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.     

Evaluation of optimised 3D turbo spin echo and gradient echo MR pulse sequences of the knee at 3T and 1.5T

IntroductionTo investigate the impact of parameter optimisation for novel three-dimensional 3D sequences at 1.5T and 3T on resultant image quality.MethodsFollowing institutional review board approval and acquisition of informed consent, MR phantom and knee joint imaging on healthy volunteers (n = 16) was performed with 1.5 and 3T MRI scanners, respectively incorporating 8- and 15-channel phased array knee radiofrequency coils. The MR phantom and healthy volunteers were prospectively scanned over a six-week period. Acquired sequences included standard two-dimensional (2D) turbo spin echo (TSE) and novel three-dimensional (3D) TSE PDW (SPACE) both with and without fat-suppression, and T21W gradient echo (TrueFISP) sequences. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were measured for knee anatomical structures. Two musculoskeletal radiologists evaluated anatomical structure visualisation and image quality. Quantitative and qualitative findings were investigated for differences using Friedman tests. Inter- and intra-observer agreements were determined with κ statistics.ResultsPhantom and healthy volunteer images revealed higher SNR for sequences acquired at 3T (p-value <0.05). Generally, the qualitative findings ranked images acquired at 3T higher than corresponding images acquired at 1.5T (p < 0.05). 3D image data sets demonstrated less sensitivity to partial volume averaging artefact (PVA) compared to 2D sequences. Inter- and intra-observer agreements for evaluation across all sequences ranged from 0.61 to 0.79 and 0.71 to 0.92, respectively.ConclusionBoth 2D and 3D images demonstrated higher image quality at 3T than at 1.5T. Optimised 3D sequences performed better than the standard 2D PDW TSE sequence for contrast resolution between cartilage and joint fluid, with reduced PVA artefact.Implications for practiceWith rapid advances in MRI scanner technology, including hardware and software, the optimisation of 3D MR pulse sequences to reduce scan time while maintaining image quality, will improve diagnostic accuracy and patient management in musculoskeletal MRI.     

Volumetric Analysis of Progressive Remodeling of Isolated Mesenteric Artery Dissection Treated by Conservative Therapy

PurposeTo characterize remodeling of conservatively treated isolated mesenteric artery dissection (IMAD) using 3-dimensional (3D) volumetric analysis.Material and MethodsPatients with Type I/II (classification of Yun) treated by conservative therapy between January 2018 and January 2020 were prospectively included. Semiautomatic morphological analysis of the superior mesenteric artery (SMA) included volumetric measurements of the true lumen (TL), false lumen (FL), and overall lumen (OL) and 3D aortomesenteric angles from computed tomography angiography data at admission (T0), 1 month (T1), and 12 months (T12). The SMA morphology of patients with IMAD (n = 15, mean age 53 years ± 7; 87% men) was also compared with that of control individuals (n = 51, mean age 56 years ± 4; 94% men).ResultsA significant reduction in OL volume was observed (P <.001), whereas TL volume remained stable (P =.23). The TL/OL volume ratio significantly increased over time (P =.001) from 53% at T1 to 78% at T12. Aortomesenteric 3D angles at 2, 4, and 6 cm from the ostium showed a progressive decrease toward values observed in the control group (P =.013, P =.002, and P =.027, respectively). At T12, 5 patients (33%) had complete remodeling, and aneurysmal change was observed in 2 patients (<20 mm). Smoking and SMA angle at a distance of 6 cm from the ostium (T0) were the only factors affecting remodeling negatively at T12.ConclusionsOne-year remodeling in IMAD followed an overall decrease in OL volume related to a decrease in FL volume. Smokers and patients with larger SMA angles at baseline showed poorer remodeling. Spontaneous arterial remodeling in IMAD might favor conservative therapy.     

Clinical Safety and Efficacy of Locoregional Therapy Combined with Adoptive Transfer of Allogeneic γδ T Cells for Advanced Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

PurposeTo investigate the safety and efficacy of locoregional therapy plus adoptive transfer of allogeneic gamma delta (γδ) T cells for patients with hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).MethodsThirty patients with HCC and 29 patients with ICC were randomly assigned to receive locoregional therapy (HCC, Group A, n = 15; ICC, Group C, n = 15) or locoregional therapy plus γδ T cell therapy (HCC, Group B, n = 15; ICC, Group D, n = 14). Groups A and C only received locoregional ablation (cryoablation or irreversible electroporation), whereas Groups B and D received locoregional therapy followed by adoptive transfer of allogeneic γδ T cells. The primary endpoints were safety, distant progression-free survival (PFS), local PFS, and overall survival (OS).ResultsThe median distant PFS was significantly longer in the combined treatment groups than the locoregional treatment groups (HCC: 8 vs 4 months, P = .04; ICC: 8 vs 4 months, P = .021). There was no significant difference in local PFS between the 2 treatment modalities. Patients with HCC in the combined treatment group had a longer OS (median OS: 13 vs 8 months, P = .029). However, there was no significant difference in OS in patients with ICC between the 2 treatment modalities (median OS: 9.5 vs 8 months, P = .546). All adverse events were manageable with no significant difference in incidence between groups.ConclusionsThe novel combination of locoregional ablation with adoptive transfer of allogeneic γδ cells was safe, with encouraging clinical efficacy against HCC and ICC.     

Iatrogenic Renal Artery Injury in 90 Cases: Arteriographic Findings and Outcomes after Embolization for Bleeding

PurposeTo evaluate differences in arteriographic findings and outcomes after embolization among patients with a suspected iatrogenic renal arterial injury (IRAI).Materials and MethodsPatients at the authors’ institution who underwent renal arteriography for suspected IRAIs after partial nephrectomy, biopsy, or percutaneous access over a 20-year period were included. Records, imaging, and outcomes were reviewed. Data analysis was performed using the Fisher exact or Kruskal-Wallis test.ResultsNinety arteriograms were performed on 83 patients after partial nephrectomy (n = 32), biopsy (n = 27), or percutaneous access (n = 24), including for nephrostomy/ureterostomy and stone removal. The median number of days between the index procedure and arteriogram was highest (15 days) after partial nephrectomy and lowest (5 days) after biopsy (P = .0001). Embolization was performed during 76% of arteriograms. If prearteriographic imaging showed positive results for IRAIs, embolization was performed in 67% versus 33% if imaging showed negative results (P = .005). The transfusion rate was higher after biopsy than after partial nephrectomy or percutaneous access (P = .002). Acute kidney injury after arteriogram occurred in 7% of patients; however, all returned to baseline by 1 week.ConclusionsDespite the different mechanism of IRAIs in partial nephrectomy, biopsy, and percutaneous access, arteriographic findings and outcomes were overall similar among groups. Prearteriographic imaging can help identify IRAIs but cannot supersede the clinical judgment regarding indication for embolization. IRAIs can present acutely or after a long interim, although patients who underwent biopsy presented earlier and more frequently required a blood transfusion. IRAIs can be treated with embolization without permanent deleterious effects on renal function.     

Radiofrequency Ablation,Cryoablation, and Microwave Ablation for T1a Renal Cell Carcinoma: A Comparative Evaluation of Therapeutic and Renal Function Outcomes

PurposeTo compare the therapeutic and renal function outcomes of radiofrequency (RF) ablation, cryoablation, and microwave (MW) ablation for treatment of T1a renal cell carcinoma (RCC).Materials and MethodsA retrospective assessment of 297 patients (mean age 72 years range 24–90 years) with biopsy-proven RCC treated with image-guided percutaneous thermal ablation was performed between October 2006 and December 2016. Mean tumor size was 2.4 cm; mean radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, hilar tumor touching the main renal artery or vein, and location relative to polar lines; Preoperative Aspects and Dimensions Used for an Anatomical; and c-centrality scores were 6.0, 7.0, and 2.8, respectively. Assessments of adverse events, treatment efficacy, and therapeutic outcomes were performed among RF ablation, cryoablation, and MW ablation. The 2-year disease-free, metastatic-free, and cancer-specific survival rates were tabulated. Estimated glomerular filtration rate was used to assess for treatment related changes in renal function.ResultsA total of 297 T1aN0M0 biopsy-proven RCCs measuring 1.2–3.9 cm were treated with computed tomography–guided RF ablation (n = 244, 82%), cryoablation (n = 26, 9%), and MW ablation (n = 27, 9%). There were no significant differences in patient demographics among the 3 groups (P = .09). Technical success rates were similar among the 3 treatments (P = .33). Primary efficacy at 1 month postablation was more likely to be achieved with RF ablation and MW ablation than with cryoablation. At 2 years’ follow-up, there was no local recurrence, metastatic progression, or RCC-related death observed in the 3 groups. There was no significant change in estimated glomerular filtration rate among the 3 ablation groups compared with baseline at 2-year follow-up (P = .71).ConclusionRF ablation, cryoablation, and MW ablation are equivalent at 2 years for treatment of T1a RCC for therapeutic outcome, stability of renal function, and low adverse event rate.     

Percutaneous CT-Guided Abdominal and Pelvic Biopsies: Comparison of an Electromagnetic Navigation System and CT Fluoroscopy

PurposeTo compare electromagnetic navigation (EMN) with computed tomography (CT) fluoroscopy for guiding percutaneous biopsies in the abdomen and pelvis.Materials and MethodsA retrospective matched-cohort design was used to compare biopsies in the abdomen and pelvis performed with EMN (consecutive cases, n = 50; CT-Navigation; Imactis, Saint-Martin-d’Hères, France) with those performed with CT fluoroscopy (n = 100). Cases were matched 1:2 (EMN:CT fluoroscopy) for target organ and lesion size (±10 mm).ResultsThe population was well-matched (age, 65 vs 65 years; target size, 2.0 vs 2.1 cm; skin-to-target distance, 11.4 vs 10.7 cm; P > .05, EMN vs CT fluoroscopy, respectively). Technical success (98% vs 100%), diagnostic yield (98% vs 95%), adverse events (2% vs 5%), and procedure time (33 minutes vs 31 minutes) were not statistically different (P > .05). Operator radiation dose was less with EMN than with CT fluoroscopy (0.04 vs 1.2 μGy; P < .001), but patient dose was greater (30.1 vs 9.6 mSv; P < .001) owing to more helical scans during EMN guidance (3.9 vs 2.1; P < .001). CT fluoroscopy was performed with a mean of 29.7 tap scans per case. In 3 (3%) cases, CT fluoroscopy was performed with gantry tilt, and the mean angle out of plane for EMN cases was 13.4°.ConclusionsPercutaneous biopsies guided by EMN and CT fluoroscopy were closely matched for technical success, diagnostic yield, procedure time, and adverse events in a matched cohort of patients. EMN cases were more likely to be performed outside of the gantry plane. Radiation dose to the operator was higher with CT fluoroscopy, and patient radiation dose was higher with EMN. Further study with a wider array of procedures and anatomic locations is warranted.     

Comparison of Transthoracic Contrast Echocardiography with High-Resolution Chest CT after Embolization of Pulmonary Arteriovenous Malformation

PurposeTo compare postembolotherapy follow-up graded transthoracic contrast echocardiography (TTCE) and high-resolution computed tomography (CT) of the chest and to evaluate the use of graded TTCE in the early postembolic period.Materials and MethodsThirty-five patients (6 men and 29 women; mean age, 56 years; range, 27–78 years) presenting for postembolotherapy follow-up between 2017 and 2021 with concurrent high-resolution CT and graded TTCE were analyzed retrospectively. Untreated pulmonary arteriovenous malformations (PAVMs) with a feeding artery of ≥2 mm were considered treatable.ResultsNinety-four percent of patients (33 of 35) did not have treatable PAVMs on high-resolution CT. TTCE was negative for shunts (Grade 0) in 34% of patients (n = 12). Of patients with a TTCE positive for shunts (23 of 35, 66%), 83% had a Grade 1 shunt, 13% had a Grade 2 shunt, and 4% had a Grade 3 shunt. No patient with a Grade 0 or 1 shunt had a treatable PAVM on high-resolution CT. Of the 2 patients with PAVMs requiring treatment, one had a Grade 2 shunt and one had a Grade 3 shunt. TTCE grade was significantly associated with the presence of a treatable PAVM on high-resolution CT (P < .01).ConclusionsGraded TTCE predicts the need for repeat embolotherapy and does so reliably in the early postembolotherapy period. This suggests that graded TTCE can be utilized in the postembolotherapy period for surveillance, which has the potential to lead to a decrease in cumulative radiation in this patient population.     

Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease

PurposeTo compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions.Materials and MethodsIn this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1–3, 66.0%; 4–6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model.ResultsThe propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05).ConclusionsThe 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.     

Percutaneous MR Imaging–Guided Laser Ablation for the Treatment of Symptomatic Cervicofacial Vascular Malformations

PurposeTo evaluate the safety and effectiveness of percutaneous magnetic resonance (MR) imaging–guided laser ablation for the treatment of symptomatic soft tissue vascular malformations (VMs) in the face and neck.Materials and MethodsAn institutional review board–approved retrospective review was undertaken of all consecutive patients who underwent MR imaging–guided and monitored laser ablation for treatment of symptomatic, cervicofacial soft tissue VM. Preablation and postablation MR imaging findings were independently reviewed. Preablation and postablation VM sizes were documented. Preablation T2 signal characteristics and enhancement patterns as well as postablation change in both signal and enhancement were semiquantitatively assessed. Changes in VM size were compared using a paired t test.ResultsThirteen patients (women, 9; age, 14.5–69.5 years) with 13 VMs were treated for moderate-to-severe pain (n = 4), swelling/mass effect (n = 8), or predominantly cosmesis (n = 1) with 22 total ablation sessions. The baseline maximum VM diameter was 5.7 cm ± 4.2. At baseline, all VMs (100%) demonstrated variable T2-weighted signal hyperintensity and enhancement. For painful VM, the baseline pain score was 8 ± 1. Clinical follow-up was available for 10 patients. Of patients with available follow-up, 3 (100%) treated for moderate-to-severe pain and 7 (100%) treated for swelling/mass effect reported subjective complete or partial symptomatic relief. The patient treated predominantly for cosmetic reasons was lost to follow-up. Two patients (15.4%) experienced minor adverse events by the Society of Interventional Radiology standards. There were no major adverse events.ConclusionsMR imaging–guided and monitored percutaneous laser ablation is safe and effective for the treatment of symptomatic, cervicofacial VMs.     

The Use of an Inflatable Adhesive External Compression Device for Maintenance of Hemostasis following Angiography in Children

PurposeTo assess the safety and efficacy of the posthemostasis use of an inflatable adhesive external compression device (SafeGuard) following angiography in children performed under general anesthesia.Materials and MethodsMedical records of 74 children (43 females) with a mean age of 8.9 years (range, 0.4–18.0 years) and mean weight of 44.0 kg (range, 7.3–115.7 kg) in whom an inflatable adhesive external compression device was used for maintaining hemostasis following angiography under general anesthesia were retrospectively reviewed. After establishing hemostasis with manual compression, the device was applied and inflated over the arteriotomy. The patients were assessed for access-related adverse events in the recovery unit and during postprocedural follow-up.ResultsThe inflatable adhesive external compression device was utilized to maintain hemostasis following 181 angiography procedures. The mean length of the procedure was 396 minutes. The common femoral artery (n = 170, 93.9%) was the most common access, using 4–5-F vascular sheath (n = 118, 65.2%) or 3–5-F sheathless (n = 8, 12.7%) catheters. The mean time to deflation was 93 minutes. There were no adverse events other than minor bleeding from the arteriotomy after deflation (n = 2, 1.1%) and early deflation of the device because of pain (n = 1, <1%). Follow-up ultrasonography (n = 109 procedures, 60.2% at a mean follow-up of 2.2 years) demonstrated patency of the access artery.ConclusionsThe use of an inflatable adhesive external compression device following angiography in children to maintain hemostasis during the emergence phase of anesthesia and recovery period is safe and effective. The use of this simple device may reduce the need for postprocedural sedation and facilitate early discharge.     

Outcome and Distal Access Patency in Subintimal Arterial Flossing with Antegrade-Retrograde Intervention for Chronic Total Occlusions in Lower Extremity Critical Limb Ischemia

PurposeTo report the outcome and distal access patency of the Subintimal Arterial Flossing with Antegrade-Retrograde Intervention (SAFARI) technique for chronic total occlusion (CTO) in critical limb ischemia (CLI).Materials and MethodsFrom January 2009 to June 2015, 220 SAFARI procedures were performed for 200 limbs in 191 patients (108 males [56.5%]; median age, 70 years old; range, 36 to 97 years old) with CLI (9.4% were Fontaine classification 3; and 90.6% were Fontaine classification 4). Distal access was obtained from the distal superficial femoral artery (n = 6), popliteal artery (n = 49), anterior tibial artery (n = 56), dorsalis pedis (n = 51), peroneal artery (n = 12), posterior tibial artery (n = 45), and lateral plantar artery (n = 1). Distal access hemostasis was obtained with internal balloon tamponade in 71.4% (n = 157). Outcome measurements were technical success, freedom from major amputation and complications. Preprocedural angiograms of clinically driven repeat interventions were reviewed in 73 cases for distal access patency.ResultsTechnical success was achieved in 80.5% (n = 177). Reasons for technical failure include inability to obtain distal access (n = 3), cross the occlusion retrogradely (n = 16), re-enter the true lumen (n = 9), and achieve antegrade blood flow after the procedure (n = 15). Freedom from major amputation for technically successful procedures was 84.7%, 82.9%, and 81.9% at 6, 12, and 24 months, respectively. There were 3 cases of distal access bleeding with 1case that required coil embolization. The distal access remained patent in 80.8% of observable cases with repeated endovascular intervention.ConclusionsDistal retrograde arterial access (SAFARI) technique is safe and effective in the treatment of CTOs in the context of CLI, after failure of antegrade revascularization.     

Superior Rectal Artery Embolization with Tris-Acryl Gelatin Microspheres: A Randomized Comparison of Particle Size

PurposeTo evaluate the safety and efficacy of superior rectal artery embolization (SRAE) with different-sized tris-acryl gelatin microspheres in symptomatic hemorrhoidal disease (HD).Materials and MethodsForty-two patients (male, 30; female, 12; median age, 45 years) with symptomatic HD (2 grade I, 8 grade II, 17 grade III, and 15 grade IV) were divided into 3 experimental arms (500–700 μm, 700–900 μm, and 900–1,200 μm groups; each had 14 patients) in a prospective randomized style to perform SRAE. Follow-up was performed by rectoscopy, clinical examination, and questionnaires. The primary outcome measure was the clinical success rate at 12 months. Secondary outcome measures were technical success rate, recurrence rate, procedure-related mortality, procedure-related complications, and any outcome changes between particle sizes.ResultsNo procedure-related deaths or major morbidities were observed. There was a 54% minor complication rate (n = 23/42) in the treated zone: 45% sustained small superficial ulcerations (n = 19/42), 7% small rectosigmoid junction ulcerations (n = 3/42), and 2% small fibrotic scar tissue (n = 1/42). The clinical success rate was 93%. Of the groups, the best French bleeding score decrease was obtained in the 900–1,200 μm group. There were improvements in the quality of life score and visual analogue scale score after the SRAE procedure, although not in the Goligher score. No recurrent disease was observed.ConclusionsSRAE with tris-acryl gelatin microspheres for symptomatic HD is a safe and efficient treatment, with results favoring the use of larger microspheres.     

MR-safety in clinical practice at 7T: Evaluation of a multistep screening process in 1819 subjects

IntroductionMR facilities must implement and maintain adequate screening and safety procedures to ensure safety during MR examinations. The aim of this study was to evaluate a multi-step MR safety screening process used at a 7T facility regarding incidence of different types of safety risks detected during the safety procedure.MethodsSubjects scheduled for an MR examination and having entered the 7T facility during 2016–2019 underwent a pre-defined multi-step MR safety screening process. Screening documentation of 1819 included subjects was reviewed, and risks identified during the different screening steps were compiled. These data were also related to documented decisions made by a 7T MR safety committee and reported MR safety incidents.ResultsPassive or active implants (n = 315) were identified in a screening form and/or an additional documented interview in 305 subjects. Additional information not previously self-reported by the subject, regarding implants necessitating safety decisions performed by the staff was revealed in the documented interview in 102 subjects (106 items). In total, the 7T MR safety committee documented a decision in 36 (2%) of the included subjects. All of these subjects were finally cleared for scanning.ConclusionA multi-step screening process allows a thorough MR screening of subjects, avoiding safety incidents. Different steps in the process allow awareness to rise and items to be detected that were missed in earlier steps.Implications for practiceSafety questions posed at a single timepoint during an MR screening process might not reveal all safety risks. Repetition and rephrasing of screening questions leads to increased detection of safety risks. This could be effectively mitigated by a multi-step screening process. A multi-disciplinary safety committee is efficient at short notice responding to unexpected safety issues.     

Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model

PurposeTo evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft.Materials and MethodsTest stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and control stent grafts, constructed of permeable expanded polytetrafluoroethylene, were implanted in the external iliac arteries of 14 adult sheep with a median weight of 73.4 kg ranging from 60.6–86.8 kg for 30 (n = 4), 90 (n = 4), and 180 (n = 6) days. Angiographic patency and percent diameter stenosis (%DS) were assessed at termination. Excised stent grafts were fixed and stained for histopathologic analysis, including neointimal coverage (NC) assessment.ResultsTest and control device migration occurred in 1 animal, resulting in test device thrombosis. Both devices were excluded from analysis. Mean %DS in test and control implants was 4.6% and 8.2% (P = .563), 2.0% and 10.9% (P = .363), and 2.1% and 10.3% (P = .009) at 30, 90, and 180 days, respectively. Median NC scores at 30, 90, and 180 days were significantly lower in middle test device sections (P < .05). Proximal and distal test and control sections exhibited similar median NC scores at all time periods (P > .05). When present, test and control devices exhibited no neointimal detachment from the graft surface. Except for the migrated test device, no thrombus was observed. Transgraft cellular migration was absent in test devices but present in control devices with tissue accumulation around the stent struts.ConclusionsTest and control devices demonstrated excellent patency in an ovine model. Compared to the control, test devices exhibited significantly lower %DS values at 180 days and significantly lower mid-device NC scores at 30, 90, and 180 days.     

MR Imaging‒Guided Intervention: Evaluation of MR Conditional Biopsy and Ablation Needle Tip Artifacts at 3T Using a Balanced Fast Field Echo Sequence

PurposeTo systematically investigate artifacts produced by biopsy and ablation needles imaged at various trajectories with respect to the static magnetic field (B0).Materials and MethodsAn acrylic phantom was scanned using a rapid balanced fast field echo sequence with 3.0-T magnetic resonance imaging. A 15-gauge microwave needle, a 17-gauge cryoneedle, and an 18-gauge coaxial biopsy needle were imaged in sagittal and axial planes, in 7 different orientations to B0 (0°, 15°, 30°, 45°, 60°, 75°, and 90°). For 4 angles (15°, 30°, 60°, and 75°), images were acquired with the slice orientation aligned to the needle angulation, resulting in the frequency encoding direction being parallel to the needle’s long axis for the sagittal slice and perpendicular to the needle angulation for the axial acquisition. The artifact length at the needle tip and maximum artifact width were recorded.ResultsNo significant difference was noted in mean artifact length for the cryoneedle (13 mm; 95% confidence interval [CI], 7–19) and coaxial biopsy needle (8 mm; 95% CI, 5–10; P = .08). The mean artifact length was significantly smaller for the microwave ablation needle (1 mm; 95% CI, 0–2; P < .05). The mean artifact width was highest for the coaxial needle (17 mm; 95% CI, 14–19) and significantly higher than the cryoneedle (12 mm; 95% CI, 10–15; P = .024) and microwave ablation needle (8 mm; 95% CI, 6–10; P < .01). The needle tip artifact was significantly smaller when the slice orientation was aligned to the needle angulation for the coaxial and cryoablation needles (P < .01).ConclusionsNeedle tip artifact length and width increase with increasing angulation to the static field. At large angles (>15°), the needle tip position can be predicted better from images acquired when the slice orientation is aligned to the needle’s angulation.     

Medical Malpractice in Image-Guided Procedures: An Analysis of 184 Cases

PurposeTo report types and outcomes of a small subset of malpractice lawsuits filed against physicians performing image-guided interventions in the United States.Materials and MethodsIn total, 1,312 cases involving common image-guided procedures were reviewed from the Westlaw and LexisNexis databases in the United States from 1963 to 2018. Social Security, disability, employment contract, product liability, criminal, and government employment claims were excluded. The final legal cohort comprised 184 (14.0%) cases. They were categorized into vascular (113/184; 61.4%), inferior vena cava filter (n = 22; 12.0%), neurointerventional (n = 13; 7.1%), gastrointestinal and genitourinary (n = 17; 9.2%), foreign body (n = 7; 3.8%), biopsy related (n = 9; 4.9%), and oncologic (n = 3; 1.6%) interventions. Claims were also organized by defendant type and by specialty, complication stage, verdict, and year.ResultsFrom 2001 to 2018, 58.7% of claims (n = 108) were reported. Procedural complications related to arteriography were most commonly litigated (63/113; 55.8%). Claims arising from intra-procedural and early post-procedural complications were common (84/184; 45.7%). Community hospitals were most often named as defendants (61/184; 33.2%). In reported outcomes, courts sided with defendants in 81.9% (104/127) of the cases, similar to national malpractice trends. Unreported outcomes comprised 31% (57/184) of the data.ConclusionsFor the small subset of claims published within national legal databases, intra-procedural and early post-procedural complications after diagnostic arteriography were most commonly litigated. Most (81.9%) claims with reported outcomes sided with the defendant physician.     

Endovascular Therapy for Vasculogenic Erectile Dysfunction: A Systematic Review and Meta-Analysis of Arterial and Venous Therapies

PurposeTo systematically review and perform a meta-analysis on the safety and efficacy of endovascular therapy in the treatment of the two most common etiologies of vasculogenic erectile dysfunction (ED): veno-occlusive dysfunction (VOD) and arterial insufficiency (AI).Materials and MethodsPubMed, Web of Science, ScienceDirect, and Scopus databases were searched for published English literature regarding endovascular ED treatments. Case series (n ≥ 3) were included. Multiple data points were obtained, including demographic data, etiology, diagnosis method, imaging studies, treatment approach, technical success, clinical success, complications, and follow-up.ResultsSixteen relevant articles were obtained and a total of 212 patients with VOD and 162 with AI were identified. The VOD cohort were treated either percutaneously (60.4%; n = 128) or after surgical exposure of the deep dorsal vein (33.5%, n = 71), or it was unspecified (6.1%; n = 13). The most common embolic used was n-butyl cyanoacrylate (51.9%; n = 109). Meta-analysis found an overall clinical success rate of 59.8% in VOD patients. Complications occurred in 5.2% of patients (n = 11), with 9 considered to be mild and 2 considered to be severe. The AI cohort contained 162 patients most commonly treated via stenting of the internal pudendal artery (40.1%; n = 65). Meta-analysis found an overall clinical success rate of 63.2% in AI patients. Complications occurred in 4.9% of patients (n = 8), with 4 considered to be mild and 4 considered to be severe.ConclusionsEndovascular therapy for medically refractory ED is safe and may provide a treatment alternative to more invasive surgical management; however, conclusions are limited by the heterogeneity of clinical success definitions among the included studies.     

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.     

Utility of Motor and Somatosensory Evoked Potentials for Neural Thermoprotection in Ablations of Musculoskeletal Tumors

PurposeTo characterize the utility of monitoring transcranial electrical motor evoked potentials (TCeMEPs) and somatosensory evoked potentials (SSEPs) for neural thermoprotection during musculoskeletal tumor ablations.Materials and MethodsRetrospective review of 29 patients (16 male; median age, 46 y; range, 7–77 y) who underwent musculoskeletal tumor radiofrequency ablation (n = 8) or cryoablation (n = 22) with intraprocedural TCeMEP and SSEP monitoring was performed. The most common tumor histologies were osteoid osteoma (n = 6), venous malformation (n = 5), sarcoma (n = 5), renal cell carcinoma (n = 4), and non–small-cell lung cancer (n = 3). The most common tumor sites were spine (n = 22) and lower extremities (n = 4). Abnormal TCeMEP change was defined by 100-V increase above baseline threshold activation for a given myotome; abnormal SSEP change was defined by 60% reduction in baseline amplitude and/or 10% increase in latency.ResultsAbnormal changes in TCeMEP (n = 9; 30%) and/or SSEP (n = 5; 17%) occurred in 12 procedures (40%) and did not recover in 5 patients. Patients with unchanged TCeMEP/SSEP activities throughout the procedure (n = 18) did not have motor or sensory symptoms after the procedure; 3 (60%) with unrecovered activity changes and 2 (29%) with transient activity changes had new motor (n = 1) or sensory (n = 4) symptoms. Relative risk for neurologic sequelae for patients with unrecovered TCeMEP/SSEP changes vs those with transient or no changes was 7.50 (95% confidence interval, 1.66–33.9; P = .009).ConclusionsAbnormal activity changes of TCeMEP or SSEP during percutaneous ablative procedures correlate with postprocedural neurologic sequelae.