Randomized clinical trial of Balloon Occlusion versus Conventional Microcatheter Prostatic Artery Embolization (PAE) for Benign Prostatic Hyperplasia (BPH)
What is the safety and efficacy of balloon occlusion PAE (bPAE) versus conventional microcatheter PAE (cPAE)?
bPAE is as effective as cPAE in treating BPH with the potential to reduce non target embolization.
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.
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Figure 5. DSA images with balloon catheter not inflated (a) and then with balloon catheter inflated (b).
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).
Zagum Bhatti, MD
Department of Vascular & Interventional Radiology
University of Texas Health Science Center at Houston-McGovern Medical School, Houston, TX