Prostatic artery embolization (PAE) offers a potential breakthrough for treating prostatic hypertrophy while potentially avoiding some of the debilitating side effects that often accompany transurethral resection of the prostate (TURP).
In findings presented at the recent Society of Interventional Radiology (SIR) 2012 annual meeting, Francisco Cesar Carnevale, M.D., Ph.D., a professor and chief of interventional radiology at the University of São Paulo Medical School in Brazil, said that results of a four-year study suggest that PAE is "safe, effective, and has a low rate of complications."
Men over 50 are more susceptible to benign prostatic hyperplasia (BPH), which can seriously impact quality of life. With PAE, clinicians use a catheter to inject small microspheres into the arteries that nourish the prostate, blocking the arteries and starving the prostate of its blood supply, eventually shrinking it.
One advantage of PAE is that it can treat even very large prostates, which may limit those who are good candidates for TURP, the current gold standard for BPH treatment. And potential side effects associated with TURP have not been seen with PAE, Dr. Carnevale said.
"We haven't seen impotence, ejaculatory disorders or urinary incontinence in our patients after prostatic artery embolization," said Dr. Carnevale, who heads a group of physicians performing the procedure in Brazil.
Dr. Carnevale's study included 11 men with acute urinary retention due to BPH who had been managed with medical treatment and indwelling urethral catheters and were waiting to undergo surgery.
Using a micro-catheter threaded into the prostatic arteries, interventional radiologists performed 12 PAE procedures under local anesthesia in 11 patients using resin microspheres as embolizing agents. The men ranged from 59 to 78 years of age, with a mean age of 68.5 years. Researchers used MR imaging and ultrasound to study the exact anatomy of the prostate arteries.
Patient follow-up ranged from 16 months to almost four years. Results showed a 30 percent reduction in prostate size in these men at final follow-up, a result "supported by urodynamic findings and symptom relief," Dr. Carnevale said. Patients reported having "mild" symptoms and an improved quality of life, he said.
"After treatment, we assessed quality of life and evaluated how well the urinary system was working," Dr. Carnevale said. "Technical success (bilateral prostatic artery embolization) was 75 percent and clinical success (Foley catheter removal and symptoms improvement) was 91 percent."
In research also presented at the 2012 SIR annual meeting, a group of researchers from the New University of Lisbon in Portugal, led by Joao Martins Pisco, M.D., reported similar results in performing PAE.
Dr. Pisco reported that 84 men treated with PAE after an average follow-up of nine months showed "significant" clinical improvement. Treatment was technically successfully in 98.5 percent of the cases, with 77 men showing "excellent" improvement, he said.
As a radiologist who has traveled to Portugal and Brazil to observe the procedure, Dr. James B. Spies, M.D., M.P.H., said the potential for PAE will be significant if the procedure is deemed safe for clinical use.
"If we can demonstrate that it's safe, we can expand PAE to a larger number of patients and begin looking at preliminary data to determine its actual therapeutic impact," said Dr. Spies, a professor and chair of the Department of Radiology at Georgetown University Hospital in Washington, D.C.
Dr. Spies said he plans to perform a safety trial on the procedure and has submitted an investigational device exemption application to the U.S. Food and Drug Administration (FDA).
"Because PAE takes an embolic approved for another purpose and applies it to a new organ system, there are some associated risks such as potential injury to the bladder or rectum," Dr. Spies said. His research team plans to perform both office cystoscopy and anoscopy to evaluate whether those organs have suffered any damage after PAE, he said.
In terms of using the treatment in clinical practice, Drs. Carnevale and Spies both stressed that PAE requires advanced expertise and stressed that training will be necessary if the technique is to be adopted on a wider scale.
"Only experienced physicians trained in interventional radiology techniques as well as someone who has a strong understanding of pelvic vascular anatomy should perform the procedure," Dr. Carnevale said.
Dr. Spies hopes to begin treating patients in coming months and said it's likely that comparative trials will be under way by next year. In the meantime, prospective patients have called him after reading about the procedure and its promising results.
"Potentially, this has a great future in this country and around the world," Dr. Spies said. "There certainly is the skill set out there for people to do this, but it's not quite ready for primetime yet."
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