In the quest for newer and more effective BPH treatment, scientists have developed a technique called prostatic arterial embolization (PAE), a minimally invasive procedure that can be performed on an outpatient basis. Also referred to as PAE, this new surgical treatment for BPH has been shown to be both safe and effective in a growing number of studies around the world. Prostatic artery embolization is being performed by a limited number of physicians in the United States and other countries, and it is gradually becoming more readily available.
PAE, which boasts a success rate of about 85 percent or better, works like this: First, men undergo ultrasound or an MRI (magnetic resonance imaging) to map the blood supply to the prostate gland. Then a clinician accesses the blood flow to the prostate through a percutaneous puncture and catheter placed into the prostate artery in the groin.
He or she then introduces Embosphere® Microspheres, minute spherical particles engineered to block the blood supply to the prostate, causing the gland to eventually shrink. In most cases, the entire procedure takes just under 1.5 hours (mean, 86 minutes; range of 25-185 minutes).
One of the advantages of PAE is the lack of sexual side effects associated with other procedures for BPH, such as incontinence, impotence, retrograde ejaculation and erectile dysfunction. In fact, about one third of patients experience an improvement in sexual function.
Studies of PAE
In a recent (September 2014) study, 13 men with BPH and lower urinary tract symptoms underwent PAE and were followed up for a mean of 244 days. The procedure was technically successful in 12 of the patients (92 percent). In the one remaining patient, atherosclerosis and tortuosity prevented the procedure from going forward. At 12 months there was a mean reduction in prostate volume of 28 percent, and the patients showed marked improvements in the International Prostate Symptoms Score (IPSS), quality of life, and International Index of Erectile Function (IIEF).
In a United States clinical trial, 20 men underwent PAE and were followed up at one, three and six months post-procedure for symptoms, quality of life, IIEF, peak urine flow rate, and prostate volume. The procedure was technically successful in 18 of the patients (90 percent), and the unsuccessful embolizations were related to atherosclerosis of the prostate arteries.
Improvements were reported in all of the follow-up features, and there were no minor or major complications associated with the procedure. The authors concluded that prostatic artery embolization is a “safe and efficacious treatment option for men with BPH.”
At the University of Sao Paulo Medical School, Francisco C. Carnevale, M.D., and his associates conducted a phase II study that involved 11 men aged 59 to 78 years with BPH. None of the men had responded to oral alpha-blockers for BPH. After the procedure the prostates reduced in size by an average of 30 percent. Ten of the men experienced relief of BPH symptoms, and the catheters were removed after an average of 12 days. The only side effects reported were mild pain in the perineal region in all men, slight rectal bleeding in three of 12 (one man underwent two embolizations), diarrhea in two, and bladder ischemia in one.
After a minimum 10-month follow-up, the 10 men were declared a clinical success and reported significantly improved quality of life. In the one remaining patient, the prostate had reduced in size by only 5 percent, and after undergoing two embolizations, he was referred for a transurethral resection of the prostate (TURP).
At St. Louis Hospital in Lisbon, Portugal, Joao Martins Pisco, M.D., one of the pioneers of PAE, conducted a study of 84 men with BPH who had not responded to other BPH treatments. After an average nine-month follow-up, prostatic arterial embolization was declared successful in 98.5 percent of the men. Extreme improvement of BPH symptoms was reported by 91.7 percent of the participants, 7.1 percent had slight improvement, and one (1.2 percent) did not improve at all.
As in other studies, there were no major complications. Pisco noted that “While the gold standard treatment for enlarged prostates has been TURP, minimally invasive prostatic artery embolization is safe, performed under local anesthesia, and comparable clinical results—without TURP’s complications.”
Prostatic arterial embolization FDA approval and cost
The Food and Drug Administration (FDA) is working along with interventional radiologists to make PAE part of standard of care for men who have BPH. According to Carnevale, “An estimated 25 percent of benign prostatic hyperplasia patients fail or experience clinical complications from medical treatment. Currently, approximately 500,000 men undergo surgery every year in the US for BPH.” Therefore there are a great number of men who could benefit from prostatic arterial embolization.
The good news is that as of May 2014, Riad Salem, M.D., MBA, Professor of Radiology, Medicine and Surgery vice-chairmen, Image-Guided therapy chief, Vascular and Interventional Radiology at Northwestern University, noted that the approval process with the FDA was proceeding smoothly. “We need to go through that process in order to establish it as another standard of care along with TURP and surgery,” he said in a Global Embolization Symposium and Technologies article. “We believe in it and we think in the next 3-7 years PAE will become part of the standard of care.”
Where can I get treated?
The other good news is that PAE is becoming more available. However, because it does not yet have FDA approval, not all insurance plans (including Medicare) will cover the cost. Fees for the procedure (physician, beads, hospital or other venue; but not including pre-procedure imaging) can range considerably depending on where you live. For example, the cost is about $6,500 at University of North Carolina Center for Heart and Vascular Care, $12,000 at Inova Alexandria Hospital in Virginia, and $12,000-$15,000 at RIA Endovascular in Colorado.
Men who are interested in learning more about PAE should talk to their physician about the procedure and where they might have it done. Until the procedure gets approval from the FDA, men should be prepared to pay for PAE out of pocket.
SOURCES:
Bagla S et al. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. Journal of Vascular and Interventional Radiology 2014 Jan; 25(1): 47-52
Carnevale FC. Presented at the Brazilian Congress of Urology, November 22-26, 2011, Santa Catarina, Brazil
Grosso M et al. Prostatic artery embolization in benign prostatic hyperplasia: preliminary results in 13 patients. La Radiologica Medica 2014 Sep 23
Knaub J. Prostate embolization. Radiology Today 2011 May; 12(5): 28
Pisco J et al. Prostatic artery embolization for benign prostatic hyperplasia: short- and intermediate-term results. Vascular and Interventional Radiology 2013 Feb; 266(2)
