol. 2011;22:11–19.

Carnevale FC, Antunes AA, da Motta Leal Filho JM, et al. Cardiovasc Intervent Radiol. 2010; 33:355–361.

DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. J Vasc Interv Radiol. 2000;11(6):767–70.

Avez-vous jugé cette information utile?

The statements by Siemens’ customers described herein are based on results that were achieved in the customer’s unique setting. Since there is no “typical” hospital and many variables exist (e.g., hospital size, case mix, level of IT adoption) there can be no guarantee that other customers will achieve the same results.

Siemens Healthineers extends their appreciation to the interventional radiologists, who donated their time and energy – without payment – in order to share their expertise in PAE.

Society of Interventional Radiology Position Statement: Prostate Artery Embolization for Treatment of Benign Disease of the Prostate McWilliams, Justin P. et al. Journal of Vascular and Interventional Radiology, 2014, Volume 25, Issue 9, 1349 – 1351.

Short-, medium-, and long-term outcome of prostate artery embolization for patients with benign prostatic hyperplasia: 1000 patients. Pisco, J et al. Journal of Vascular and Interventional Radiology, 2017, Volume 28, Issue 2, S 3.

FDA Grants De Novo Clearance for Merit Medical’s Embosphere. Food and Drug Administration, June 26, 2017

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