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

PurposeTo 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 MethodsThis 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).ResultsThe 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.ConclusionsEASYX 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.     

Evaluation of a Hydrogel Liquid Embolic Agent in a Porcine Mesenteric Hemorrhage Model

PurposeTo evaluate the ability to achieve hemostasis of a new liquid embolic agent in a porcine mesenteric artery hemorrhage model.Materials and MethodsAn anticoagulated porcine mesenteric artery hemorrhage model was created using a transarterial approach. Arterial hemorrhage was the result of aspiration needle punctures and simultaneous radiofrequency current application. Ten injured mesenteric arteries in 8 swine were treated. The hydrogel liquid embolic agent under investigation, an aqueous-based and in situ polymerizing liquid embolic agent, was used to treat actively bleeding sites. At 7 days, confirmation angiography was performed, followed by necropsy.ResultsThe mesenteric arterial injuries produced persistent and angiographically visible hemorrhage before initiating embolic therapy. Arteriovenous fistulae were observed in 4 cases. Embolization led to hemostasis in 10 of the 10 bleeds (100%). The mean embolic agent delivery time was 5.3 minutes (range, 1–15 minutes) with a mean embolic agent volume of 2.9 mL (range, 0.8–5.2 mL) delivered to achieve hemostasis. Notably, 40% of the treatments embolized the injury in the artery at the treatment site while leaving the native arterial lumen patent for the 7-day term of survival. All animals survived with no clinical evidence of hemorrhage through 7 days. Necropsy did not reveal evidence of ischemia within the bowel, liver, or lung.ConclusionsA new hydrogel liquid embolic agent was found to achieve rapid and durable hemostasis in an animal model of acute mesenteric hemorrhage.     

A Water-Based Liquid Embolic: Evaluation of its Safety and Efficacy in a Rabbit Kidney Model

PurposeTo evaluate a novel aqueous-based liquid embolic (Embrace Hydrogel Embolic System, [HES]) that has been developed to embolize hypervascular tumors by filling the tumor vascular bed and solidifying into a hydrogel. HES was evaluated for embolization safety and efficacy relative to microspheres in a preclinical rabbit kidney model.Materials and MethodsA renal embolization model in New Zealand white rabbits was utilized. Twenty-four rabbits underwent unilateral kidney embolization via the main renal artery with either HES or 40-μm microspheres. Twenty-two rabbits survived the procedure and were monitored for 2, 12, 17.5, or 26 weeks before sacrifice. All rabbits underwent a repeat renal angiogram before necropsy. HES was evaluated for nontarget embolization, safety, and embolization effectiveness as measured by recanalization and viability of embolized tissue.ResultsBoth embolization materials were found to be safe, with targeted tissue necrosis and absence of nontarget embolization. Prenecropsy angiograms found vascular recanalization in 0/14 (0%) HES-embolized kidneys and in 3/8 (38%) microsphere-embolized kidneys (P = .036). Viable kidney tissue was observed in 2/14 (14%) kidneys embolized with HES and 5/8 (63%) kidneys embolized with microspheres (P = .052). All kidneys embolized with microspheres that showed vascular recanalization had viable tissue on histological sections. HES was observed in vessels as small as 10 μm in diameter in histological analysis.ConclusionsHES provided deep, durable vascular bed embolization that resulted in less recanalization and, on an average, less viable target tissue compared with 40-μm microspheres. No systemic effects or nontarget tissue embolization was identified.     

Nontarget Radiopaque Embolic Deposition during Prostatic Artery Embolization

This study evaluated detectable nontarget embolization (NTE) during prostatic artery embolization (PAE) and the safety and efficacy of using radiopaque particles in PAE. Ten patients aged >40 years with prostate glands of >50 mL and refractory lower urinary tract symptoms were analyzed. Unenhanced computed tomography scans at baseline and at 3 months after PAE, using 40–90-μm radiopaque spherical embolic beads, were compared to assess the NTE. Growth models evaluated changes from baseline to 3, 6, and 12 months in International Prostate Symptom Score (IPSS), peak urine flow rate (Qmax), quality of life (QoL), International Index of Erectile Function (IIEF), and postvoid residual (PVR). The IPSS, QoL, and Qmax improved at all time points (P < .05), with no trend in PVR or IIEF. Adverse events that occurred were minor. Radiographic NTE was seen in all patients, correlating at times with postprocedural symptoms (eg, rectal pain). Symptoms were not correlated with the NTE in some patients, whereas other patients remained asymptomatic despite NTE.     

Left Gastric Artery Embolization in Obese,Prediabetic Patients: A Pilot Study

PurposeTo evaluate the effect of left gastric artery embolization (LGAE) on glycated hemoglobin (HbA1c) in a prospective obese, prediabetic cohort.Materials and MethodsThis prospective pilot study included 10 obese, prediabetic patients (7 females and 3 males; mean age 37.5 ± 8.8 years; range 28–51 years) admitted to the Interventional Radiology Unit between January 2017 and June 2018 for LGAE for weight reduction. The main inclusion criteria were body mass index (BMI) >30 kg/m² and HbA1c ranging from 5.7 to 6.4. Body weight, BMI, and HbA1c were assessed for each patient preprocedure and at 6 months postprocedure. Statistical analysis was performed using a paired sample t test.ResultsThe baseline mean body weight, BMI, and HbA1c were 107.4 ± 12.8 kg, 37.4 ± 3.3 kg/m², and 6 ± 0.2, respectively. Concerning complications, no serious adverse events were detected. Six months after the procedure, the mean body weight and BMI significantly decreased to 98 ± 11.6 kg and 34.1 ± 3 kg/m², respectively (P < .0001). A paired sample t test showed a significant reduction in HbA1c from pre- to postprocedure (6.1 ± 0.2 preprocedure vs 4.7 ± 0.6 postprocedure, P < .0001). The mean percent reductions in body weight, BMI, and HbA1c were 8.9% ± 1.2, 8.8% ± 1, and 21.4% ± 8.9, respectively. A statistically significant positive correlation was found between BMI and HbA1c after the procedure (r = 0.91, P = .0002).ConclusionsLGAE is well tolerated and leads to clinically significant decreases in weight and HbA1c in obese, prediabetic patients.     

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis

PurposeTo assess the efficacy and safety of middle meningeal artery (MMA) embolization with liquid embolic agents and the outcomes of patients following this procedure.Materials and MethodsA review of the literature was conducted to identify studies investigating the efficacy and safety of MMA embolization with liquid embolic agents in patients with chronic subdural hematoma (cSDH) in PubMed, Scopus, Embase, and Web of Science. The keywords “liquid embolic agent,” “middle meningeal artery,” “cSDH,” and “embolization” as well as their synonyms were used to build up the search strategy. The R statistical software and random-effects model were used for analysis. Heterogeneity was reported as I², and publication bias was calculated using the Egger test.ResultsOf 628 articles retrieved, 14 studies were eligible to be included in this study. Data of 276 patients were analyzed. n-Butyl cyanoacrylate and ethylene vinyl alcohol copolymer were the most commonly used embolic agents. This study revealed a pooled mortality rate of 0% (95% confidence interval [CI], 0.00%–100%), recurrence and failure rate of 3% (95% CI, 1%–10%), reoperation/reintervention rate of 4% (95% CI, 2%–12%), rate of size decrease of 94% (95% CI, 79%–98%), technical success rate of 100% (95% CI, 76%–100%), and adverse event rate of 1% (95% CI, 0.00%–4%).ConclusionsWith low mortality, recurrence, reoperation, and adverse event rates and a remarkable decrease in the size of hematomas, MMA embolization with liquid embolic agents may be considered a safe and effective treatment option in patients in whom surgical intervention has previously failed and as an alternative to conventional treatments.     

Image-Guided Percutaneous Needle Biopsy for Benign and Malignant Bone Tumors: Systematic Review and Meta-Analysis

PurposeTo compare the diagnostic yield and accuracy of both image-guided core-needle biopsy (CNB) and fine-needle biopsy and evaluate the benefit of performing fine-needle biopsy in addition to CNB in patients with suspected benign and malignant bone tumors.Materials and MethodsA systematic search was performed on March 10, 2021, to determine whether fine-needle aspiration (FNA) plays any role when performed alone or in combination with CNB. The included studies were aggregated for the pooled estimates of diagnostic yield and histologic accuracy of image-guided percutaneous needle biopsy of bone tumors. Twenty-nine studies published between 1996 and 2021 were included.ResultsWhen all patients with bone tumors were included, the rates of diagnostic yield and accuracy of FNA and CNB were 88.5% and 82.5% and 91.4% and 92.7%, respectively; the rates of both the methods combined were 96.5% and 94.1%, respectively; and for the lytic subgroup, the rates of diagnostic yield and accuracy of CNB and both the methods combined were 94.3% and 100% and 98.9% and 90.4%, respectively. A P value of <.05 was considered statistically significant.ConclusionThe present meta-analysis showed that core biopsy alone outperformed fine-needle biopsy alone in all categories of benign and malignant tumors. Additionally, the diagnostic yield was improved when FNA was used in addition to CNB for lytic bone lesions.     

Polyethylene Glycol Drug-Eluting Embolic Microspheres Loaded with Doxorubicin for the Treatment of Hepatocellular Carcinoma: Feasibility,Safety, and Pharmacokinetic Study

PurposePolyethylene glycol drug-eluting microspheres (PEG-DEMs) can be loaded to elute doxorubicin. The current study evaluated the pharmacokinetic profile and safety of PEG-DEMs in the treatment of patients with hepatocellular carcinoma (HCC).Materials and methodsThe current prospective, multicenter, dose-escalation study enrolled 25 patients (68% men) with early or intermediate stage HCC and a performance status of 0. Patients in Cohort I were assigned to receive target doxorubicin doses of 75, 100, or 150 mg. Analyses were performed on the basis of the specific dose of doxorubicin that the patients received because some patients received less than the assigned dose. Patients in Cohort II received the maximum safe tested dose. Adverse events were classified according to the Common Terminology Criteria for Adverse Events version 4.03. The tumor response was evaluated every 3 months according to the European Association for the Study of the Liver criteria and modified Response Evaluation Criteria in Solid Tumors.ResultsThe maximum tested safe dose of doxorubicin was 150 mg. For the groups that received ≤75, 75–100, and 101–150 mg of doxorubicin, the peak plasma concentrations were 286.7 ng/mL ± 220.1, 157.1 ng/mL ± 94.6, and 245.4 ng/mL ± 142.8, respectively; the areas under the curves calculated from 0 to 24 h were 421.7 (ng × h)/mL ± 221.2, 288.1 (ng × h)/mL ± 100.9, and 608.3 (ng × h)/mL ± 319.3, respectively, with almost complete clearance at 24 h. There was no death within 30 d. The best objective response rate was 81%, and the disease control rate was 91%. The median overall survival was 27.2 months (95% confidence interval [CI], 17.5 months to not evaluated [n.e.]); the median progression-free survival was 9.8 months (95% CI, 5.5 months to n.e.).ConclusionsPEG-DEMs demonstrated a favorable safety profile with low systemic concentration of doxorubicin, and promising efficacy.     

Transcatheter Arterial Embolization for Benign Chronic Inflammatory Joint Pain: A Systematic Review and Meta-Analysis

PurposeTo evaluate the efficacy and safety of transcatheter arterial embolization (TAE) for the treatment of chronic inflammatory joint pain via systematic review and meta-analysis.Materials and MethodsMEDLINE and EMBASE databases were searched for studies reporting outcomes in patients with chronic inflammatory joint pain treated with TAE. Meta-analyses of pain score changes, changes in proportions of patients on analgesic medications, range of motion changes, technical success rates, and adverse events rates were performed. Subgroup analyses were conducted with respect to pain site (knee versus shoulder).ResultsFourteen observational studies, which included 346 patients, were reviewed. The pooled technical success rate was 95.8%, and no major adverse events were observed. The pooled mean difference in pain score at 1 week was 3.1. At 1, 3, and 6 months, the difference in score was 4.0, 4.2, and 5.1, respectively. At 1 year, the difference was 5.5. Subgroup analysis demonstrated that shoulder embolization was associated with greater reduction of pain than knee embolization at 3 and 6 months (P < .001 and P = .018, respectively), whereas there was no significant difference between the sites at 1 month (P = .734). The pooled proportions of patients on analgesic medication at baseline and at 1, 3, 6, and 12 months were 81.1%, 36.3%, 42.3%, 28.2%, and 22.4%, respectively. The pooled estimated increase in the range of motion among patients who underwent shoulder embolization was 55.6° for anterior elevation and 64.7° for abduction.ConclusionsTAE is an effective and safe therapeutic option for patients with chronic inflammatory joint pain.     

Clinical Outcomes of Transarterial Embolization for Chronic Achilles Tendinopathy Refractory to Conservative Treatment: A Pilot Study

PurposeTo evaluate the effectiveness and safety of transarterial embolization (TAE) for chronic Achilles tendinopathy (AT) refractory to conservative treatment.Materials and MethodsThis retrospective study included 20 patients (12 men and 8 women; mean age, 30.3 years) who received TAE using imipenem/cilastatin sodium for refractory chronic AT from May 2019 to April 2021. Nine patients had bilateral involvement. A total of 29 procedures were performed (8 for nonathletes and 21 for athletes). If feasible, embolization was performed superselectively of the arterial branch demonstrating hypervascularity, early venous drainage, and/or supplying the pain site noted using a radiopaque marker. The visual analog scale (VAS, 0–10) score was used to assess pain symptoms at baseline and during the follow-up period (1 day; 1 week; 1, 3, and 6 months; and open period). Clinical success was defined as a decrease of >50% in the VAS score at 6 months when compared with baseline.ResultsIn 25 (86.2%) of 29 procedures, clinical success was achieved. Significant decreases in the VAS scores were noted at 1 day, 1 week, 1 month, 3 months, and 6 months (6.86 at the baseline vs 3.48, 3.41, 3.10, 2.55, and 1.62, respectively; all P < .01). For patients available for the 12- and 24-month follow-ups (n = 19 and 6, respectively), the mean VAS scores significantly decreased (6.84 vs 2.00 and 7.33 vs 1.17, respectively; all P < .01). No serious adverse events were observed during follow-up.ConclusionsTAE may alleviate pain for patients with chronic AT refractory to the conservative treatment with a low risk of adverse events.     

The Safety and Effectiveness of Hepatic Transarterial Embolic Locoregional Therapy in Patients with Contraindications to Hepatectomy after Portal Vein Embolization

The safety and effectiveness of hepatic transarterial embolic locoregional therapy (LRT) was assessed, including transarterial chemoembolization (TACE) and transarterial radioembolization (TARE), in patients who underwent portal vein embolization (PVE) before major hepatectomy in whom surgery was then contraindicated. Adverse events (AEs) were graded according to the Society of Interventional Radiology classification of AEs. Tumor response was assessed based on the Response Evaluation Criteria In Solid Tumors 1.1. Overall survival (OS) and progression-free survival (PFS) were estimated. Fifteen patients underwent 37 transarterial LRTs (25 TACEs, 11 TAREs, and 1 bland embolization), most (73%) with hepatocellular carcinoma. Eleven AEs occurred in 7 patients, including 2 Grade 3/5 (severe) and 2 Grade 4/5 (life-threatening) events. The best response was partial response in 4 (27%) and stable disease in 10 (66%) patients. The median OS and PFS were 42 (95% CI, 35–49 months) and 33 months (95% CI, 24–42 months), respectively. In conclusion, hepatic transarterial LRT can be considered as a therapeutic option in patients with contraindicated liver surgery after PVE.     

Repeat Prostatic Artery Embolization for Patients with Benign Prostatic Hyperplasia

PurposeTo evaluate the safety and efficacy of repeat prostatic artery (PA) embolization (PAE) for benign prostatic hyperplasia (BPH).Materials and MethodsA single-center retrospective study was conducted from 2009 to 2018 in 108 patients with symptomatic BPH treated with repeat PAE: group A (n = 39; 36.1%) were patients who never showed a response to PAE, and group B (n = 69; 63.9%) were patients who had clinical improvement in the first 6 months following PAE but relapsing symptoms afterward. The main patterns of revascularization were 75% from the previously embolized PA and 25% from collateral vessels (superior vesical, posterior-lateral PA, penile branches). Technical outcomes and adverse events were registered. International Prostate Symptom Score (IPSS), quality of life (QOL), and clinical success were compared between groups.ResultsMedian follow-up was 18 months (range, 1–36 mo); median interval between PAE and repeat PAE was 420 days (range, 77–2,240 d). Mean procedural time was significantly longer for repeat PAE vs initial PAE (81.1 min vs 67.4 min; P = .0007). There were no major complications and no urinary incontinence. Mean IPSS/QOL improvements were greater in group B vs group A: 9.51 vs 6.13 and 1.30 vs 0.56, respectively (P < .001). The cumulative probability of clinical success after repeat PAE was higher in group B than in group A (P = .0001): 84.1% vs 46.2% at 1 month, 56.7% vs 28.2% at 12 months, and 51.9% vs 16.9% at 24–36 months.ConclusionsRepeat PAE is safe and effective for recurrence of lower urinary tract symptoms caused by BPH but has limited impact in patients who did not show a response to initial PAE.     

Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation,a Pilot Study

PurposeTo evaluate the feasibility of prostatic artery embolization in patients with low-risk prostate cancer (PC) under active surveillance (AS).MethodsThis monocentric prospective pilot study, running from June 2018 to June 2019, included 10 patients with low-risk PC under AS, median age 72 years (range, 62–77 years), with a unilateral focal lesion visible on magnetic resonance (MR) imaging, with Prostate Imaging Reporting and Data System v2 score ≥3/5 confirmed by multiparametric MR imaging-targeted biopsy and Gleason score 6. The patients underwent unilateral prostatic artery embolization with 300–500 μm Embospheres in the affected prostatic lobe. The primary endpoint was technical feasibility (prostate and no off-target ischemia in the imaging). The secondary endpoints included safety, negative biopsies/MR imaging response/functional outcomes at 6 months, and oncologic efficacy at 1 year.ResultsEmbolization was successfully achieved in all patients; prostate ischemia was confirmed on multiparametric MR imaging, and no off-target ischemia was reported. No major complications were reported. Four patients (40%) presented with both negative targeted and systematic biopsies at 6 months. No lesions were seen on the MR imaging in 30% of patients. The mean International Prostate Symptom Score and International Index of Erectile Function score were 7 and 19 and 5 and 20 at baseline and 6 months, respectively, with no significant difference. Nine patients (90%) were still under AS at 1 year. One patient (10%) had PC progression outside the target lesion and was switched over to curative radiotherapy.ConclusionsProstatic artery embolization is feasible and appears safe for prostate cancer patients under AS, with no impact on erectile function or continence status. These results justify the pursuit of further studies.     

Genicular Artery Embolization to Improve Pain and Function in Early-Stage Knee Osteoarthritis—24-Month Pilot Study Results

Ten patients with painful early-stage knee osteoarthritis underwent transcatheter arterial embolization of neoangiogenic branches from genicular arteries. At 12 months, 6 patients had responded to treatment according to study criteria. Median pain, function, and quality-of-life scores had improved by 15.4%, 21.3%, and 100%, respectively, for the 10 patients. Median 30-second chair stand test and 6-minute walk test scores had improved by 43% and 26%, respectively. No major adverse events occurred. Improvements following transcatheter arterial embolization provide evidence that embolization might be an effective treatment technique for people with early-stage knee osteoarthritis, although more rigorous evaluation is required.     

Prostatic Artery Embolization Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: A Cost-Effectiveness Analysis

PurposeTo compare the cost effectiveness of prostatic artery embolization (PAE) with that of transurethral resection of the prostate (TURP) for the treatment of medically refractory benign prostatic hyperplasia (BPH).Materials and MethodsA cost-effectiveness analysis with Markov modeling was performed, comparing the clinical course after PAE with that after TURP for 3 years. Probabilities were obtained from the available literature, and costs were based on Medicare reimbursements and published cost analyses. Outcomes were measured using quality-adjusted life-year (QALY). Statistical analyses included base case calculation, probabilistic sensitivity analysis, and deterministic sensitivity analysis to assess the robustness of the conclusion under different clinical scenarios.ResultsBase case calculation showed comparable outcomes (PAE, 2.845 QALY; TURP, 2.854 QALY), with a cost difference of $3,104 (PAE, $2,934; TURP, $6,038). The incremental cost-effectiveness ratio was $360,249/QALY. PAE was dominant in 23.2% and more cost effective in 48.4% of the probabilistic sensitivity analysis simulations. PAE was better if its recurrence risk was <20.4% per year and even when the TURP recurrence risk was assumed to be 0%. TURP would be more cost effective when its procedural cost was <$3,367 or the PAE procedural cost >$4,409. PAE remained cost effective when varying the risks and costs of the minor and major short-term or long-term adverse events of both procedures. TURP would be the better strategy if the utility of BPH recurrence was <0.85 QALY.ConclusionsPAE is a cost-effective strategy to treat medically refractory BPH, resulting in comparable health benefits at a lower cost than that of TURP even when accounting for extreme alterations in adverse events, costs, and recurrence rates.     

Results from a United States Investigational Device Study of Adhesive Capsulitis Embolization in the Treatment of Shoulder Pain: The Adhesive Capsulitis Embolization Study

PurposeTo evaluate the safety and efficacy of arterial embolization to relieve shoulder pain secondary to adhesive capsulitis (AC).Materials and MethodsIn total, 20 patients (18 females, 2 males; mean age, 51 years) with AC resistant to >30 days of conservative treatment were enrolled in a multicenter prospective study. Adhesive capsulitis embolization was performed with 75-μm or 200-μm spherical particles. Subjects were assessed before and after the procedure with magnetic resonance imaging, visual analog scale (VAS; 0–100 mm) scores, Single Assessment Numeric Evaluation (SANE; 0–100) scores, and American Shoulder and Elbow Surgeons (ASES; 0–100) scores. Adverse events were recorded at all follow-up time points.ResultsHypervascularity was identified and embolization was technically successful in all patients, with 83 arteries embolized in 20 patients. Baseline VAS, SANE, and ASES scores before the procedure were 89.2 mm, 27.2, and 30.9, respectively. The 1-month (n = 19), 3-month (n = 18), and 6-month (n = 12) follow-ups demonstrated significant improvements. At the 1-month follow-up, VAS score decreased by 31.8 (P = 1.2E?11), SANE score increased by 22.1 (P = 1.8E?8), and ASES score increased by 14.2 (P = 4.3E?5). At the 6-month follow-up, VAS score decreased by 62.1 (P = 7.0E?11), SANE score increased by 55.4 (P = 4.1E?10), and ASES score increased by 44.5 (P = 1.8E?6). Due to the coronavirus pandemic, the study ended early; 6 patients did not complete the 6-month follow-up. No major adverse events were noted.ConclusionsInterim findings suggest that arterial embolization is safe and effective for patients with AC refractory to conservative treatment.     

First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism

PurposeTo prospectively evaluate the initial human experience with an absorbable vena cava filter designed for transient protection from pulmonary embolism (PE).Materials and MethodsThis was a prospective, single-arm, first-in-human study of 8 patients with elevated risk of venous thromboembolism (VTE). Seven absorbable IVC filters (made of polydioxanone that breaks down into H₂O and CO₂ in 6 mo) were placed prophylactically before orthopedic (n = 5) and gynecologic (n = 2) surgeries, and 1 was placed in a case of deep vein thrombosis. Subjects underwent CT cavography and abdominal radiography before and 5, 11, and 36 weeks after filter placement to assess filter migration, embolization, perforation, and caval thrombosis and/or stenosis. Potential PE was assessed immediately before and 5 weeks after filter placement by pulmonary CT angiography.ResultsNo symptomatic PE was reported throughout the study or detected at the planned 5-week follow-up. No filter migration was detected based on the fixed location of the radiopaque markers (attached to the stent section of the filter) relative to the vertebral bodies. No filter embolization or caval perforation was detected, and no caval stenosis was observed. Throughout the study, no filter-related adverse events were reported.ConclusionsImplantation of an absorbable vena cava filter in a limited number of human subjects resulted in 100% clinical success. One planned deployment was aborted as a result of stenotic pelvic veins, resulting in 89% technical success. No PE or filter-related adverse events were observed.     

Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Bleomycin-Eluting versus Bland Microspheres in a Canine Model

PurposeTo prospectively assess safety and efficacy of prostatic artery embolization (PAE) with bleomycin-eluting microspheres for benign prostatic hyperplasia (BPH) in a canine model.Materials and MethodsTwelve adult male beagles (mean age, 1.6 y ± 0.2; range, 1.2–2.0 y) were randomly assigned to group A (n = 6; PAE with bleomycin-eluting 30–60-μm HepaSphere microspheres) and group B (n = 6; PAE with bland 30–60-μm HepaSphere microspheres) between April 2017 and November 2018. Plasma bleomycin concentration in group A was measured within 7 days. Prostate volume (PV) and ischemic volume after PAE were measured by magnetic resonance imaging. Prostates and adjacent organs were harvested after the last magnetic resonance study and histopathologically examined.ResultsPlasma bleomycin concentration peaked at 10 minutes at 2,055.0 ng/mL ± 606.1 and lasted for 1,440 min at low levels after PAE. PV reduction percentage was greater in group A than in group B at 1 month (74.1% ± 4.3 vs 63.7% ± 3.5; P = .006) and 3 months (61.5% ± 6.7 vs 46.1% ± 3.8; P = .001) after PAE. Proportion of prostate ischemic volume was greater in group A than in group B (75.3% ± 3.0 vs 62.0% ± 7.1; P = .006) at 1 month after PAE. Proportion of prostate ischemic volume at 1 month positively correlated with PV percentage reduction at 3 months in group A (r = 0.840, P = .036) and group B (r = 0.844, P = .035). There were no complications or nontarget embolization to surrounding organs after the procedures.ConclusionsIn a canine model, PAE with bleomycin-eluting microspheres was feasible and well tolerated and caused ischemic necrosis and reduction in PV.     

Effectiveness and Safety of Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia in Men with Concurrent Localized Prostate Cancer

PurposeTo assess the effectiveness and safety of prostatic artery embolization (PAE) on lower urinary tract symptoms (LUTS) in the setting of localized prostate cancer (PCa).Materials and MethodsThis was a retrospective, single-center, institutional review board-approved study from December 2016 to June 2020 of 21 patients (median age, 72; range, 63–83 years) with moderate LUTS and localized PCa. Clinical effectiveness was evaluated at 6 and 12 weeks using International Prostate Symptom Score (IPSS) and quality of life (QoL) improvement. Seventeen patients were scheduled to receive definitive radiotherapy (RT) after PAE; 13 patients completed RT. Short-term imaging signs of oncologic progression were evaluated at 6 and 12 weeks defined by at least one of the following on magnetic resonance imaging: increased Prostate Imaging-Reporting and Data System score of index lesion(s) to at least 4, new extracapsular extension, seminal vesicle involvement, or pelvic lymphadenopathy. Nonparametric Wilcoxon signed-rank test was used for analysis.ResultsIPSS improved by a median of 12 (n = 19, P < .0001) and 14 (n = 14, P < .0001) at 6 and 12 weeks, respectively. QoL improved by a median of 2 (n = 19, P < .0001) and 3 (n = 3, P < .0001) at 6 and 12 weeks. Prostate volume decreased by a median of 24% (n = 19, P < .0001) and 36% (n = 12, P = .015) at 6 and 12 weeks. No patients demonstrated disease progression at 6 (n = 16) or 12 (n = 8) weeks by imaging. No patients experienced increased prostate-specific antigen after RT, grade ≥3 adverse events, or greater genitourinary toxicity.ConclusionsPAE is effective and safe for the treatment of men with LUTS from benign prostatic hyperplasia in the setting of concomitant, localized, non-obstructive PCa.     

Transarterial Embolization of Neovascularity for Refractory Nighttime Shoulder Pain: A Multicenter,Open-Label,Feasibility Trial

PurposeTo assess the feasibility of transarterial embolization (TAE) for recalcitrant nighttime shoulder pain in a multicentric study.Materials and MethodsThis prospective, open-label, feasibility trial included 100 patients treated at 5 institutions. TAE was performed in 76 patients with adhesive capsulitis (AC) and 24 patients with symptomatic rotator cuff tears (sRCTs). The ipsilateral radial artery was punctured, and imipenem/cilastatin sodium was infused as an embolic agent. Adverse events, 10 point pain numerical rating scale (NRS), range of motion (ROM) of the shoulder joint, and quality of life (via the EuroQol-5D [EQ-5D]) were evaluated.ResultsAll patients exhibited neovascularity on baseline angiography, and all TAE procedures were performed successfully. No patient experienced a major adverse event. The mean nighttime pain NRS scores at baseline and 1, 3, and 6 months after TAE were 6.4 ± 2.2, 3.4 ± 2.6, 2.3 ± 2.5, and 1.6 ± 2.2, respectively (for all, P < .001). The mean ROM of anterior elevation at baseline and 1, 3, and 6 months after TAE were 97° ± 29°, 119° ± 28°, 135° ± 27°, and 151° ± 17°, respectively (for all, P < .001). The mean EQ-5D scores at baseline and 1, 3, and 6 months after TAE were 0.63 ± 0.17, 0.73 ± 0.16, 0.80 ± 0.17, and 0.84 ± 0.17, respectively (for all, P < .001). There was no significant difference in the clinical success rate between the AC and sRCT groups.ConclusionsTAE for nighttime shoulder pain caused by AC and sRCTs was feasible with sufficient safety and efficacy.