VenaTech Convertible Vena Cava Filter 6 Months after Conversion Follow-up

PurposeTo report device-related adverse events 6 months after placement or conversion of the VenaTech convertible vena cava filter (VTCF).Materials and MethodsA review of 6-month follow-up data of an investigational device exemption multicenter, prospective, single-arm study was performed. The VTCF was implanted in 149 patients. Conversion was attempted in 64.4% of those patients (n = 96) and successfully in 96.9% of the patients (n = 93). A total of 76 patients completed imaging evaluation at 6 months after filter conversion. Patients who required continued venous thromboembolism prophylaxis at 6 months did not undergo a conversion attempt and were designated as nonconverted filter subjects. A total of 28 nonconverted filter subjects completed imaging evaluation at 6 months after implantation.ResultsEvaluation of patients at 6 months after conversion demonstrated 1 of 76 (1.3%) inferior vena cava (IVC) perforations with a filter strut greater than 3 mm outside of the caval lumen. No cases of recurrent PE, clinically significant filter migration, filter fracture, or IVC thrombosis were reported in the converted subjects. In the nonconverted filter subjects, there was a 14.3% (4 of 28) complete or nearly complete rate of IVC thromboses. There were no cases of recurrent pulmonary embolism, penetration, fracture, or spontaneous conversion in the nonconverted filter subjects. There was a significant reduction in the rate of IVC thrombosis and migration in the converted cohort compared to that in the nonconverted cohort.ConclusionsAt 6 months, the VTCF demonstrated low adverse event rates in the converted configuration, whereas a minority of patients with the nonconverted configuration demonstrated a high risk of IVC thrombosis.     

Stability of Retained Inferior Vena Cava Filter Fragments after Filter Removal

PurposeTo assess the stability and outcome of fractured inferior vena cava (IVC) filter fragments that are retained in patients after IVC filter removal.Materials and MethodsA retrospective analysis was conducted on all patients at a single tertiary referral center between May 2005 and June 2020 with fractured IVC filters where fragment(s) were retained after removal of the main filter body. IVC filter fragment stability was assessed by a clinician review of computed tomography images, chosen from available radiologic studies, to best visualize the fragments. Data collected included filter type, fragment location, duration of fragment follow-up, fragment stability in location, and further fragment fracture or clinical sequelae.ResultsSeventy-seven patients with retained IVC filter fragment(s) after complex filter removal were identified. Of this, 37 patients (14 men, 23 women) were deemed to have adequate imaging follow-up to assess positional stability of the retained fragments, whereas the remainder were excluded from further analysis. Excluding fractured foot processes, 51 separate filter fragments were retrospectively identified and followed for a median duration of 726 days (interquartile range, 843 days; range, 28–3353 days). Filter designs producing the studied fragments included Celect, G2, Recovery, Günther, OptEase, Meridian, and G2X/Eclipse. In all, 50 of 51 (98%) fragments were found to be unchanged in position during their respective intervals of observation. One fragment displayed a rotational change without migrating from its original location. No further fragment fractures or clinical sequelae were observed among the group.ConclusionsWhen asymptomatic, retained IVC filter fragments are predominantly stable and can be safely followed on an intermediate-term basis.     

Prostatic Artery Embolization Using 100–300-μm Trisacryl Gelatin Microspheres to Treat Lower Urinary Tract Symptoms Attributable to Benign Prostatic Hyperplasia: A Single-Center Outcomes Analysis with Medium-Term Follow-up

PurposeTo report medium-term outcomes of prostatic artery embolization (PAE) using 100–300-μm trisacryl gelatin microspheres to treat lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) and to evaluate how cone-beam computed tomography-measured prostate gland volume (PGV), median lobe enlargement (MLE), age, and Charlson Comorbidity Index (CCI) affect these results.Materials and MethodsSeventy-four consecutive patients who underwent PAE from April 2014 through August 2018 were retrospectively reviewed. Patients had International Prostate Symptom Score (IPSS) >12, Quality of Life (QoL) score >2, prostate gland volume (PGV) >40 mL, age older than 45 years, and medical therapy failure. Twelve patients were excluded for bladder pathology or prostate cancer. Patients (n = 62, age = 71.8 ± 9.3 years, CCI = 3.5 ± 1.7, PGV = 174 ± 110 mL) had pre-procedure IPSS = 22.4 ± 5.6, QoL score = 4.4 ± 0.9, and post-void residual (PVR) = 172 ± 144 mL. Post-procedure values were compared to baseline at 1, 3, 6, 12, and 24 months. Associations between outcomes and PGV, MLE, age, and CCI were evaluated. Adverse event recording used Clavien-Dindo classification.ResultsOne month after PAE (n = 37), IPSS improved to 7.6 ± 5.2 (P < .0001) and QoL score improved to 1.7 ± 1.4 (P < .0001). At 3 months (n = 32), improvements continued, with IPSS = 6.4 ± 5.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 53 ± 41 mL (P < .001), and PGV = 73 ± 38 mL (P < .0001). Results were sustained at 6 months (n = 35): IPSS = 6.4 ± 4.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 68 ± 80 mL (P < .0001), PGV = 60 ± 19 mL (P < .001). At 12 months, patients (n = 26) had IPSS = 7.3 ± 5.5 (P < .0001), QoL score = 1.2 ± 0.8 (P <.0001), PVR = 89 ± 117 mL (P < .0001), PGV = 60 ± 48 mL (P < .01). At 24 months, patients (n = 8) had IPSS = 8.0 ± 5.4 (P < .0001), QoL score = 0.7 ± 0.5 (P < .0001), PVR = 91 ± 99mL (P = 0.17), and PGV = 30 ± 5mL (P = .11). Improvements were independent of PGV, MLE, age, and CCI. Two grade II urinary infections occurred.ConclusionsPAE with 100–300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.     

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.     

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.     

Suprarenal Inferior Vena Cava Filter Placement and Retrieval: Safety Analysis

PurposeTo evaluate safety and retrieval success of retrievable suprarenal inferior vena cava (IVC) filters.Materials and MethodsA retrospective chart review of patients who received a retrievable suprarenal IVC filter between January 2008 and December 2017 was conducted. Suprarenal IVC filters were placed in 24 female and 27 male patients. The most common indications for filter placement were IVC thrombus (n = 20; 39.2%) and iliofemoral venous thrombosis with contraindication to anticoagulation (n = 16; 31.3%). The most common indications for suprarenal placement were IVC thrombus (n = 20; 39.2%), anatomic variants (n = 17; 33.3%), and external IVC compression (n = 8; 15.8%). Duplicated IVC was the most common anatomic variant requiring suprarenal placement (n = 7; 13.7%).ResultsGünther Tulip (n = 40; 78.4%), Denali (n = 10; 19.6%), and Celect (n = 1; 2.0%) filters were used. Retrieval was attempted in 27 of the 51 filters placed (52.9%). Of the 27 attempted retrievals, the technical success rate was 100% (27/27). The median dwell time was 87.0 days (95% confidence interval, 28–137 d). One complication involving fractured struts during filter retrieval occurred. No significant change in craniocaudal filter position, lateral filter tilt, or renal function between placement and retrieval was observed (P < .05). There were no instances of indwelling filter fracture.ConclusionsSuprarenal IVC filters, when indicated, can be placed and retrieved with a low complication rate.     

Minimally Invasive Treatments for Benign Prostatic Hyperplasia: Systematic Review and Network Meta-Analysis

PurposeTo review and to compare indirectly the outcomes of minimally invasive therapies for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.Materials and MethodsA literature search via Medline and Cochrane Central databases was completed for randomized control studies published between January 2000 to April 2020 for the following therapies: Rezum, Urolift, Aquablation, and prostatic artery embolization (PAE). Data on the following variables were included: International prostate symptom score (IPSS), maximum urinary flow rate, quality of life, and postvoid residual (PVR). Standard mean differences between treatments were compared through a meta-analysis using transurethral resection of the prostate (TURP) to assess differences in treatment effect.ResultsThere was no significant difference in outcomes between therapies for IPSS at the 3, 6, and 12-month follow ups. Although outcomes for Rezum were only available out to 3 months, there were no consistently significant differences in outcomes when comparing Aquablation versus PAE versus Rezum. TURP PVR was significantly better than Urolift at 3, 6, and 12 months. No significant differences in minor or major adverse events were noted.ConclusionAlthough significant differences in outcomes were limited, Aquablation and PAE were the most durable at 12 months. PAE has been well studied on multiple randomized control trials with minimal adverse events while Aquablation has limited high quality data and has been associated with bleeding-related complications.     

Inferior Vena Cava Filter Litigation Review: An Analysis of Medicolegal Cases Pertaining to Inferior Vena Cava Filters

PurposeTo identify and analyze all medical malpractice and product liability lawsuits pertaining to inferior vena cava (IVC) filters published within a well-recognized legal research database.Materials and MethodsLexisNexis, a legal research database, was used to retrieve cases that mentioned harm from IVC filters, or lack thereof, as the cause for legal action. A total of 672 cases were analyzed for type of case (medical malpractice or product liability), filter model implanted, filter complications, court decisions, and settlement payments if any.ResultsOf 95 analyzed cases, 20 (21.1%) were medical malpractice cases and 75 (78.9%) were product liability cases. C.R. Bard was the manufacturer associated with the most lawsuits (n = 41, 48.8%). The most litigious filters were the G2 filter from C.R. Bard (n = 17, 20.2%) and Greenfield filter from Boston Scientific (n = 17). The most common complications were IVC penetration (n = 26, 29.9%), filter migration (n = 26, 29.9%), filter fracture (n = 23, 26.4%), and tilt (n = 16, 18.4%). The number of product liability cases has increased from accounting for 25.0% (2 of 8) of filter lawsuits between 2000 and 2010 to 83.9% (73 of 87) during 2011–2020. Of the 20 medical malpractice claims, 9 (45%) were filed for failure to place a filter. One physician was found liable for filter-related complications by a state court in 2014.ConclusionsThe majority of recent IVC filter–related lawsuits are filed against manufacturers on the basis of product liability claims, with the main litigious filters being the G2 and Greenfield filters. Most cases resulted in rulings for physicians or manufacturers. Some were filed against physicians for filter-related complications or for failure to place an IVC filter.     

Grasp-and-Fold Technique for Complex Inferior Vena Cava Filter Retrieval

This study evaluated the use of the grasp-and-fold technique for complex forceps retrieval of inferior vena cava (IVC) filters. A retrospective study of 14 patients (12 women and 2 men) who had either deeply tip-embedded or severely distorted IVC filters was performed at a single institution over 10 years. In this technique, endobronchial forceps were used to fold the filter in half to remove it through the sheath because the filter tip could not be accessed by dissection. The grasp-and-fold technique successfully removed all 14 filters. One patient had retained filter struts, which were present before the procedure. One mild and 5 moderate adverse events (AEs), including fracture fragment embolization requiring retrieval and self-limited IVC extravasation, occurred. No severe AEs occurred. In this small patient cohort, the grasp-and-fold forceps technique successfully retrieved deeply tip-embedded or distorted IVC filters with inaccessible tips.     

Thrombotic Risk Associated with Inferior Vena Cava Filter Placement in Patients with Heparin-Induced Thrombocytopenia

PurposeThis study sought to define thromboembolic risk and mortality in patients with heparin-induced thrombocytopenia (HIT) undergoing inferior vena cava filter (IVCF) placement, in light of the American Society of Hematology’s 2018 guidelines against routine use of IVCFs in this population.MethodsA total of 26 patients with HIT who received IVCFs were retrospectively reviewed, and the outcomes of this group were compared with those of 4,707 controls with either HIT or IVCFs alone and with reported outcomes in prior studies.ResultsThe patient group demonstrated 6- and 12-month mortality rates of 26.9% and 30.8%, respectively, which did not differ significantly from those of the control groups and were in line with published mortality rates in the literature. The measured thromboembolic risk of 19.2% in the patient group was also within the range of published rates for patients with HIT or IVCF alone.ConclusionsIVCF placement did not significantly increase the risk of thromboembolism or death in patients with HIT and may be a viable option in the subset of these patients who are not candidates for anticoagulation.     

Bronchial Artery Aneurysm: Prevalence,Clinical Characteristics,and Long-Term Prognosis Following Bronchial Artery Embolization

PurposeTo investigate the prevalence, clinical characteristics, and long-term prognosis of bronchial artery aneurysm (BAA) following bronchial artery embolization (BAE).Materials and MethodsThe medical records of consecutive patients who underwent bronchial artery angiography between August 2013 and December 2019 were retrospectively reviewed. Patients who were diagnosed with BAA during this period were included in this study. The prevalence, patients’ characteristics, symptoms, comorbidities, angiographic findings, and long-term prognosis following BAE were investigated.ResultsBAA was observed in 20 of 508 patients who underwent bronchial artery angiography (3.9%). The patients’ median age was 69 (interquartile range [IQR], 63.5–76.7) years. The main causes of BAA were cryptogenic, bronchiectasis or cystic fibrosis, and pulmonary aspergillosis. The median diameter of ruptured BAAs was significantly smaller than that of unruptured BAAs (5.4 mm [IQR, 4.8–7.3 mm] vs 9.0 mm [IQR, 7.2–13.9 mm], P = .009). All the patients were successfully treated with BAE, without major adverse events. The median follow-up period after BAE was 970 (IQR, 561–1,796) days. The BAA-related survival rate was 100% at 2 and 3 years after BAE, and the overall survival rate after BAE was 89.2% (95% confidence interval [CI] 89.0–89.3) at 2 years and 74.3% (95% CI 74.0–74.5) at 3 years. BAA-related adverse events and mortality did not occur during the follow-up period.ConclusionsBAA was observed in 3.9 % (20/508) of the patients who underwent bronchial artery angiography. All the patients with BAA were successfully treated with BAE. BAA rupture and consequent mortality did not occur during the follow-up period.     

Randomized Controlled Study of an Absorbable Vena Cava Filter in a Porcine Model

PurposeTo compare the safety and efficacy of an absorbable inferior vena cava (IVC) filter and a benchmark IVC filter in a porcine model.Materials and MethodsA randomized controlled Good Laboratory Practice study was performed in Domestic Yorkshire cross swine. Sixteen swine were implanted with an absorbable IVC filter (test device; Adient Medical, Pearland, Texas); 8 were implanted with a benchmark metal IVC filter (control device; Cook Medical, Bloomington, Indiana). All animals underwent rotational digital subtraction pulmonary angiography and cavography (anteroposterior and lateral) before filter deployment and 5 and 32 weeks after deployment. Terminal procedures and necropsy were performed at 32 weeks. The IVC, heart, lungs, liver, and kidneys were harvested at necropsy. The reported randomized controlled GLP animal study was conducted at Synchrony Labs, Durham, North Carolina.ResultsOne animal died early in the test cohort of a recurring hemorrhage at the femoral access site resulting from a filter placement complication. All other animals remained clinically healthy throughout the study. No pulmonary embolism was detected at the 5- and 32-week follow-up visits. The absorbable filter subjects experienced less caval wall perforation (0% vs 100%) and thrombosis (0% vs 75%). The control device routinely perforated the IVC and occasionally produced collateral trauma to adjacent tissues (psoas muscle and aorta). The veins implanted with the absorbable filter were macroscopically indistinguishable from normal adjacent veins at 32 weeks except for the presence of radiopaque markers. Nontarget tissues showed no device-related changes.ConclusionsImplantation of the absorbable IVC filter in swine proved safe with no pulmonary emboli detected. There was complete to near-complete resorption of the filter polymer by 32 weeks with restoration of the normal appearance and structure of the IVC.     

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.     

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

PurposeTo report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).Materials and MethodsIn a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years.ResultsThe composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms.ConclusionsThe Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.     

Renal Cystic Echinococcosis: Long-Term Outcomes of Percutaneous Treatment

PurposeTo evaluate the long-term outcomes of percutaneous treatment of renal cystic echinococcosis (CE) stratified by cyst stages according to the World Health Organization (WHO) classification.Materials and MethodsBetween January 1997 and February 2019, 34 patients with renal CE (18 women; mean age, 38 years) were treated with 3 different percutaneous techniques. According to the World Health Organization classification, the cysts were classified as CE1, CE2, CE3a, and CE3b. Puncture, aspiration, injection, reaspiration (PAIR) or standard catheterization was used for the dimension-based treatment of CE1 and CE3a cysts. Modified catheterization (MoCaT) was used to treat all CE2 and CE3b cysts. Technical and clinical success, complications, and reduction in cyst cavities were evaluated.ResultsThe technical success rate was 100%. PAIR, standard catheterization, and MoCaT were used to treat 12, 9, and 13 cysts, respectively. The only severe adverse event was a bacterial superinfection that occured in the cyst cavity of a patient (3%) treated with MoCaT. Four patients (12%) experienced mild/moderate periprocedural allergic adverse events and were managed conservatively. The mean length of hospital stay was 1, 5, and 7 days for patients treated with PAIR, standard catheterization, and MoCaT, respectively. The clinical success rate was 97%. In 1 of 34 cysts (3%), recurrence was detected and the cyst was successfully re-treated. During the 10.5-year follow-up period, 95% volume reduction was achieved. The median final cyst volume was 10 mL.ConclusionsRenal CE can be successfully treated with minimum adverse events and recurrence rates using appropriate percutaneous techniques selected according to their stages as classified according to WHO.     

A Pilot First-in-Human Study of Embrace,a Polyethylene Glycol-Based Liquid Embolic Agent,in the Embolization of Malignant and Benign Hypervascular Tumors

PurposeTo investigate the safety and efficacy of an aqueous polyethylene glycol-based liquid embolic agent, Embrace Hydrogel Embolic System (HES), in the treatment of benign and malignant hypervascular tumors.Materials and MethodsA prospective, single-arm, multicenter study included 8 patients, 5 males and 3 females, with a median age of 58.5 years (30–85 years), who underwent embolization in 8 tumors between October 2019 and May 2020. Technical success was defined as successful delivery of HES to the index vessel, with disappearance of >90% of the targeted vascular enhancement or, for portal vein embolization, occlusion of the portal branches to the liver segments for future resection. The volume of HES administered, ease of use (5 point Likert scale), administration time, and adverse events (AEs) were recorded. Evaluation was performed at 7, 30, and 90 days via clinical assessment and blood testing, and follow-up imaging was performed at 30 days.ResultsEight patients were enrolled, and 10 embolizations were performed in 8 lesions. Tumors included hepatocellular carcinoma (n = 4), renal angiomyolipoma (n = 3), and intrahepatic cholangiocarcinoma (n = 1). Technical success was 100%, and the average ease of use was 3.3 ± 1.0 SD. The HES delivery time was 1–28 minutes (median, 16.5 minutes), and the HES volume injected was 0.4–4.0 mL (median, 1.3 mL). All patients reached 30-day follow-up with imaging, and 6 patients reached 90-day follow-up. There were 3 serious AEs in 2 patients that were unrelated to the embolic agent.ConclusionHES resulted in a 100% embolization technical success rate. The product ease of use was acceptable, and no target vessel recanalization was noted on follow-up imaging at 30 days.     

Analysis of Costs and Payments for Inferior Vena Cava Filter Retrieval in the Medicare Population

Over the past decade, inferior vena cava (IVC) filter retrieval has been increasing, in part due to Food and Drug Administration recommendations and legal pressure. The costs and margin of IVC filter removal are poorly understood. Medicare claims data from 2016 for the 103 highest volume centers for IVC filter retrieval were examined. Pooled mean charges, costs, payments, and margin were calculated by institution. Mean ± SD charges, costs, and payments were $14,138.00 ± $8,400.48, $3,693.28 ± $2,294.27, and $1,949.82 ± $702.91, respectively. Average (range) margin was −$1,706.18 (−$7,509.93 to $362.77). The margin was negative in 99 of the 103 (96%) institutions evaluated. The most significant contributors to the total procedure cost were operating room, supplies, and recovery (44.5%, 23.5%, and 10.4%, respectively). While IVC filter retrieval is often medically indicated, it is typically associated with a financial loss under current reimbursement structure.     

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.     

Magnification Spot Radiographs Improve Assessment for Inferior Vena Cava Filter Fractures prior to Removal Compared to CT

PurposeTo determine if magnification spot radiographs acquired before attempting inferior vena cava (IVC) filter removal have value in the assessment for filter fractures.Materials and MethodsA retrospective review of complex IVC filter removals performed at a tertiary referral center from October 2015 to May 2017 was performed. Magnification spot radiographs (frontal and at least 2 oblique views) were obtained with the fluoroscopic unit in the procedure suite prior to venous access for filter removal. Patients were included in the study if a computed tomography (CT) scan of the abdomen/pelvis before filter removal was available. Ninety-six patients (47 women and 49 men) were included. Most removed filters were the Recovery/G2/G2X/Eclipse/Meridian (n = 28), the Günther Tulip (n = 26), and the Celect/Celect Platinum (n = 22). Blinded review of the pre-procedural CT scans and spot radiographs for the presence of filter fractures was performed by 2 interventional radiologists. Accuracy of each modality was assessed using the status of the explanted filter as the gold standard. Agreement between the 2 readers was assessed with the kappa statistic.ResultsFractures were present in 27 explanted filters (28%). Accuracy of CT was 88% and 68% for readers 1 and 2, respectively, which increased to 98% and 97% with magnification spot radiographs. The kappa statistic was 0.12 for CT and 0.97 for spot radiographs.ConclusionsMagnification spot radiographs acquired before attempting IVC filter removal improve detection of filter fractures and agreement among interventional radiologists. Therefore, these should be performed routinely to allow for optimal treatment planning.     

Midterm and Long-Term Outcomes following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: Three- to 5-Year Results of the VIRTUS Study

PurposeTo assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.Materials and MethodsPatients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed.ResultsA total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture.ConclusionsThe results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.