Purpose: The aim of this study is to evaluate long-term effectiveness of prostatic artery embolization (PAE) with Embosphere® microspheres as assessed by the International Prostate Symptom Score (IPSS).
Material and Methods: We are conducting a multicenter, prospective cohort study on 486 consecutive patients with symptomatic benign prostatic hyperplasia (BPH) who underwent PAE at 7 U.S. and 7 European tertiary care centers. The mean age of patients was 69 years (range: 49-93). Patient data was reviewed at baseline and follow-up visits will continue for 3 years.
Results: Five hundred patients signed informed consent and 486 patients were treated. Of these, 14% had indwelling urinary catheters before treatment. The mean baseline IPSS and SHIM were 22 (range: 5-35) and 13 (range: 0-25). Procedure time mean was 1 hour 52 minutes. The Embosphere® microspheres sizes used were 100-300μm (5%), 300-500μm (80%), 500-700μm (4%), and combination of 100-300μ/300-500μ (13%). PErFecTED technique was completed on 65% of PAE procedures. Bilateral embolization was achieved in 89% and unilateral in 11% of patients. The most common adverse event was post embolic syndrome, and there were no instances of nontarget embolization resulting in severe complications.
Conclusions: PAE was performed successfully and safely in 486 patients at 14 centers in 4 countries. Long term follow-up is in progress.