Tris-acryl Gelatin Microspheres Research Articles

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.

To 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. Seventy-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. One 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. PAE with 100-300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.

Partial Splenic Artery Embolization in 35 Cancer Patients: Results of a Single Institution Retrospective Study

PurposeTo evaluate the safety and efficacy of partial splenic embolization (PSE) in cancer patients with different etiologies of splenomegaly/hypersplenism. Materials and MethodsThe medical records of 35 cancer patients who underwent 39 PSE procedures were analyzed. The splenomegaly/hypersplenism was due to chemotherapy (n = 17), portal hypertension (n = 10), or hematologic malignancy (n = 8). After the first 11 PSEs, celiac plexus neurolysis, corticosteroids, and non-steroid anti-inflammatory drugs (NSAIDs) were included in the post-procedural management. ResultsPSE led to 59 ± 16% (mean ± standard deviation) splenic infarcts. The infarct volume per 1 mL 300–500 μm tris-acryl gelatin microspheres was not significantly different between the chemotherapy-induced group (264 ± 89 cm3) and the portal hypertension group (285 ± 139 cm3) but was significantly higher in the hematology group (582 ± 345 cm3). Platelet count increased from 65.7 ± 19.7 k/μl to a peak platelet count of 221 ± 83 k/μl at 2 weeks after PSE. Patients with a follow-up period of more than 1 year had the most recent platelet count of 174 ± 113 k/μl. Platelet count increase was significantly higher in the chemotherapy-induced group than the portal hypertension group. Adding celiac plexus neurolysis, corticosteroids, and NSAIDs to the post-procedural management resulted in a decreased rate of major complications from 73% to 46% and a decrease in the rate of moderate or severe pain from 92% to 20%. ConclusionsPSE improved platelet counts in cancer patients despite different etiologies of splenomegaly. The addition of celiac plexus neurolysis, corticosteroids, and NSAIDS to the post-PSE treatment protocol reduced complications. Data from this study could help to predict the amount of 300–500 μm tris-acryl gelatin microspheres required to achieve a planned infarct size.

Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Prospective Randomized Trial of 100–300 μm versus 300–500 μm versus 100- to 300-μm + 300- to 500-μm Embospheres

PurposeThis study compared the safety and efficacy of prostatic arterial embolization (PAE) with that of trisacryl gelatin microspheres of different sizes for treatment of benign prostatic hyperplasia (BPH). Materials and MethodsThis study consisted of a single-center, randomized controlled clinical trial in 138 patients who underwent PAE for BPH between July 2015 and December 2016. Patients were randomized to PAE using microspheres of different sizes: group A patients were treated with microspheres 100–300 μm, group B with 300–500 μm, and group C with 100–300 μm followed by 300–500 μm. All patients were evaluated before and at 1, 3, 6, 12, and 18 months after PAE. Baseline data were comparable across the 3 groups, using the following mean International Prostate Symptom Score/quality of life (IPSS/QoL); prostate volume (PV) scores, respectively: 23.0/4.14; 87.9 cm3 (group A); 23.0/4.09; 89.0 cm3 (group B); and 24.2/4.29; 81.0 cm3 (group C) (P > 0.05). ResultsMean IPSS/QoL scores; PV after PAE were: 9.98/2.49; 65.1 cm3 (group A); 8.24/2.26; 63.1 cm3 (group B); and 10.1/2.69; 53.1 cm3 (group C) (P = 0.23; P = 0.39; P = 0.24). There were 26 clinical failures. The cumulative probabilities of clinical success at 18 months were 76.7% in group A, 82.6% in group B, and 83.3% in group C (P = 0.68). Nontarget embolization was prevented in 6 patients by coil embolization. All adverse events were mild and self-limited with rates of 86.0% in group A (37 of 43); 41.3% in group B (19 of 46); and 58.3% in group C (28 of 48) (P < 0.001). Dysuria was the most frequent adverse event (28 of 137 [20.4%]). ConclusionsPAE outcomes were not significantly different among microspheres of different sizes. The use of 100- to 300-μm microspheres was associated with an increased risk of minor adverse events.

Insufficient Leiomyoma Infarction in Uterine Artery Embolization: Relationship with Tumor Location

PurposeTo evaluate which leiomyoma location in the uterus predicts insufficient tumor infarction after uterine artery embolization (UAE). Materials and MethodsIn this single-institution retrospective study, 45 patients (mean age, 43.4 y ± 4.1) underwent UAE for leiomyomas using trisacryl gelatin microspheres alone with “pruned-tree” endpoint performed by qualified interventional radiologists between October 2015 and July 2017. Technical outcomes and complications were assessed. All patients underwent unenhanced and enhanced MR imaging before and after UAE. A total of 476 tumors of ≥ 1 cm observed in all patients were evaluated. Multivariate generalized linear mixed model analysis was performed to investigate relationships between insufficient tumor infarction (< 90%) on contrast-enhanced MR imaging after UAE and baseline factors, including tumor location in the long-axis, front-back, and inner-outer directions and tumor size. ResultsAll patients successfully underwent UAE with no major complications. Multivariate analysis revealed that there was a higher likelihood of insufficient infarction of tumors at the cervix (odds ratio [OR] 80.45; 95% confidence interval [CI] 9.97, 649.09; P < .001) and lower body (OR 4.31; 95% CI 2.52, 7.38; P < .001) than at the upper body and of tumors at the front than at the back wall (OR 2.20; 95% CI 1.32, 3.67; P = .002). Tumor size (OR 0.71; 95% CI 0.61, 0.82; P < .001) was a significant factor, whereas tumor location in the inner-outer direction was not. ConclusionsInsufficient leiomyoma infarction after UAE was more likely to involve tumors at the cervix, lower body, or front wall of the uterus or smaller tumors.

Midterm Follow-Up of Patients with Middle Meningeal Artery Embolization in Intractable Chronic Subdural Hematoma

A subset of patients with chronic subdural hematoma (CSDH) remains refractory to standard treatment with hematoma drainage by burr-hole craniotomy and irrigation. We recently reported the usefulness of middle meningeal artery (MMA) embolization for intractable CSDH in patients with multiple intractable risk factors. We present the midterm outcomes of MMA embolization in patients with intractable CSDHs. Seventeen consecutive patients (average age, 76.4 years; 12 men [71%]) underwent MMA embolization of CSDH from January 2014 to July 2017. Earlier interventions included embolization using N-butyl-2-cyanoacrylate (although trisacryl gelatin microspheres were used in recent cases), followed by burr-hole craniotomy and irrigation in all cases. None of the patients experienced perioperative complications or postoperative recurrence. The modified Rankin Scale scores, which were unfavorable at admission, improved significantly at discharge but were comparable to those at the time of hospitalization when measured during the follow-up period. Although the patients required rehospitalization at other departments for unrelated causes, none required rehospitalization in our department. Despite the known unfavorable outcomes of patients with intractable CSDHs, MMA embolization was not associated with recurrent CSDH or rehospitalization in our department in the current case series. MMA embolization should be considered a preferred therapeutic option for intractable CSDHs.

Initial experience with the use of tris-acryl gelatin microspheres for transcatheter arterial embolization for enlarged polycystic liver.

To assess the safety and effectiveness of transcatheter arterial embolization (TAE) with tris-acryl gelatin microspheres for patients with symptomatic enlarged polycystic liver disease (PCLD). This prospective study was approved by our hospital's institutional review board and planned for patients with symptoms related to enlarged PCLD, such as distended abdomen, gastrointestinal obstruction and abdominal pain. Hemi-hepatic embolization with tris-acryl gelatin microspheres was performed in the hepatic artery supplying the hepatic lobe that showed the predominant presence of cysts. Each patient underwent an assessment of liver function, a questionnaire survey about symptoms, measurement of the estimated volume of the whole liver before and after TAE, and an assessment of complications associated with TAE. Five patients (four females, one male; mean age 52.6 ± 9.1years) were treated. All five patients successfully completed TAE. The left lobe was treated in three patients and the right in two. After TAE, post-embolization syndrome and transient elevation of white blood cells, aspartate aminotransferase, and alanine aminotransferase occurred in all patients, but none developed hepatic insufficiency or severe complications. The mean whole liver volume was 7406 ± 2323mL before TAE, and 6995 ± 2139mL (95.1 ± 5.2% of the pre-therapeutic value) at 3months and 6855 ± 2246mL (93.3 ± 9.7%) at 12months after TAE. Three of the five patients reported an improvement of clinical symptoms within 12months after TAE. TAE with microspheres can be a safe and effective treatment for symptomatic enlarged PCLD.

Outcome after prostatic artery embolization in patients with symptomatic benign prostatic hyperplasia.

Background Prostatic artery embolization (PAE) has recently been described as a promising alternative treatment for lower urinary tract symptoms (LUTS) due to an enlarged, benign prostate. Purpose To evaluate the safety, morbidity, and functional outcomes after PAE. Material and Methods Twenty-nine consecutive patients were included. All patients had computed tomography angiography before the procedure. Microcatheters were used for selective embolization of the PAs. Large side branches to non-target organs were embolized with coils. The PAs were embolized with calibrated 300–500 µm tris-acryl gelatin microspheres. Complications were recorded before discharge. Clinical visit was performed after three months, magnetic resonance imaging (MRI) after 6–12 months, and any further intervention recorded in the chart. Mean follow-up was 23 months. Clinical success was defined as no longer needing urinary catheter, no long-term complications, and no need of further interventions. Results Sixteen patients (55%) had permanent or intermittent catheter before the procedure. Bilateral embolization was performed in 26 patients (90%). Five patients underwent two procedures. Twelve of 16 patients (75%) with permanent or intermittent catheter were able to remove the catheter. Five patients were operated with transurethral resection of the prostate (TURP). Except for one patient, all patients without catheter at baseline improved in the International Prostate Symptom Score (IPSS) and had no further treatment. Twelve patients experienced complications; all were grade 1 according to the Clavien–Dindo classification. Conclusion PAE reduced LUTS symptoms in most patients without severe complications. The treatment did not exclude additional surgical treatment when needed.

Predisposing factors for predicting the therapeutic response of adenomyosis after uterine artery embolization: serum CA125 levels and accompanying endometriosis.

We aimed to identify predisposing factors that could help predict the therapeutic response of adenomyosis after uterine artery embolization (UAE). This was a retrospective, single-center study of patients admitted to the hospital for adenomyosis between 2013 and 2015. Sixty-eight patients with adenomyosis who underwent UAE with tris-acryl gelatin microspheres were divided into two groups based on their therapeutic response (complete or incomplete necrosis of lesions), and pre- and postprocedural pelvic magnetic resonance imaging (MRI) data. Patients were followed up for 12 months after UAE. Improvements in dysmenorrhea and menorrhagia were evaluated based on the symptom relief criteria. Improvement rates in both groups were analyzed and compared. Multivariate logistic regression analysis was used to identify the predisposing factors from retrospectively gathered baseline data that might affect the therapeutic response, including MRI features, clinical symptoms, biochemical index, and accompanying diseases of adenomyosis. Then, a prognostic model was established, and the receiver operating characteristic (ROC) curve of identified factors was drawn to determine their predictive value. Following UAE, 46 patients (67.6%) showed complete necrosis, while 22 patients (32.4%) showed incomplete necrosis. At 12-month follow-up, dysmenorrhea symptom improvement was seen in 94.7% of complete necrosis and 50% of incomplete necrosis group (P < 0.001); menorrhagia symptom improvement was seen in 96.2% of complete necrosis and 57.1% of incomplete necrosis groups (P = 0.004). Multivariate logistic regression analysis determined serum cancer antigen 125 (CA125) levels (odds ratio [OR], 1.006; 95% confidence interval [CI], 1.002-1.010; P = 0.005) and accompanying endometriosis (OR, 6.869; 95% CI, 1.881-25.016; P = 0.004) as predisposing factors. The areas under the ROC curve of CA125, endometriosis, and these two indicators combined were 0.785, 0.708, and 0.845, which corresponded to sensitivities of 95.5%, 66.7%, and 68.2% and specificities of 52.2%, 80.0%, and 87.0% at optimal cutoff values, respectively. Symptom relief of dysmenorrhea and menorrhagia for patients with complete necrosis was significantly better than that for patients with incomplete necrosis. Serum CA125 levels and accompanying endometriosis can effectively distinguish complete necrosis from incomplete necrosis.

Volume of embolic agents in uterine artery embolization for leiomyoma: relation to baseline MRI

Purpose: To assess whether pre-procedural MRI findings predict the volume of tris-acryl gelatin microspheres (TAGM) used in uterine artery embolization (UAE) for leiomyomas.Material and methods: This was a retrospective, single-institution study. Between June 2014 and December 2017, 73 patients with leiomyomas underwent UAE with TAGM alone. Univariate and multivariate analyses were performed to assess the relationships between the volume of TAGM and baseline parameters. Technical outcomes, tumor infarction on post-procedural contrast-enhanced MRI, and complications were evaluated.Results: Technical success was achieved in all patients. Infarction of ≥90% of the total leiomyoma volume was observed in 93% (67/72) of patients. No major complications were noted. The mean (SD) volume of 500- to 700-μm particles used in all (73/73) patients was 10.3 ± 4.6 ml. The multivariate analysis revealed that uterine volume (p = .034) correlated with the 500- to 700-μm TAGM volume. Seven hundred- to 900-μm particles were added for 70% (51/73) of patients at a mean (SD) volume of 3.6 ± 4.6 ml. The dominant tumor volume (p = .028) correlated with the 700- to 900-μm TAGM volume.Conclusion: The dominant tumor or uterine volume on pre-procedural MRI was directly associated with the volume of TAGM required for embolization of leiomyomas.

3:40 PM Abstract No. 8 Prostatic artery embolization for benign hyperplasia: outcome after the 1-year follow-up in 40 consecutive cases performed at a single center

To present the outcome observed after a 1-year follow-up of a series of 40 patients with benign prostate hyperplasia treated consecutively with prostatic artery embolization as an alternative to surgery. Between January 2015 and August 2016, 40 patients (mean age 62.3 years) with lower urinary tract symptoms due to benign prostatic hyperplasia and refractory to medical therapy underwent prostatic artery embolization. All patients were evaluated with specific questionnaires to determine the severity of symptoms and impact on quality of life and erectile function, pelvic ultrasound and MRI, urinary flowmetry, and PSA before the procedure (baseline) and 30 days and 1 year after the procedure. Procedures were performed in an outpatient condition with local anesthesia and mild sedation through the right femoral vascular access. Tris-acryl gelatin microspheres in the range of 300–500um were used as an embolic agent in all cases. Embolization was successful in all patients; in 36 cases, embolization was achieved bilaterally. The average time for completion of the procedure was 65 minutes with mean radiation time of 28.2 minutes. Various anatomical origins of the PA were found. Cone-beam CT was used in 29 cases whether to confirm or to discard the prostatic artery for delivering the embolic agent. At 30 days it was observed a mean reduction of 25.3% in prostate volume, 6.1-point improvement in IPSS, 2 point improvement in QOL, and 3 point improvement in IIEF. The peak urinary flow improved by 46% and PSA dropped 42%. No major complications. Minor adverse events were verified and easily resolved in 14 patients. Seven patients (17.5%) needed to continue their medication and were considered unsuccessful cases. At the 1-year follow-up, there were no significant changes in clinical parameters in comparison to those observed after 30 days. At that time, 13 patients (32.5%) needed to continue medication. Prostatic artery embolization as an alternative treatment to surgery for patients with BPH and LUTS was safe and effective in improving symptoms. Most clinical improvement was observed during the initial 30 days post procedure and remained for 1 year in approximately 70% patients.

Leiomyoma Infarction after Uterine Artery Embolization: Influence of Embolic Agent and Leiomyoma Size and Location on Outcome

PurposeTo study the factors that might impact infarction of individual uterine leiomyomas and total tumor burden after uterine artery embolization (UAE). Materials and MethodsThis retrospective study included 91 patients (mean age, 44 y [range, 34–54 y]) who underwent UAE with tris-acryl gelatin microspheres (TAGMs) or nonspherical polyvinyl alcohol (PVA) particles. Twenty-one patients were treated with PVA (23%) and 70 were treated with TAGMs (77%). A total of 356 uterine leiomyomas were assessed, with a median uterine volume of 533 cm3 (range, 321–848 cm3). A reader masked to demographic and technical details reviewed contrast-enhanced magnetic resonance images before and 3 months after UAE to estimate the extent of tumor infarction. ResultsThere was no significant difference in global or individual tumor infarction rate between embolizations with TAGMs and PVA particles (P = .73 and P = .3, respectively). Global infarction was not affected by age (P = .53), race (P = .12), number of leiomyomas (P = .72), or uterine volume (P = .74). Leiomyoma size did not influence individual tumor infarction (P = .41). Leiomyoma location was the sole factor that influenced individual tumor infarction rates, with pedunculated serosal tumors significantly less likely to show complete infarction than transmural tumors (odds ratio, 0.24; P = .01). ConclusionsNonspherical PVA particles and TAGMs produce similar rates of uterine leiomyoma infarction. Complete infarction of individual tumors is less likely in serosal and pedunculated serosal tumors.

Assessment of uterine fibroid infarction after embolization with tris-acryl gelatin microspheres

AbstractPurpose: To evaluate the degree of fibroid infarction after uterine fibroid embolization (UFE) with tris-acryl gelatin microsphere (Embosphere) visualized by contrast-enhanced magnetic resonance imaging (MRI) and evaluation of the clinical outcome measured with symptom and quality of life questionnaire (UFS-QOL) after 3 months follow-up. Materials and Methods: A prospective study included twenty-six pre-menopausal women. UFE with Embosphere of 500–900 μm was performed. Residual contrast enhancement in the total fibroid burden was analyzed and residual contrast enhancement ≤10% was defined as a satisfactory result after embolization. The dominant fibroids and total uterine volumes were assessed by MRI before and at follow-up. The UFS-QOL questionnaire answers were analysed and compared. Results: Twenty-five of 26 patients (96%) had a technically successful UFE. Twenty-four of the patients (92%) had MRI controls 3 months after UFE of which 23 patients had complete or almost complete fibroid burden i...

Fertility after uterine artery embolization for symptomatic multiple fibroids with no other infertility factors.

To evaluate the fertility of women eligible for surgical multiple myomectomy, but who carefully elected a fertility-sparing uterine artery embolization (UAE). Non-comparative open-label trial, on women ≤40years, presenting with multiple symptomatic fibroids (at least 3, ≥3cm), immediate pregnancy wish, and no associated infertility factor. Women had a bilateral limited UAE using tris-acryl gelatin microspheres ≥500μm. Fertility, ovarian reserve, uterus and fibroid sizes, and quality of life questionnaires (UFS-QoL) were prospectively followed. Fifteen patients, aged 34.8years (95%CI 32.2-37.5, median 36.0, q1-q3 29.4-39.5) were included from November 2008 to May 2012. During the year following UAE, 9 women actively attempting to conceive experienced 5 live-births (intention-to-treat fertility rate 33.3%, 95%CI 11.8%-61.6%). Markers of ovarian reserve remained stable. The symptoms score was reduced by 66% (95%CI 48%-85%) and the quality of life score was improved by 112% (95%CI 21%-204%). Uterine volume was reduced by 38% (95%CI 24%-52%). Women were followed for 43.1months (95%CI 32.4-53.9), 10 live-births occurred in 8 patients, and 5 patients required secondary surgeries for fibroids. Women without associated infertility factors demonstrated an encouraging capacity to deliver after UAE. Further randomized controlled trials comparing UAE and myomectomy are warranted. • Women without infertility factors showed an encouraging delivery rate after UAE. • For women choosing UAE over abdominal myomectomy, childbearing may not be impaired. • Data are insufficient to definitively recommend UAE as comparable to myomectomy. • Further randomized trials comparing fertility after UAE or myomectomy are warranted.

Selective Arterial Prostatic Embolization (SAPE) for the Treatment of Lower Urinary Tract Symptoms in the Setting of Benign Prostatic Hyperplasia: A Brief Review

Tel: 212-241-9955 Benign prostatic hyperplasia (BPH) is a common condition related to aging that can lead to a cluster of chronic symptoms collectively known as lower urinary tract symptoms (LUTS), including urinary frequency, urinary urgency, nocturia, hematuria, and decreased urinary stream. It is estimated that BPH affects 75% of men in the United States by age 70, with more than $1 billion US dollars a year spent in direct health care expenditures related to BPH, exclusive of outpatient medications [1]. Treatment options for BPH are outlined out by the American Urologic Association Clinical Guidelines and include watchful waiting, medical therapy, minimally invasive therapies (including transurethral ablations), or surgical therapies including open prostatectomy or transurethral resection of the prostate (TURP) [2]. Medical therapy is often considered the first-line option for symptomatic patients; however, a large subset of patients does not respond to or cannot tolerate pharmacotherapy, in part owing to a number of side effects including sexual dysfunction [3]. TURP has remained the ‘gold standard’ surgical treatment for BPH for over half a century, owing to its high success rate in reducing LUTS. Over the past two decades, the TURP procedure has undergone significant technical improvements, with morbidity rates reported to be <1% [4]. However, with a general shift towards minimally invasive treatment options, the number of TURPs performed has fallen in more recent years [5]. Manuscript Click here to download Manuscript SAPE final (1).docx Embolization of the prostatic arteries has been used for many years as a technique to control severe bladder and prostate hemorrhage as well as hematuria following TURP [6-9]. A case report by DeMeritt et al in 2000 described a patient with BPH and refractory hematuria treated by prostatic artery embolization, who subsequently had alleviation in his LUTS and reduction in the volume of his prostate [10]. This case report introduced the idea that BPH could intentionally be treated by selective arterial prostatic embolization (SAPE). In 2008, Carnevale et al used SAPE as the primary treatment in two patients with BPH [11]. After 6-month follow-up, MRI demonstrated a relative prostate reduction of 47.8% in the patient who had undergone bilateral SAPE and 27.8% in the patient who had undergone unilateral SAPE. Since this initial study, there has been an enthusiastic response in the literature regarding the future role of this technique, and the Society of Interventional Radiology has encouraged further research into this intervention [12]. A growing body of literature suggests that SAPE enables reduction in prostate volume with improvements in uroflometry parameters, quality of life, and sexual function [13]. The largest prospective non-randomized series published to date looked at 255 patients who underwent SAPE [14]. The authors describe technical success in 250 of the patients (98%), with a clinical success rate of 82% at one month decreasing to 72% at 3 years. In the only RCT to date assessing SAPE, 57 patients were assigned to prostatic artery embolization and 57 were assigned to TURP for the treatment of BPH [15]. The authors demonstrated that all parameters: including improvement of the International Prostate Symptom Score (IPSS), quality of life (QOL), peak urinary flow, and post void residual(PVR) urine volume were improved by both treatment modalities and there was no difference at two years between the treatment arms. The paper does state there was a higher complication rate for PAE, if one controls for acute urinary retention post operatively, there would be similar complication rates for both groups. The technique for SAPE involves unilateral access of the femoral artery and subsequent catheterization of the anterior division of the internal iliac artery. Digital subtraction angiography is used to confirm arterial anatomy and allow for superselective catheterization of the prostatic artery. A number of different embolic materials have been used, including polyvinyl alcohol particles, trisacryl gelatin microspheres, and Embozene Selective Arterial Prostatic Embolization (SAPE) for the Treatment of Lower Urinary Tract Symptoms in the Setting of Benign Prostatic Hyperplasia: A Brief Review

Transarterial embolization of hypervascular tumors using trisacryl gelatin microspheres (Embosphere): a prospective multicenter clinical trial in Japan.

To evaluate the feasibility and safety of transarterial embolization (TAE) using trisacryl gelatin microspheres (TGMs) for hypervascular tumors. This was a prospective multicenter clinical trial involving five institutions. TAE using TGMs was performed for hypervascular tumors in various locations. The primary endpoint was the technical success. The secondary endpoints included catheter accessibility, preservation of the feeding arteries, local tumor response based on the Response Evaluation Criteria in Cancer of the Liver (RECICL) and adverse events related to TAE based on the Common Terminology Criteria for Adverse Events, version 4.0. Twenty-three patients with liver tumors (n=9), uterine fibroids (n=3) and other tumors (n=11) were enrolled. The technical success rate was 95.7% (22 of 23 patients). Catheter accessibility and preservation of the feeding arteries were obtained in all 55 target vessels (100%). Local tumor response rates were 46.7 and 55.8% at 4 and 12weeks, respectively. Eighteen (78.3%) patients developed 53 symptomatic events including grade ≧3 events: hypertension 21.7%, pain 8.7%, vomiting 4.3% and anorexia 4.3%, all related to postembolization syndromes. TAE using TGMs was technically feasible and safe for devascularization of hypervascular tumors.

The evaluation of uterine artery embolization as a nonsurgical treatment option for adenomyosis.

To evaluate the safety and efficacy of uterine artery embolization (UAE) for the treatment of adenomyosis. A prospective study was performed at Yuhuangding Hospital, China, between January 2012 and December 2013, enrolling premenopausal patients diagnosed with adenomyosis. All patients were treated with bilateral UAE using 500-700-μm tris-acryl gelatin microspheres. At baseline, and 3, 6, and 12months after UAE, magnetic resonance imaging was used to assess uterine volume and patient-assessed improvements in dysmenorrhea were recorded. Any complications and adverse events were reported. In total, 117 patients with adenomyosis were enrolled. The bilateral UAE procedure was successful in 115 (98.3%) patients, who were able to return to normal activity within 1week of treatment. At 12-month follow-up, a median 51.0% reduction in uterine volume from baseline was recorded (P=0.005). Marked and moderate improvements in dysmenorrhea symptoms were reported by 64 (55.7%) and 31 (27.0%) participants, respectively. Pelvic pain of varying intensity was reported by 112 (97.4%) patients but was managed with analgesia. Persistent amenorrhea was experienced by 2 (1.7%) individuals following treatment. Patients did not encounter any new gynecologic or general complications following UAE treatment. UAE could be considered as a minimally invasive treatment option for patients with adenomyosis. Further research to compare the efficacy and safety of UAE with conventional hysterectomy is warranted.

Trisacryl Gelatin Microembolism and Metastases in the Lung after Renal Artery Embolization and Nephrectomy for Renal Cell Carcinoma.

This is the first report, to our knowledge, of widespread, histologically confirmed trisacryl gelatin pulmonary microembolism after renal artery embolization (RAE). In addition, this is the first report of lung involvement by both metastatic renal cell carcinoma (RCC) and an embolic agent used for RAE. The patient was a 63-year-old woman who recently presented with both dyspnea on exertion and productive cough. Her past medical history included clear cell RCC, which was treated with preoperative trisacryl gelatin microsphere RAE and right nephrectomy 9 years earlier. Computed tomography of the chest showed multiple lung nodules, a mass-like density in the left lower lobe, and mediastinal and hilar lymphadenopathy. Wedge resections of the lung showed multiple foci of metastatic RCC and extensive involvement of the muscular pulmonary arteries by trisacryl gelatin microspheres.

A Novel Resorbable Embolization Microsphere for Transient Uterine Artery Occlusion: A Comparative Study with Trisacryl-Gelatin Microspheres in the Sheep Model

PurposeTo evaluate angiographic recanalization, inflammatory reaction, and uterine damage after sheep uterine artery embolization (UAE) with a novel calibrated resorbable embolization microsphere (REM) and compare the results with control nonresorbable microspheres. Materials and MethodsSix hormonally artificially cycled sheep underwent bilateral UAE until stasis with either REM or trisacryl-gelatin microspheres (TGMS). At 7 days, control angiograms were obtained to assess the residual vascularization at arterial and parenchymal phases. The animals were then sacrificed for analysis of the presence of microspheres, inflammatory foreign body reaction, and surface areas of uterine damage. ResultsMean volume of microspheres injected per uterine artery (UA) or per animal did not differ between groups. At day 7, the flow was normal for six of six UAs that received embolization with REM versus only three of six UAs with TGMS (P = .0455, χ2 test). Uterine parenchymography showed no defects in six UAs in the REM group versus five defects in six UAs in the TGMS group (P = .0060, χ2 test). No REM or residual fragments of microspheres were observed on histologic analysis. TGMS were observed in tissues and accompanied by a mild inflammatory response. Necrosis rates were not significantly different between the two products, either in endometrium (REM 23.5% ± 28.8% [median 8.1%] vs TGMS 21.8% ± 23.7% [median 14.6%]) or in myometrium (REM 8.2% ± 22.7% [median 0.0%] vs TGMS 8.8% ± 20.8% [median 0.9%]). Endometrium alteration rate was lower with REM than with TGMS (39.7% ± 25.7% [median 34%] vs 60.6% ± 27.1% [median 71%]; P = .0060, Mann-Whitney test). Myometrium alteration rates were not significantly different between REM (45.7% ± 37.1% [median 63.0%]) and TGMS (37.8% ± 34.0% [median 19.1%]). ConclusionsAt 1 week after sheep UAE with REM, the recanalization was complete, the microspheres were completely degraded, and there was no remnant inflammatory response.

Comparison of Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Fibroid Embolization: Results of a Single-Center Randomized Study

PurposeTo assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas. Materials and MethodsA randomized, prospective, single-center study enrolled 60 women with symptomatic uterine leiomyomas. Uterine artery embolization (UAE) with spherical polyvinyl alcohol (SPVA) microspheres (n = 30; 700–900 μm and 900–1,200 μm; near-stasis or stasis endpoint) and tris-acryl gelatin (TAG) microspheres (n = 30; 500–700 μm; “pruned-tree” endpoint) was performed. Infarction rates were calculated for the dominant tumor and for small (< 2 cm) and large (> 2 cm) nondominant tumors. The primary endpoint was tumor infarction at 24 hours measured by contrast-enhanced magnetic resonance imaging assessed by a blinded reviewer. ResultsBaseline characteristics were similar between groups. The primary endpoint was similar in both treatments (≥ 91% dominant tumor infarction; SPVA. 86.2%; TAG, 93.3%, P = .35). Complete infarction (100%) was also similar between arms at 24 hours and 3 months. Symptom severity was reduced and quality of life improved equally at 3 and 12 months in each treatment group. Complications were minor in both groups. ConclusionsUterine leiomyoma infarction at 24 hours and 3 months after treatment with SPVA or TAG microspheres was comparable when using near-stasis as a procedural endpoint with SPVA microspheres. Symptom relief was maintained for as long as 12 months for both embolic agents.

Comparison of Embolic Agents Used in Uterine Artery Embolisation: A Systematic Review and Meta-Analysis

This study was designed to undertake systematic review and meta-analysis of published comparative trials comparing embolic agents used in uterine artery embolisation (UAE) for uterine leiomyomata. Systematic literature searches were performed in MEDLINE, Embase, PubMed, and Cochrane Central databases from database inception to July 2012. Randomised and nonrandomised trials comparing two or more embolic agents used in UAE were included. Assessment included five widely used embolic agents: nonspherical polyvinyl alcohol (PVA) (Contour PVA, Boston Scientific or PVA Cook Medical); spherical PVA (Contour SE, Boston Scientific); acrylamido PVA (Beadblock, Biocompatibles, Terumo); tris-acryl gelatin microspheres (TAGM) (Embospheres, Merit Medical Inc); and polyzene-F hydrogel microspheres (Embozenes, CeloNova Biosciences). Outcomes assessed included: quality of life (QOL), assessment, magnetic resonance imaging (MRI), uterine and fibroid volumes and degrees of MRI fibroid enhancement and devascularisation. A total of 262 citations were reviewed with 5 randomised, controlled trials involving 295 women and 5 non-RCTs involving 617 women included. No evidence of superiority of any embolic agent was demonstrated. Meta-analysis was performed between TAGM (Embospheres) and spherical PVA microspheres. Two RCTs found a trend toward greater uterine and dominant fibroid volume reductions with Embospheres but the combined differences were not statistically significant (p = 0.78 and p = 0.94 respectively). Embospheres demonstrated greater percentage fibroid devascularisation than spherical PVA (p = 0.039). This study confirms that the current evidence demonstrates superiority of Embospheres over spherical PVA but no reported differences in outcomes between any of the other agents. Comparison of embolic agents was limited by lack of RCT data and further research is warranted.