Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia.

BACKGROUND: Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. OBJECTIVE: To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. DESIGN, SETTING, AND PARTICIPANTS: A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. INTERVENTION: Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. RESULTS AND LIMITATIONS: Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. CONCLUSIONS: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. PATIENT SUMMARY: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.

Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia.

PURPOSE: To perform meta-analysis of available data on prostatic artery embolization (PAE). MATERIALS AND METHODS: Meta-analysis was conducted on articles published between November 2009 and December 2015. Peer-reviewed studies with > 5 patients and standard deviations and/or individual-level data on one or more of the following outcomes were included: prostate volume (PV), peak flow rate (Qmax), postvoid residual (PVR), International Prostate Symptom Score (IPSS), quality of life (QOL) score, International Index of Erectile Function (IIEF) score, and prostate-specific antigen (PSA) level. A random-effects meta-analysis was performed on the outcomes at 1, 3, 6, and 12 months after PAE compared with baseline values, with a P < .05 decision rule as the null hypothesis rejection criterion. RESULTS: Nineteen of 268 studies were included in data collection, with 6 included in the meta-analysis. At 12 months, PV decreased by 31.31 cm3 (P < .001), PSA remained unchanged (P = .248), PVR decreased by 85.54 mL (P < .001), Qmax increased by 5.39 mL/s (P < .001), IPSS improved by 20.39 points (P < .001), QOL score improved by -2.49 points (P < .001), and IIEF was unchanged (P = 1.0). There were a total of 218 adverse events (AEs) among 662 patients (32.93%), with 216 being Society of Interventional Radiology class A/B (99%). The most common complications were rectalgia/dysuria (n = 60; 9.0%) and acute urinary retention (n = 52; 7.8%). No class D/E complications were reported. CONCLUSIONS: PAE provided improvement in Qmax, PVR, IPSS, and QOL endpoints at 12 months, with a low incidence of serious AEs (0.3%), although minor AEs were common (32.93%). There was no adverse effect on erectile function.

Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up.

OBJECTIVES: To evaluate the short- and medium-term results of prostatic arterial embolisation (PAE) for benign prostatic hyperplasia (BPH). METHODS: This was a prospective non-randomised study including 255 patients diagnosed with BPH and moderate to severe lower urinary tract symptoms after failure of medical treatment for at least 6 months. The patients underwent PAE between March 2009 and April 2012. Technical success is when selective prostatic arterial embolisation is completed in at least one pelvic side. Clinical success was defined as improving symptoms and quality of life. Evaluation was performed before PAE and at 1, 3, 6 and every 6 months thereafter with the International Prostate Symptom Score (IPSS), quality of life (QoL), International Index of Erectile Function (IIEF), uroflowmetry, prostatic specific antigen (PSA) and volume. Non-spherical polyvinyl alcohol particles were used. RESULTS: PAE was technically successful in 250 patients (97.9 %). Mean follow-up, in 238 patients, was 10 months (range 1-36). Cumulative rates of clinical success were 81.9 %, 80.7 %, 77.9 %, 75.2 %, 72.0 %, 72.0 %, 72.0 % and 72.0 % at 1, 3, 6, 12, 18, 24, 30 and 36 months, respectively. There was one major complication. CONCLUSIONS: PAE is a procedure with good results for BPH patients with moderate to severe LUTS after failure of medical therapy. KEY POINTS: • Prostatic artery embolisation offers minimally invasive therapy for benign prostatic hyperplasia. • Prostatic artery embolisation is a challenging procedure because of vascular anatomical variations. • PAE is a promising new technique that has shown good results.

Prostatic arterial supply: anatomic and imaging findings relevant for selective arterial embolization.

PURPOSE: To describe the anatomy and imaging findings of the prostatic arteries (PAs) on multirow-detector pelvic computed tomographic (CT) angiography and digital subtraction angiography (DSA) before embolization for symptomatic benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: In a retrospective study from May 2010 to June 2011, 75 men (150 pelvic sides) underwent pelvic CT angiography and selective pelvic DSA before PA embolization for BPH. Each pelvic side was evaluated regarding the number of independent PAs and their origin, trajectory, termination, and anastomoses with adjacent arteries. RESULTS: A total of 57% of pelvic sides (n = 86) had only one PA, and 43% (n = 64) had two independent PAs identified (mean PA diameter, 1.6 mm ± 0.3). PAs originated from the internal pudendal artery in 34.1% of pelvic sides (n = 73), from a common trunk with the superior vesical artery in 20.1% (n = 43), from the anterior common gluteal-pudendal trunk in 17.8% (n = 38), from the obturator artery in 12.6% (n = 27), and from a common trunk with rectal branches in 8.4% (n = 18). In 57% of pelvic sides (n = 86), anastomoses to adjacent arteries were documented. There were 30 pelvic sides (20%) with accessory pudendal arteries in close relationship with the PAs. No correlations were found between PA diameter and patient age, prostate volume, or prostate-specific antigen values on multivariate analysis with logistic regression. CONCLUSIONS: PAs have highly variable origins between the left and right sides and between patients, and most frequently arise from the internal pudendal artery.

Branching patterns of the male internal iliac artery: imaging findings.

The aim of this study was to establish the imaging findings of the main branching patterns of the male internal iliac arteries, using different imaging modalities (angio MR, angio CT and digital angiography). Twenty-one males (mean age 73.2 years) underwent imaging evaluation with angio MR, angio CT and digital angiography to define the internal iliac artery anatomy before selective embolization of the pelvic arteries. All three modalities were used in 3 patients, angio MR and digital angiography in 17 patients, angio CT and digital angiography in 6 patients and only angio CT in 1 patient. Internal iliac arteries were classified into four groups using the Yamaki classification (modified from the Adachi's classification). Twenty-six pelvic sides were classified as Group A (61.9%), 13 as Group B (31%) and 3 as Group C (7.1%) with no cases of Group D found. Angio MR, angio CT and digital angiography were able to detect most branches of the internal iliac artery. Group A was the most frequent internal iliac artery branching pattern. Angio CT showed better detailed anatomy than angio MR and digital angiography was considered the gold-standard. Non-invasive vascular imaging with angio MR or angio CT is essential before invasive interventions, allowing better planning of the procedure.

The Role of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in the Management of the Post-Embolization Symptoms after Uterine Artery Embolization.

Uterine artery embolization (UAE) is usually a very painful procedure. Although pain after the procedure can occur as a single symptom, it usually is associated with other symptoms such as nausea, vomiting, pelvic pain, general malaise, fever and leukocytosis that characterize the post-embolization syndrome. Management of the post-embolization symptoms and of pain in particular, is paramount if UAE is to be performed as an outpatient procedure. Different protocols have used analgesic and/or anti-inflammatory agents to control these symptoms. Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used in association with analgesic drugs to control post-embolization symptoms. In our institution the patients start oral medication with NSAIDs the day before the procedure and continue it during and after UAE. We also mix NSAIDs with the embolizing particles. This enables a reduction in the inflammation present in the uterine fibroids and helps controlling the pain. The purpose of this paper is to review the importance of NSAIDs in the management of the post-embolization symptoms. We describe the protocol that we use in our institution that enables us to perform the procedure on an outpatient basis with same day discharge and good control of the post-embolization symptoms with oral NSAIDs and analgesics.

[Pulmonary embolism diagnosis]. / Diagnóstico do embolismo pulmonar.

Pulmonary Embolism is often considered a difficult diagnosis to establish. It is important to recognise clinical situations that leads to it. There are a few laboratory and imaging tests, that should be tailored to the available facilities in each institution.