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.

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.

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.

Is dual-phase C-arm CBCT sufficiently accurate for the diagnosis of colorectal cancer liver metastasis during liver intra-arterial treatment?

PURPOSE: This study aimed to estimate the accuracy of dual-phase C-arm cone beam computed tomography (CBCT) for the detection of colorectal cancer liver metastases, as compared with multidetector computed tomography (MDCT). MATERIALS AND METHODS: Between March 2014 and December 2016, 49 consecutive patients referred for intra-arterial treatment for colorectal cancer liver metastases were enrolled in a single-center observational study. All patients were examined with MDCT and with dual-phase C-arm cone beam computed tomography performed after iodine injection in the proper hepatic artery before intra-arterial treatment. Two blinded observers independently reviewed all examinations. Diagnostic accuracy was determined using both a six-cell matrix method and a "worst-case scenario." RESULTS: Readers identified at MDCT 264 colorectal liver metastases and 43 other liver lesions. The early and late arterial phase showed 240 and 277 liver lesions respectively. A certainty of the diagnosis was obtained in 63% and 85% at the early (EAP) and late arterial phase (LAP), respectively. Streak artifacts or liver segment truncation, or inadequate enhancement was responsible for the inability to see or to correctly adjudicate a lesion to a diagnosis in 27% and 15% of the cases at the EAP and LAP. The "worst-case scenario" yielded a Se and Sp of 58% and 51%, respectively, at EAP and 84% and 70%, respectively, at LAP. CONCLUSION: On CBCT, EAP showed limited accuracy. LAP provided the best tumor detectability. KEY POINTS: • The early arterial phase (EAP) yielded poor accuracy: Se = 58% and Sp = 51% (p < 0.0001). • The late arterial phase (LAP) phase yielded good accuracy: Se = 84% and Se = 70% (p = 0.02). • The probability of a correct diagnosis at the EAP was 60%.

Can cone-beam CT tumor blood volume predicts the response to chemoembolization of colorectal liver metastases? Results of an observational study.

PURPOSE: To determine whether intraprocedural C-arm cone-beam CT (CBCT) parenchymal blood volume (PBV) can predict the response of colorectal cancer liver metastases (CRCLM) 2 months after irinotecan drug-eluting bead (DEBIRI) chemoembolization. MATERIALS AND METHODS: This single-center observational study was compliant with the Helsinki Declaration and approved by our institutional review board. Thirty-four consecutive CRCLM patients referred for DEBIRI chemoembolization were enrolled between March 2015 and December 2016. Tumor size was assessed at baseline and 2 months after DEBIRI chemoembolization by multidetector CT (Response Evaluation Criteria in Solid Tumors RECIST 1.0), and PBV was measured before and after DEBIRI chemoembolization. Two independent readers reviewed all data. We determined the potential correlation (Spearman's rank correlation) between intraprocedural PBV values and tumor response at 2 months. The relationship between tumor response and PBV was studied using a mixed model. A logistic regression model was applied to study the relationship between patient "Responder/Non-responder" and PBV. RESULTS: There was a strong correlation between baseline PBV or the percent change of PBV and the 2-month tumor response (rho = - 0.8587 (p = 0.00001) and rho = 0.8027 (p = 0.00001), respectively). The mixed model showed that an increase of 1 ml/1000 ml in PBV of a tumor before DEBIRI chemoembolization led to a 0.54 mm decrease in diameter (p < 0.005). A 1% decrease in PBV after DEBIRI chemoembolization resulted in tumor shrinkage of 0.75 mm (p < 0.005). The logistic regression model showed that patients with a 1% smaller mean decrease of PBV after DEBIRI chemoembolization had a 10% lower likelihood of achieving disease control (OR = 0.9, 95% confidence interval (CI) = 0.81-1; p = 0.0493). CONCLUSION: Intraprocedural PBV may predict tumor response to DEBIRI chemoembolization. KEY POINTS: • There is a strong relationship between the parenchymal blood volume (PBV) of colorectal liver metastases before DEBIRI chemoembolization and tumor response at 2 months. • Higher PBV values before DEBIRI chemoembolization correlate with greater tumor shrinkage, but only if the PBV decreases by more than 70% after DEBIRI chemoembolization. • Each increase of 1% in the mean decrease of PBV after DEBIRI chemoembolization resulted in a 10% lower likelihood of achieving disease control (OR = 0.9, 95% confidence interval (CI) = 0.81-1; p = 0.0493).

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.

Multiparametric optical and MR imaging demonstrate inhibition of tumor angiogenesis natural history by mural cell therapy.

PURPOSE: To determine whether functional imaging using MRI and fibered confocal fluorescence microscopy (FCFM) could be used to monitor cell therapy by mural progenitor cells (MPC). METHODS: Fifty mice bearing TC1 murine xenograft tumors were allocated into: control (n = 17), sham (phosphate buffer saline, n = 16), and MPC-treated (MPC, n = 17) groups. MRI was performed before (D0 ) and 7 days (D7 ) after injection measuring tumor size, R2 * under air, oxygen, and carbogen using blood oxygen level dependent (BOLD) and f (fraction linked to microcirculation), D* (perfusion related coefficient) and Dr (restricted diffusion coefficient) using diffusion-weighted sequences based on the IVIM (intravoxel incoherent motion) method. FCFM was performed at D7 measuring "index leakage" (capillary permeability). RESULTS: Tumor growth was significantly slowed down in the MPC-treated animals (P = 0.002) on D7 . R2 *air significantly decreased in controls between D0 and D7 (P = 0.03), reflecting a decrease in tumor oxygenation. ΔR2 *O2CO2 significantly increased in controls between D0 and D7 (P = 0.01) reflecting loss of vessel response to carbogen. D* significantly decreased in controls between D0 and D7 (P = 0.03). Finally, "index leakage" was lower in the MPC-treated tumors (P = 0,009). CONCLUSION: Treatment by MPC resulted in slowing down of tumor growth, capillary permeability decrease, and stabilization of tumor angiogenesis.

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.

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.

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.

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.

Neuroblast survival depends on mature vascular network formation after mouse stroke: role of endothelial and smooth muscle progenitor cell co-administration.

Pro-angiogenic cell-based therapies constitute an interesting and attractive approach to enhancing post-stroke neurogenesis and decreasing neurological deficit. However, most new stroke-induced neurons die during the first few weeks after ischemia, thus impairing total recovery. Although the neovascularization process involves different cell types and various growth factors, most cell therapy protocols are based on the biological effects of single-cell-type populations or on the administration of heterogeneous populations of progenitors, namely human cord blood-derived CD34(+) cells, with scarce vascular progenitor cells. Tight cooperation between endothelial cells and smooth muscle cells/pericytes is critical for the development of functional neovessels. We hypothesized that neuroblast survival in stroke brain depends on mature vascular network formation. In this study, we injected a combination of endothelial progenitor cells (EPCs) and smooth muscle progenitor cells (SMPCs), isolated from human umbilical cord blood, into a murine model of permanent focal ischemia induced by middle cerebral artery occlusion. The co-administration of SMPCs and EPCs induced enhanced angiogenesis and vascular remodeling in the peri-infarct and infarct areas, where vessels exhibited a more mature phenotype. This activation of vessel growth resulted in the maintenance of neurogenesis and neuroblast migration to the peri-ischemic cortex. Our data suggest that a mature vascular network is essential for neuroblast survival after cerebral ischemia, and that co-administration of EPCs and SMPCs may constitute a novel therapeutic strategy for improving the treatment of stroke.

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.

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.

"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.

PSGL-1-mediated activation of EphB4 increases the proangiogenic potential of endothelial progenitor cells.

Endothelial progenitor cell (EPC) transplantation has beneficial effects for therapeutic neovascularization; however, only a small proportion of injected cells home to the lesion and incorporate into the neocapillaries. Consequently, this type of cell therapy requires substantial improvement to be of clinical value. Erythropoietin-producing human hepatocellular carcinoma (Eph) receptors and their ephrin ligands are key regulators of vascular development. We postulated that activation of the EphB4/ephrin-B2 system may enhance EPC proangiogenic potential. In this report, we demonstrate in a nude mouse model of hind limb ischemia that EphB4 activation with an ephrin-B2-Fc chimeric protein increases the angiogenic potential of human EPCs. This effect was abolished by EphB4 siRNA, confirming that it is mediated by EphB4. EphB4 activation enhanced P selectin glycoprotein ligand-1 (PSGL-1) expression and EPC adhesion. Inhibition of PSGL-1 by siRNA reversed the proangiogenic and adhesive effects of EphB4 activation. Moreover, neutralizing antibodies to E selectin and P selectin blocked ephrin-B2-Fc-stimulated EPC adhesion properties. Thus, activation of EphB4 enhances EPC proangiogenic capacity through induction of PSGL-1 expression and adhesion to E selectin and P selectin. Therefore, activation of EphB4 is an innovative and potentially valuable therapeutic strategy for improving the recruitment of EPCs to sites of neovascularization and thereby the efficiency of cell-based proangiogenic therapy.

Coadministration of endothelial and smooth muscle progenitor cells enhances the efficiency of proangiogenic cell-based therapy.

Cell-based therapy is a promising approach designed to enhance neovascularization and function of ischemic tissues. Interaction between endothelial and smooth muscle cells regulates vessels development and remodeling and is required for the formation of a mature and functional vascular network. Therefore, we assessed whether coadministration of endothelial progenitor cells (EPCs) and smooth muscle progenitor cells (SMPCs) can increase the efficiency of cell therapy. Unilateral hindlimb ischemia was surgically induced in athymic nude mice treated with or without intravenous injection of EPCs (0.5 x 10(6)), SMPCs (0.5 x 10(6)) and EPCs+SMPCs (0.25 x 10(6)+0.25 x 10(6)). Vessel density and foot perfusion were increased in mice treated with EPCs+SMPCs compared to animals receiving EPCs alone or SMPCs alone (P<0.001). In addition, capillary and arteriolar densities were enhanced in EPC+SMPC-treated mice compared to SMPC and EPC groups (P<0.01). We next examined the role of Ang-1/Tie2 signaling in the beneficial effect of EPC and SMPC coadministration. Small interfering RNA directed against Ang-1-producing SMPCs or Tie2-expressing EPCs blocked vascular network formation in Matrigel coculture assays, reduced the rate of incorporated EPCs within vascular structure, and abrogated the efficiency of cell therapy. Production of Ang-1 by SMPCs activates Tie2-expressing EPCs, resulting in increase of EPC survival and formation of a stable vascular network. Subsequently, the efficiency of EPC- and SMPC-based cotherapy is markedly increased. Therefore, coadministration of different types of vascular progenitor cells may constitute a novel therapeutic strategy for improving the treatment of ischemic diseases.