Prostate arterial embolization (PAE) has been investigated as a minimally invasive alternative to transurethral resection of the prostate (TURP), considered the traditional standard treatment for benign prostatic hyperplasia (BPH). PAE differs from other minimally invasive surgical therapies in treatment approach (endovascular vs transurethral) and mechanism (embolic), and thus requires different considerations. An interventional radiologist injects microspheres through a catheter to the blood vessels around the prostate, reducing the blood supply to multiple different areas. No surgical intervention is required for this procedure and recovery times are often less than that of TURP.
For individuals who have benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) who receive prostate artery embolization (PAE), the evidence includes systematic reviews, randomized controlled trials (RCTs) and noncomparative studies. The outcomes of interest are symptoms, functional outcomes, quality of life, and procedure-related morbidity. A Cochrane meta-analysis of 7 RCTs comparing PAE with transurethral resection of the prostate (TURP) or a sham procedure in men with LUTS due to BPH reported similar improvements in symptom scores and quality of life across procedures over both short-term (≤12 months) and long-term (13-24 months) follow-up. There remained significant uncertainty about major adverse events (very low-certainty evidence), but PAE was associated with a higher likelihood of retreatment (moderate-certainty evidence). The long-term effect on erectile function was minimal (low-certainty evidence), and PAE may continue to lower the incidence of ejaculatory disorders (low-certainty evidence). A qualitative systematic review of 5 RCTs and two observational studies found that PAE and TURP resulted in comparable symptom and quality of life improvements at 12 months. TURP offered greater increases in urine flow and prostate volume reduction, while PAE had shorter hospital stays and fewer complications. Three RCTs, published following the systematic reviews, have assessed the efficacy of PAE relative to conventional therapies for BPH. One RCT conducted in Switzerland (2024) reported that TURP demonstrated superior efficacy to PAE in improving LUTS and urinary flow rates at 5-years of follow-up, although erectile function outcomes favored PAE. Another RCT from Australia (2024) indicated that PAE, when utilized as a first-line therapy, resulted in greater reductions in prostate volume, improved symptom scores, and enhanced quality of life relative to medical therapy, with a lower incidence of adverse events. The third RCT, performed in France (2023), found that PAE was more effective than combined medical therapy for patients with moderate LUTS, yielding greater improvements in both symptoms and erectile function, with no major adverse events and a decreased need for retreatment. All three trials were open-label and characterized by high loss to follow-up and significant patient crossover between study arms. A retrospective, single-center study of 317 men with moderate to severe BPH found bilateral PAE had lower recurrence rates than a unilateral approach at over 2-years of follow-up. There is a paucity of direct comparative data between PAE and other minimally invasive therapies for BPH, such as transurethral water vapor thermal therapy, water jet ablation, prostatic urethral lift, and temporarily implanted nitinol devices; these modalities are addressed in separate evidence reviews. Future studies should specifically assess outcomes related to repeat interventions and unilateral PAE procedures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Prostate artery embolization is considered investigational as a treatment for benign prostatic hyperplasia.
| CPT | 37243 | Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction |
| ICD-10 CM | N40.1 | Benign prostatic hyperplasia with lower urinary tract symptoms |
Benign prostatic hyperplasia (BPH) is a common condition in older men, affecting to some degree 40% of men in their 50s, 70% of those between ages 60 and 69, and almost 80% of those ages 70 years and older.1, BPH is a histologic diagnosis defined as an increase in the total number of stromal and glandular epithelial cells within the transition zone of the prostate gland. In some men, BPH results in prostate enlargement which can, in turn, lead to benign prostate obstruction and bladder outlet obstruction, which are often associated with lower urinary tract symptoms (LUTS) including urinary frequency, urgency, irregular flow, weak stream, straining, and waking up at night to urinate. LUTS are the most commonly presenting urological complaint and can have a significant impact on quality of life (QOL).
BPH does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on QOL along with the potential side effects of treatment. Options for treatment include watchful waiting, medication, and minimally invasive surgical procedures. Patients with persistent symptoms despite medical treatment may be considered for surgical treatment. The traditional standard treatment for BPH is transurethral resection of the prostate (TURP). TURP is generally considered the reference standard for comparisons of BPH procedures. A variety of minimally invasive surgical approaches are available as an alternative to TURP for management of LUTS in men with BPH. These methods include water vapor thermal therapy, prostatic urethral lift, and temporary implanted prostatic devices. Each of these approaches is discussed in detail in separate evidence reviews: 2.01.49, 7.01.151, and 7.01.175, respectively (see Related Policies).
Prostate arterial embolization (PAE) is a minimally invasive treatment option that works by reducing blood supply to prostatic arteries. PAE differs from other minimally invasive surgical therapies in treatment approach (endovascular vs transurethral) and mechanism (embolic), and thus requires different considerations.2,An interventional radiologist injects microspheres through a catheter to the blood vessels around the prostate, reducing the blood supply to multiple different areas. No surgical intervention is required for this procedure and recovery times are often less than that of TURP. PAE requires significant clinician training and is associated with some common side effects such as post-PAE syndrome, blood in urine or semen, rare cases of prostatic or bladder spasms.
Prostate surgeries are procedures and, therefore, not regulated by the FDA. However, devices and instruments used during the surgery may require FDA approval. Refer to the following website for additional information:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
