BestFLR Trial: Liver Regeneration at CT before Major Hepatectomies for Liver Cancer-A Randomized Controlled Trial Comparing Portal Vein Embolization with N-Butyl-Cyanoacrylate Plus Iodized Oil versus Polyvinyl Alcohol Particles Plus Coils.

Background In patients with liver cancer, portal vein embolization (PVE) is recommended to promote liver growth before major hepatectomies. However, the optimal embolization strategy has not been established. Purpose To compare liver regeneration as seen at CT in participants with liver cancer, before major hepatectomies, with N-butyl-cyanoacrylate (NBCA) plus iodized oil versus standard polyvinyl alcohol (PVA) particles plus coils, for PVE. Materials and Methods In this single-center, prospective, randomized controlled trial (Best Future Liver Remnant, or BestFLR, trial; International Standard Randomized Controlled Trial Number 16062796), PVE with NBCA plus iodized oil was compared with standard PVE with PVA particles plus coils in participants with liver cancer. Participant recruitment started in November 2017 and ended in March 2020. Participants were randomly assigned to undergo PVE with PVA particles plus coils or PVE with NBCA plus iodized oil. The primary end point was liver growth assessed with CT 14 days and 28 days after PVE. Secondary outcomes included posthepatectomy liver failure, surgical complications, and length of intensive care treatment and hospital stay. The Mann-Whitney U test was used to compare continuous outcomes according to PVE material, whereas the Χ2 test or Fisher exact test was used for categoric variables. Results Sixty participants (mean age, 61 years ± 11 [standard deviation]; 32 men) were assigned to the PVA particles plus coils group (n = 30) or to the NBCA plus iodized oil group (n = 30). Interim analysis revealed faster and superior liver hypertrophy for the NBCA plus iodized oil group versus the PVA particles plus coils group 14 days and 28 days after PVE (absolute hypertrophy of 46% vs 30% [P < .001] and 57% vs 37% [P < .001], respectively). Liver growth for the proposed hepatectomy was achieved in 87% of participants (26 of 30) in the NBCA plus iodized oil group versus 53% of participants (16 of 30) in the PVA particles plus coils group (P = .008) 14 days after PVE. Liver failure occurred in 13% of participants (three of 24) in the NBCA plus iodized oil group and in 27% of participants (six of 22) in the PVA particles plus coils group (P = .27). Conclusion Portal vein embolization with N-butyl-cyanoacrylate plus iodized oil produced greater and faster liver growth as seen at CT in participants with liver cancer, compared with portal vein embolization with polyvinyl alcohol particles plus coils, allowing for earlier surgical intervention. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Arellano in this issue.

Randomized Clinical Trial of Balloon Occlusion versus Conventional Microcatheter Prostatic Artery Embolization for Benign Prostatic Hyperplasia.

PURPOSE: To compare balloon occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE). MATERIALS AND METHODS: In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients received embolization with 300-500 µm Embosphere microspheres and were evaluated before and 1 and 6 months after PAE. Primary outcome measure was change from baseline in International Prostate Symptom Score (IPSS). Student t test was used for between-group comparisons of change from baseline, and paired t test was used for within-group comparisons. RESULTS: At baseline, groups were identical (P > .05). Unilateral PAE was performed in 4 patients receiving cPAE and 3 patients receiving bPAE (9.30% and 6.52%, P = .708). Procedural and fluoroscopy times, dose area product, air kerma, embolic volume, and mean prostate-specific antigen (PSA) 24 hours after PAE did not differ between groups (P > .05). Coils were used in 6 patients receiving cPAE and 4 patients receiving bPAE (14.0% and 8.70%, P = .51). Assessments at 6 months after PAE showed mean IPSS reduction was 7.58 ± 6.88 after cPAE and 8.30 ± 8.12 after bPAE (P = .65); mean prostate volume reduction was 21.9 cm3 ± 51.6 (18.2%) after cPAE and 6.15 cm3 ± 14.6 (7.3%) after bPAE (P = .05); mean PSA reduction was 0.9 ng/mL ± 2.22 after cPAE and 0.22 ng/mL ± 1.65 after bPAE (P = .10). Penile skin lesions (n = 3) and rectal bleeding (n = 2) were documented only in patients receiving cPAE (11.9%, P = .01). No major adverse events occurred. CONCLUSIONS: bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.

Chemoembolization of Hepatocellular Carcinoma with Drug-Eluting Polyethylene Glycol Embolic Agents: Single-Center Retrospective Analysis in 302 Patients.

PURPOSE: To evaluate the efficacy and safety of transarterial chemoembolization with polyethylene glycol (PEG) drug-eluting embolic agents in the treatment of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A single-center retrospective study of 302 patients (258 men; 85.4%) with HCC treated during a 20-month period was conducted. The mean patient age was 66 years ± 10; 142 (47%) had Barcelona Clinic Liver Cancer stage A disease and 134 had (44.4%) stage B disease; 174 (57.6%) had a single HCC tumor, 65 (21.5%) had 2, and 62 (20.9%) had 3 or more. Mean index tumor size was 36.6 mm ± 24.8. One-month follow-up computed tomography (CT) response per modified Response Evaluation Criteria In Solid Tumors and clinical and biochemical safety were analyzed. Progression-free and overall survival were calculated by Kaplan-Meier method. RESULTS: Median follow-up time was 11.9 months (95% confidence interval, 11.0-13.0 mo). One-month follow-up CT revealed complete response in 179 patients (63.2%), partial response in 63 (22.3%), stable disease in 16 (5.7%), and progressive disease in 25 (8.8%). The most frequent complications were postembolization syndrome in 18 patients (6%), liver abscess in 5 (1.7%), and puncture-site hematoma in 3 (1%). Biochemical toxicities occurred in 57 patients (11.6%). Survival analysis at 12 months showed a progression-free survival rate of 65.9% and overall survival rate of 93.5%. Patients who received transplants showed a 57.7% rate of complete pathologic response. CONCLUSIONS: Chemoembolization with PEG embolic agents for HCC is safe and effective, achieving an objective response rate of 85.5%.

Predictors of Clinical Outcome after Prostate Artery Embolization with Spherical and Nonspherical Polyvinyl Alcohol Particles in Patients with Benign Prostatic Hyperplasia.

Purpose To assess predictors of outcome after prostate artery embolization (PAE) for benign prostatic hyperplasia with spherical particle polyvinyl alcohol (sPVA) and compare outcomes with the use of nonspherical particle polyvinyl alcohol (nsPVA). Materials and Methods This was a single-center retrospective institutional review board-approved study conducted from 2009 to 2015 in patients undergoing PAE with sPVA (n = 186; mean age ± standard deviation, 65.5 years ± 7.7) and nsPVA (n = 300; mean age, 65.3 years ± 7.6). The two cohorts were compared and analyzed for predictors of outcome with a Cox proportional hazards model and linear regression. Post-PAE prostate ischemia was measured with contrast material-enhanced magnetic resonance (MR) imaging in 23 patients with nsPVA and 25 patients with sPVA. The 24-hour post-PAE prostate-specific antigen (PSA) level was registered in 133 patients with sPVA. Prognostic values of MR imaging and PSA levels 24 hours after PAE were assessed with Cox and random-effects regressions. Results Predictors of clinical failure were older age (age over 65 years, P = .002), unilateral procedure (P = .002), and higher baseline International Prostate Symptom Score (IPSS, P = .033). Adjusted hazard ratio for clinical failure of sPVA was 1.273 (P = .16). Acute urinary retention was a predictor of lower IPSS after PAE (P = .002). The mean proportion of prostate ischemia was 11% with sPVA and 10% with nsPVA (P = .65). Lower IPSS after PAE was associated with a higher proportion of prostate ischemia (P = .009). Patients with a PSA level of at least 75 ng/mL (75 µg/L) 24 hours after PAE had a greater decrease in IPSS (P = .01). Prostate ischemic volume and PSA level 24 hours after PAE were correlated (Pearson r = 0.64, P = .014). Conclusion Clinical outcome was similar after PAE with sPVA and nsPVA. Younger age (up to 65 years), bilateral PAE, lower baseline IPSS, and acute urinary retention were predictors of better clinical outcome. The PSA level 24 hours after PAE correlated with prostate ischemia, and both correlated with clinical outcome. (©) RSNA, 2016.

Post-treated prostate cancer: normal findings and signs of local relapse on multiparametric magnetic resonance imaging.

The use of multiparametric magnetic resonance imaging (mp-MRI) for prostate cancer has increased over recent years, mainly for detection, staging, and active surveillance. However, suspicion of recurrence in the set of biochemical failure is becoming a significant reason for clinicians to request mp-MRI. Radiologists should be able to recognize the normal post-treatment MRI findings. Fibrosis and atrophic remnant seminal vesicles after prostatectomy are often found and must be differentiated from local relapse. Moreover, brachytherapy, external beam radiotherapy, cryosurgery, and hormonal therapy tend to diffusely decrease the signal intensity of the peripheral zone on T2-weighted images (T2WI) due to the loss of water content, consequently mimicking tumor and hemorrhage. The combination of T2WI and functional studies like diffusion-weighted imaging and dynamic contrast-enhanced improves the identification of local relapse. Tumor recurrence tends to restrict on diffusion images and avidly enhances after contrast administration either within or outside the gland. The authors provide a pictorial review of the normal findings and the signs of local tumor relapse after radical prostatectomy, external beam radiotherapy, brachytherapy, cryosurgery, and hormonal therapy.

Evaluation of Vessel Tracking Software for Prostatic Artery Embolization.

PURPOSE: To evaluate Vessel Tracking software for determining the prostatic arteries feeding the prostate gland during prostatic artery embolization (PAE) using Conebeam-CT (CBCT). MATERIALS AND METHODS: EmboGuide is a software developed to assist interventional radiologists in performing embolization of hypervascular tumors in the liver. In this study, a single-center retrospective image collection of 120 intraprocedural CBCT of 60 patients with benign prostatic hyperplasia treated using PAE between May 2017 and January 2019 was evaluated. All patients received 1 intraprocedural CBCT per side for evaluation of vessel anatomy. The "reference standard" of the vascular anatomy was defined by segmentation of the prostatic gland and marking of the prostatic artery in conjunction with pre-embolization DSA series. The datasets were then anonymized. Three interventional radiologists with experience in PAE from different centers reviewed the images and used the automatic feeder detection to determine the prostatic artery. Finally, two clinical experts compared the feeding vessels indicated in the "reference standard" and those identified by the readers. Objectives of the study were to evaluate the clinical performance of the software based on sensitivity and the agreement between interventional radiologists. RESULTS: Sensitivity was estimated as 0.968 with a 90% confidence interval. Overall agreement was estimated as 0.801 with a 90% confidence interval. On both objectives (Sensitivity and Agreement), specifications were met. CONCLUSIONS: The results of this study suggest that EmboGuide can be used to determine the prostate arteries in PAE. The findings could be used to expand the intended use of EmboGuide to include PAE.

Long-Term Outcome of Prostatic Artery Embolization for Patients with Benign Prostatic Hyperplasia: Single-Centre Retrospective Study in 1072 Patients Over a 10-Year Period.

PURPOSE: Assess long-term outcomes of prostatic artery embolization (PAE) for patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Single centre retrospective study from 2009-2019 including 1072 patients who received PAE and had available follow-up. Patients were evaluated yearly at 1-10 years post PAE using the International Prostate Symptom Score (IPSS) and quality of life (QoL), prostate volume (PV), prostate-specific antigen (PSA), peak urinary flow rate (Qmax) and postvoid residual (PVR) volume. The need for prostatic medication, re-intervention rates, repeat PAE and prostatectomy rates were assessed with Kaplan-Meier survival analysis and compared between different embolic agents using Cox regression analysis. RESULTS: Mean follow-up time was 4.39 ± 2.37 years. At last follow-up visit, mean IPSS and QoL improvements were - 10.14 ± 8.34 (p < .0001) and - 1.87 ± 1.48 (p < .0001) points, mean PV reduction was - 6.82 ± 41.11 cm3 (p = 0.7779), mean PSA reduction was - 1.12 ± 4.60 ng/mL (p = 0.9713), mean Qmax increase was 2.72 ± 6.38 mL/s (p = 0.0005), mean PVR reduction was - 8.35 ± 135.75 mL (p = 0.6786). There were 335 patients (31.3%) needing prostatic medication after PAE. Re-intervention rates were 3.4% at 1 year, 21.1% at 5 years and 58.1% at 10 years. Repeat-PAE rates were 2.3% at 1 year, 9.5% at 5 years and 23.1% at 10 years. Prostatectomy rates were 1.1% at 1 year, 11.6% at 5 years and 35.0% at 10 years. No significant differences were found between polyvinyl alcohol particles, Bead Block, Embospheres and Embozenes. CONCLUSION: PAE induces durable long-term LUTS relief, with re-intervention rates of 20% in the first 5 years and 30%-60% > 5 years post-PAE.

Successful Revascularization has a Significant Impact on Limb Salvage Rate and Wound Healing for Patients with Diabetic Foot Ulcers: Single-Centre Retrospective Analysis with a Multidisciplinary Approach.

PURPOSE: Analyze the impact of endovascular revascularization on major amputation rates and wound healing for patients with diabetic foot ulcers (DFUs). MATERIALS AND METHODS: Single-center retrospective study from 2014-2018 including 314 patients with DFUs submitted to endovascular revascularizations. Group A-patients with a successful endovascular revascularization (n = 285; 90.8%); Group B-patients submitted to a failed attempt of endovascular revascularization (n = 29; 9.2%). Baseline data were not significantly different between the 2 groups (p > 0.05). Both groups were compared regarding: major amputation rates; wound healing, mortality and adverse events. Survival and regression analyses were used. RESULTS: Mean follow-up time was 734.1 ± 610.2 days. Major amputation rates were 3.9% versus 24.1% (p < 0.0001) and complete wound healing was 53.7% versus 20.7% (p < 0.0001) for patients from Group A versus Group B, respectively. Major adverse events were registered in 2 patients (one from each group); minor adverse events included 10 patients from Group A and 2 patients from Group B (p = 0.3654). Major amputation rates were: 3.9% versus 27.5% at 1 year; 4.6% versus 27.5% at 2-5 years for Group A versus Group B, respectively (p < 0.0001). Survival rates were: 87.8% at 1 year; 84.4% at 2 years; and 77.9% at 5 years with no significant differences between groups. Predictors for major amputation included failed revascularization (p < 0.0001), older age (p = 0.0394), prior stroke (0.0018), dialysis (0.0476). Predictors for mortality included older age (p < 0.0001) and coronary artery disease (p = 0.0388). CONCLUSION: Endovascular revascularization for patients with DFUs is safe and has a significant impact on limb salvage and wound healing.