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Prostate Artery EmbolizationProud partner of the PAE pioneers

PAE pioneers

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Interventional Radiology - PAE pioneers - Professor Carnevale
Interventional Radiology - PAE pioneers - Professor Carnevale
Interventional Radiology - PAE pioneers - Hacking
Interventional Radiology - PAE pioneers - Sapoval
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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.

Interventional Radiology - PAE - syngo Dyna CT

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

Interventional Radiology - PAE - syngo Fusion Package

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

 

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.

Interventional Radiology - PAE - syngo Dyna CT with lower dose

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

 

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.

Interventional Radiology - PAE - syngo embolization guidance

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

  

Interventional Radiology - PAE - syngo 3D Roadmap

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

 

PAE workflow support

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

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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
Interventional Radiology - PAE - lesion segmentation syngo embolization guidance
Interventional Radiology - PAE - Faster catheter navigation reduces fluoroscopy times
Interventional Radiology - PAE - Confirming or redefining the treatment strategy
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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.

Interventional Radiology - PAE - Benign Prostate Hyperplasia treatment supported by syngo DynaCT

Benign Prostate Hyperplasia treatment supported by syngo DynaCT - Clinical case report by Prof. Sapoval

A 66-year-old male with BPH was treated with bilateral prostatic artery embolization.

See how syngo DynaCT, syngo DynaCT low dose, syngo DynaCT Fusion and syngo Embolization Guidance were used in this case. 

 

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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.

 

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

Interventional Radiology - PAE - Interview with Prof. Francisco Cesar 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


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

Watch video: Using DynaCT to avoid non-target embolizations

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

Publications

Interventional News Educational Supplement

Interventional News Educational Supplement

Interventional News, Educational Supplement, Prostatic artery embolization - Imaging for success , 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. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). bju.14249. Epub 2018 May 6.


Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, et al. Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results from a Prospective FDA-Approved Investigational Device Exemption Study. Urology. 2018;

Abt D, Hechelhammer L, Müllhaupt G, et al. Comparison of prostatic artery embolization (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018;361:k2338.


Teichgräber U, Aschenbach R, Diamantis I, von Rundstedt FC, Grimm MO, Franiel T. Prostate Artery Embolization: Indication, Technique and Clinical Results. Fortschr Röntgenstr 2018; 190(09): 847-855


Bhatia S, Harward SH, Sinha VK, et al. Prostate Artery Embolization via Transradial or Transulnar versus Transfemoral Arterial Access: Technical Results. J Vasc Interv Radiol. 2017;28:898–905.

Carnevale FC, Soares GR, de Assis AM, Moreira AM, Harward SH, Cerri GG. Anatomical variants in prostate artery embolization: a pictorial essay. Cardiovasc Interv Radiol. 2017;40:1321–37.

Bagla S, Smirniotopoulos J, Orlando J, Piechowiak R. Cost analysis of prostate artery embolization (PAE) and transurethral resection of the prostate (TURP) in the treatment of benign prostatic hyperplasia. Cardiovasc Interv Radiol. 2017;40:1694–7.

Pisco JM, et al. Medium- and long-term outcome of prostate artery embolization for patients with benign prostatic hyperplasia: results in 630 patients. J Vasc Intvent Radiol. 2016;27:1115–22.

Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-analysis of prostatic artery embolization for benign prostatic hyperplasia. 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. Clinical results after prostatic artery embolisation using the PErFecTED technique: a single-center study. Cardiovasc Intervent Radiol. 2016;39(3):367–75.


Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Transurethral resection of the prostate (TURP) versus original and PErFecTED prostate artery embolization (PAE) due to benign prostatic hyperplasia (bph): preliminary results of a single center, prospective, urodynamic-controlled analysis. Cardiovasc Interv Radiol. 2016;39(1):44–52.


Bagla S, Smirniotopoulos JB, Orlando JC, van Breda A, Vadlamudi V. Comparative analysis of prostate volume as a predictor of outcome in prostate artery embolization. J Vasc Interv Radiol. 2015;26(12):1832–8.


McWilliams JP, Kuo MD, Rose SC, Bagla S, Caplin DM, Cohen EI, et al. Society of interventional radiology position statement: prostate artery embolization for treatment of benign disease of the prostate. J Vasc Interv Radiol. 2014;25:1349–51.


Somani BK, Hacking N, Bryant T, Coyne J, Flowers D, Harris M, et al. Prostate artery embolization (PAE) for benign prostatic hyperplasia (BPH). BJU Int. 2014;114(5):639–40.


Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, et al. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014;25(1):47–52.


Carnevale FC, Moreira AM, Antunes AA. The “PErFecTED technique”: proximal embolization first, then embolize distal for benign prostatic hyperplasia. Cardiovasc Interv Radiol. 2014;37(6):1602–5.


Bagla S, Rholl KS, Sterling KM, et al. Utility of Cone-Beam CT Imaging in Prostatic Artery Embolization. J Vasc Interv Radiol. 2013;24:1603–1607.


Carnevale FC, Antunes AA. Prostatic artery embolization for enlarged prostates due to benign prostatic hyperplasia. How I do it. 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. Quality of life and clinical symptom improvement support prostatic artery embolization for patients with acute urinary retention caused by benign prostatic hyperplasia. J Vasc Interv Radiol. 2013;24:535–42.


Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, et al. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary tract symptoms secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013;23(9):2561–72.


Antunes AA, Carnevale FC, da Motta Leal Filho JM, Yoshinaga EM, Cerri LM, et al. Clinical laboratorial, and urodynamic findings of prostatic artery embolization for the treatment of urinary retention related to benign prostatic hyperplasia: a prospective single-center pilot study. Cardiovasc Interv Radiol. 2013;36(4):978–86.


Pisco JM, Pinheiro LC, Bilhim T, Duarte M, Mendes JR, Oliveira AG. Prostatic arterial embolization to treat benign prostatic hyperplasia. J Vasc Interv Radiol. 2011;22:11–19.


Carnevale FC, Antunes AA, da Motta Leal Filho JM, et al. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010; 33:355–361.


DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinal alcohol prostate embolization. J Vasc Interv Radiol. 2000;11(6):767–70.

1
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.
2
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.
3
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.
4
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.
5
FDA Grants De Novo Clearance for Merit Medical’s Embosphere. Food and Drug Administration, June 26, 2017