Cardiovascular Comorbidities Do Not Impact Prostate Artery Embolisation (PAE) Outcomes: Retrospective Analysis of the National UK-ROPE Registry.

PURPOSE: Prostate artery embolisation (PAE) is a key treatment for the management of symptomatic benign prostatic hyperplasia (BPH). Common cardiovascular risk factors might be associated with suboptimal outcomes and thus influence patient treatment selection. The aim of the study was to evaluate whether cardiovascular comorbidities affect PAE outcomes. METHODS: Retrospective subset analysis of the UK Registry of Prostate Artery Embolisation (UK-ROPE) database was performed with patients who had a full documented past medical histories including hypertension, diabetes, coronary artery disease (CAD), diabetes and smoking status as well as international prostate symptom score (IPSS) at baseline and at 12 months. Multiple regression was performed to assess for any significant predictors. RESULTS: Comorbidity data were available for 100/216 patients (mean age 65.8 ± 6.4 years), baseline IPSS 20.9 ± 7.0). Regression analysis revealed that the presence of hypertension (53.7% IPSS reduction vs. absence 51.4%, p = 0.94), diabetes (52.6% vs. absence 52.1%, p = 0.6), CAD (59.2% vs. absence 51.4%, p = 0.95), no comorbidities (49.8% vs. any comorbidity present 55.3%, p = 0.66), smoking status (non-smoker, 52.6%, current smoker, 61.5%, ex-smoker, 49.8%, p > 0.05), age (p = 0.52) and baseline Qmax (p = 0.41) did not significantly impact IPSS reduction at 12 months post-PAE. Baseline prostate volume significantly influenced IPSS reduction (≥ 80 cc prostates, 58.9% vs. < 80 cc prostates 43.2%, p < 0.05). CONCLUSION: The presence of cardiovascular comorbidities/smoking history does not appear to significantly impact PAE symptom score outcomes at 12 months post procedure. Our findings suggest that if the prostatic artery can be accessed, then clinical success is comparable to those without cardiovascular comorbidities.

The Effect of Protective Coil Embolization of Penile Anastomoses during Prostatic Artery Embolization on Erectile Function: A Propensity-Matched Analysis.

PURPOSE: To explore whether coil embolization of penile collateral arteries to prevent nontarget embolization during prostatic artery embolization (PAE) negatively affects erectile function. MATERIALS AND METHODS: Retrospective analysis was performed on a prospectively maintained multicenter PAE database on all patients with benign prostatic hyperplasia (January 2014 to July 2016). International Index of Erectile Function (IIEF-5) scores were collected at baseline and within 12 months after the procedure. A logistic regression and nearest neighbor propensity-matched analysis (matched for age, baseline IIEF-5 scores, and use of 5α-reductase inhibitors) and paired t test were used to evaluate for differential impact on IIEF-5 scores between the group of patients who underwent (unilateral) penile collateral coil embolization and a matched control group of patients who did not. RESULTS: Of a total of 216 patients, 26 underwent coil protection of an accessory pudendal vessel/penile collateral. After exclusions, 22 propensity-matched pairs were identified. The mean IIEF-5 score at baseline for the coil-embolized group was 14.8 ± 8.3 (out of a possible score of 30) and that for the matched control group was 14.0 ± 7.8. At the 12-month follow-up after the procedure, the mean follow-up IIEF-5 score was 15.5 ± 8.0 for the coil-embolized group and 14.2 ± 8.2 for the matched control group. The change in IIEF-5 scores after PAE was not significantly different between the 2 groups (0.66 ± 3.8 vs 0.20 ± 2.0; P = .64; 95% CI, -1.53 to 2.44). CONCLUSIONS: When penile collateral arteries were identified, protective coil embolization of penile collateral/accessory pudendal vessels during PAE was unlikely to affect erectile function negatively.

10-year experience of Paediatric varicocele embolization in a tertiary centre with long-term follow-up.

INTRODUCTION: Paediatric varicocele embolization has many benefits over surgical ligation, but lacks published long-term data. We investigated technical and clinical outcomes in this under reported patient group. OBJECTIVE: To evaluate technical success, complications and recurrence rates following varicocele embolization in paediatric patients. MATERIALS AND METHODS: A single-centre retrospective review of procedural data and electronic notes of consecutive patients referred for varicocele embolization over a 10-year period was performed (February 2010-March 2020). The primary outcomes were technical success and clinical efficacy (lack of symptom recurrence). Secondary outcomes included complications, testicular vein size reduction and procedural parameters including radiation exposure. Chi-square analysis was used to identify predictors of clinical success. Follow-up involved outpatient clinical assessment and telephone interview. RESULTS: 40 patients (median age 15) were referred for left-sided symptomatic varicocele. Technical embolization success was achieved in 36/40 patients (90%), with 4 procedures abandoned (inaccessible vein). Embolization technique was platinum-based coils ± sclerosant. There were no immediate or long-term procedural complications. 32/36 patients completed short term follow-up at a median interval of 2.8 months. 30/32 (93.78%) experienced early clinical success. We found a significant reduction in peritesticular vein size following embolization (pre-3.70 vs post-2.56 mm, p = 0.00017) and a significant relationship between varicocele grade and early clinical success (χ2 = 4.2, p = 0.04), but not pre-treatment peritesticular vein size (χ2 = 0.02, p = 0.88). 33/36 patients completed long-term follow-up (median 4.2 years, range 0.36-9.9 years) producing a late clinical success rate of 93.9% (31/33). No post procedural complications including hydroceles were identified. DISCUSSION: This study demonstrates technical success, matching rates described in adult patients which is reassuring and in support of embolization in the younger patient cohort. More importantly, the overall clinical success rate is comparable with previous embolization studies. Reassuringly, all symptom recurrences occurred early in follow-up, and there is a cogent argument for a single follow-up appointment at this juncture. Our long-term average follow-up duration, primarily gained via telephone interview, exceeds other studies. Although our study has the longest follow-up for varicocele embolization in children, it is limited by a few patients being lost to early and long-term follow-up. This is a recognised issue faced by studies attempting to follow-up benign conditions with a high clinical success rate. CONCLUSION: Paediatric varicocele embolization is a successful alternative to surgical ligation, with no complications and good clinical outcomes over a long-term follow-up.

The impact on Anti-Mullerian Hormone (AMH), uterine fibroid size and uterine artery patency following Uterine Fibroid Embolization (UFE) with a resorbable embolic agent.

The effect of Uterine Fibroid Embolization on fertility and ovarian reserve remains uncertain. We assessed the impact of a new resorbable, spherical particle (Gelbead) on concentration of Anti-Mullerian (AMH) hormone, fibroid volume and uterine artery patency. This prospective cohort study recruited consecutive patients from July 2017 to June 2018. Serum AMH, fibroid and uterine volume, UFS-QOL (uterine fibroid score-quality of life) scores were measured prior to and at 1 month and/or 3 months post embolization. Twenty-four participants were enrolled (median age 44 years, uterine volume 484 cm3, initial dominant fibroid volume 167 cm3). One patient was lost to follow-up. AMH (median ± SD) immediately prior to embolization was 3.2 ± 13.7 pmol/L. At 1-month postembolization, AMH was 4.1 ± 8.6 pmol/L and at 3 months 4.4 ± 8.6 pmol/L. We found no significant difference in AMH levels between baseline and at 1 month (p = 0.58) or baseline and 3 months (p = 0.17). The median dominant uterine fibroid volume decreased (167 to 64 cm3, p < 0.001). At 3 months post-embolization, 17/23 patients had patent uterine arteries bilaterally (73.9%). UFE with Gel-bead did not significantly affect AMH at 3 months post embolization, whilst maintaining a high rate of uterine artery patency.

Prostatic Artery Embolization (PAE) and Transurethral Resection of the Prostate (TURP) have a Differential Impact on Lower Urinary Tract Symptoms (LUTS): Retrospective Analysis of the Multicentre UK-ROPE (UK Register of Prostate Embolization) Study.

PURPOSE: To compare the relative IPSS (International Prostate Symptom Score) improvement in storage and voiding symptoms between prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). METHOD: Retrospective analysis of the UK-ROPE (UK Register of Prostate Embolization) multicentre database was conducted with inclusion of all patients with full IPSS questionnaire score data. The voiding and storage subscore improvement was compared between interventions. Student's t-test (paired and unpaired) and ANOVA (Analysis of variance) were used to identify significant differences between the groups. RESULTS: 146 patients (121 PAE, 25 TURP) were included in the analysis. Storage symptoms were more frequently the most severe symptom ('storage' in 75 patients vs 'voiding' in 17 patients). Between groups, no significant difference was seen in raw storage subscore improvement (TURP 4.9 vs PAE 4.2; p = 0.34) or voiding subscore improvement (TURP 8.4 vs PAE 6.7; p = 0.1). ANOVA demonstrated a greater proportionate reduction (relative to total IPSS) towards voiding symptoms in the TURP group (27.3% TURP vs 9.9% PAE, p = 0.001). CONCLUSION: Although both TURP and PAE improve voiding symptoms more than storage, a significantly larger proportion of total symptom reduction is due to voiding in the TURP cohort, with PAE providing a more balanced improvement between voiding and storage.

1-year cost-utility analysis of prostate artery embolization (PAE) versus transurethral resection of the prostate (TURP) in benign prostatic hyperplasia (BPH).

OBJECTIVE: To determine whether prostate artery embolization (PAE) is a cost-effective alternative to transurethral resection of the prostate (TURP) in the management of benign prostate hyperplasia (BPH) after 1-year follow-up. DESIGN SETTING AND MAIN OUTCOME MEASURES: A retrospective cost-utility analysis over a 12-month time period was conducted to compare the two interventions from a National Health Service perspective. Effectiveness was measured as quality-adjusted life years (QALYs) derived from data collected during the observational UK Register of Prostate Embolisation (UK-ROPE) Study. Costs for both PAE and TURP were derived from University Hospital Southampton, a tertiary referral centre for BPH and the largest contributor to the UK-ROPE. An incremental cost-effectiveness ratio (ICER) was derived from cost and QALY values associated with both interventions to assess the cost-effectiveness of PAE versus TURP. Further sensitivity analyses involved a decision tree model to account for the impact of patient-reported complications on the cost-effectiveness of the interventions. RESULTS: The mean patient age for TURP (n=31) and PAE (n=133) was 69 and 65.6 years, respectively. In comparison to TURP, PAE was cheaper due to shorter patient stays and the lack of necessity for an operating theatre. Analysis revealed an ICER of £64 798.10 saved per QALY lost when comparing PAE to TURP after 1-year follow-up. CONCLUSION: Our findings suggest that PAE is initially a cost-effective alternative to TURP for the management of BPH after 1-year follow-up. Due to a higher reintervention rate in the PAE group, this benefit may be lost in subsequent years. TRIAL REGISTRATION NUMBER: NCT02434575.

Uterine Fibroid Embolization (UFE) with Optisphere: A Prospective Study of a New, Spherical, Resorbable Embolic Agent.

INTRODUCTION: Optisphere (Teleflex, Wayne, PA, USA, currently distributed by Medtronic, Minneapolis, MN, USA) is a new, resorbable, calibrated spherical embolic agent. We aimed to evaluate its clinical safety and effectiveness for fibroid embolization through a prospective case series. METHOD: This prospective case series studied patients treated with fibroid embolization using Optisphere between July 2017 and June 2018. The primary outcomes were device-related adverse event assessments and MRI-determined percentage infarct of the dominant fibroid (DF %) and infarct of all fibroids (AF %) at 3 months post-embolization. Secondary outcomes included symptom improvement with the validated Uterine Fibroid Symptom Score and Quality of Life questionnaire (UFS-SS and UFS-QOL) at 3 months and 12 months post-embolization. Statistical analysis was through the Wilcoxon signed-rank test for nonparametric paired data. RESULTS: Twenty-three consecutive patients were treated with Optisphere (median age 44.0, uterine volume 484.0 ml, dominant fibroid volume 167.0 ml). The complete dominant fibroid infarction (DF %) rate was 91.3% (21/23 patients), and the complete all fibroid infarction rate (AF %) was 82.6% (19/23). No adverse device-related safety events were encountered. Significant improvement was demonstrated in 3-month UFS-SS (56 vs 19, p < 0.0001), UFS-QOL (40 vs 88, p = 0.0008), uterine volume (484 ml vs 246 ml, p < 0.0001) and dominant fibroid volume (167 vs 64 ml, p < 0.0001). Symptomatic improvement continued to 12 months (UFS-SS 56 vs 11, p = 0.0008, UFS-QOL 40 vs 98.7, p = 0.0008). CONCLUSION: Optisphere is an effective embolic agent for fibroid embolization with good symptomatic response and percentage fibroid infarct.

Does Prostate Artery Embolization (PAE) Improve Voiding Symptoms, Storage Symptoms, or Both?

INTRODUCTION: Many studies have looked at global changes in the International Prostate Symptom Score (IPSS) following PAE; however, no studies have examined the breakdown between storage and voiding symptoms. We aimed to explore the extent to which PAE improves storage symptoms in relation to voiding symptoms. METHOD: This single-center, prospective cohort study recruited consecutive patients undergoing PAE from June 2012 to June 2016. The IPSS breakdown was recorded pre-PAE, at 3 months and 12 months post-PAE. Planned statistical analysis included the paired t test. RESULTS: A total of 43 patients were recruited (mean age 64.72 ± 6.27, prostate volume 88.65 ± 37.23 cm3, IPSS 23.02 ± 5.84, QoL 4.98 ± 1.01, PSA 4.2 ± 2.8). Storage symptoms were more frequently the most severe symptom (58.1%). Voiding score (13.35-5.39, p < 0.001) and storage score (9.67-5.08, p < 0.001) both improved; however, voiding improved to a greater extent (1.9 vs. 1.5 mean per question, p = 0.023). PAE was most consistent when improving storage symptoms ('Urgency' improved in 86% patients, 'Frequency' and 'Nocturia' 77%). CONCLUSION: Storage symptoms are a significant problem for patients with benign prostatic obstruction. PAE is an effective treatment for both storage and voiding symptoms. More research is needed to evaluate how this compares with surgical techniques.

The First 48 Consecutive Patients with 3-Year Symptom Score Follow-Up Post-Prostate Artery Embolization (PAE) at a Single-Centre University Hospital.

INTRODUCTION: Few studies on prostate artery embolization (PAE) follow patients up after 12 months. We aimed to evaluate the symptomatic efficacy of PAE in our patient cohort at 3 years. METHOD: A total of 48 consecutive patients undergoing PAE from June 2012 to August 2014 were included in this retrospective study. All patients underwent formal urodynamics to confirm bladder outflow obstruction prior to PAE. International Prostate Symptom Score (IPSS) was performed at baseline, 3 months, 12 months and 3 years post-PAE. RESULTS: Mean patient age was 65.6 ± 7.4, prostate volume 99.1 ± 56.6 cm3, IPSS 23.5 ± 6.0, quality-of-life score 4.6 ± 0.9, Qmax 8.4 ± 2.8 ml/s, post-void residual volume 185.8 ± 55.6 ml. Technical success (bilateral embolization) was achieved in 43 out of 48 cases (89.6%). 11/39 bilateral PAE patients completing follow-up (2 died, 2 lost to follow-up) underwent surgery, indicating a 71.8% clinical success rate at 3 years. No significant change was demonstrated in IPSS or QOL between 1 and 3 years for patients free from surgical intervention (IPSS 8.3 vs 10.0, p = 0.09 and QOL 1.3 vs 1.5, p = 0.23). 3/11 patients undergoing surgery had a prominent 'ball-valve' median lobe, and 1/11 patients had a high bladder neck elevation contributing to symptoms. CONCLUSION: Clinical success post-PAE remains high with few patients opting for surgery or experiencing a worsening of symptoms after 12 months.

Technical and Imaging Outcomes from the UK Registry of Prostate Artery Embolization (UK-ROPE) Study: Focusing on Predictors of Clinical Success.

INTRODUCTION: The UK Registry of Prostate Artery Embolization (UK-ROPE) was a prospective, multicentre study comparing PAE against surgical therapies for symptomatic benign prostatic hyperplasia (BPH). A wealth of data was collected supplementary to the main study outcomes which provide a snapshot of UK PAE practice. We aimed to interpret these data in the hope of providing insight into factors which affect clinical outcome and radiation dose. METHODS: 216 patients (mean age 66, mean IPSS 21.3) undergoing PAE at 20 British centres from July 2014 to January 2016 were prospectively followed up to 12 months with retrospective analysis of the data. Technical outcome was evaluated based on procedural and fluoroscopy times, skin dose and dose area product (DAP). Clinical outcome was evaluated through collection of Qmax, IPSS reduction and prostate volume reduction. Multiple analysis of variance (MANOVA) was used to assess the significance of various patients and procedural factors on clinical outcome and patient dose. RESULTS: Significant predictors of technical outcome which affected patient skin dose included severity of CTA-detected atheroma (p < 0.001), the practitioner (p < 0.001) and use of protective coil embolization (p = 0.019). Predictors of clinical outcome included initial prostate size (dichotomized into groups > 80 ml and = <80 ml, d = 1, p = 0.0138), embolic agent (spherical particles < 300 nm performed best, p = 0.01) and number of arteries embolized (IPSS reduction of 32.9% in unilateral PAE versus 54.4% for bilateral PAE, p = 0.026). CONCLUSION: We have identified several important factors which are associated with improved clinical outcome and increased patient dose which we hope will facilitate optimal patient selection and encourage improved embolization technique.

Uterine Necrosis after Uterine Artery Embolization for Symptomatic Fibroids.

INTRODUCTION: Uterine artery embolization (UAE) is a minimally invasive intervention that is used in the treatment of fibroids. UAE can lead to complications including postembolization syndrome, postprocedure pain, infection, endometrial atrophy leading to secondary amenorrhea, and uterine necrosis. Uterine necrosis after UAE is very rare and hence poses a clinical dilemma for any clinician in its identification and management. We document a case of uterine necrosis after UAE and conduct a literature review on its causation, clinical features, and management principles. CASE: A patient presented one month after UAE with abdominal pain and abdominal vaginal discharge. Her work-up revealed features of possible uterine necrosis with sepsis and she was scheduled for a laparotomy and a subtotal hysterectomy was performed. She was subsequently managed with broad spectrum antibiotic and recovered well. CONCLUSION: Uterine necrosis after UAE is a rare occurrence and we hope the documentation of this case will add to the body of knowledge around it. Theories that explain its occurrence include the use of small particles at embolization, the use of Contour-SE a spherical poly-vinyl alcohol, and lack of collateral supply to the uterus. Its symptoms may be nonspecific but unremitting abdominal pain is invariably present. Finally although conservative management may be successful at times, surgical management with hysterectomy will be required in some cases. The prognosis is good after diagnosis and surgical management.

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

OBJECTIVES: To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK-ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK-ROPE study database. RESULTS: The results showed that PAE was clinically effective, producing a median 10-point IPSS improvement from baseline at 12 months post-procedure. PAE did not appear to be as effective as TURP, which produced a median 15-point IPSS score improvement at 12 months post-procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality-of-life (QoL) improvement, there was no evidence of PAE being non-inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post-procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolization that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights. CONCLUSION: Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone-beam computed tomography is encouraged to improve operator confidence and minimize non-target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation.

Planning Prostate Artery Embolisation: Is it Essential to Perform a Pre-procedural CTA?

PURPOSE: A highly variable prostatic artery origin coupled with frequent anastomoses to adjacent organs makes prostate artery embolisation a challenging procedure. Despite CT angiography facilitating procedural planning, it is not performed in all centres. Therefore, we explored the utility of prostatic CT angiography by assessing its capacity to identify the prostatic arteries and highlight troublesome anastomoses. MATERIALS AND METHODS: A retrospective review of patients undergoing prostate artery embolisation for symptoms of benign prostatic obstruction between June 2012 and October 2016 was conducted, with analysis of the pre-procedural CT angiography. CT findings were compared with subsequent intraprocedural angiography to assess the accuracy with which CT angiography predicts the origin of prostatic arteries and identifies anastomoses. RESULTS: In total, 110 patients underwent prostate artery embolisation, with pre-procedural CT angiography acquired in all patients, enabling assessment of 220 pelvic sides of hemiprostatic arterial supply. Mean dose length product was 808.4 mGycm. CT angiography successfully identified prostatic arterial supply in 214/220 pelvic sides, an accuracy of 97.3%. Anastomoses of prostatic vessels were suggested by CT angiography in 52 pelvic sides. These were confirmed by angiogram in 49/52 sides (94.2%). CT angiography demonstrated a sensitivity of 59.0% and specificity of 94.2% for anastomoses detection. CONCLUSION: CT angiography prior to embolisation reliably predicts the arterial anatomy and facilitates procedural planning. Therefore, it should be a considered as a pre-procedural investigation for patients undergoing prostate artery embolisation. Sensitivity is low for predicting anastomoses, so careful periprocedural evaluation of the target vessels is still required.

One year symptom severity and health-related quality of life changes among Black African patients undergoing uterine fibroid embolisation.

BACKGROUND: The main aim in the treatment of symptomatic fibroids by various modalities including uterine fibroid embolisation (UFE) is to alleviate symptoms and ultimately improve the quality of life. The efficacy of this modality of treatment in Black African women with significant fibroid burden and large uterine volumes is not clear. The main objective of the study was to examine potential changes in symptom severity among Black African patients 1 year following UFE for symptomatic uterine fibroids in a resource-constrained setting, rated using a validated questionnaire (UFS-QOL). Secondary outcomes examined were changes in quality of life and potential associations with age, parity, uterine volume and fibroid number prior to UFE. Additional interventions after UFE were also recorded. METHODS: A prospective before and after study of Black African patients undergoing UFE was undertaken. Participants underwent pelvic MR imaging prior to UFE and completed the UFS-QOL, a validated condition-specific questionnaire at baseline and at 1 year. Ninety five participants were recruited and data from 80 completing 1 year of follow up were available for analysis of changes in the symptom severity scores. RESULTS: The mean reduction in symptom severity score was 29.6 [95% CI 23.6 to 35.6, P < 0.001] and the mean improvement in HRQOL score was 35.7 [95% CI 28.4 to 42.9, P < 0.001]. A greater number of fibroids identified prior to UFE was associated with a more substantial improvement in symptom severity score (rs = 0.28, n = 80, P = 0.013) and participants of higher parity reported a greater improvement in HRQOL score (r = 0.336, P = 0.002). Major and minor surgical interventions were needed in 5 (6.3%) and 10 (12.5%) participants respectively. CONCLUSIONS: UFE is associated with clinically useful and statistically significant symptom relief in Black African patients. Symptom improvement following UFE is not compromised by a large fibroid burden and the rate of subsequent intervention is within an acceptable range. UFE is a safe alternative and efforts are needed to widen access to this non-surgical treatment modality.

Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial.

BACKGROUND: Transarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while the multikinase inhibitor sorafenib improves survival in patients with advanced disease. We aimed to determine whether TACE with sorafenib improves progression-free survival versus TACE with placebo. METHODS: We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for patients with unresectable, liver-confined hepatocellular carcinoma. Patients were eligible if they were at least aged 18 years, had Eastern Cooperative Oncology Group performance status of 1 or less, and had Child-Pugh A liver disease. Patients were randomised 1:1 by computerised minimisation algorithm to continuous oral sorafenib (400 mg twice-daily) or matching placebo combined with TACE using drug-eluting beads (DEB-TACE), which was given via the hepatic artery 2-5 weeks after randomisation and according to radiological response and patient tolerance thereafter. Patients were stratified according to randomising centre and serum α-fetoprotein concentration (<400 ng/mL and ≥400 ng/mL). Only the trial coordinator was unmasked to treatment allocation before patient progression during the study. The primary endpoint was progression-free survival defined as the interval between randomisation and progression according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) or death due to any cause, and was analysed by intention-to-treat. Safety was analysed by intention-to-treat. The trial has been completed and the final results are reported. The trial is registered at EudraCT, number 2008-005073-36, and ISRCTN, number ISRCTN93375053. FINDINGS: Between Nov 4, 2010, and Dec 7, 2015, the trial enrolled 399 patients and was terminated after a planned interim futility analysis. 86 patients failed screening and 313 remaining patients were randomly assigned: 157 to sorafenib and 156 to placebo. The median daily dose was 660 mg (IQR 389·2-800·0) sorafenib versus 800 mg (758·2-800·0) placebo, and median duration of therapy was 120·0 days (IQR 43·0-266·0) for sorafenib versus 162·0 days (70·0-323·5) for placebo. There was no evidence of difference in progression-free survival between the sorafenib group and the placebo group (hazard ratio [HR] 0·99 [95% CI 0·77-1·27], p=0·94); median progression-free survival was 238·0 days (95% CI 221·0-281·0) in the sorafenib group and 235·0 days (209·0-322·0) in the placebo group. The most common grade 3-4 adverse events were fatigue (29 [18%] of 157 patients in the sorafenib group vs 21 [13%] of 156 patients in the placebo group), abdominal pain (20 [13%] vs 12 [8%]), diarrhoea (16 [10%] vs four [3%]), gastrointestinal disorders (18 [11%] vs 12 [8%]), and hand-foot skin reaction (12 [8%] and none). At least one serious adverse event was reported in 65 (41%) of 157 patients in the sorafenib group and 50 (32%) of 156 in the placebo group, and 181 serious adverse events were reported in total, 95 (52%) in the sorafenib group and 86 (48%) in the placebo group. Three deaths occurred in each group that were attributed to DEB-TACE. Four deaths were attributed to study drug; three in the sorafenib group and one in the placebo group. INTERPRETATION: The addition of sorafenib to DEB-TACE does not improve progression-free survival in European patients with hepatocellular carcinoma. Alternative systemic therapies need to be assessed in combination with TACE to improve patient outcomes. FUNDING: Bayer PLC and BTG PLC.

Prostate artery embolization: a new, minimally invasive treatment for lower urinary tract symptoms secondary to prostate enlargement.

Prostate artery embolization (PAE) is emerging as a safe and efficacious treatment which approaches benign prostatic obstruction (BPO) from a unique perspective. This brings with it distinct advantages and solutions, which we discuss along with cost, evidence, complications and disadvantages.

Uterine fibroid embolization for symptomatic fibroids: study at a teaching hospital in kenya.

OBJECTIVE: Characterization of magnetic (MRI) features in women undergoing uterine fibroid embolization (UFE) and identification of clinical correlates in an African population. MATERIALS AND METHODS: Patients with symptomatic fibroids who are selected to undergo UFE at the hospital formed the study population. The baseline MRI features, baseline symptom score, short-term imaging outcome, and mid-term symptom scores were analyzed for interval changes. Assessment of potential associations between short-term imaging features and mid-term symptom scores was also done. RESULTS: UFE resulted in statistically significant reduction (P < 0.001) of dominant fibroid, uterine volumes, and reduction of symptom severity scores, which were 43.7%, 40.1%, and 37.8%, respectively. Also, 59% of respondents had more than 10 fibroids. The predominant location of the dominant fibroid was intramural. No statistically significant association was found between clinical and radiological outcome. CONCLUSION: The response of uterine fibroids to embolization in the African population is not different from the findings reported in other studies from the west. The presence of multiple and large fibroids in this study is consistent with the case mix described in other studies of African-American populations. Patient counseling should emphasize the independence of volume reduction and symptom improvement. Though volume changes are of relevance for the radiologist in understanding the evolution of the condition and identifying potential technical treatment failures, it should not be the main basis of evaluation of treatment success.