Embolization for BPH shows long-term safety, efficacy

Findings of a retrospective study including 1,000 men with follow-up ranging to 8 years demonstrate the long-term safety and efficacy of prostatic artery embolization (PAE) for relieving lower urinary tract symptoms secondary to BPH, researchers reported at the Society of Interventional Radiology annual scientific meeting in Washington.

“This first-of-its-kind study provides clear evidence of the safety and long-term effectiveness of PAE as a treatment of BPH. We believe that these data, considered together with the benefits of PAE, support its presentation as a minimally invasive option to men seeking intervention for relief of BPH-related symptoms,” said lead author João M. Pisco, MD, PhD, professor of radiology at the New University of Lisbon, Lisbon, Portugal.

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Dr. Pisco noted that PAE can be performed under local anesthesia as an outpatient procedure. Compared with some other procedures, he said PAE is less invasive and is associated with a shorter recovery and minimal risk of sexual dysfunction.

“Time and time again, I have seen patients who are not able to tolerate the side effects of medications for BPH but who do not want traditional surgery because of its risks, recovery period, and sexual side effects. Many of these men are grateful to learn about PAE as an alternative,” said Dr. Pisco.

“Nevertheless, PAE may not be appropriate for all patients. In particular, it may not be technically feasible in men with advanced arterial atherosclerosis that may be related to smoking or diabetes. Patients should speak with an interventional radiologist or other members of their care team to discuss whether PAE is a viable option and learn about its risks and benefits.”

The retrospective analysis included men who underwent PAE between March 2007 and March 2016. In a small percentage of patients (<2%), PAE could not be performed because of anatomic issues; ie, tortuosity and atherosclerotic changes of the iliac and prostatic arteries or a very angled origin of the prostatic artery.

Follow-up evaluations were scheduled at 1, 3, and 6 months after PAE and then at 6-month intervals until 3 years. Thereafter, men returned for annual examinations. All men were available for early follow-up analyses (through 6 months), 807 men completed medium-term follow-up (6 months to 3 years), and data were available from 406 men who had long-term follow-up (>3 years).

Next: All parameters show significant improvement

All parameters show significant improvement

Mean baseline characteristics for the cohort were as follows: International Prostate Symptom Score (IPSS) 23.1, International Index of Erectile Function score 18.5, IPSS quality of life (QoL) score 4.23, prostate volume 81.4 cm3, postvoid residual urine volume (measured in men not in acute retention) 109.4 mL, peak urinary flow rate 11.2 mL/min, and PSA 5.13 ng/mL.

All of the parameters showed statistically significant improvement after the procedure, Dr. Pisco reported.

Cumulative clinical success rates over the short-, medium-, and long-term follow-up intervals were 89%, 82%, and 78%, respectively. To be categorized as a “clinical success,” men had to have an IPSS ≤15 with a decrease ≥25% from baseline and IPSS QoL score ≤3 or ≥1 point decrease from baseline without any need for other BPH treatment.

Dr. Pisco also presented a subgroup analysis that focused on 112 men who were in acute urinary retention (AUR) before PAE. Almost 95% of those men had their catheter removed and could void spontaneously between 2 days and 3 months after PAE. Ninety-five men were available for medium-term follow-up, and long-term follow-up data were available for 89 men. Freedom from AUR recurrence was maintained by 85% and 78.5% of men in the medium- and long-term follow-up cohorts, respectively.

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Early-, medium-, and long-term success rates among a subgroup of 210 men who had a baseline prostate volume >100 cm3 were 84%, 76.2%, and 76.2%, respectively. About one-half of the 210 men were available for the medium- and long-term follow-up.

Dr. Pisco reported two major PAE-related complications were encountered. They included one case of bladder wall ischemia that was managed surgically and one case of perineal pain that persisted for 3 months. Neither complication was associated with longer term sequelae.

“This data set, in a large population with long-term follow-up, suggests both safety and efficacy,” commented Steven A. Kaplan, MD, professor of urology, Icahn School of Medicine at Mount Sinai, New York.

“However, PAE should still be considered investigational and the reported results should be considered carefully because they represent a single center’s experience and used an arbitrary definition for success,” added Dr. Kaplan, who was not involved with the study.

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