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Digital subtraction angiography in posteroanterior view with microcatheter tip (arrow) advanced as distally as possible inside the left prostatic artery into the intraprostatic branches.
Source publication
Purpose:
To compare balloon-occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE).
Materials and methods:
In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients receiv...
Contexts in source publication
Context 1
... digital subtraction angiography protocol was in posteroanterior view with the same contrast agent and with pump injection of 5 mL at 2 mL/s. The microcatheter was advanced as distally as possible inside the prostatic arteries into the intraprostatic branches in the cPAE group, and a wedged embolization was performed allowing reflux toward the main prostatic artery trunk (Fig 1). The endpoint was set when reflux of embolic material approached the prostatic artery origin. ...
Context 2
... observations are probably clinically relevant, as they represent indirect measures of nontarget embolization. Rectal bleeding has been reported in 3%-10% of patients and penile skin lesions have been reported in 1%-5% of patients after PAE (1-8). The slightly higher rate of these adverse events in the cPAE group could be due to the wedged embolization technique used as opposed to a freeflow embolization and to a low usage of protective coils (14%). ...
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Citations
... Some studies [6,7] have reported conflicting results or highlighted potential safety concerns, such as complications related to embolization or post-procedural symptoms. Additionally, the follow-up duration and sample sizes in some studies had been relatively small, which may affect the generalizability of the results [8,9]. To evaluate the efficacy of PAE, a well-designed research needed with larger sample sizes and more extended follow-up periods, safety in managing hematuria in BPH patients, and identify the optimal patient selection criteria and procedural techniques for achieving the best outcomes. ...
Background
Benign prostate hyperplasia (BPH) commonly affects aging men that can result in hematuria. For patients who are not suitable candidates for surgery, prostatic artery embolization (PAE) has emerged as a minimally invasive alternative. This study aimed to assess the safety and efficacy of PAE specifically for treating hematuria in BPH patients who cannot undergo surgery.
Methods
The study included n = 110 participants. PAE was performed, and outcomes of interest, including resolution of hematuria, improvement in lower urinary tract symptoms (LUTS), prostate volume (PV), and quality of life (QoL), were assessed. Adverse events were also analyzed.
Results
The study demonstrated a 100% clinical success rate in resolving hematuria at 3 months, with no recurrence observed during the 6-month follow-up. Mean hemoglobin levels increased, indicating successful resolution of bleeding. PAE also led to a significant reduction in LUTS severity, as measured by the International Prostate Symptom Score (IPSS). Improvement in the mean maximum urinary flow rate (Qmax) indicated enhanced urinary flow. Additionally, MRI measurements showed a reduction in prostate volume following PAE. These improvements contributed to enhanced QoL for the patients.
Conclusions
Prostatic artery embolization (PAE) was found to be a safe and effective treatment option for hematuria in BPH patients not suitable for surgery. PAE demonstrated a high success rate in resolving hematuria and resulted in significant improvements in LUTS, prostate volume, and QoL outcomes. These findings have important implications for clinical decision-making and improving patient care for BPH patients with hematuria. Further research and long-term follow-up studies are necessary to validate these findings and assess the durability of PAE outcomes in this patient population.
... A 2019 randomized clinical trial reported on 89 patients with symptomatic BPH, who were randomly assigned to conventional microcatheter PAE (cPAE) vs balloonocclusion PAE (bPAE) [28]. At 6-month follow-up, both methods showed statistically similar IPPS improvement rates of − 7.58 points ± 6.88 for the cPAE and − 8.30 points ± 8.12 for the bPAE groups. ...
... At 6-month follow-up, both methods showed statistically similar IPPS improvement rates of − 7.58 points ± 6.88 for the cPAE and − 8.30 points ± 8.12 for the bPAE groups. According to IIEF scores, erectile function was unchanged [28]. ...
Purpose of Review
This review serves to explore minimally invasive BPH therapies, with a focus on the sexual side effects of each given modality. The article seeks to give the reader a better understanding of the risk of erectile and ejaculatory dysfunction following various bladder outlet procedures and surgeries.
Recent Findings
Multiple urologic treatment technologies are entering the market and gaining FDA approval. UroLift®, Rezūm™, and Aquablation are now supported by the American Urological Association guidelines for the treatment of BPH-related LUTS. Each modality has a relatively low risk of erectile or ejaculatory dysfunction when compared to traditional transurethral resection of the prostate (TURP). Other treatment options, such as prostatic arterial embolization and the Temporarily Implanted Nitinol Device (iTind), may edge their way toward standard of care as new evidence regarding safety and efficacy becomes available.
Summary
Various treatment modalities have been proven to be safe when considering a bladder outlet procedure. Depending on the patient’s prostatic size, anatomy, and his goals of care, clinicians should be able to offer a BPH treatment option with a favorable prognosis as well as an acceptable risk profile.
... New evidence has since been published on anatomy [11][12][13] and technical achievements, such as the coil/gelatin protection of extra-prostatic supplies during PAE [14,15], and the use of different embolic types and sizes [16,17] or new devices, such as a balloon occlusion micro catheter [18][19][20][21], all aiming to improve efficacy and decrease non-target embolization. Obviously, in addition to these new tools/technical evolutions, another major asset for safety in performing PAE is the learning curve. ...
... Coil protection of pattern B PA, when possible, was safe in this study, as previously reported [14,15]. When coil protection is precluded, a balloon occlusion micro catheter may be of use [21] to prevent reflux. ...
Background:
to report the safety of outpatient prostatic artery embolization (PAE) after a significant learning curve.
Methods:
a retrospective bi-institutional study was conducted between June 2018 and April 2022 on 311 consecutive patients, with a mean age of 69 years ± 9.8 (47-102), treated by outpatient PAE. Indications included lower urinary tract symptoms, acute urinary retention, and hematuria. When needed, 3D-imaging and/or coil protection of extra-prostatic supplies were performed to avoid non-target embolization. Adverse events were monitored at 1-, 6-, and 12-month follow-ups.
Results:
bilateral PAE was achieved in 305/311 (98.1%). Mean dose area product/fluoroscopy times were 16,408.3 ± 12,078.9 (2959-81,608) μGy.m2/36.3 ± 1.7 (11-97) minutes. Coil protection was performed on 67/311 (21.5%) patients in 78 vesical, penile, or rectal supplies. Embolization-related adverse events varied between 0 and 2.6%, access-site adverse events between 0 and 18%, and were all minor. There was no major event.
Conclusion:
outpatient PAE performed after achieving a significant learning curve may lead to a decreased and low rate of adverse events. Experience in arterial anatomy and coil protection may play a role in safety, but the necessity of the latter in some patterns may need confirmation by additional studies in randomized designs.
... The embolization technique and pre-procedural medication have been extensively described previously ( [24][25][26][27][28][29], supplementary materials). Embolic agents used for PAE included: 100-300 lm polyvinyl alcohol (PVA) particles (Bearing nsPVA, Merit Medical Systems, Inc.; Contour, Boston Scientific Corporation) and spherical embolic agents such as 300-500 lm spherical PVA (Bead Block, Boston Scientific Corporation), 100-300 and/or 300-500 lm trisacryl gelatin microspheres (Embosphere, Merit Medical Systems, Inc.) and 250 and/or 400 lm polyzene-coated hydrogel microspheres (Embozene, Varian Medical Systems). ...
Purpose:
Assess long-term outcomes of prostatic artery embolization (PAE) for patients with benign prostatic hyperplasia (BPH).
Materials and methods:
Single centre retrospective study from 2009-2019 including 1072 patients who received PAE and had available follow-up. Patients were evaluated yearly at 1-10 years post PAE using the International Prostate Symptom Score (IPSS) and quality of life (QoL), prostate volume (PV), prostate-specific antigen (PSA), peak urinary flow rate (Qmax) and postvoid residual (PVR) volume. The need for prostatic medication, re-intervention rates, repeat PAE and prostatectomy rates were assessed with Kaplan-Meier survival analysis and compared between different embolic agents using Cox regression analysis.
Results:
Mean follow-up time was 4.39 ± 2.37 years. At last follow-up visit, mean IPSS and QoL improvements were - 10.14 ± 8.34 (p < .0001) and - 1.87 ± 1.48 (p < .0001) points, mean PV reduction was - 6.82 ± 41.11 cm3 (p = 0.7779), mean PSA reduction was - 1.12 ± 4.60 ng/mL (p = 0.9713), mean Qmax increase was 2.72 ± 6.38 mL/s (p = 0.0005), mean PVR reduction was - 8.35 ± 135.75 mL (p = 0.6786). There were 335 patients (31.3%) needing prostatic medication after PAE. Re-intervention rates were 3.4% at 1 year, 21.1% at 5 years and 58.1% at 10 years. Repeat-PAE rates were 2.3% at 1 year, 9.5% at 5 years and 23.1% at 10 years. Prostatectomy rates were 1.1% at 1 year, 11.6% at 5 years and 35.0% at 10 years. No significant differences were found between polyvinyl alcohol particles, Bead Block, Embospheres and Embozenes.
Conclusion:
PAE induces durable long-term LUTS relief, with re-intervention rates of 20% in the first 5 years and 30%-60% > 5 years post-PAE.
... Other protective measures such as the use of re ux-controlling and balloon occlusion microcatheters were scarcely described so far and can potentially reduce the incidence of complications after PAE, specially NTE (11,12). The aim of this study is to evaluate feasibility, e cacy, and safety of PAE using a re ux control microcatheter in patients with LUTS / BPH. ...
... In 2019, a clinical trial comparing the outcomes of PAE using conventional (cPAE) versus balloon-occlusion microcatheter (bPAE) showed no difference regarding e cacy outcomes between groups (11). Although coiling was employed as protective measure in both arms (8.7% in the bPAE group and 14.0% in the cPAE group, P = 0.51), NTE resulting in penile lesions (n = 3, 7.0%) and rectal bleeding (n = 2, 4.7%) occurred only in the cPAE group. ...
Purpose: To describe the initial experience regarding efficacy and safety of Prostatic Artery Embolization (PAE) using a reflux control microcatheter.
Materials and methods: This is a prospective, single-center investigation that included 10 patients undergoing PAE for treatment of lower urinary tract symptoms (LUTS) attributed to benign prostate hyperplasia (BPH). Baseline, 3-month and 12-month efficacy endpoints were obtained for all patients, and included prostate-specific antigen (PSA), uroflowmetry, pelvic magnetic resonance imaging (MRI) and clinical assessment using the International Prostate Symptom Score (IPSS) questionnaire and the IPSS-Quality of life (QoL) item. Complications were assessed using the Cirse classification system.
Results: Ten patients entered statistical analysis and presented with significant LUTS improvement 12 months after PAE, as follows: mean IPSS reduction of 86.6% (2.8 vs. 20.7, -17.9, P < 0.001), mean QoL reduction of 79.4% (1.1 vs. 5.4, -4.3, P < 0.001), mean prostatic volume reduction of 38.4% (69.3 cm³ vs. 112.5 cm³, - 43.2 cm³, P < 0.001), mean peak urinary flow (Qmax) increase of 199.4% (19.9 mL/s vs. 6.6 mL/s, +13.3 mL/s, P = 0.006) and mean PSA reduction of 50.1% (3.0 ng/mL vs. 6.1 ng/mL, -3.0 ng/mL, P < 0.001). One patient (10%) needed transurethral resection of the prostate (TURP) after PAE due to a ball-valve effect. One patient (10%) needed coil protective embolization of a high flow intraprostatic anastomosis. One microcatether (10%) needed to be replaced during PAE due to occlusion. Non-target embolization was not observed in the cohort.
Conclusion: This initial experience suggests that PAE using a reflux control microcatheter is effective and safe for the treatment of LUTS attributed to BPH. High flow intraprostatic anastomosis still need coil protective embolization to avoid NTE even with the use of reflux-control microcatheters.
... Studies examining the effect of prostatic artery embolization applied to patients with benign prostatic hyperplasia determined patient prostate volumes to decrease after the procedure compared to before. 4,[16][17][18][19][20][21][22][23] This study measured patient prostate volume as averaging 68 ± 23.25 cm³ before the procedure; and measured prostate volume after the procedure as 61.5 ± 25.5 cm³ in the 1st month, 48.2 ± 15.7 cm³ in the 3rd month, 45.5 ± 16.2 cm³ in the 6th month, and 45.0 ± 16.0 cm³ in the 12th month. The study determined patient prostate volumes to decrease after the procedure compared to before, but there was no statistically significant difference comparing the 6th and the 12th month results. ...
... This result is similar to those of previous studies in the literature. 4,[15][16][17][18][19][20][21][22][23] In 2014, Kurbatov et al 15 found the PSA value to decrease after the procedure, but there was no statistically significant difference when the post-procedural 3rd, 6th, and 12th month values were compared. The 2017 study by Carnevale et al 17 found the PSA value to decrease 12 months after the procedure, with no significant difference in results the 3rd and 12th month after the procedure. ...
... The results of similar studies support our findings. However, there is also a study in the literature in which PAE application did not affect the PSA value 22 ; the results of this research do not correlate with those of our study. Studies conducted to determine the effect of prostatic artery embolization on patients with benign prostatic hyperplasia have determined that the Q max values of the patients increased after the procedure compared to before the procedure. ...
Objective:
To determine the clinical outcomes of prostatic artery embolization applied to patients with Material and methods: The study includes 30 patients diagnosed with benign prostatic hyperplasia in the urology clinic between 2012 and 2016, for whom anesthesia was contraindicated due to advanced age and comorbidities and who underwent prostatic artery embolization. These patients were evaluated before the procedure and in the 1st, 3rd, 6th, and 12th months after the procedure.
Results:
The mean prostate volume of the patients was 68 cm3 before the procedure and 45 cm3 12 monthsafter the procedure. A statistically significant decrease was observed (P = .001). The mean prostate-specific antigen value was 4.9 ng/dL before the procedure and 2.8 ng/dL 12 months after the procedure (P = .008). The mean Qmax value was 0 mL/s before the procedure and 12 mL/s 12 months after the procedure (P = .001). The mean international prostatic symptom scores value was 35 before and 16 twelve months after the proce-dure (P = .001). While the international index of erectile function value was 8.25 before the procedure, it was8.46 12 months after the procedure (P = .32). The quality of life index value was measured as 3.02 before theprocedure and 3.09 twelve months after the procedure; a statistically significant difference was determined (P = .027).
Conclusion:
Prostatic artery embolization, which is a minimally invasive procedure, can be applied as a safe and effective method to patients with benign prostatic hyperplasia who cannot tolerate anesthesia due to advanced age and comorbidities.
... The quality of non-RCT studies evaluated with the Newcastle-Ottawa scale ranged from poor to good [19][20][21][22][23][24][26][27][28][29][30][31][32][33][34][35][37][38][39][40][41][42][43][44]46,47,50,51,53,54,[57][58][59][60][61]66]. All the RCTs were found to be of acceptable quality (!3 points) [25,36,45,48,49,52,55,56,[62][63][64][65]]. ...
Context:
Benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS) is diagnosed in up to 80% of men during their lifetime. Several novel ultra-minimally invasive surgical treatments (uMISTs) for BPH/benign prostatic obstruction (BPO) have become available over the past 5 yr.
Objective:
To evaluate the perioperative and functional outcomes of recently introduced uMISTs for BPH/BPO, including Urolift, Rezūm, temporary implantable nitinol device, prostatic artery embolization (PAE), and intraprostatic injection.
Evidence acquisition:
A systematic literature search was conducted in December 2020 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science (registered on PROSPERO as CRD42021225014). The search strategy used PICO criteria and article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. Pooled and cumulative analyses were performed to compare perioperative and functional outcomes between study groups. A random-effects model using the DerSimonian and Laird method was used to evaluate heterogeneity. Stata version 15.0 software was used for all statistical analyses.
Evidence synthesis:
The initial electronic search identified 3978 papers, of which 48 ultimately met the inclusion criteria and were included in the analysis. Pooled analysis revealed a uMIST benefit in terms of International Prostate Symptom Score (IPSS; -9.81 points, 95% confidence interval [CI] -11.37 to -8.25 at 1 mo; -13.13 points, 95% CI -14.98 to -11.64 at 12 mo), maximum flow rate (from +3.66 ml/s, 95% CI 2.8-4.5 to +4.14 ml/s, 95% CI 0.72-7.56 at 12 mo), and postvoid residual volume (-10.10 ml, 95% CI -27.90 to 7.71 at 12 mo). No negative impact was observed on scores for the International Index of Erectile Function-5, Male Sexual Health Questionnaire-Ejaculatory Dysfunction bother and function scales (overall postintervention change in pooled median score of 1.88, 95% CI 1.34-2.42 at the start of follow-up; and 1.04, 95% CI 0.28-1.8 after 1 yr), or the IPSS-Quality of Life questionnaire.
Conclusions:
Novel uMISTs can yield fast and effective relief of LUTS without affecting patient quality of life. Only Rezūm, UroLift, and PAE had a minimal impact on patients' sexual function with respect to baseline, especially regarding preservation of ejaculation.
Patient summary:
We reviewed outcomes for recently introduced ultra-minimally invasive surgical treatments for patients with lower urinary tract symptoms caused by benign prostate enlargement or obstruction. The evidence suggests that these novel techniques are beneficial in terms of controlling symptoms while preserving sexual function.
Take home message:
Novel ultra-minimally invasive treatments can yield fast and effective relief of lower urinary tract symptoms without affecting a patient's quality of life.
... A PRISMA flow diagram depicts the process of study selection ( Figure 1). Seven of the included studies were RCTs [5][6][7][22][23][24][25], as presented in Table 1. Study characteristics of prospective and retrospective studies are presented in Tables 2 and 3, respectively. ...
Postembolization syndrome (PES) is the most common side effect of vascular embolization of solid organs. The aim of this review was to determine the incidence of PES and its individual components after prostatic artery embolization (PAE). A systematic review with a pre-specified search strategy for PubMed, Embase, Web of Science and Cochrane Library was performed according to PRISMA guidelines. Studies in English regarding PAE in humans with 10 or more participants were eligible for inclusion. No restrictions on participant demographics or PAE technique were imposed. The search returned 378 references, of which 32 studies with a total of 2116 patients met the inclusion criteria. The results for overall PES frequency and individual PES components were presented as median (interquartile range, (IQR)). Overall median PES frequency was 25.5% (12.5–45.8). The two most frequent individual PES components were dysuria/urethral burning and local pain, with a median frequency of 21.7% (13.8–33.3) and 20% (5.4–29.4), respectively. Most outcome measures were characterized by a marked lack of uniformity and inconsistency in reporting across studies. Development of a uniform reporting system would help the clinicians recognize and treat PES accordingly.
Background:
Surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are affected by potentially bothersome side effects on sexual, and, above all, ejaculatory function. Several minimally invasive techniques have been proposed in the last years in order to overcome these consequences. Our aim is to summarize and evaluate the efficacy on LUTS relieve and the impact on sexual/ejaculatory function of Rezum, prostate artery embolization (PAE), implantation of a prostatic urethral lift (PUL) and the temporary implantable nitinol device (TIND).
Methods:
A systematic review of the English-language literature was conducted using the MEDLINE, Embase, and Web of Science databases from January 2000 to October 2022, according to the PRISMA guidelines (PROSPERO ID: CRD42023466515). Randomized controlled trials (RCTs), prospective studies and non-comparative or comparative studies assessing the impact on functional and ejaculatory function after minimally invasive surgical therapies for Male LUTS were evaluated. Risk of bias assessment was performed according to the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool for comparative studies, and the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) for RCTs.
Results:
Overall, 47 studies were included (n = 4 for TIND; n = 9 for Rezum; n = 13 for PUL; n = 21 for PAE). Most studies relied on prospective patient cohorts and were rated as low risk of bias. Across studies assessing the efficacy of Rezum, a significant improvement in terms of IPSS (ranging from -47% to -56%) and Qmax (ranging from +39% to +87%) was reported. On the other hand, according to IIEF-5 score, Rezum had a minimal impact on sexual function (ranging from -1% to -3%). PUL showed a positive impact on IPSS (ranging from -35% to -58.2%) and Qmax (ranging from +49.9% to +114.7%) and sexual function. Finally, PAE showed encouraging functional results with IPSS score reducing from -12.8% to 63.3% and Qmax improving from +8% to 114.9% but the available evidence regarding the potential impact of PAE on sexual outcomes were limited.
Conclusion:
Rezum, PAE, PUL and TIND are safe and feasible techniques associated with a significant functional improvement. While available data suggest a minimal impact of Rezum and PUL on ejaculatory function, the evidence after PAE and TIND are still limited. Therefore, our review lays the foundation for further research aiming to identify the criteria to select best candidates for uMIST to tailor the management in light of specific patient- and disease- factors.
