Prostatic Artery Embolization: Mid- to Long-Term Outcomes in 1,075 Patients.

To assess the mid- to long-term safety and effectiveness of prostatic artery embolization (PAE) at a single-center cohort of 1,075 patients. This institutional review board-approved retrospective study included patients with moderate-to-severe lower urinary tract symptoms (LUTS) or urinary retention who underwent PAE from January 2014 to July 2023. Patients were assessed at 1, 3, 6, and 12 months after PAE and yearly thereafter. The International Prostate Symptom Score (IPSS), quality of life (QoL) score, International Index of Erectile Function-5 (IIEF-5) score, prostate-specific antigen (PSA), prostate volume (PV), postvoid residual, benign prostatic obstruction (BPO) medication usage, urinary catheter status, and further prostatic interventions were assessed. Adverse events were recorded and classified using the Society of Interventional Radiology (SIR) adverse events (AEs) severity classification. The mean follow-up was 458.4 days (SD ± 559.5). The mean age was 70.4 years (SD ± 9.0), the median (interquartile range) PV was 107 g (76-150 g), and the median preprocedural IPSS, QoL, and IIEF-5 scores and PSA level were 23 (18-28), 5 (4-6), 17 (10-21), and 4.7 ng/mL (2.6-8), respectively. In the LUTS subgroup, at 1-3, 6-12, and 48-60 months, the median IPSS values were 7 (4-12, P < .001), 6 (3-11, P < .001), and 9 (4-15, P < .001), respectively. The QoL scores at the same time points were 2 (1-2, P < .001), 1 (0-2, P < .001), 2 (0-3, P < .001), respectively. Of 126 patients in the retention cohort, 119 (94%) were catheter-free at the 3-month follow-up. Ninety-patients (16% of reintervention eligible patients) required a second prostatic intervention up to 60 months after PAE. After PAE, 65.5% of patients were BPO medication-free at 1 year. Seven patients (0.65%) had severe AEs according to the SIR AE severity classification: (a) transient ischemic attacks, 3; (b) urosepsis, 2 (treated in the inpatient setting with intravenous antibiotics); and (c) prostate sloughing, 2 (needing transurethral resection of the prostate). All AEs resolved without permanent sequelae. In a large cohort with long-term longitudinal follow-up, PAE showed significant, sustained long-term relief of LUTS, improved QoL, low reintervention rate, and high BPO medication-free rates. Ninety-four percent of catheter-dependent patients at baseline were catheter-free at 3 months.

Bhatia S ，Bhatia A ，Richardson AJ ，Richardson K ，Issa C ，Kumar JG ，Jalaiean H ，Kava B ，Shah HN ... -  《-》

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial.

Prostatic artery embolisation (PAE) and transurethral resection of the prostate (TURP) are two of the surgical options for treatment of lower urinary tract symptoms/benign prostatic obstruction (LUTS/BPO). Our aim was to compare the efficacy and safety of PAE and TURP for LUTS/BPO treatment at long-term follow-up. We conducted a randomised, open-label, single-centre trial at a Swiss tertiary care centre. The main outcome was the change in International Prostate Symptom Score (IPSS) after PAE versus TURP. Secondary outcomes included patient-reported outcomes, functional measures, and adverse events assessed at baseline and at 3, 6, 12, 24, and 60 mo. Between-group differences in the change from baseline to 5 yr were tested using two-sided Mann-Whitney and t tests. Of the 103 patients with refractory LUTS/BPO who were randomised between 2014 and 2017, 18/48 who underwent PAE and 38/51 who underwent TURP reached the 60-mo follow-up visit. The mean reduction in IPSS from baseline to 5 yr was -7.78 points after PAE and -11.57 points after TURP (difference 3.79 points, 95% confidence interval [CI] -0.66 to 8.24; p = 0.092). TURP was superior for most patient-reported secondary outcomes except for erectile function. At 5 yr, PAE was less effective than TURP regarding objective parameters, such as the improvement in maximum urinary flow rate (3.59 vs 9.30 ml/s, difference -5.71, 95% CI -10.72 to -0.70; p = 0. 027) and reduction in postvoid residual volume (27.81 vs 219.97 ml; difference 192.15, 95% CI 83.79-300.51; p = 0.001). The improvement in LUTS/BPO at 5 yr after PAE was inferior to that achieved with TURP. The limitations of PAE should be considered during patient selection and counselling. In this study, we show the long-term results of prostate artery embolisation (PAE) in comparison to transurethral resection of the prostate (TURP) for the treatment of benign prostate enlargement causing urinary symptoms. PAE shows good long-term results in properly selected patients, although the improvements are less pronounced than with TURP. This trial is registered on ClinicalTrials.gov as NCT02054013.

Müllhaupt G ，Hechelhammer L ，Graf N ，Mordasini L ，Schmid HP ，Engeler DS ，Abt D ... -  《European Urology Focus》

Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study.

To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE). This was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics. Four hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE. PAE is a safe and effective treatment for symptomatic BPH and LUTS. Level of Evidence Level 3 Trial registration ClinicalTrials.gov NCT03527589.

Sapoval MR ，Bhatia S ，Déan C ，Rampoldi A ，Carnevale FC ，Bent C ，Tapping CR ，Bongiovanni S ，Taylor J ，Brower JS ，Rush M ，McWilliams JP ，Little MW ，PROstate Study Investigators ... -  《-》

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study

One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Kristensen-Alvarez A ，Fode M ，Stroomberg HV ，Nielsen KK ，Arch A ，Lönn LB ，Taudorf M ，Widecrantz SJ ，Røder A ... -  《-》

Comparing embolic particles for prostatic artery embolization to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Compare the safety and efficacy of polyvinyl alcohol particles (PVA) versus trisacryl gelatin microspheres (Embospheres) versus hydrogel microspheres coated with polyzene-F (Embozenes) for prostatic artery embolization (PAE) to treat patients with benign prostatic hyperplasia (BPH). A single-center prospective cohort study from 2019 to 2023, including patients with international prostate symptom score (IPSS) ≥ 15 and/or quality of life score (QoL) ≥ 4. Allocation to embolic agents was performed chronologically: 100-300 µm PVA (n = 53), followed by 300-500 µm Embospheres (n = 50), and finally, 400 µm Embozenes (n = 50). All patients were evaluated at baseline and at 1 and 6 months after PAE with IPSS/QoL; peak urinary flow rate, post-void residual volume, and prostate volume with ultrasound and prostate-specific antigen. Adverse events and the need for prostatic re-interventions were assessed. There were no significant baseline differences between the three groups except for patient age (62.5 years PVA; 66.1 years Embospheres and 66.6 years Embozenes; p = 0.019). There were no major adverse events and no differences between groups regarding minor adverse events. All outcome measures improved significantly from baseline, with no significant differences between groups. Mean ± standard deviation IPSS/QoL improvement at 6 months: -10.7 ± 7.9/-2.2 ± 1.7 PVA; -10.4 ± 7.3/-2.0 ± 1.5 Embospheres; -10.4 ± 7.0/-2.2 ± 1.6 Embozenes (p = 0.987). Re-intervention rates after 6 months: 9% (n = 5/53) PVA; 14% (n = 7/50) Embospheres; 8% (n = 4/50) Embozenes (p = 0.591). PAE with PVA particles, Embospheres, and Embozenes is equally safe and effective in treating BPH-related lower urinary tract symptoms. This is the first prospective study showing equivalence between the most frequently used embolic agents for prostatic artery embolization. Different particles can be used interchangeably for prostatic artery embolization. The improvements in measured metrics were the same between groups, with no differences in adverse events. The need for prostatic medication and re-intervention rates were the same at 1 and 6 months after embolization.

Bilhim T ，Vasco Costa N ，Torres D ，Akış S ，Alves M ，Papoila AL ... -  《-》