Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). MATERIALS AND METHODS: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. RESULTS: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. CONCLUSION: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Repeat Prostatic Artery Embolization with the Addition of a Liquid Embolic Agent: Short-term Results.

RATIONALE AND OBJECTIVES: The long-term effectiveness of prostatic artery embolization (PAE) can be hampered by the recanalization of the previously embolized prostatic arteries (PA). The use of a liquid embolic agent (LEA) could limit this risk. The purpose of this study was to assess the safety and efficacy of repeat PAE (rePAE) using a LEA (Squid Peri) coupled with microspheres in patients experiencing recurring symptoms after initial embolization. MATERIALS AND METHODS: This retrospective single-center study included all consecutive patients who underwent rePAE using Squid Peri coupled with microspheres. Angiographic patterns of prostatic revascularization were identified. Outcomes were assessed at the 3-month follow-up using the International Prostate Symptom Score (IPSS) and the Quality of Life (QoL) score. The primary endpoint was clinical success defined as an IPSS < 18 with > 25% decrease and a QoL score ≤ 3 with ≥ 1 point decrease. Safety was assessed by using the modified Clavien-Dindo classification. RESULTS: 30 consecutive men (mean age: 67.1 ± 9.5 years) were included. Recanalization of the previously embolized PA was found in 83.3% of patients. Technical success was 93.3%. Median follow-up was 4.9 months [IQR: 3.9 - 9.8]. Clinical success rate was 76.7%, with a mean decrease in IPSS of -9.3 ± 7.3 (p < 0.001) and a median decrease in QoL of -2 [IQR: - 4 - - 1] (p < 0.001). One patient presented with an acute urinary retention requiring readmission (grade IIIa complication). CONCLUSION: Repeat PAE using Squid Peri coupled with microspheres is safe and effective for patients with recurring symptoms after initial embolization.

Exploring a Novel Technique to Tackle the Shortage of Devices for Hepatic Arterial Infusion Chemotherapy: Early Results of an Alternate Approach for Percutaneous Arterial Port Catheter Placement.

Dedicated catheters for hepatic arterial infusion chemotherapy were removed from the market. The purpose of this study was to assess the results of a novel approach to overcome the shortage of dedicated catheters for hepatic arterial infusion chemotherapy in the treatment of colorectal cancer liver metastases. We retrospectively included patients who underwent a percutaneous placement of a hepatic intra-arterial port catheter in a single tertiary center from February 2021 to June 2022. We examined the patient baseline characteristics, technical features of the modified procedures, technical success rates, complications and oncological outcomes. Fourteen patients (median age: 60 years; q1 = 54; q3 = 70; range: 53-81 years) underwent 15 modified procedures. The main modification of our placement technique consisted of the use of an indwelling 5-Fr Vertebral catheter, on the tip of which we created a two-sided additional lateral hole. The catheter was connected to a pediatric port. The primary success rate was 100%, and the secondary success rate was 93.3%. There were two late major complications, graded IIIa according to the Clavien-Dindo classification. The median liver progression free survival was 6.1 months (q1 = 2.5; q3 = 7.2; range: 1.3-11.6). Our experience suggests that the derived utilization of the devices used routinely in interventional radiology provides an effective solution that can compensate for the shortage of dedicated devices.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

Benefits of Repeat Prostatic Artery Embolization on Persistent or Recurrent Lower Urinary Tract Symptoms in Patients with Benign Prostatic Hyperplasia.

OBJECTIVES: To evaluate the benefits of repeat prostatic artery embolization (rePAE) for patients with persistent or recurrent symptoms after initial prostatic artery embolization (PAE). MATERIALS AND METHODS: This is a single-center retrospective study of all patients who underwent a rePAE between December 2014 and November 2020 for persistent or recurrent lower urinary tract symptoms. Symptoms were assessed before and after PAE and rePAE, using the International Prostate Symptom Score and quality of life (QoL) questionnaires. Patient characteristics, anatomical presentations, technical success rates, and complications of both procedures were collected. Clinical failure was defined as one of the following: less than 2 points' decrease in QoL, a QoL score higher than 3, acute urinary retention, and secondary surgery. RESULTS: A total of 21 consecutive patients (mean age: 63.8 ± 8.1; [40-75] years) who underwent rePAE were included. The median follow-up after PAE was 27.7 [18.1-36.9]) months and 8.9 [3.4-10.8] months after rePAE. rePAE was performed at a mean of 19 ± 11.1 [6.9-49.6] months following PAE, and the overall clinical success rate was 33% (7/21). In patients undergoing rePAE because of persistent symptoms, the clinical success rate (18%) was non-significantly lower than that for patients treated for recurrent symptoms (50%) [OR 4.5 (95% CI 0.63-32 P = 0.13)]. The main anatomical revascularization pattern was recanalization of the native prostatic artery (29/45, 66%). CONCLUSION: Patients who experience recurrent symptoms after PAE may benefit more from rePAE than those with persistent symptoms after PAE. Clinical success rates seem to be relatively low in both clinical scenarios.

Long-term outcomes of prostate artery embolization for acute urinary retention: An analysis of 88 patients.

PURPOSE: The purpose of this study was to assess long-term outcome of prostate artery embolization (PAE) in patients presenting with acute urinary retention related to benign prostatic hyperplasia. MATERIALS AND METHODS: All consecutive patients who underwent PAE for acute urinary retention due to benign prostatic hyperplasia from August 2011 to December 2021 in a single institution were retrospectively included. There were 88 men with a mean age of 72 ± 12 (standard deviation [SD]) years (range: 42-99 years). Patients underwent a first attempt of catheter removal two weeks after PAE. Clinical success was defined as the absence of acute urinary retention recurrence. Correlations between long-term clinical success and patient variables or bilateral PAE were searched for using Spearman correlation test. Catheter-free survival was assessed using Kaplan-Meier analysis. RESULTS: Successful catheter removal in the month following PAE was performed in 72 (72/88; 82%) patients and 16 (16/88; 18%) patients had immediate recurrence. Clinical success persisted for 58 (58/88; 66%) patients at long-term follow-up (mean follow-up: 19.5 months ± 16.5 [SD]; range: 2-74 months). Recurrence occurred at a mean of 16.2 months ± 12.2 (SD) (range: 1.5-43 months) post-PAE. Overall, 21 (21/88; 24%) patients of the cohort underwent prostatic surgery, at a mean of 10.4 months ± 12.2 (SD) (range: 1.2-42.4 months) from initial PAE. No correlations between patients variables or bilateral PAE and long-term clinical success were identified. Kaplan-Meier analysis showed a three-year catheter free probability of 60%. CONCLUSION: PAE is a valuable technique for acute urinary retention related to benign prostatic hyperplasia, with a long-term success rate of 66%. However acute urinary retention relapse affects 15% of patients.

Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study.

BACKGROUND: Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter. This open-label prospective single-center study was conducted on 40 consecutive patients requiring temporary or permanent IVC filtration. Patient characteristics, technical success rates of filter placement and removal, and the occurrence of complications were assessed. Follow-up imaging was performed using CT-scan before retrieval or at 6 months in the permanent indication population. RESULTS: The filter was successfully implanted at the intended location in all the patients. Retrieval was attempted in 21 (52.5%) patients after a mean period of 50 days (range: 6-94 days), and the filter was successfully removed in 18 patients (85.7%). Reason for retrieval failure was filter with trapped thrombus (n = 2) and a > 15° tilt (n = 1). No complication was observed during the filter placement and retrieval. Follow-up imaging available in 30 patients (75%) demonstrated deep filter penetration (> 3 mm) in four patients (13.3%), severe filter tilt (> 15o) in five patients (16.7%), filter with trapped thrombus in three patients (10%), but no fracture or IVC thrombosis. CONCLUSION: This prospective study showed encouraging preliminary results of the safety and efficacy of the Venatech® retrievable IVC filter. The filter was easily delivered in the intended position and successfully removed in a high percentage of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02674672.

Prostate artery chemoembolization in prostate cancer: A proof of concept study in spontaneous prostate cancer in a canine model.

PURPOSE: The purpose of this study was to assess the feasibility and efficacy of docetaxel-loaded bead chemoembolization in spontaneous prostate cancer in a canine model. MATERIALS AND METHODS: Five pet dogs with histopathologically proven prostate cancer were referred for prostate artery chemoembolization (PACE). After PACE, all animals were followed, including pharmacokinetic study and clinical and biological evolution, until death. Pelvic contrast-enhanced computed tomography examination was performed at one and two months. Animals were subjected to pathological examination after death. RESULTS: Both prostate arteries were successfully chemoembolized in all dogs. A median dose of 18 mg (Q1, Q3; 11.8, 20 mg) docetaxel loaded in 3 mL of 50-100 µm super absorbent polymer beads was injected into each dog. At one month, four of the five dogs were still alive and the median prostate volume was 51% lower (prePACE median prostate volume, 18.4 mL [Q1, Q3; 12, 32.1 mL] vs. postPACE median prostate volume, 6.2 mL [Q1, Q3; 6.2, 11 mL]). At two months, three dogs died because of disease progression. The two remaining dogs showed a 70% median decrease in prostate volume. Prostate pathological examination showed 73% of necrosis. No worsening of urinary symptoms was observed. Pharmacokinetic analysis showed limited systemic passage of docetaxel. All dogs died of metastatic spread at nine months. CONCLUSION: This study suggests that PACE is feasible and safe for the treatment of spontaneous prostate cancer in a canine model and may provide a new approach to treat selected patients with prostate cancer.

Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A Multicenter Prospective Study.

PURPOSE: To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization. MATERIALS AND METHODS: This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months). RESULTS: The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items. CONCLUSIONS: EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.

"Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia.

PURPOSE: Restenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: Between November 2016 and November 2017, 30 consecutive patients (mean 68.8 ± 12.7 years, 6 female) with BTK lesions and CLI were included in this single-centre, prospective non-randomized cohort study. All patients with rest pain and/or ischemic wound associated with BTK lesions were included in the study. Mean lesion length was 133.6 ± 94.5 mm and 18(60%) were chronic total occlusions. The primary safety outcome parameter was a composite of all-cause mortality and major amputation at 6 months. The primary efficacy outcome parameter was the primary angiographic patency at 6 months (defined as freedom from clinically driven target lesion revascularization and the absence of significant restenosis (> 50%) as determined by core laboratory angiography assessment. Immediate technical success, late lumen loss (LLL), clinical target lesion revascularization (TLR) and ulcer healing rates at 12 months were also evaluated. RESULTS: Immediate technical success was 97%(29/30): one patient had an acute thrombosis at the completion of index procedure. Primary safety outcome parameter was 94%(28/30): one patient underwent major amputation and one patient died of other comorbidities at 2 months. Another patient had a major amputation at 7.5 months. Angiographic follow-up was available in 20 patients. Primary angiographic patency was 57%(12/21 lesions), and LLL was 0.99 ± 0.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months. CONCLUSION: Ranger DCB balloons to treat CLI patients demonstrated a positive trend with good safety outcomes parameters. Further randomized studies are needed to understand the usefulness compared to POBA.

Association between intravesical prostatic protrusion and clinical outcomes in prostatic artery embolization.

PURPOSE: To evaluate the influence of intravesical prostatic protrusion (IPP) on clinical outcomes after prostatic artery embolization (PAE) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: All consecutive patients who underwent PAE for lower urinary tract symptoms between January 2017 and January 2019 were retrospectively included. IPP was evaluated on pre-treatment magnetic resonance imaging examination and symptoms were assessed at follow-up consultations using the international prostate symptom score (IPSS) and quality of life (QOL) questionnaire. IPPs were classified as grade 1 (<5mm), grade 2 (5-10mm), or grade 3 (>10mm). RESULTS: A total of 160 consecutive men (mean age 65±7.8 [SD] years; range: 45-89 years), underwent PAE. The mean IPSS was 21±7.3 (SD) (range: 5-35) and prostate volume 87±38 (SD) mL (range: 30-200mL). The IPP grade was 1 for 28 (28/160; 18%), 2 for 52 (52/160; 33%), and 3 for 80 (80/160; 50%) patients. There were no significant differences in IPSS at baseline between the three IPP grades. Patients with severe (grade 3) IPP had a significantly higher reduction in IPSS than those with non-severe IPP (grade 1 or 2), with estimated mean reductions of 12±2.5 (SD) (range: -4-28) and 8.3±1.9 (SD) (range: -8-21) (P=0.02), respectively. The mean reduction in the QOL score was 3.0 for grade 3 and 2.0 for grade 1 or 2 IPP (P=0.02). CONCLUSIONS: The degree of IPP does not limit the efficacy of PAE in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.

Repeat Prostatic Artery Embolization.

This is a single-center retrospective analysis of 3 patients (mean age, 61 y ± 8.6) who underwent repeat prostatic artery (PA) embolization (PAE; rPAE) because of clinical failure after PAE. Revascularization of the central gland through a recanalized PA was the most frequent pattern observed (5 of 7; 71.4%), followed by revascularization through penile collateral vessels (2 of 7; 28.6%). Technical success during rPAE was achieved in 5 hemiprostates (83.3%). Clinical success at 6 months after rPAE was achieved in 2 of 3 patients (66.6%). Implications of these findings could be valuable to those performing PAE.

Contrast-Enhanced Ultrasonography for the Early Evaluation of Prostate Artery Embolization.

AIM: To prospectively evaluate the feasibility and reproducibility of the semiquantitative measurement of the unenhanced area of the prostate by trans-abdominal contrast-enhanced ultrasound (CEUS) performed immediately after prostate artery embolization (PAE) as a prognostic factor of success. METHODS: Thirty-nine patients with PAE were prospectively included. They all underwent pre- and post-PAE trans-abdominal prostate CEUS. Two readers independently evaluated the pre- and post-PAE unenhanced area using a semiquantitative method: unenhanced areas were measured on 3 different slices (basis, middle, and apex) and reported to the whole prostate area. The mean of the three measures was reported semiquantitatively in classes of ten percent and quartiles. We evaluated correlation with clinical success, at 3 months after PAE, defined as a > 25% reduction in the International Prostatic Symptoms Score and a Quality of life < 3. RESULTS: Twenty-three patients who had bilateral PAE were analyzed. Pre-PAE trans-abdominal prostate CEUS showed visible early and marked enhancement of the entire prostate in all patients. After PAE, all patients had a semiquantitatively measured unenhanced area > 25%. The semiquantitative measurement was found to be highly reproducible, with an interclass correlation > 0.8. No correlation was found between the area of unenhanced tissue and clinical success evaluated at 3 months. CONCLUSION: Trans-abdominal prostate CEUS performed early after PAE provides reproducible results and is a valuable tool to evaluate unenhanced areas of the prostate. LEVEL OF EVIDENCE: 3, local non random sample.

Does Bead Size Affect Patient Outcome in Irinotecan-Loaded Beads Chemoembolization Plus Systemic Chemotherapy Regimens for Liver-Dominant Colorectal Cancer? Results of an Observational Study.

PURPOSE: We investigated the clinical effects of bead size in irinotecan-loaded beads chemoembolization (DEBIRI) used for treating liver-dominant colorectal cancer. MATERIALS AND METHODS: Between March 2009 and January 2018, all consecutive patients with colorectal cancer liver metastases referred for DEBIRI at our tertiary center were included in an observational study. Patients were treated exclusively with either 100-mg irinotecan-loaded DC beads of 70-150 µm (small bead group or SB) or 100-300 µm (large bead group or LB) in diameter, in addition to systemic therapy. Liver tumor response rate at 3 months, liver and overall progression-free survival (PFS) and overall survival were estimated. RESULTS: In total, 84 patients with liver-dominant progressive disease underwent 232 DEBIRI sessions. Fifty-four patients were treated in the SB group and 30 patients in the LB group. Liver progression-free rates at 3 months were 86.7% for the LB group and 79.6% for the SB group (NS). Median liver-PFS and overall PFS were, respectively, 7.15 months and 7.15 months for the LB group and 7.65 and 7.55 months for the SB group (NS). Median overall survival was 13.04 months for the LB group and 15.59 months for the SB group (p = 0.04). Specific treatment grade 3 + 4 toxicity occurrence was 5 (17%) in the LB group and 20 (37%) in the SB group. CONCLUSION: No significant difference in patient outcome was observed between DEBIRI bead sizes of 70-150 µm and 100-300 µm. A trend toward higher treatment-specific toxicity was observed with the smaller beads.

Four-Year Impact of Voiding and Storage Symptoms in Patients with Benign Prostatic Hyperplasia Treated with Prostatic Artery Embolization.

PURPOSE: To study the subscore improvement in International Prostate Symptom Scores (IPSS) after prostatic artery embolization (PAE). MATERIALS AND METHODS: A single-center retrospective study was carried out with follow-up from December 2013 to July 2019 in 37 consecutive patients (66.0 ± 8.8 years old) who underwent PAE, comparing resultant scores before and after PAE. IPSS were divided into storage (IPSS-s) subscores and voiding (IPSS-v) subscores. The changes between IPSS-s and IPSS-v at 1, 3, 6, and 12 months' follow-up as well as the last follow-up were compared with baseline scores. The changes in percentages of IPSS-s and IPSS-v and the changes in average IPSS-s-to-total IPSS ratios (IPSS-s/IPSS-t) and IPSS-v-to-IPSS-t ratios (IPSS-v/IPSS-t) were also analyzed. RESULTS: In the study population, consisting of 37 patients, IPSS-t significantly decreased from 16.5 ± 7.2 at baseline to 8.3 ± 5.7 at the last follow-up (4 years later) (P < .0001). Additionally, the changes in IPSS-v symptoms were greater than the changes in IPSS-s symptoms at 1, 3, 6, and 12 months' follow-up, reaching a statistical significance at 6 months with a decrease of 72.9% ± 42.4% for IPSS-v and a decrease of 50.1% ± 52.2% for IPSS-s (P = .009). CONCLUSIONS: PAE can successfully reduce both IPSS-s and IPSS-v with predominant IPSS-v reduction. The improvements in both subscores were sustained for up to 4 years of follow-up.

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.

New European Regulation for Medical Devices: What Is Changing?

INTRODUCTION: The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. MATERIALS AND METHODS: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. RESULTS: This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. CONCLUSIONS: In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.