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Friday, November 8, 2019

Randomized clinical trial of Balloon Occlusion versus Conventional Microcatheter Prostatic Artery Embolization (PAE) for Benign Prostatic Hyperplasia (BPH)


Clinical question

What is the safety and efficacy of balloon occlusion PAE (bPAE) versus conventional microcatheter PAE (cPAE)?

Take-away point
bPAE is as effective as cPAE in treating BPH with the potential to reduce non target embolization. 

Reference
Bilhim, Tiago et al. Randomized Clinical Trial of Balloon Occlusion versus Conventional Microcatheter Prostatic Artery Embolization for Benign Prostatic Hyperplasia. Journal of Vascular and Interventional Radiology, Volume 30, Issue 11, 1798 - 1806.

Click here for abstract

Study design
Prospective randomized single-blind clinical trial

Funding source
Self-funded or unfunded 


Setting
Single-center






Figure 5. DSA images with balloon catheter not inflated (a) and then with balloon catheter inflated (b).


Summary


Prostatic artery embolization is gaining increasing acceptance as a minimally invasive treatment for men with benign prostatic hypertrophy. Despite, its increased utilization, clinical failure rates approach 25%. Additionally, complex arterial anatomy and the presence of arterial anastomoses which may lead to non target embolization remains a concern and makes this one of the more challenging procedures we offer our patients. Balloon occlusion PAE (bPAE) may reduce this risk of non target embolization and also increase the efficacy of PAE by improving embolic penetration.

In this prospective randomized single-blind clinical trial, 89 patients were randomly assigned to cPAE (Maestro; n=43) or bPAE (Sniper; n=46), with no difference in efficacy variables between the two groups. In the cPAE group, embolization was performed after advancing the microcatheter as distal as possible into the intraprostatic branches. In the bPAE group, embolization was performed via the balloon occlusion catheter positioned within the middle third of the prostatic artery. Coil embolization was performed when necessary. No patients crossed over from bPAE to cPAE or vice versa. Patients were reevaluated at 1 month and 6 months post PAE. The parameters assessed were IPSS (primary outcome)/quality of life and International Index of Erectile Function scores, prostate volume measured with transrectal ultrasound, prostate-specific antigen (PSA), uroflowmetry measuring peak flow rate, and post-void residual.

Procedural time and radiation dose did not differ between the cPAE and bPAE groups. Perhaps somewhat unexpectedly, there was no difference in coil usage or in embolic volume between cPAE and bPAE. Relating to outcomes, the change in baseline of IPSS was not statistically significant between the cPAE and bPAE groups (mean change from baseline was 7.58 points ± 6.88 and 8.30 points ± 8.12 in the cPAE and bPAE groups, respectively). The reduction in prostate volume was 21.9 cm3 ± 51.6 and 6.15 cm3 ± 14.6 in the cPAE and bPAE groups, respectively (P =.05). None of the other outcome variables showed statistical significance between the two groups.

There were no major adverse events in either group. Minor adverse events were seen in both groups. Of note, penile skin lesions (n=3; 7.0%) and rectal bleeding (n=2; 4.7%) were only seen in patients in the cPAE group (11.7%, P=.01).

Commentary


While bPAE did not demonstrate a significant improvement from baseline IPSS compared to cPAE in this trial, it appears to be just as efficacious as cPAE with a decreased potential for non-target embolization (bPAE showed significantly less penile lesions and rectal bleeding compared to cPAE; other minor adverse events were similar). Further investigations into catheter size and type, embolic type, size and volume, and the use of adjunct pharmacotherapy in PAE are necessary but this trial is important because it gives us the ability to further refine our techniques for this emerging treatment and achieve less morbidity for our patients.

Post Author
Zagum Bhatti, MD
Assistant Professor
Department of Vascular & Interventional Radiology
University of Texas Health Science Center at Houston-McGovern Medical School, Houston, TX
@ZagumBhatti

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