Safety Profile of Ambulatory Prostatic Artery Embolization after a Significant Learning Curve: Update on Adverse Events.

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.

Feasibility of Outpatient Transradial Prostatic Artery Embolization and Safety of a Shortened Deflation Protocol for Hemostasis.

BACKGROUND: to evaluate the safety and feasibility of a shorter time to hemostasis applied to outpatient transradial (TR) Prostatic Artery Embolization (PAE). METHODS: a retrospective bi-institutional study was conducted between July 2018 and April 2022 on 300 patients treated by outpatient TR PAE. Indications included lower urinary tract symptoms, acute urinary retention, and hematuria. Mean patient height was 176 ± 6.3 (158-192) cm. The primary endpoint was safety of a 45 min deflation protocol for hemostasis. The secondary endpoint was the feasibility of PAE using TR access. RESULTS: technical success was 98.7% (296/300). There was one failure due to patient height. Mean DAP/fluoroscopy times were 16,225 ± 12,126.3 (2959-81,608) µGy·m2/35 ± 14.7 (11-97) min, and mean time to discharge was 80 ± 6 (75-90) min. All access site and embolization-related adverse events were minor. Mild hematoma occurred in 10% (30/300), radial artery occlusion (RAO) in 10/300 (3.3%) cases, and history of smoking was a predictor for RAO. There was no major event. CONCLUSION: the safety of TR PAE using a 45 min time to hemostasis was confirmed, and TR PAE is feasible in most cases. Radial artery occlusion was still observed and may be favored by smoking.

Prostatic Artery Embolization Allows to Maintain Full Sexual Activity in Patients Suffering from Bothersome Lower Urinary Tracts Symptoms related to Benign Prostatic Hyperplasia.

INTRODUCTION: The effect of prostate artery embolization (PAE) on male sexual function is currently the subject of debate in the literature. The main purpose of this study was to define changes in all domains of sexual activity after PAE, using the international index of erectile function score (IIEF-15). METHODS: A single-center retrospective study was conducted on 129 patients (mean age of 65.5 ± 7 years), who underwent PAE from February 2014 to January 2017 for symptomatic benign prostatic hyperplasia (BPH). Fifty consecutive patients fulfilling the inclusion criteria were evaluated before and after PAE follow-up using the IIEF-15, IPSS, prostate volume (PV) and cardiovascular risk factor and BPH drugs. The IIEF-15 domains analyzed were: erectile function (EF) ejaculation and orgasm (Ej/O), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). A paired sample t test or Wilcoxon signed-rank test was used to compare IIEF-15 between baseline and follow-up. RESULTS: The study showed nonsignificant change in IIEF-15 total score (58.0 ± 13.8 SD; p = 0.71) and the five domains (EF 24.5 ± 7.0 SD, p = 0.82; EJ/O 8.2 ± 2.3 SD, p = 0.50; SD 7.2 ± 2.7 SD, p = 0.57; IS 10.3 ± 3.0 SD, p = 0.77; OS 8.2 ± 2.7 SD; p = 0.11) after PAE. We also found a significant improvement in IPSS score after PAE. CONCLUSION: Based on the IIEF-15 questionnaire, PAE was showed to allow good urinary symptoms results and no deterioration in sexual function.

Prostate Artery Embolization in Patients With Acute Urinary Retention.

BACKGROUND: This prospective study assessed the efficacy of prostate artery embolization after failure of a trial without catheter in patients suffering a first episode of acute urinary retention as a result of benign prostatic hyperplasia (BPH). METHODS: Patients with failure of a trial without catheter despite alpha-blocker therapy were invited to participate in this protocol. Twenty patients were included in the study, and all underwent prostate artery embolization with calibrated polyvinyl alcohol (PVA) microspheres (Bead Block, BTG Ltd., Farnham, UK). RESULTS: Successful removal of the indwelling bladder catheter and spontaneous voiding was achieved in 15 of 20 (75%) patients, and the overall clinical success at 6 months after prostate embolization was 14 of 20 (70%). No patient experienced severe adverse events. CONCLUSIONS: Prostate artery embolization might be a valuable treatment after a failure of a trial without catheter. Further studies are needed to better define its place in this setting.

Variants of Patterns of Intra- and Extra-prostatic Arterial Distribution of the Prostatic Artery Applied to Prostatic Artery Embolization: Proposal of a Classification.

The development of prostatic artery embolization has led to better understand the complex male pelvic arterial anatomy. To the best of our knowledge, there is still no precise description of the distribution of the branches of the prostatic artery (PA) after its origin. In this study, the patterns of prostatic feeders near to and into the prostate were analyzed, and a classification was proposed. MATERIALS AND METHODS: This study is based on angiograms of 101 consecutive male patients, mean age 70, who underwent PAE between December 2013 and June 2016, to treat symptomatic benign prostatic hyperplasia. RESULTS: The proposed classification is derived from the analysis of 143 solitary PAs from 199 hemipelves (72%). Pattern A was defined as an artery feeding only the prostate, patterns B and C as a PA with a concomitant large supply to the penis (pattern B) or to the rectum (pattern C). A pattern A was found in 89/143 (62%), a pattern B in 16/143 (12%) and pattern C in 38/143 (26%). Protection of a penile/rectal supply was never required in pattern A, while it was performed in 14/16 (87%) of pattern B, and in 7/38 (18%) of pattern C PAs. The PErFecTED technique could be performed in 51%, 50 and 55% of cases in pattern A to C. CONCLUSION: This study proposes a new classification of intra-/extra-prostatic arterial distribution of the PA that could be helpful to prevent complications of PAE. Further prospective angiographic investigations are necessary to confirm its clinical value.

5-FU or mitomycin C hepatic arterial infusion after failure of arterial oxaliplatin in patients with colorectal cancer unresectable liver metastases.

INTRODUCTION: Hepatic arterial infusion (HAI) chemotherapy with oxaliplatin is an accepted option in the management of colorectal cancer (CRC) with dominant liver metastases (LM). However, despite prolonged control, some patients experience disease progression. On the other hand, oxaliplatin leads to dose-limiting toxicity. In these cases, the use of a second-line HAI with an alternative drug has never been reported to date. We evaluated treatment outcomes in patients receiving second-line HAI with 5-FU or mitomycin C, after first-line HAI of oxaliplatin in heavily pretreated patients. MATERIAL AND METHODS: Between March 2010 and June 2016, this observational study included 24 patients with unresectable CRC LM and treated with HAI of 5-FU (17 patients) or mitomycin C (7 patients), after HAI of oxaliplatin. RESULTS: Mean age was 61.7 years. Forty-two percent of patients (10/24) had extra-hepatic metastases and 75% (18/24) at least 8 liver metastases. Including HAI of oxaliplatin, all patients had previously received at least 2 lines of chemotherapy±targeted agents (100%) and 96% (23/24) received concomitant systemic therapies together with HAI of 5-FU or mitomycin C. The overall objective response rate and disease control rate were, respectively, 42% (10/24) and 71% (17/24). Median progression-free survival and overall survival (OS) were, respectively, 5.6 and 25.8 months; hepatic progression-free survival was 8.5months. Thirteen percent (3/24) of the patients received further curative intent treatment after HAI 5-FU and mitomycin C. No toxic death occurred and the toxicity profile was acceptable. CONCLUSIONS: HAI of 5-FU or mitomycin C is an alternative option in patients with predominant CRC LM, when they experience disease progression or do not tolerate HAI of oxaliplatin.

Doxorubicin-Loaded 70-150 µm Microspheres for Liver-Dominant Metastatic Breast Cancer: Results and Outcomes of a Pilot Study.

PURPOSE: Patients with breast cancer liver metastasis have a poor prognosis. Local therapy for liver metastasis increases survival. The purpose of this pilot prospective study was to evaluate the efficacy and safety of doxorubicin drug-eluting beads chemoembolization for liver-dominant breast cancer metastasis (LdBM) refractory to chemotherapy. MATERIALS AND METHODS: All patients with LdBM refractory to of two or more lines of systemic chemotherapy were screened. Two chemoembolizations at 1-month intervals were scheduled for each patient. Tumor responses were evaluated by MRI every 3 months until progression or death. Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.02) 1 month after each chemoembolization. All patients were free from systemic treatment until progression. Patients with hormone-positive receptors and/or HER-positive disease status continued their targeted therapy. RESULTS: Out of 23 patients enrolled (mean age: 57.5 ± 11.5 years), 17 completed two chemoembolizations and six underwent only one because of severe adverse events. At 3-month follow-up, the disease control rate was 83 %. The median progression-free survival from the first chemoembolization was 8 months, and the median overall survival was 17 months. Nineteen patients remained free from any systemic chemotherapy for a mean of 209 ± 92 days until progression. Eight grade 3 (asthenia n = 3, anemia n = 2, thrombocythemia n = 2, liver toxicity n = 1) (Rev 1 Comment 1) occurred after the first procedure. No patient died directly due to the procedure. CONCLUSION: While chemoembolization with doxorubicin eluding beads for refractory LdBM leads to an 83 % disease control rate, it also causes severe side effects that need to be adequately managed.

Bilateral Arterial Embolization of the Prostate Through a Single Prostatic Artery: A Case Series.

Peri-prostatic shunts are frequent during PAE, carrying the risk of non-target embolization of penis/corpus cavernosum or rectum but also the potential advantage to irrigate the contralateral lobe. Sometimes, bilateral embolization is impossible, carrying the risk of limited clinical success. The possibility to reach contralateral prostatic territory from the ipsilateral prostatic artery (PA) and embolize it via peri/intra-prostatic anastomoses could be of interest in this situation. We describe a series of three consecutive patients (among 89 consecutive patients treated by PAE for symptomatic BPH) who underwent successful embolization of both prostatic lobes through catheterization of a PA on only one side. All patients had clinical success after a mean follow-up of 3.3 months. Dosimetry of these three procedures indicates that there may be radiation dose savings.

Safety and Efficacy of Occlusion of Large Extra-Prostatic Anastomoses During Prostatic Artery Embolization for Symptomatic BPH.

INTRODUCTION: During PAE, preembolization angiography of the prostatic artery can show large extra-prostatic shunts, at high risk, if embolized, of rectal or penile necrosis. We report our experience with 11 consecutive patients who underwent protective embolization of large extra-prostatic shunts before successful PAE. MATERIALS AND METHODS: We treated 11 consecutive male patients (mean age 67 years), part of a series of 55 consecutive male patients referred for PAE to treat LUTS due to BPH, between December 2013 and January 2015. The procedure involved the exclusion of an extra-prostatic shunt originating from the PA, prior to complete bilateral PAE. We compared the safety and efficacy of the 11 shunt exclusions followed by embolization of the PA to the other 44 basic PAE. Clinical success was defined as a decrease of 25 % or eight points of IPSS, QoL <3 or a one-point decrease, and a Qmax improvement of 25 % or 2.5 mL/s. RESULTS: We had a 100 % rate of occlusion of the anastomosis. Bilateral embolization of the PA was performed in all patients with no additional time of procedure (p = 0.18), but a significant increase of dose area product (p = 0.03). Distal (PErFecTED) embolization was possible in 64 %. There was no worsening of erectile dysfunction, no rectal or penile necrosis, no immediate or late other clinical complications. Clinical success was 91 % (mean follow-up: 3.5 months), compared to 78 % for the entire PAE group. CONCLUSION: PAE using the protection technique in case of large extra-prostatic shunts is as safe and effective as basic procedures and does not induce any additional time of procedure.

Can prostatic arterial embolisation (PAE) reduce the volume of the peripheral zone? MRI evaluation of zonal anatomy and infarction after PAE.

OBJECTIVES: To assess the impact of prostatic arterial embolisation (PAE) on various prostate gland anatomical zones. METHODS: We retrospectively reviewed paired MRI scans obtained before and after PAE for 25 patients and evaluated changes in volumes of the median lobe (ML), central gland (CG), peripheral zone (PZ) and whole prostate gland (WPV) following PAE. We used manual segmentation to calculate volume on axial view T2-weighted images for ML, CG and WPV. We calculated PZ volume by subtracting CG volume from WPV. Enhanced phase on dynamic contrasted-enhanced MRI was used to evaluate the infarction areas after PAE. Clinical results of International Prostate Symptom Score and International Index of Erectile Function questionnaires and the urodynamic study were evaluated before and after PAE. RESULTS: Significant reductions in volume were observed after PAE for ML (26.2 % decrease), CG (18.8 %), PZ (16.4 %) and WPV (19.1 %; p < 0.001 for all these volumes). Patients with clinical failure had smaller volume reductions for WPV, ML and CG (all p < 0.05). Patients with significant CG infarction after PAE displayed larger WPV, ML and CG volume reductions (all p < 0.01). CONCLUSIONS: PAE can significantly decrease WPV, ML, CG and PZ volumes, and poor clinical outcomes are associated with smaller volume reductions. KEY POINTS: • The MRI segmentation method provides detailed comparisons of prostate volume change. • Prostatic arterial embolisation (PAE) decreased central gland and peripheral zone volumes. • Prostates with infarction after PAE showed larger decreases in volume. • A larger decrease in prostate volume is associated with clinical success.

Clinical Results After Prostatic Artery Embolization Using the PErFecTED Technique: A Single-Center Study.

BACKGROUND: Prostatic artery embolization (PAE) has been performed for a few years, but there is no report on PAE using the PErFecTED technique outside from the team that initiated this approach. OBJECTIVE: This single-center retrospective open label study reports our experience and clinical results on patients suffering from symptomatic BPH, who underwent PAE aiming at using the PErFecTED technique. MATERIALS AND METHODS: We treated 32 consecutive patients, mean age 65 (52-84 years old) between December 2013 and January 2015. Patients were referred for PAE after failure of medical treatment and refusal or contra-indication to surgery. They were treated using the PErFecTED technique, when feasible, with 300-500 µm calibrated microspheres (two-night hospital stay or outpatient procedure). Follow-up was performed at 3, 6, and 12 months. RESULTS: We had a 100% immediate technical success of embolization (68% of feasibility of the PErFecTED technique) with no immediate complications. After a mean follow-up of 7.7 months, we observed a 78% rate of clinical success. Mean IPSS decreased from 15.3 to 4.2 (p = .03), mean QoL from 5.4 to 2 (p = .03), mean Qmax increased from 9.2 to 19.2 (p = .25), mean prostatic volume decreased from 91 to 62 (p = .009) mL. There was no retrograde ejaculation and no major complication. CONCLUSION: PAE using the PErFecTED technique is a safe and efficient technique to treat bothersome LUTS related to BPH. It is of interest to note that the PErFecTED technique cannot be performed in some cases for anatomical reasons.

Intra-vesical Prostatic Protrusion (IPP) Can Be Reduced by Prostatic Artery Embolization.

BACKGROUND: Prostate artery embolization (PAE) is a new approach to improve lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia. PAE results in global reduction of prostate volume (PV). There are no data available on the efficacy of PAE in reducing intra-vesical prostatic protrusion (IPP), an anatomic feature that is clinically related with bladder outlet obstruction and LUTS. OBJECTIVE: To assess the results of PAE in patients with significant IPP due to median lobe hyperplasia and to compare the IPSS decrease and IPP change. MATERIAL AND METHODS: Prospective analysis of 18 consecutive patients with significant IPP (>5 mm) related to median lobe hyperplasia undergoing PAE using 30-500-µm-calibrated trisacryl microspheres. We measured IPP on sagittal T2-weighted images before and 3 months after PAE. IPSS and clinical results were also evaluated at 3 months. RESULTS: PAE resulted in significant IPP reduction (1.57 cm ± 0.55 before PAE and 1.30 cm ± 0.46 after PAE, p = 0.0005) (Fig. 1) with no complication. IPSS, quality of life (QoL), total prostate-specific antigen (PSA) level, and PV showed significant reduction after PAE, and maximum urinary flow rate (Q max) showed significant increase after PAE. No significant change of International Index of Erectile Function (IIEF) for clinical evaluation after PAE. A significant correlation was found between the IPP change and the IPSS change (r = 0.636, p = 0.0045). CONCLUSION: Patients had significant IPP reduction as well as significant symptomatic improvement after PAE, and these improvements were positively correlated.

Early results and complications of prostatic arterial embolization for benign prostatic hyperplasia.

PURPOSE: To review current knowledge on clinical outcomes and peri-operative complications of prostatic arterial embolization (PAE) in patients treated for lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO). METHODS: A systematic review of the literature published from January 2008 to January 2015 was performed on PubMed/MEDLINE. RESULTS: Fifty-seven articles were identified, and four were selected for inclusion in this review. Only one randomized clinical trial compared transurethral resection of the prostate (TURP) to PAE. At 3 months after the procedure, mean IPSS reduction from baseline ranged from 7.2 to 15.6 points. Mean urine peak-flow improvement ranged from +3.21 ml/s to +9.5 ml/s. When compared to TURP, PAE was associated with a significantly lower IPSS reduction 1 and 3 months after the procedure. A trend toward similar symptoms improvement was however reported without statistical significance from 6 to 24 months. Major complications were rare with one bladder partial necrosis due to non-selective embolization. Mild adverse events occurred in 10 % of the patients and included transient hyperthermia, hematuria, rectal bleeding, painful urination or acute urinary retention. Further comparative studies are mandatory to assess post-operative rates of complications, especially acute urinary retention, after PAE and standard procedures. CONCLUSION: Early reports suggest that PAE may be a promising procedure for the treatment of patients with LUTS due to BPO. However, the low level of evidence and short follow-up of published reports preclude any firm conclusion on its mid-term efficiency. Further clinical trials are warranted before any use in clinical practice.

Brainstem responses can predict death and delirium in sedated patients in intensive care unit.

OBJECTIVES: In critically ill patients, the assessment of neurologic function can be difficult because of the use of sedative agents. It is not known whether neurologic signs observed under sedation can predict short-term outcomes. The objective of this study was to assess whether abnormal brainstem responses within the first 24 hrs of sedation are associated with mortality and altered mental status postsedation. DESIGN: Observational prospective study including an initial single-center and a subsequent multicenter study to develop and then validate the prognostic models. SETTING: Three mixed and two medical intensive care units. PATIENTS: Mechanically ventilated intensive care unit patients sedated with midazolam (± sufentanyl). INTERVENTIONS: Neurologic examination including the Glasgow Coma Scale, the Assessment to Intensive Care Environment score, cranial nerve examination, response to noxious stimuli, and the cough reflex was performed. MEASUREMENTS AND MAIN RESULTS: Seventy-two patients were included in the initial group and 72 in a subsequent validation study. Neurologic responses were independent of sedative dose. Twenty-two patients in the development cohort and 21 (29%) in the validation group died within 28 days of inclusion. Adjusted for Simplified Acute Physiology Score II score, absent cough reflex was independently associated with 28-day mortality in the development (adjusted odds ratio [OR], 7.80; 95% confidence interval [CI], 2.00-30.4; p = .003) and validation groups (adjusted OR, 5.44; 95% CI, 1.35-22.0; p = .017). Absent oculocephalic response, adjusted for Simplified Acute Physiology Score II score, was independently associated with altered mental status after the withdrawal of sedation in the development (adjusted OR, 4.54; 95% CI, 1.34-15.4; p = .015) and validation groups (adjusted OR, 6.10; 95% CI, 1.18-25.5; p = .012). CONCLUSIONS: Assessment of brainstem responses is feasible in sedated critically ill patients and loss of selected responses is predictive of mortality and altered mental status.