The Brazilian Interventional Radiologist Francisco Cesar Carnevale, MD, PhD, recognized for pioneering the new therapy using Prostatic Arterial Embolization (PAE), reported promising results from the initial BPH PAE clinical study. He also presented the first video case studies of this new PAE technique to interventional radiologists attending the annual CIRSE conference. Merit Medical Systems, Inc. was the education sponsor of the CIRSE Emerging Therapies Symposium.
Marc Sapoval, MD, PhD, an Interventional Radiologist from Paris, France, moderated the symposium commenting, “BPH is the progressive enlargement of the prostate gland, and when advanced, causes acute urinary retention. Prostatic Arterial Embolization is of great interest to interventional radiologists and urologists. Studies to date are demonstrating great promise as an alternate treatment option.”
“In this patient population, mainly middle-aged men ages 50 years and older, we have more and more significant co-morbidities that can potentially enhance the interest of minimally invasive treatments compared to surgery,” added Sapoval.
The aim of the ongoing BPH PAE clinical study by Carnevale and his urology colleague Alberto Antunes, MD, is to develop an outpatient minimally invasive therapy that reduces the prostate size so urinary function resumes and avoids the complications that come from long-term medical therapy or surgery.
“Merit Medical has a history of supporting innovative medicine,” said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. “Our embolic product Embosphere® Microspheres and the Embocath® microcatheter are well-suited for emerging therapies. Dr. Carnevale and his colleagues at the University of Sao Paulo are making great strides to better understand prostate disease and we applaud their interventional radiology and urology multidisciplinary approach to managing this major men’s health issue.”
“An estimated 25 percent of benign prostatic hyperplasia patients fail or experience clinical complications from medical treatment,” said Carnevale. “Currently, approximately 500,000 men undergo surgery every year in the U.S. for BPH.”
Carnevale reported at CIRSE that ten of 11 patients demonstrated an average 30 percent reduction in prostate volume following the PAE procedure. Symptom relief and catheter removal were achieved in 10 patients with a mean time of 12 days. After a three-year follow-up in two patients and a minimum 10-month follow-up in all patients, 91 percent clinical success was achieved based on 12 PAE procedures. Overall, the quality of life factors significantly improved for ten of the 11 patients. Of the 11, one patient had a mean prostate reduction of 5% and after two bilateral embolizations was referred for transurethral resection of the prostate (TURP). “The surgeon indicated this patient experienced a much smaller blood loss compared to other TURP procedures,” added Carnevale.
The PAE technique was developed at the University of Sao Paulo Medical School through the Interventional Radiology Unit and in cooperation with the Urology Department as a potential outpatient procedure. Unlike TURP, which removes a section of the prostate through the urethra, in PAE the prostatic arteries supplying the blood flow to the prostate are accessed through a percutaneous puncture in the upper thigh. Embosphere® Microspheres 300-500 µm (Merit Medical) are used in this study to occlude the blood supply to the prostate. This microsphere has been successfully used for over a decade to treat women with uterine fibroids. Microcatheters Embocath Plus (Merit Medical) and Progreat (Terumo) were used to navigate the prostate arteries in this initial PAE study.
The recently posted medical monograph on BPH management as well as SIR and AUA annual meeting conference coverage reports on this issue are available at http://urotoday.com. These reports provide additional data from the BPH PAE clinical study by Drs. Carnevale and Antunes.
Cardiovascular and Interventional Radiological Society of Europe (CIRSE)
[ PRESS RELEASE ]
