Incidence of Major Complications from Prostatic Artery Embolization: Multicenter Experience of 9,000 procedures

Prostatic Artery Embolization (PAE) has emerged as standard of care treatment for benign prostatic hyperplasia (BPH) in men with lower urinary tract symptoms, however there is a paucity of reported data on major post-procedural complications. This study reports major complications after PAE for BPH in a large outpatient multicenter group.

Materials and Methods:

Review of the adverse event reporting software and medical charts of patients that underwent PAE between May 2020 and May 2024 was performed. 9,000 patients were identified, and patient records were reviewed for severe adverse events (AEs). . All patients underwent outpatient PAE with follow-up at 3-4 days, 1 month, and 3-4 months post-procedure.  Complications were classified as severe based on the SIR AE Classification system: marked escalation of care, ie, hospital admission or prolongation of existing hospital admission for > 24 hours, hospital admission that is atypical for the procedure, inpatient transfer from regular floor/telemetry to intensive care unit, or complex intervention performed requiring general anesthesia in previously nonintubated patient.

Results:

Twelve Interventional Radiologists performed all procedures with varying experience (Range 0-24 years).  A total of 5 major complications (0.0006) were identified. There were 2 cases of emphysematous prostatitis that resolved after prolonged hospitalization and intravenous antibiotics. One case resulted in contained bladder perforation after emphysematous cystitis with bowel obstruction that resolved after surgical repair. One case resulted in contrast induced nephropathy that required hemodialysis and subsequently recovered. One case had emphysematous cystitis with concomitant urinary retention that required prolonged hospitalization with intravenous antibiotics. Major complications included: Grade 3 (n=4, 0.0004), Grade 4 (n=1, 0.0001), and Grade 5 (n=0).

Conclusion:

The incidence of major complications from PAE is extraordinarily rare in this large patient experience. PAE is a safe procedure for the treatment of lower urinary tract symptoms in the setting of BPH.